Key Developments: Achillion Pharmaceuticals Inc (ACHN.O)
22 Aug 2014
Latest Key Developments (Source: Significant Developments)
Achillion Pharmaceuticals Inc:Announces that the U.S. Patent & Trademark Office has granted Achillion U.S. Patent No. 8,809,313, covering composition-of-matter and method of use claims for ACH-3102 and structurally related NS5A inhibitor compounds. Full Article
Achillion Pharmaceuticals Inc achieves 100 pct sustained virologic response rate from an eight week phase 2 trial
Achillion Pharmaceuticals Inc:Says interim results from ongoing Phase 2 proxy study evaluating ACH-3102, Achillion's second-generation NS5A inhibitor, in combination with sofosbuvir, without ribavirin, for eight weeks of treatment in patients with treatment-naïve genotype 1 chronic hepatitis C virus (HCV) infection.Says of the 12 patients treated, 100 percent (n=12/12) remained HCV RNA undetectable four weeks after completing therapy (SVR4).Says based upon these results, 12 additional patients will begin treatment with six weeks of once daily ACH-3102 and sofosbuvir.Says ACH-3102 continues to demonstrate good safety and tolerability through three Phase 2 studies.Says primary objective of the study is determination of sustained viral response 12 weeks (SVR12) after the completion of therapy\.Says Twelve patients completed eight weeks of treatment consisting of 50 mg of ACH-3102 and 400 mg of sofosbuvir administered once daily while observational patients received no drug during this phase of the trial.Says Ten of 12 patients receiving eight weeks of treatment had genotype 1a HCV with median HCV RNA at baseline of 7.22 log10(range 5.5 - 7.8 log10).Says no on-treatment viral breakthrough or post-treatment viral relapse has been observed to date.Says ACH-3102 and sofosbuvir were well tolerated with no significant adverse events, ECG findings, or lab abnormalities observed during treatment. Full Article
Achillion Pharmaceuticals Inc announces initiation of ACH-3422 Dosing in HCV-Infected Patients and ability to resume Sovaprevir clinical program for treatment of Chronic HCV
Achillion Pharmaceuticals Inc:Company has begun dosing ACH-3422, a uridine-analog nucleotide polymerase inhibitor, for seven days in patients with genotype 1 chronic hepatitis C viral infection (HCV) in its ongoing Phase 1 clinical trial.Proof-of-concept results from this trial are expected to be reported during the fall of 2014.FDA removed clinical hold to permit the conduct of therapeutic trials with a maximum of 200 mg once daily of sovaprevir in HCV patients and in single dose trials in healthy volunteers.Says but maintained a partial clinical hold for multiple dose studies that may be conducted in healthy volunteers, requiring prior review and approval of the protocol by FDA.Achillion expects to continue to work collaboratively with FDA on the continued clinical development of sovaprevir. Full Article
Achillion Pharmaceuticals Inc:Expects FY 2014 net loss per share to about $0.70 per share.FY 2014 EPS of ($0.81) - Thomson Reuters I/B/E/S. Full Article
Pomerantz Grossman Hufford Dahlstrom & Gross LLP announced that it has filed a class action lawsuit against Achillion Pharmaceuticals Inc (Achillion or the Company) and certain of its officers. The class action, filed in United States District Court, District of Connecticut, and docketed under 13-cv-1479, is on behalf of a class consisting of all persons or entities who purchased or otherwise acquired securities of Achillion between April 21, 2012 and September 27, 2013 both dates inclusive (the Class Period). This class action seeks to recover damages against the Company and certain of its officers and directors as a result of alleged violations of the federal securities laws pursuant to Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder. The Complaint alleges that throughout the Class Period, Defendants made false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects, including the safety and suitability of its premier investigative drug for the treatment of hepatitis, sovaprevir. Full Article
Wolf Haldenstein Adler Freeman & Herz LLP Commences Class Action Lawsuit On Behalf Of Achillion Pharmaceuticals Inc. Investors
Wolf Haldenstein Adler Freeman & Herz LLP announced that a class action lawsuit has been filed in the United States District Court, District of Connecticut, on behalf of all persons who purchased or otherwise acquired common stock of Achillion Pharmaceuticals, Inc. (Achillion or the Company) (NASDAQ GS:ACHN) between August 8, 2012 and September 30, 2013, inclusive (the Class Period), against the Company and certain of the Company`s officers (Defendants). The Complaint alleges that during the Class Period, Achillion engaged in a fraudulent scheme to artificially inflate the Company`s stock price by disseminating materially false and misleading statements concerning its clinical trials of the drug sovaprevir. The Company falsely represented that sovaprevir, one of the protease inhibitor compounds in its portfolio of oral treatments for the hepatitis C virus, was well-tolerated and had a low potential for drug-drug interactions. Indeed, Achillion touted the results of its clinical tests even though, in July 2013, the United States Food and Drug Administration ("FDA") placed a clinical hold on sovaprevir after elevations in liver enzymes were noted in a phase 1 interaction study. Full Article
Bernstein Liebhard LLP announced that a class action has been commenced in the United States District Court for the District of Connecticut on behalf of all those (the Class) who purchased securities of Achllion Pharmaceuticals, Inc. (Achillion or the Company) between April 21, 2012 and September 27, 2013, inclusive (the Class Period). The Complaint alleges that throughout the Class Period, Defendants made false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects, including the safety and suitability of its investigative drug for the treatment of hepatitis, sovaprevir. Defendants failed to inform investors that sovaprevir in fact did not interact well with other drugs commonly administered to treat hepatitis and/or HIV. Specifically, the Company misled investors to believe that even though patients in the Company's clinical trials for sovaprevir had elevations in liver enzymes, these liver enzymes elevations were transient and returned to baseline values and were attributable to non-drug-related factors. As a result of the foregoing, the Company's statements were materially false and misleading at all relevant times. Full Article
Robbins Arroyo LLP Announces Securities Class Action Lawsuit Has Been Filed Against Achillion Pharmaceuticals, Inc.
Shareholder rights law firm Robbins Arroyo LLP announced that an investor of Achillion Pharmaceuticals, Inc. has filed a federal securities fraud class action complaint in the U.S. District Court, District of Connecticut. The complaint alleges that the Company and certain of its officers violated the Securities and Exchange Act of 1934 between April 21, 2012 and September 27, 2013 (the "Class Period"). Achillion Accused of Misleading Investors Regarding Viability of Sovaprevir Shares of Achillion fell $4.22 per share, or more than 58%, on September 27, 2013, after the Company disclosed that the U.S. Food and Drug Administration ("FDA") continued its clinical hold on sovaprevir, its investigative drug for the treatment of hepatitis. This steep decline comes just two months after Achillion experienced an initial 25% decline per share on the announcement that the FDA instituted the clinical hold on July 1, 2013. Full Article
Federman & Sherwood Announces Securities Class Action Lawsuit Has Been Filed Against Achillion Pharmaceuticals, Inc.
Achillion Pharmaceuticals Inc announced that on October 8, 2013, a class action lawsuit was filed in the United States District Court for the District of Connecticut against Achillion Pharmaceuticals, Inc. 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 April 21, 2012 through September 27, 2013. Plaintiff seeks to recover damages on behalf of all Achillion Pharmaceuticals, inc. 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 December 9, 2013 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
Reuters reported that Achillion Pharmaceuticals Inc said the U.S. Food and Drug Administration had placed a clinical hold on its hepatitis C drug sovaprevir after elevations in liver enzymes were noted in an early-stage study of the drug's interaction with an HIV drug. The Company said the U.S. Food and Drug Administration had placed a clinical hold on its hepatitis C drug sovaprevir after elevations in liver enzymes were noted in an early-stage study of the drug's interaction with an HIV drug. The Company said it expected to provide the information to the FDA within about six weeks. Full Article
- Achillion Pharmaceuticals Inc said all patients treated with its experimental hepatitis C drug showed no detectable levels of the virus four weeks after the therapy, sending its shares up 18 percent.