Key Developments: Chelsea Therapeutics International Ltd (CHTP.PH)
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21 May 2013
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Latest Key Developments (Source: Significant Developments)
Branham Law, LLP Announces Investigation Of Chelsea Therapeutics International, Ltd. For Possible Securities Law Violations
Branham Law, LLP announced an investigation has been launched into the actions of the officers and directors of Chelsea Therapeutics International, Ltd. (Chelsea or the Company) for possible violations of securities and shareholder protection laws. The investigation focuses on whether the Company and its executives violated federal securities laws by failing to disclose that: Chelsea’s Northera (droxidopa) product, an orally-active synthetic precursor of norepinephrine being developed for the treatment of symptomatic neurogenic orthostatic hypotension, would not receive approval from the U.S. Food and Drug Administration; and the Company’s numerous statements regarding the safety and efficacy of the product, as well as reportedly positive results from Northera’s clinical trials, were materially false and misleading. Full Article
Chelsea Therapeutics International Ltd. To Implement Corporate Reorganization; Announces Board Changes
Chelsea Therapeutics International Ltd. announced that 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 plan to explore and evaluate strategic options for the Company, all with goal of optimizing long-term stockholder value. As part of reorganization, Chelsea's Board of Directors expects to significantly reduce the Company's headcount. As part of this effort, the Company plans to stop patient enrollment in ongoing 306B study in July. The reduction in force is expected to be completed in the third quarter of 2012. At the executive level, Simon Pedder Founder, President and CEO, has resigned as a director, officer and employee of the Company, effective immediately. Dr. Pedder will continue to serve the Company in an advisory capacity for smooth transition. The Board will begin evaluating candidates to succeed him as Chief Executive Officer. Joseph G. Oliveto, who has been the Company's Vice President, Operations since June 2008, has been appointed interim President and Chief Executive Officer until a permanent CEO is appointed. Keith Schmidt, Vice President, Marketing and Sales, will also be leaving the Company, but will remain available in an advisory capacity. At the Board level, Kevan Clemens has stepped down as Chairman and remains a director, with director Michael Weiser assuming the role of Chairman. Full Article
Chelsea Therapeutics International Ltd. Provides Update On Northera (droxidopa) Regulatory Status And Development Program
Chelsea Therapeutics International Ltd. announced that it has 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 for marketing approval of Northera (droxidopa) in the U.S. In its response, FDA advised Chelsea that, based on the theoretical potential for certain patients from Study 306B to have been unblinded in conjunction with the reporting of 306A data, the FDA cannot be confident that this information did not influence an amendment of the statistical analytic plan, and therefore believes, as presently planned, Study 306B is unlikely to provide sufficient confirmatory evidence to support a Northera (droxidopa) Capsules New Drug Application (NDA). However, as this analytic approach appears to exclude at least 109 patients from Study 306B, the FDA further recommends that Chelsea design and conduct an additional trial to demonstrate that droxidopa has persistent effect on symptoms of neurogenic orthostatic hypotension. The FDA did not provide feedback or express any concerns regarding Chelsea's proposal to assess efficacy two-weeks post titration using OHSA item (dizziness) nor did the FDA provide further guidance regarding the duration of clinical efficacy data needed to support a persistent effect. Full Article
Chelsea Therapeutics International Ltd. Reports Results Of Phase II Trial Of CH-4051 In Rheumatoid Arthritis
Chelsea Therapeutics International Ltd. announced that a preliminary analysis of its dose-ranging exploratory Phase II trial of CH-4051, a non-metabolized antifolate, in patients with rheumatoid arthritis (RA) who experience an inadequate response to methotrexate (MTX) treatment indicates that CH-4051 did not demonstrate superior efficacy to methotrexate in the dose range evaluated. Using a modified intent-to-treat (ITT) population of 244 patients with a post-baseline efficacy assessment, the primary efficacy analyses utilized the hybrid American College of Rheumatology score (hACR) followed by the traditional ACR 20 (20% improvement in ACR criteria) to compare responses among patients treated with 0.3 mg (n=48), 1.0 mg (n=48) or 3.0 mg (n=49) of CH-4051 daily, 3.0 mg of CH-4051 daily in combination with a folate supplement (n=49) or 20.0 mg MTX weekly (n=50) with a folate supplement for 12 weeks following a two-week MTX-washout. At the end of the 12-week period, patients treated with MTX showed greater improvement in both mean hACR (38.4) and ACR20 response rate (56.0%) compared to patients treated with 0.3mg CH-4051, 1.0 mg CH-4051, 3.0mg CH-4051 or 3.0mg CH-4051 with folate supplement. CH-4051 was found to be safe and well tolerated in the study, with no dose-limiting toxicities or clear differences in the overall adverse event rate between the MTX (52.9%) and 0.3mg, 1.0mg and 3.0mg CH-4051 (38.0%, 42.9% and 30.0%) and 3.0mg CH-4051 plus folate (49.0%) treatment groups. Full Article
Faruqi & Faruqi, LLP Notifies Investors of June 4, 2012, Lead Plaintiff Deadline for Class Action Filed Against Chelsea Therapeutics International Ltd,
Faruqi & Faruqi, LLP, a national securities law firm, announced that it is investigating potential securities fraud at Chelsea Therapeutics International Ltd. The investigation focuses on whether the Company and its executives violated federal securities laws by failing to disclose that: (1) Chelsea's Northera (droxidopa) product, an orally-active synthetic precursor of norepinephrine being developed for the treatment of symptomatic neurogenic orthostatic hypotension, would not receive approval from the U.S. Food and Drug Administration; and (2) the Company's numerous statements regarding the safety and efficacy of the product, as well as reportedly positive results from Northera's clinical trials, were materially false and misleading. On February 13, 2012, Chelsea disclosed that the Food and Drug Administration (FDA) had raised questions regarding the efficacy, size and duration of the Company's clinical trials for the drug Northera. Furthermore, the FDA indicated that three deaths were potentially related to the drug's trials. In the aftermath of these disclosures, Chelsea's stock price declined by more than 37 %. Then on March 28, 2012, the Company announced that its New Drug Application for Northera was rejected by the FDA. Upon this news, Chelsea shares fell more than 28%, to close at $2.62 per share on March 29, 2012. Full Article
Levi & Korsinsky Notifies Investors With Losses on Investment In Chelsea Therapeutics International Ltd.
Levi & Korsinsky announced that a class action lawsuit has been commenced in the United States District Court for the Western District of North Carolina on behalf of investors who purchased Chelsea Therapeutics International Ltd. (Chelsea or the Company) stock between November 3, 2008 and March 28, 2012. The complaint alleges that Chelsea made a series of materially false and misleading statements regarding the safety and efficacy of the drug Northera and the likelihood of its approval by the U.S. Food and Drug Administration (FDA). On February 13, 2012, Chelsea disclosed that the FDA had raised questions regarding the size and duration of its clinical trials for Northera. Furthermore, the FDA indicated that three deaths were potentially related to the drug. As a result of the aforementioned, shares of Chelsea stock declined more than 37%. Then on March 28, 2012, the Company announced that their New Drug Application for Northera was rejected by the FDA. Upon this news, Chelsea shares fell more than 28%, to close at $2.62 per share on March 29, 2012. Full Article
Faruqi & Faruqi, LLP Announces Investigation Of Chelsea Therapeutics International Ltd.
Faruqi & Faruqi, LLP, a national securities law firm, announced that it is investigating potential securities fraud at Chelsea Therapeutics International, Ltd. The investigation focuses on whether the Company and its executives violated federal securities laws by failing to disclose that: (1) Chelsea's Northera (droxidopa) product, an orally-active synthetic precursor of norepinephrine being developed for the treatment of symptomatic neurogenic orthostatic hypotension, would not receive approval from the U.S. Food and Drug Administration; and (2) the Company's numerous statements regarding the safety and efficacy of the product, as well as reportedly positive results from Northera's clinical trials, were materially false and misleading. Full Article
Brower Piven Encourages Investors Who Have Losses In Excess Of $200,000 From Investment In Chelsea Therapeutics International Ltd.
Brower Piven, A Professional Corporation announced that a class action lawsuit has been commenced in the United States District Court for the Western District of North Carolina on behalf of purchasers of the common stock of Chelsea Therapeutics International, Ltd. during the period between June 9, 2011 and February 17, 2012, inclusive (the "Class Period"). No class has yet been certified in the above action. Members of the Class will be represented by the lead plaintiff and counsel chosen by the lead plaintiff. If you wish to choose counsel to represent you and the Class, you must apply to be appointed lead plaintiff no later than June 4, 2012 and be selected by the Court. The lead plaintiff will direct the litigation and participate in important decisions including whether to accept a settlement and how much of a settlement to accept for the Class in the action. . The complaint accuses the defendants of violations of the Securities Exchange Act of 1934 by virtue of the Company's failure to disclose during the Class Period, contrary to the Company's representation that Northera (droxidopa), an orally-active synthetic precursor of norepinephrine being developed for the treatment of symptomatic neurogenic orthostatic hypotension, would receive approval from the U.S. Food and Drug Administration ("FDA"), there were concerns regarding the safety and efficacy of Northera. Full Article
The Briscoe Law Firm and Powers Taylor, LLP Investigate Possible Breaches Of Fiduciary Duty By Officers And Directors Of Chelsea Therapeutics International, Ltd
The Briscoe Law Firm and Powers Taylor, LLP announced that the firms are investigating legal claims against the officers and Board of Directors of Chelsea Therapeutics International, Ltd. related to potential securities violations between June 9, 2011 and February 17, 2012. Chelsea and certain of its officers and directors were charged with violating the Securities Exchange Act of 1934. Chelsea is a biopharmaceutical company that had been developing the drug Northera for use in treating neurogenic orthostatic hypotension in patients with primary autonomic failure, including Parkinson’s disease. The complaint alleges that during the Class Period, defendants made material misstatements and omissions concerning (i) the safety and efficacy of Droxidopa for patients with NOH; (ii) the results of the Phase III testing of Droxidopa for patients with NOH; and (iii) the post-marketing events in Japan and the likelihood of FDA approval of Droxidopa for patients with NOH in light of the known adverse material facts concerning Droxidopa for patients with NOH. It is further alleged that these misstatements and omissions artificially inflated Chelsea’s common stock price during the Class Period, so that when the true facts concerning the safety and efficacy of Droxidopa were revealed, Chelsea’s common stock price declined. Specifically, Chelsea’s stock price dropped from $4.99 per share on February 13, 2012 to $2.64 per share on February 21, 2012. Full Article
Federman & Sherwood Files Securities Class Action Lawsuit Against Chelsea Therapeutics International Ltd.
Federman & Sherwood announced that On April 4, 2012, a class action lawsuit was filed in the United States District Court for the Western District of North Carolina against Chelsea Therapeutics International Ltd. The complaint alleges violations of federal securities laws, Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5, including allegations of issuing a series of material or false misrepresentations to the market which had the effect of artificially inflating the market price during the Class Period, which is November 3, 2008 through March 28, 2012. Plaintiff seeks to recover damages on behalf of all Chelsea Therapeutics International Ltd. shareholders who purchased common stock during the Class Period and are therefore a member of the Class as described above. You may move the Court no later than, June 4, 2012 to serve as a lead plaintiff for the entire Class. However, in order to do so, you must meet certain legal requirements pursuant to the Private Securities Litigation Reform Act of 1995. Full Article
Chelsea says FDA allows Northera resubmission with existing data
- Chelsea Therapeutics International Ltd plans to repitch its once-rejected hypotension drug Northera in the second quarter after a review by U.S. health regulators determined that the company could use its original data for the resubmission.
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