logo
Share SHARE
FONT-SIZE Plus   Neg

Achillion Stock Jumps 83% As FDA Lifts Clinical Hold On Hepatitis C Drug

Shares of Achillion Pharmaceuticals Inc. (ACHN) surged 83 percent on Tuesday after the U.S. Food and Drug Administration lifted the clinical hold on the company's investigational hepatitis C drug sovaprevir.

This is the second time in as many days that Achillion shares have seen a rally. Yesterday, the stock surged to its highest level since late January, as investors, seeing promise for its hepatitis C pipeline, speculated that Achillino could be a takeover target.

It was about a year ago, when the FDA placed a clinical hold on Achillion's sovaprevir after elevated liver enzyme levels were observed in patients, due to higher-than-expected exposures to sovaprevir and another drug, atazanavir.

The FDA move to lift clinical hold indicates Achillion can conduct trials with a maximum of 200 mg once daily of sovaprevir in hepatitis C viral infection (HCV) patients and in single dose trials in healthy volunteers.

However, the FDA has maintained a partial clinical hold for multiple dose studies of sovaprevir that may be conducted in healthy volunteers, requiring prior review and approval of the protocol by the Agency.

Achillion said that the previously evaluated dose of sovaprevir—which was well-tolerated with clinical activity in two completed Phase 2 studies—may be used in additional therapeutic clinical trials.

The development at Achillion comes at a time when hepatitis C drug makers are seen as promising acquisition targets. Merck (MRK) on Monday agreed to acquire Idenix Pharmaceuticals (IDIX), a developer of hepatitis C drugs, for $3.85 billion.

A biopharmaceutical company, New Haven, Connecticut-based Achillion focuses on developing combination therapies for the treatment of chronic hepatitis C (HCV) infection and resistant bacterial infections. The company currently has no products on the market.

Sovaprevir is a Phase 2 NS3/4A protease inhibitor being developed for the potential treatment of chronic HCV infection. To date, about 550 subjects have been exposed to sovaprevir with clinical activity reported in two Phase 2 12-week treatment duration studies.

The hepatitis C virus is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 150 million people are infected with HCV worldwide including more than 5 million people in the U.S.

Achillion stock closed Tuesday at $7.79, up $3.54 or 83.29%, on a volume of 74 million shares on the Nasdaq. In after hours, the stock dropped $0.11 or 1.41%, to trade at $7.68.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
French aircraft maker Dassault Aviation SA said Wednesday that following repeated delays, it has terminated a contract with French defense company Safran for its Silvercrest engine that was intended to power Dassault's Falcon 5X business jet. Walt Disney Co. has agreed to buy certain assets of Rupert Murdoch's Twenty-First Century Fox, Inc. for about $52.4 billion in stock, the two companies said Thursday. Immediately prior to the acquisition by Disney, 21st Century Fox will separate the Fox Broadcasting network, Fox News Channel, Fox Business Network, FS1, FS2 and Big Ten Network into a newly listed company that will be spun off. Crypto Co., engaged in the digital currencies and blockchain sector, announced its plans to execute a 10-for-1 stock split, citing the significant growth in the value and demand for its shares amid the ongoing digital currency market boost. CEO Mike Poutre said, ""We are aware of the recent fluctuation in our stock, and want to see orderly market activity surrounding the trading of our stock."
comments powered by Disqus
Follow RTT