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| CIK | 1333763 |
SEC Filings
All companies that sell securities in the United States must register with the Securities and Exchange Commission (SEC) and file reports on a regular basis.
These reports include company annual reports (10K, 10Q), news updates (8K), investor presentations (found in 8Ks), insider trades (form 4), ownership reports (13D, and 13G), and reports related to the specific securities sold, such as registration statements and prospectus. This page shows recent SEC filings related to Chelsea Therapeutics International, Ltd.
SEC Filings (Chronological Order)
Halaman ini menyediakan daftar lengkap dan kronologis dari Pengajuan SEC, tidak termasuk pengajuan kepemilikan yang kami sediakan di tempat lain.
| July 3, 2014 |
CHTP / Chelsea Therapeutics International, Ltd. 15-12G - - 15-12G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 15 CERTIFICATION AND NOTICE OF TERMINATION OF REGISTRATION UNDER SECTION 12(g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR SUSPENSION OF DUTY TO FILE REPORTS UNDER SECTIONS 13 AND 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. Commission File Number 000-51462 Chelsea Therapeutics International, Ltd. (Exact name of registrant |
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| June 25, 2014 |
As filed with the Securities and Exchange Commission on June 25, 2014 Registration No. |
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| June 25, 2014 |
As filed with the Securities and Exchange Commission on June 25, 2014 Registration No. |
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| June 25, 2014 |
As filed with the Securities and Exchange Commission on June 25, 2014 Registration No. |
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| June 25, 2014 |
As filed with the Securities and Exchange Commission on June 25, 2014 Registration No. |
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| June 25, 2014 |
As filed with the Securities and Exchange Commission on June 25, 2014 Registration No. |
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| June 25, 2014 |
As filed with the Securities and Exchange Commission on June 25, 2014 Registration No. |
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| June 25, 2014 |
As filed with the Securities and Exchange Commission on June 25, 2014 Registration No. |
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| June 25, 2014 |
As filed with the Securities and Exchange Commission on June 25, 2014 Registration No. |
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| June 25, 2014 |
As filed with the Securities and Exchange Commission on June 25, 2014 Registration No. |
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| June 25, 2014 |
As filed with the Securities and Exchange Commission on June 25, 2014 Registration No. |
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| June 25, 2014 |
As filed with the Securities and Exchange Commission on June 25, 2014 Registration No. |
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| June 25, 2014 |
As filed with the Securities and Exchange Commission on June 25, 2014 Registration No. |
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| June 25, 2014 |
As filed with the Securities and Exchange Commission on June 25, 2014 Registration No. |
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| June 24, 2014 |
AMENDED AND RESTATED BYLAWS OF CHELSEA THERAPEUTICS INTERNATIONAL, LTD. ARTICLE I STOCKHOLDERS AMENDED AND RESTATED BYLAWS OF CHELSEA THERAPEUTICS INTERNATIONAL, LTD. ARTICLE I STOCKHOLDERS 1.1. Place of Meetings. All meetings of stockholders shall be held at such place within or without the State of Delaware as may be designated from time to time by the Board of Directors, the Chairman of the Board (if any), the President or the Secretary. 1.2. Annual Meeting. The annual meeting of stockho |
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| June 24, 2014 |
AMENDED AND RESTATED CERTIFICATE OF INCORPORATION CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF CHELSEA THERAPEUTICS INTERNATIONAL, LTD. |
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| June 24, 2014 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 23, 2014 Chelsea TherapEUtics International, Ltd. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of incorporati |
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| June 23, 2014 |
SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14D-9 (Rule 14d-101) (Amendment No. 3) Solicitation/Recommendation Statement Under Section 14(d)(4) of the Securities Exchange Act of 1934 Chelsea Therapeutics International, Ltd. (Name of Subject Company) Chelsea Therapeutics International, Ltd. (Names of Persons Filing Statement) Common Stock, par value $0.0001 per share (Title o |
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| June 23, 2014 |
Exhibit (a)(5)(F) H. Lundbeck A/S Ottiliavej 9 DK-2500 Valby, Copenhagen CVR number: 56759913 Tel +45 36 30 13 11 Fax +45 36 43 82 62 E-mail [email protected] www.lundbeck.com Corporate Release Lundbeck successfully completes tender offer for Chelsea Therapeutics · Merger expected to close today, 62.5% of outstanding shares tendered and Notices of Guaranteed Delivery delivered for 16.1% of out |
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| June 23, 2014 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 (Amendment No. 4) CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Name of Subject Company (Issuer)) CHARLIE ACQUISITION CORP. (Offeror) A Wholly-Owned Indirect Subsidiary of H. LUNDBECK A/S (Offeror) (Names of Filing Persons |
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| June 19, 2014 |
SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14D-9 (Rule 14d-101) (Amendment No. 2) Solicitation/Recommendation Statement Under Section 14(d)(4) of the Securities Exchange Act of 1934 Chelsea Therapeutics International, Ltd. (Name of Subject Company) Chelsea Therapeutics International, Ltd. (Names of Persons Filing Statement) Common Stock, par value $0.0001 per share (Title o |
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| June 19, 2014 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 (Amendment No. 3) CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Name of Subject Company (Issuer)) CHARLIE ACQUISITION CORP. (Offeror) A Wholly-Owned Indirect Subsidiary of H. LUNDBECK A/S (Offeror) (Names of Filing Persons |
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| June 11, 2014 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 (Amendment No. 2) CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Name of Subject Company (Issuer)) CHARLIE ACQUISITION CORP. (Offeror) A Wholly-Owned Indirect Subsidiary of H. LUNDBECK A/S (Offeror) (Names of Filing Persons |
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| June 6, 2014 |
Chelsea Therapeutics Announces the Expiration of the Hart-Scott-Rodino Waiting Period in Relation to the Proposed Acquisition of Chelsea Therapeutics by Lundbeck CHARLOTTE, N. |
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| June 6, 2014 |
SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14D-9 (Rule 14d-101) (Amendment No. 1) Solicitation/Recommendation Statement Under Section 14(d)(4) of the Securities Exchange Act of 1934 Chelsea Therapeutics International, Ltd. (Name of Subject Company) Chelsea Therapeutics International, Ltd. (Names of Persons Filing Statement) Common Stock, par value $0.0001 per share (Title o |
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| June 6, 2014 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 (Amendment No. 1) CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Name of Subject Company (Issuer)) CHARLIE ACQUISITION CORP. (Offeror) A Wholly-Owned Indirect Subsidiary of H. LUNDBECK A/S (Offeror) (Names of Filing Persons |
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| May 28, 2014 |
CHTP / Chelsea Therapeutics International, Ltd. / RTW INVESTMENTS, LLC Passive Investment SC 13G 1 d147881313-g.htm UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* Chelsea Therapeutics International Ltd. (Name of Issuer) Common Stock, $0.01 Par Value (Title of Class of Securities) 163428105 (CUSIP Number) May 19, 2014 (Date of Event Which Requires Filing of this Statement) Check the appropria |
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| May 23, 2014 |
Exhibit (a)(5)(E) H. Lundbeck A/S Ottiliavej 9 DK-2500 Valby, Copenhagen CVR number: 56759913 Tel +45 36 30 13 11 Fax+45 36 43 82 62 E-mail investor@ www.lundbeck.com lundbeck.com Corporate Release Lundbeck commences tender offer for all outstanding shares of Chelsea Therapeutics · Tender offer consistent with terms announced on 8 May 2014 Valby, Denmark, 23 May 2014 - H. Lundbeck A/S (Lundbeck) t |
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| May 23, 2014 |
Exhibit (a)(1)(A) Offer To Purchase For Cash All Outstanding Shares of Common Stock of CHELSEA THERAPEUTICS INTERNATIONAL, LTD. |
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| May 23, 2014 |
Exhibit (d)(3) CHELSEA THERAPEUTICS INTERNATIONAL, LTD. 3530 Toringdon Way Suite 200 Charlotte, North Carolina 28277 April 12, 2013 STRICTLY PRIVATE AND CONFIDENTIAL H. Lundbeck A/S Ottiliavej 9 2500 Valby — Denmark Ladies and Gentlemen: In connection with your interest concerning a possible business transaction (a “Possible Transaction”) between you and Chelsea Therapeutics International, Ltd. (t |
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| May 23, 2014 |
EX-99.A1D 5 v379539ex-a1d.htm EXHIBIT (A)(1)(D) Exhibit (a)(1)(D) Offer To Purchase For Cash All Outstanding Shares of Common Stock of CHELSEA THERAPEUTICS INTERNATIONAL, LTD. at $6.44 net per share, plus one non-transferable contingent value right for each share, which represents the contractual right to receive a cash payment of up to $1.50 per share upon the achievement of certain sales milesto |
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| May 23, 2014 |
EX-99.A1F 7 v379539ex-a1f.htm EXHIBIT (A)(1)(F) Exhibit (a)(1)(F) This announcement is neither an offer to purchase nor a solicitation of an offer to sell Shares (as defined below). The Offer (as defined below) is made only by the Offer to Purchase, dated May 23, 2014, and the related Letter of Transmittal and any amendments or supplements thereto, and is being made to all holders of Shares. The O |
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| May 23, 2014 |
Exhibit (a)(1)(E) Offer To Purchase For Cash All Outstanding Shares of Common Stock of CHELSEA THERAPEUTICS INTERNATIONAL, LTD. |
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| May 23, 2014 |
EX-99.A1C 4 v379539ex-a1c.htm EXHIBIT (A)(1)(C) Exhibit (a)(1)(C) NOTICE OF GUARANTEED DELIVERY For Tender of Shares of Common Stock of CHELSEA THERAPEUTICS INTERNATIONAL, LTD. at $6.44 net per share, plus one non-transferable contingent value right for each share, which represents the contractual right to receive a cash payment of up to $1.50 per share upon the achievement of certain sales milest |
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| May 23, 2014 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Name of Subject Company (Issuer)) CHARLIE ACQUISITION CORP. (Offeror) A Wholly-Owned Indirect Subsidiary of H. LUNDBECK A/S (Offeror) (Names of Filing Persons (identifying statu |
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| May 23, 2014 |
SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14D-9 (Rule 14d-101) Solicitation/Recommendation Statement Under Section 14(d)(4) of the Securities Exchange Act of 1934 Chelsea Therapeutics International, Ltd. (Name of Subject Company) Chelsea Therapeutics International, Ltd. (Names of Persons Filing Statement) Common Stock, par value $0.0001 per share (Title of Class of Securit |
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| May 23, 2014 |
Exhibit (a)(1)(B) LETTER OF TRANSMITTAL To Tender Shares of Common Stock of CHELSEA THERAPEUTICS INTERNATIONAL, LTD. |
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| May 12, 2014 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 9, 2014 Chelsea TherapEUtics International, Ltd. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of incorporation |
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| May 12, 2014 |
SC14D9C 1 v378222sc14d9c.htm FORM SC14D9C UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14D-9 (Rule 14d-101) Solicitation/Recommendation Statement Under Section 14(d)(4) of the Securities Exchange Act of 1934 Chelsea Therapeutics International, Ltd. (Name of Subject Company) Chelsea Therapeutics International, Ltd. (Names of Persons Filing Statement) Common Stock |
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| May 9, 2014 |
10-Q 1 v37644810q.htm FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2014 or ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission file numb |
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| May 8, 2014 |
Exhibit 99.2 Lundbeck to acquire Chelsea Therapeutics Valby, Denmark and Charlotte, North Carolina, USA, May 8, 2014 - H. Lundbeck A/S (Lundbeck) and Chelsea Therapeutics International, Ltd. (Chelsea) (NASDAQ: CHTP) today announced that the companies have entered into a definitive agreement under which Lundbeck will commence a tender offer to acquire Chelsea. To view a press release about this ann |
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| May 8, 2014 |
FORM OF CONTINGENT VALUE RIGHTS AGREEMENT Exhibit 2.2 FORM OF CONTINGENT VALUE RIGHTS AGREEMENT THIS CONTINGENT VALUE RIGHTS AGREEMENT, dated as of [●], 2014 (this “Agreement”), is entered into by and between H. Lundbeck A/S, a Danish corporation (“Parent”), and [●], a [Jurisdiction] [Type of Entity], as Rights Agent. RECITALS WHEREAS, Parent, Charlie Acquisition Corp., a Delaware corporation (“Acquisition Sub”), and Chelsea Therapeutics |
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| May 8, 2014 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14D-9 (Rule 14d-101) Solicitation/Recommendation Statement Under Section 14(d)(4) of the Securities Exchange Act of 1934 Chelsea Therapeutics International, Ltd. (Name of Subject Company) Chelsea Therapeutics International, Ltd. (Names of Persons Filing Statement) Common Stock, par value $0.0001 per share (Title of Cl |
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| May 8, 2014 |
SC TO-C 1 sc-toc.htm SCHEDULE TO UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Name of Subject Company (Issuer)) CHARLIE ACQUISITION CORP. (Offeror) a wholly owned indirect subsidiary of H. LUNDBECK A/S (Offeror) (Names of |
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| May 8, 2014 |
EX-99.4 5 ex99-4.htm TRANSCRIPT OF H. LUNDBECK A/S Exhibit 99.4 Important Information The tender offer described in this material has not yet commenced. This material is for informational purposes only, and it is neither an offer to purchase nor a solicitation of an offer to sell shares of Chelsea Therapeutics International, Ltd.’s common stock. At the time any such tender offer is commenced, H. L |
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| May 8, 2014 |
8-K 1 v3778578k.htm FORM 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 7, 2014 Chelsea TherapEUtics International, Ltd. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other |
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| May 8, 2014 |
Exhibit 2.1 AGREEMENT AND PLAN OF MERGER by and among H. LUNDBECK A/S, CHARLIE ACQUISITION CORP., and CHELSEA THERAPEUTICS INTERNATIONAL, LTD. Dated as of May 7, 2014 Table of Contents Page ARTICLE I DEFINITIONS & INTERPRETATIONS 2 1.1 Certain Definitions 2 1.2 Certain Interpretations 10 1.3 Index of Defined Terms 11 ARTICLE II THE OFFER 12 2.1 The Offer 12 2.2 Company Actions 15 2.3 Notices of Gu |
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| May 8, 2014 |
08 May 2014 Corporate Release No 531 page 1 of 8 Exhibit 99.1 H. Lundbeck A/S Ottiliavej 9 Tel +45 36 30 13 11 E-mail [email protected] DK-2500 Valby, Copenhagen Fax +45 36 43 82 62 www.lundbeck.com CVR number: 56759913 Corporate Release Lundbeck to acquire Chelsea Therapeutics ● By acquiring Chelsea Therapeutics, Lundbeck gains the rights to Chelsea Therapeutics’ recently FDA-approved product, NORTHERATM (droxidopa), which is expected to be |
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| May 8, 2014 |
Exhibit 99.3 The tender offer described in this material has not yet commenced. This material is for informational purposes only, and it is neither an offer to purchase nor a solicitation of an offer to sell shares of Chelsea Therapeutics International, Ltd.’s common stock. At the time any such tender offer is commenced, H. Lundbeck A/S will cause a new indirect wholly-owned subsidiary, Charlie Ac |
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| May 8, 2014 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14D-9 (Rule 14d-101) Solicitation/Recommendation Statement Under Section 14(d)(4) of the Securities Exchange Act of 1934 Chelsea Therapeutics International, Ltd. (Name of Subject Company) Chelsea Therapeutics International, Ltd. (Names of Persons Filing Statement) Common Stock, par value $0.0001 per share (Title of Cl |
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| May 8, 2014 |
Exhibit 99.1 H. Lundbeck A/S Ottiliavej 9 Tel +45 36 30 13 11 E-mail [email protected] DK-2500 Valby, Copenhagen Fax +45 36 43 82 62 www.lundbeck.com CVR number: 56759913 Corporate Release Lundbeck to acquire Chelsea Therapeutics · By acquiring Chelsea Therapeutics, Lundbeck gains the rights to Chelsea Therapeutics’ recently FDA-approved product, NORTHERATM (droxidopa), which is expected to be |
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| April 30, 2014 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K/A Amendment No. 1 x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2013, OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission file number 000-51462 CHELSEA |
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| March 11, 2014 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2013, OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission file number 000-51462 CHELSEA THERAPEUTICS INTER |
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| March 11, 2014 |
AMENDED AND RESTATED BYLAWS CHELSEA THERAPEUTICS INTERNATIONAL, LTD. I. CORPORATE OFFICES EX-3.3 2 v369831ex3-3.htm EXHIBIT 3.3 AMENDED AND RESTATED BYLAWS OF CHELSEA THERAPEUTICS INTERNATIONAL, LTD. I. CORPORATE OFFICES 1.1 Registered Office The registered office of the Corporation shall be in the City of Dover, County of Kent, State of Delaware. The name of the registered agent of the Corporation at such location is Incorporating Services, Ltd. 1.2 Other Offices The Board of Director |
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| February 19, 2014 |
EX-99.1 2 v369088ex99-1.htm EXHIBIT 99.1 Chelsea Therapeutics Announces FDA Accelerated Approval of NORTHERATM (Droxidopa) for the Treatment of Symptomatic NOH First New Treatment Option for Symptomatic NOH in Nearly Two Decades First and Only FDA Approved Therapy to Demonstrate Symptomatic Benefit in Patients with NOH CHARLOTTE, N.C., February 18, 2014 - Chelsea Therapeutics International, Ltd. ( |
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| February 19, 2014 |
Financial Statements and Exhibits, Other Events - FORM 8K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 18, 2014 Chelsea TherapEUtics International, Ltd. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of incorpo |
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| February 14, 2014 |
EX-99.1 2 v368565ex99-1.htm EXHIBIT 99.1 EXHIBIT 99.1 AGREEMENT In accordance with Rule 13d-1(k)(1) under the Securities Exchange Act of 1934, as amended, the undersigned hereby agree that this Statement on Schedule 13G relating to the Common Stock of Chelsea Therapeutics International, Ltd. is being filed with the Securities and Exchange Commission on behalf of each of them. February 14, 2014 BAK |
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| February 14, 2014 |
SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G/A UNDER THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. 5)* CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Name of Issuer) COMMON STOCK (Title of Class of Securities) 163428105 (CUSIP Number) December 31, 2013 (Date of Event Which Requires Filing of This Statement) Check the appropriate box to designate the |
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| February 14, 2014 |
SCHEDULE 13G SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Under the Securities Exchange Act of 1934 (Amendment No. |
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| February 14, 2014 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 14, 2014 Chelsea TherapEUtics International, Ltd. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of incorpo |
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| February 3, 2014 |
SC 13G/A SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G UNDER THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. 5)* CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Name of Issuer) COMMON STOCK (Title of Class of Securities) 163428105 (CUSIP Number) December 31, 2013 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the Rule pursuant t |
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| January 30, 2014 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 27, 2014 Chelsea TherapEUtics International, Ltd. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of incorpor |
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| January 30, 2014 |
Chelsea Therapeutics Names Keith W. Schmidt Chief Commercial Officer Exhibit 99.1 Chelsea Therapeutics Names Keith W. Schmidt Chief Commercial Officer CHARLOTTE, N.C., January 30, 2014 - Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP) today announced that Keith W. Schmidt has been named Chief Commercial Officer, effective January 28, 2014. Mr. Schmidt has served as a consultant to the Company since 2012. Prior to this role, he was Vice President, Marketing |
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| January 27, 2014 |
EX-99.1 2 v366301ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Chelsea Therapeutics Announces Joseph G. Oliveto Named President and Chief Executive Officer, Director CHARLOTTE, N.C., January 27, 2014 - Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP) today announced that Joseph G. Oliveto has been named President and Chief Executive Officer and a member of the Company’s Board of Directors, effective |
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| January 27, 2014 |
8-K 1 v3663018k.htm 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 22, 2014 Chelsea TherapEUtics International, Ltd. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other |
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| November 21, 2013 |
SCHEDULE 13D CUSIP No. 15100K201 Page 1 of 5 Pages UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 14) CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Name of Issuer) Common Stock, $.0001 par value (Title of Class of Securities) 15100K201 (CUSIP Number) David J. Harris, Esq., 1775 Eye Street, N.W. Washington, D |
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| November 15, 2013 |
Financial Statements and Exhibits, Other Events - FORM 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 12, 2013 Chelsea TherapEUtics International, Ltd. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of incorpo |
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| November 15, 2013 |
CHELSEA THERAPEUTICS ANNOUNCES PRICING OF PUBLIC OFFERING OF COMMON STOCK Exhibit 99.2 CHELSEA THERAPEUTICS ANNOUNCES PRICING OF PUBLIC OFFERING OF COMMON STOCK Charlotte, N.C. – November 13, 2013 – Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP), a development stage pharmaceutical company focused on the acquisition, development and commercialization of innovative pharmaceutical products, announced today that it has priced an underwritten public offering of 6,66 |
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| November 15, 2013 |
CHELSEA THERAPEUTICS ANNOUNCES PUBLIC OFFERING OF COMMON STOCK Exhibit 99.1 CHELSEA THERAPEUTICS ANNOUNCES PUBLIC OFFERING OF COMMON STOCK Charlotte, N.C. – November 12, 2013 – Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP), a development stage pharmaceutical company focused on the acquisition, development and commercialization of innovative pharmaceutical products, announced today that it plans to offer shares of its common stock in an underwritten |
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| November 15, 2013 |
Exhibit 1.1 EXECUTION COPY 6,666,667 Shares Chelsea Therapeutics International, Ltd. Common Stock ($0.0001 Par Value) UNDERWRITING AGREEMENT November 13, 2013 JMP Securities LLC As Representative of the several Underwriters 600 Montgomery Street, Suite 1100 San Francisco, CA 94111 Ladies and Gentlemen: Chelsea Therapeutics International, Ltd., a Delaware corporation (the “Company”), proposes to se |
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| November 14, 2013 |
Filed Pursuant to Rule 424(b)(5) Registration Statement No. 333-179183 PROSPECTUS SUPPLEMENT (to Prospectus dated February 9, 2012) 6,666,667 Shares Common Stock We are offering 6,666,667 shares of common stock, par value $0.0001 per share. Our common stock is listed on the Nasdaq Capital Market under the symbol “CHTP.” The last reported sale price of our common stock on the Nasdaq Capital Market |
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| November 13, 2013 |
Subject to Completion, Dated November 12, 2013 Filed Pursuant to Rule 424(b)(5) Registration Statement No. 333-179183 The information in this preliminary prospectus supplement is not complete and may be changed. Neither this preliminary prospectus supplement nor the accompanying prospectus is an offer to sell the securities described herein and neither is soliciting any offer to buy these securities in any jurisdiction where the solicitation, |
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| November 5, 2013 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2013 or ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission file number: 000-51462 CHELSEA THERAP |
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| November 5, 2013 |
Termination of a Material Definitive Agreement - 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 1, 2013 Chelsea TherapEUtics International, Ltd. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of incorpor |
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| October 10, 2013 |
Financial Statements and Exhibits, Other Events - 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 9, 2013 Chelsea TherapEUtics International, Ltd. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of incorpora |
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| October 10, 2013 |
Exhibit 99.1 October 9, 2013 Chelsea Therapeutics Announces FDA Advisory Committee to Review NORTHERA™ (droxidopa) Panel Date Tentatively Set for January 14, 2014 CHARLOTTE, N.C., October 9, 2013 - Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that the New Drug Application (NDA) seeking approval to m |
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| October 10, 2013 |
8-K 1 v3571648k.htm 8-K CURRENT REPORT UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 9, 2013 Chelsea TherapEUtics International, Ltd. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (S |
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| August 7, 2013 |
[Chelsea Therapeutics International, Ltd. Letterhead] August 7, 2013 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-3628 Attn: Jeffrey P. Riedler Christina De Rosa Re: Chelsea Therapeutics International, Ltd. Annual Report on Form 10-K: Fiscal Year Ended December 31, 2012 Filed on March 7, 2013 File No. 000-51462 |
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| July 29, 2013 |
Financial Statements and Exhibits, Other Events 8-K 1 v3511008k.htm FORM 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 29, 2013 Chelsea TherapEUtics International, Ltd. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or othe |
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| July 29, 2013 |
Chelsea Therapeutics Announces Update to NORTHERA™ (Droxidopa) NDA Filing July 29, 2013 Chelsea Therapeutics Announces Update to NORTHERA™ (Droxidopa) NDA Filing CHARLOTTE, N. |
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| July 9, 2013 |
Financial Statements and Exhibits, Other Events - FORM 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 9, 2013 Chelsea TherapEUtics International, Ltd. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of incorporatio |
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| July 9, 2013 |
Chelsea Therapeutics Corporate Overview July 2013 © 2004 - 2013 Chelsea Therapeutics, Inc. Chelsea Therapeutics Corporate Overview July 2013 © 2004 - 2013 Chelsea Therapeutics, Inc. |
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| July 9, 2013 |
July 9, 2013 Chelsea Therapeutics Resubmits New Drug Application for NORTHERA™ (droxidopa) for the Treatment of Symptomatic NOH • Submission Includes Successful 300 mg Bioequivalence Study • Six Month Review Decision Expected Under PDUFA CHARLOTTE, N. |
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| June 17, 2013 |
SCHEDULE 13D CUSIP NO. 15100K201 PAGE 1 OF 5 PAGES UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 13) CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Name of Issuer) Common Stock, $.0001 par value (Title of Class of Securities) 15100K201 (CUSIP Number) David J. Harris, Esq., 1900 K Street, N.W. Washington, D.C |
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| June 11, 2013 |
CERTIFICATE OF AMENDMENT TO CERTIFICATE OF INCORPORATION OF CHELSEA THERAPEUTICS INTERNATIONAL, LTD. Exhibit 3.1 CERTIFICATE OF AMENDMENT TO CERTIFICATE OF INCORPORATION OF CHELSEA THERAPEUTICS INTERNATIONAL, LTD. The undersigned, for purposes of amending the Certificate of Incorporation, as amended (the “Certificate”) of Chelsea Therapeutics International, Ltd., a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware, does hereby certify a |
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| June 11, 2013 |
Financial Statements and Exhibits, Submission of Matters to a Vote of Security Holders - 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 11, 2013 Chelsea TherapEUtics International, Ltd. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of incorporati |
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| April 30, 2013 |
SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant x Filed by a Party other than the Registrant ¨ Check the appropriate box: ¨ Preliminary Proxy Statement ¨ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) x Definitive Proxy Statement ¨ Definitive Additional Materials ¨ Soliciting Material Pursuant to § 240. |
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| April 19, 2013 |
SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant x Filed by a Party other than the Registrant ¨ Check the appropriate box: x Preliminary Proxy Statement ¨ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ¨ Definitive Proxy Statement ¨ Definitive Additional Materials ¨ Soliciting Material Pursuant to § 240. |
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| April 19, 2013 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 16, 2013 Chelsea TherapEUtics International, Ltd. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of incorporat |
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| April 19, 2013 |
CHELSEA THERAPEUTICS INTERNATIONAL LTD. EXECUTIVE RETENTION BONUS PLAN Effective April 16, 2013 CHELSEA THERAPEUTICS INTERNATIONAL LTD. EXECUTIVE RETENTION BONUS PLAN Effective April 16, 2013 1. Purpose. The purpose of this Chelsea Therapeutics International Ltd. Executive Retention Bonus Plan (the “Plan”) is to promote the interests of Chelsea Therapeutics International Ltd. (the “Company”) by providing an incentive to selected key executive level employees of the Company to remain employed |
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| April 19, 2013 |
CHELSEA THERAPEUTICS INTERNATIONAL LTD. EXECUTIVE SEVERANCE PLAN SUMMARY PLAN DESCRIPTION CHELSEA THERAPEUTICS INTERNATIONAL LTD. EXECUTIVE SEVERANCE PLAN and SUMMARY PLAN DESCRIPTION APRIL 16, 2013 INTRODUCTION Chelsea Therapeutics International Ltd. (the “Company”) has established the Chelsea Therapeutics International Ltd. Executive Severance Plan (the “Plan”), effective as of April 16, 2013, for the benefit of its eligible employees. The Plan is designed to give the Company a basis |
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| April 8, 2013 |
SC 13G/A SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G UNDER THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. 4)* CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Name of Issuer) COMMON STOCK (Title of Class of Securities) 163428105 (CUSIP Number) March 31, 2013 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the Rule pursuant to w |
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| March 8, 2013 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 7, 2013 Chelsea TherapEUtics International, Ltd. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of incorporati |
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| March 4, 2013 |
SCHEDULE 13D CUSIP NO. 15100K201 PAGE 1 OF 5 PAGES UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 12) CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Name of Issuer) Common Stock, $.0001 par value (Title of Class of Securities) 15100K201 (CUSIP Number) David J. Harris, Esq., 1900 K Street, N.W. Washington, D.C |
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| February 20, 2013 |
February 20, 2013 Chelsea Therapeutics Receives FDA Guidance for a Northera™ (Droxidopa) NDA Resubmission with Study 306B ● Company to Resubmit NDA in Late Second Quarter 2013 ● Short-term Clinical Benefit Adequate to Support Approval ● Company to Host Conference Call Today at 9:00 AM ET CHARLOTTE, N. |
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| February 20, 2013 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 20, 2013 Chelsea TherapEUtics International, Ltd. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of incorpo |
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| February 20, 2013 |
Financial Statements and Exhibits, Other Events 8-K 1 v3356538k.htm FORM 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 20, 2013 Chelsea TherapEUtics International, Ltd. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or |
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| February 14, 2013 |
SC 13G/A SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G UNDER THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. 3)* CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Name of Issuer) COMMON STOCK (Title of Class of Securities) 163428105 (CUSIP Number) December 31, 2012 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the Rule pursuant t |
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| February 14, 2013 |
EXHIBIT 99.1—JOINT FILING AGREEMENT EX-99.1 Exhibit 99.1 EXHIBIT 99.1—JOINT FILING AGREEMENT The undersigned hereby agree that they are filing this statement jointly pursuant to Rule 13d-1(k)(1). Each of them is responsible for the timely filing of such Schedule 13G and any amendments thereto, and for the completeness and accuracy of the information concerning such person contained therein; but none of them is responsible for the co |
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| February 14, 2013 |
CHTP / Chelsea Therapeutics International, Ltd. / TCW GROUP INC - SC 13G/A Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G UNDER THE SECURITIES EXCHANGE ACT OF 1934 (AMENDMENT NO. 2)* Chelsea Therapeutics International, Ltd. (Name of Issuer) Common Stock (Title of Class of Securities) 163428105 (CUSIP Number) 12/31/2012 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant to |
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| February 14, 2013 |
Amendment No. 4 to Schedule 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G/A UNDER THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. 4)* CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Name of Issuer) COMMON STOCK (Title of Class of Securities) 163428105 (CUSIP Number) December 31, 2012 (Date of Event Which Requires Filing of This Statement) Check the appropria |
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| January 31, 2013 |
Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 28, 2013 Chelsea TherapEUtics International, Ltd. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of incorpor |
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| December 19, 2012 |
SCHEDULE 13D CUSIP NO. 15100K201 PAGE 1 OF 5 PAGES UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 11) CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Name of Issuer) Common Stock, $.0001 par value (Title of Class of Securities) 15100K201 (CUSIP Number) David J. Harris, Esq., 1775 Eye Street, N.W. Washington, D |
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| December 5, 2012 |
Financial Statements and Exhibits, Other Events 8-K 1 v3297478k.htm FORM 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 4, 2012 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or o |
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| December 5, 2012 |
© 2004 - 2012 Chelsea Therapeutics, Inc. Northera ™ ( droxidopa ) Study 306B Preliminary Results 4 December 2012 NASDAQ: CHTP 2 Forward - Looking Statements This presentation is being provided for informational and discussion purposes . This presentation is not intended to provide and should not be relied upon as investment advice or an opinion regarding the appropriateness or suitability of any i |
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| December 5, 2012 |
Chelsea Therapeutics Announces Northera™ (Droxidopa) Study 306B Meets Primary Endpoint Exhibit 99.1 December 4, 2012 Chelsea Therapeutics Announces Northera™ (Droxidopa) Study 306B Meets Primary Endpoint · Northera™ Demonstrated Statistically Significant Improvement Over Placebo in Reduction of Dizziness/Lightheadedness at Week 1 (p=0.018), the Primary Endpoint, and Standing Blood Pressure at Week 1 (p=0.032), a Key Secondary Endpoint · Northera Patients Experienced Fewer Falls and |
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| November 26, 2012 |
Up to $20,000,000 of Shares Common Stock Filed Pursuant to Rule 424(b)(5) Registration Statement No. 333-179183 Prospectus Supplement (to Prospectus dated February 9, 2012) Up to $20,000,000 of Shares Common Stock We have entered into an amendment to our existing sales agreement with Cantor Fitzgerald & Co. relating to shares of our common stock offered by this prospectus supplement and the accompanying prospectus. In accordance with the |
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| November 26, 2012 |
Exhibit 10.20 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. CONTROLLED EQUITY OFFERINGSM Amendment No. 3 to SALES AGREEMENT November 26, 2012 Cantor Fitzgerald & Co. 499 Park Avenue New York, NY 10022 Ladies and Gentlemen: Reference is made to the Sales Agreement, dated July 2, 2010, as amended by Amendment No. 1 dated July 26, 2011 and Amendment No. 2 dated December 28, 2011 (the “Sales Agreement”), b |
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| November 26, 2012 |
Entry into a Material Definitive Agreement, Financial Statements and Exhibits - FORM 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 26, 2012 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of incorpo |
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| October 19, 2012 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 17, 2012 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of incorpor |
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| October 19, 2012 |
Exhibit 10.19 SEVERANCE AGREEMENT THIS SEVERANCE AGREEMENT (the “Agreement”) is effective as of October 16, 2012 (the “Effective Date”), by and between Chelsea Therapeutics International, Ltd., a Delaware corporation with its principal place of business in Charlotte, North Carolina (the “Company”), and Joseph Oliveto (“Executive”). W I T N E S S E T H: WHEREAS, Executive is employed by the Company |
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| October 17, 2012 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 17, 2012 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of incorpor |
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| September 10, 2012 |
Exhibit 99.1 © 2004 - 2011 Chelsea Therapeutics, Inc. Rodman and Renshaw Investor Conference Joseph Oliveto Interim CEO September 10, 2012 Forward - Looking Statements This presentation is being provided for informational and discussion purposes . This presentation is not intended to provide and should not be relied upon as investment advice or an opinion regarding the appropriateness or suitabili |
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| September 10, 2012 |
Financial Statements and Exhibits, Other Events - 8-K CURRENT REPORT UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): September 10, 2012 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of incorp |
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| July 13, 2012 |
Chelsea Therapeutics to Implement Corporate Reorganization Exhibit 99.1 Chelsea Therapeutics to Implement Corporate Reorganization CHARLOTTE, N.C., July 10, 2012 (GLOBE NEWSWIRE) - Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today announced that its Board of Directors plans to promptly implement a corporate reorganization that includes a reduction in force, executive changes and changes to the Company's Board of Directors, and has authorized a |
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| July 13, 2012 |
SEVERANCE AND RELEASE AGREEMENT Exhibit 10.18 SEVERANCE AND RELEASE AGREEMENT This SEVERANCE AND RELEASE AGREEMENT (the “Agreement”) is made and entered into this 9th day of July, 2012 by and between Dr. Simon Pedder, an individual residing in Fort Mill, South Carolina (hereinafter “Executive”) and Chelsea Therapeutics International, Ltd., a Delaware corporation with its principal place of business in Charlotte, North Carolina ( |
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| July 13, 2012 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 9, 2012 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of incorporatio |
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| July 6, 2012 |
JOSIAH T. AUSTIN 4673 Christopher Place Dallas, TX 75204 Exhibit A JOSIAH T. AUSTIN 4673 Christopher Place Dallas, TX 75204 July 6, 2012 Simon Pedder, Ph.D., President and CEO And Members of the Board of Directors Chelsea Therapeutics International, Ltd. 3530 Toringdon Way, Suite 200 Charlotte, NC 28277 Dear Sirs: I am writing to alert you formally of my concern and dissatisfaction with the performance and direction of the Company. Over the past year, I |
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| July 6, 2012 |
SCHEDULE 13D CUSIP No. 15100K201 Page 1 of 5 Pages UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 10) CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Name of Issuer) Common Stock, $.0001 par value (Title of Class of Securities) 15100K201 (CUSIP Number) David J. Harris, Esq., 1775 Eye Street, N.W. Washington, D |
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| July 3, 2012 |
Exhibit 99.1 Press Release Chelsea Therapeutics Provides an Update on Northera™ (droxidopa) Regulatory Status and Development Program Charlotte, NC, July 3, 2012 – Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP) received a written response from the U.S. Food and Drug Administration (FDA) to Chelsea’s modified proposal for utilizing data from ongoing Study 306B to support its application fo |
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| July 3, 2012 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 3, 2012 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of incorporatio |
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| June 22, 2012 |
Financial Statements and Exhibits, Other Events - FORM 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 21, 2012 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of incorporati |
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| June 22, 2012 |
Exhibit 99.1 Press Release Combined Northera(TM) (droxidopa) Data From Two Phase 3 Trials Confirm Symptom Improvement in Patients With Neurogenic OH Seven Additional Droxidopa Posters Presented at Movement Disorder Society's Annual Congress CHARLOTTE, N.C., June 21, 2012 - Chelsea Therapeutics International, Ltd. (CHTP) today announced results from an integrated dataset of two phase 3 studies, Stu |
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| June 12, 2012 |
Submission of Matters to a Vote of Security Holders - FORM 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 12, 2012 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of incorporati |
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| June 7, 2012 |
8-K 1 v3155618k.htm FORM 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 7, 2012 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other |
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| June 7, 2012 |
Exhibit 99.1 Press Release Chelsea Therapeutics Announces $6 million in Cost Saving Initiatives To Support Expanded Enrollment Initiatives For Northera Study and Extend Cash Runway into Third Quarter 2013 · Officers and Directors Agree to 25% Reduction in Compensation · Approximately 35% of Remaining Employees to Transition to Part-Time Status · Chelsea Eliminating All Performance Bonuses Until U. |
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| June 5, 2012 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 5, 2012 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of incorporatio |
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| May 31, 2012 |
Financial Statements and Exhibits, Other Events - FORM 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 31, 2012 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of incorporatio |
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| May 31, 2012 |
Exhibit 99.1 Press Release Chelsea Therapeutics Reports Top-Line Results of Phase II Trial of CH-4051 in Rheumatoid Arthritis Study Demonstrates Therapeutic Activity of Multiple Doses of CH-4051 but Misses Primary Endpoint Charlotte, NC, May 31, 2012 – Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP) announced that a preliminary analysis of its dose-ranging exploratory Phase II trial of CH- |
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| May 22, 2012 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 22, 2012 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of incorporatio |
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| May 22, 2012 |
Exhibit 99.1 Press Release Chelsea Therapeutics Completes End-of-Review Meeting with FDA for Northera™ (droxidopa) Capsules New Drug Application Chelsea Proposing to Change Primary Endpoint and Submit Dizziness Data from Ongoing Study 306B to Support Resubmission of Northera NDA for the treatment of Symptomatic Neurogenic Orthostatic Hypotension Company to Host Conference Call at 8:30 AM ET Charlo |
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| May 4, 2012 |
Form 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 2, 2012 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of inco |
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| April 30, 2012 |
Definitive Proxy Statement Table of Contents SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant x Filed by a Party other than the Registrant ¨ Check the appropriate box: ¨ Preliminary Proxy Statement ¨ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) x Definitive Proxy Statement ¨ Definitive Additional Materials ¨ Soliciting Material Pursuant to § 240. |
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| April 10, 2012 |
Form 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 4, 2012 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of in |
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| March 29, 2012 |
Press release Exhibit 99.1 Chelsea Therapeutics Receives Complete Response Letter from Food and Drug Administration for NORTHERA™ (droxidopa) Capsules FDA Requests Additional Clinical Efficacy Data to Confirm Findings from Study 301 and Support Durability of Effect Charlotte, NC, March 28, 2012 – Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP) announced today that the U.S. Food and Drug Ad |
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| March 29, 2012 |
Financial Statements and Exhibits, Other Events - FORM 8-K Form 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 28, 2012 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of i |
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| March 6, 2012 |
Financial Statements and Exhibits, Results of Operations and Financial Condition - FORM 8-K Form 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 6, 2012 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of in |
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| March 6, 2012 |
Press Release Exhibit 99.1 Chelsea Therapeutics Reports Fourth Quarter and Full Year 2011 Results Company to Host Conference Call at 4:30 PM ET Charlotte, NC, March 6, 2012 – Chelsea Therapeutics International, Ltd. (NASDAQ: CHTP) today reported financial results for the fourth quarter and full year 2011 and will host a conference call this afternoon at 4:30 PM ET to discuss these results and prov |
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| February 24, 2012 |
Financial Statements and Exhibits, Other Events - FORM 8-K Form 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 23, 2012 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction o |
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| February 24, 2012 |
Exhibit 99.1 Press Release FDA Advisory Panel Recommends Approval of Chelsea’s NORTHERA™ (droxidopa) for the Treatment of Symptomatic Neurogenic OH Company to Host Conference Call to Discuss Charlotte, NC, February 23, 2012 – Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP) today announced that the Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC |
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| February 14, 2012 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G/A UNDER THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. 3)* CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Name of Issuer) COMMON STOCK (Title of Class of Securities) 163428105 (CUSIP Number) December 31, 2011 (Date of Event Which Requires Filing of This Statement) Check the appropriate box to designate the rule pur |
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| February 13, 2012 |
Schedule 13G Amendment No. 2 SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G UNDER THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. 2)* CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Name of Issuer) COMMON STOCK (Title of Class of Securities) 163428105 (CUSIP Number) December 31, 2011 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate |
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| February 13, 2012 |
EXHIBIT 99.1 - JOINT FILING AGREEMENT Joint Filing Agreement Exhibit 99.1 EXHIBIT 99.1 - JOINT FILING AGREEMENT The undersigned hereby agree that they are filing this statement jointly pursuant to Rule 13d-1(k)(1). Each of them is responsible for the timely filing of such Schedule 13G and any amendments thereto, and for the completeness and accuracy of the information concerning such person contained therein; but none of them is respo |
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| February 13, 2012 |
Financial Statements and Exhibits, Other Events - FORM 8-K Form 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 13, 2012 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction o |
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| February 13, 2012 |
Press Release Exhibit 99.1 Chelsea Therapeutics CEO to Review NORTHERA™ NDA and Provide an Update on Upcoming Advisory Committee Meeting During Presentation at BIO CEO Dr. Pedder’s Presentation and Webcast is Scheduled for Today at 10:30 AM ET Charlotte, NC, February 13, 2012 – Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP) announced that during a presentation at the 14th Annual BIO CEO a |
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| February 9, 2012 |
CHTP / Chelsea Therapeutics International, Ltd. / TCW GROUP INC - SC 13G/A Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G UNDER THE SECURITIES EXCHANGE ACT OF 1934 (AMENDMENT NO. 1)* Chelsea Therapeutics International, Ltd. (Name of Issuer) Common Stock (Title of Class of Securities) 163428105 (CUSIP Number) 12/31/2011 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant to |
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| February 8, 2012 |
As filed with the Securities and Exchange Commission on February 8, 2012 Registration Statement No. |
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| February 8, 2012 |
CHELSEA THERAPEUTICS INTERNATIONAL, LTD. , as Trustee FORM OF INDENTURE Exhibit 4.4 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. and , as Trustee INDENTURE Dated as of , TABLE OF CONTENTS PAGE ARTICLE 1 DEFINITIONS AND INCORPORATION BY REFERENCE 1 1.1. DEFINITIONS 1 1.2. OTHER DEFINITIONS 4 1.3. INCORPORATION BY REFERENCE OF TRUST INDENTURE ACT 5 1.4. RULES OF CONSTRUCTION 5 ARTICLE 2 THE SECURITIES 5 2.1. ISSUABLE IN SERIES 5 2.2. ESTABLISHMENT OF TERMS |
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| January 26, 2012 |
STATEMENT OF COMPUTATION OF RATIO OF EARNINGS TO FIXED CHANGES Exhibit 12.1 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. COMPUTATION OF RATIO OF EARNINGS TO FIXED CHARGES (Amounts in thousands) For the Years Ended December 31, Nine Months Ended September 30, 2011 2006 2007 2008 2009 2010 Earnings: Loss before income taxes $ (8,671 ) $ (15,081 ) $ (35,086 ) $ (25,772 ) (37,330 ) $ (37,994 ) Plus: Fixed |
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| January 26, 2012 |
FORM S-3 Table of Contents As filed with the Securities and Exchange Commission on January 26, 2012 Registration Statement No. |
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| January 6, 2012 |
Form 424B5 Table of Contents Filed Pursuant to Rule 424(b)(5) Registration Statement Nos. |
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| January 6, 2012 |
Form 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 6, 2012 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of |
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| January 6, 2012 |
Underwriting Agreement Exhibit 1.5 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (a Delaware corporation) 4,338,500 Shares of Common Stock UNDERWRITING AGREEMENT Dated: January 6, 2012 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (a Delaware corporation) 4,338,500 Shares of Common Stock (Par Value $0.0001 per Share) UNDERWRITING AGREEMENT January 6, 2012 Leerink Swann LLC As Representative of the Several U |
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| January 6, 2012 |
CHELSEA THERAPEUTICS PRICES PUBLIC OFFERING OF COMMON STOCK Press Release Exhibit 99.1 Press Release CHELSEA THERAPEUTICS PRICES PUBLIC OFFERING OF COMMON STOCK Charlotte, NC, January 6, 2012 – Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP) announced today that it has priced an underwritten public offering of 4,338,500 shares of its common stock at a price of $4.75 per share. Net proceeds after underwriting discounts and commissions and expenses w |
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| January 5, 2012 |
Form S-3MEF As filed with the Securities and Exchange Commission on January 5, 2012 Registration Statement No. |
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| January 5, 2012 |
CHELSEA THERAPEUTICS ANNOUNCES PROPOSED PUBLIC OFFERING OF COMMON STOCK Press Release Exhibit 99.1 Press Release CHELSEA THERAPEUTICS ANNOUNCES PROPOSED PUBLIC OFFERING OF COMMON STOCK Charlotte, NC, January 5, 2012 – Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP) announced today its intention to offer, subject to market and other conditions, $20.0 million of its common stock in an underwritten public offering pursuant to its existing shelf registration state |
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| January 5, 2012 |
Financial Statements and Exhibits, Other Events - FORM 8-K Form 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 5, 2012 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of |
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| January 5, 2012 |
Subject to completion, dated January 5, 2012 Preliminary Prospectus Supplement Table of Contents Filed Pursuant to Rule 424(b)(3) Registration Statement Nos. |
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| January 3, 2012 |
Financial Statements and Exhibits, Other Events - FORM 8-K Form 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 3, 2012 CHELSEA THERAPEUTICS INTERNATIONAL, LTD. (Exact name of registrant as specified in its charter) Delaware 000-51462 20-3174202 (State or other jurisdiction of |
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| January 3, 2012 |
Press Release Exhibit 99.1 Chelsea Therapeutics Announces FDA Advisory Committee Meeting Date for Review of NORTHERA(TM) NDA for the Treatment of Symptomatic NOH Cardiovascular and Renal Drugs Advisory Committee Meeting Scheduled for February 23, 2012 CHARLOTTE, N.C., Jan. 3, 2012 (GLOBE NEWSWIRE) — Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that the U.S. Food and Drug Admini |
