NEW YORK--(BUSINESS WIRE)--The law firm of Wolf Haldenstein Adler Freeman & Herz LLP announces that it is investigating potential federal securities claims against Achillion Pharmaceuticals Inc. (“Achilion” or “Company”) (NASDAQ GS:ACHN) and certain of its officers and directors in connection with allegations that the Company made materially false and misleading statements regarding Company’s experimental hepatitis C drug.
Specifically, on September 30, 2013, the Company disclosed it received a response from the U.S. Food and Drug Administration on the clinical hold already in effect since June 2013, related to sovaprevir, Achillion's NS3 protease inhibitor.
The FDA response indicated that, “while Achillion's submission addressed all issues noted in the FDA's June 29, 2013 letter, the FDA concluded that the removal of the clinical hold is not warranted.” Presumably, the FDA’s decision to continue the hold was because it observed high levels of liver enzymes in healthy patients, which can indicate damage, when sovaprevir was combined with two medicines used to treat HIV infection.
On this news, shares of Achillion shares fell $4.30 per share, more than 59.53% on intraday trading, to a price of $2.94 on September 30, 2013.
Even though the sovaprevir trial was on hold since June, as recently as September 10, 2013, the Company’s President/CEO Milind S. Deshpande stated at the Robert W. Baird and Co. Health Care Conference that he anticipated the Company would “receive a favorable response from the [FDA].” Moreover, he said with a 99.99% confidence interval that there is no overlap between the exposures we see in our – [sic] with our clinical doses versus the exposure we’re seeing in the DDI study.”
Wolf Haldenstein has been representing individual and institutional investors for many years, serving as lead counsel in numerous cases in United States federal and state courts. Please visit the Wolf Haldenstein website (http://www.whafh.com) for more information about the firm.
Please contact us if you own Achillion common stock and wish to discuss this matter with us, or have any questions concerning your rights and interests:
Gregory M. Nespole or Patrick Donovan
Wolf Haldenstein Adler Freeman & Herz LLP
270 Madison Avenue
New York, New York 10016