Vivus Inc. reported disappointing sales for its obesity drug Qsymia (phentermine/topiramate), driving its stock price down more than 12 percent. The drug brought in $6.4 million in net revenue in the third quarter of 2013, missing consensus estimates of $12 million by a wide margin. The company’s net loss for the quarter was $48 million, or 48 cents per share, compared to a net loss of $40.4 million, or 40 cents per share, in the third quarter of 2012.
Shares of Paladin Labs Inc. soared 49.4 percent Tuesday on news of an acquisition by Endo Health Solutions for $1 .6 billion in stock and cash. The merger will marry Paladin’s pipeline of products in attention deficit hyperactivity disorder, pain, urology and allergy with Endo’s health care assets under a newly formed entity based in Ireland, led by Endo’s management team.
Orbimed Advisors LLC closed a new fund of more than $735 million for investment in biopharmaceutical, medical device and diagnostics companies in North America and Europe.
Ariad Pharmaceuticals Inc. suspended sales of its leukemia drug Iclusig (ponatinib) due to potential blood clot issues upon request from the FDA. The discouraging news follows termination of Ariad’s Phase III EPIC trial in first-line chronic myelogenous leukemia (CML), and a clinical hold due to those same safety issues.
A Gilead Sciences Inc. earnings report filled with confidence about the upcoming launch of sofosbuvir and solid bottom-line beats boosted the company’s stock by 4.6 percent Wednesday.
A new Series D financing round worth $35 million will support Calithera Biosciences Inc.’s Phase I study of its cancer candidate, CB-839. The compound is designed to block cancer cell growth through inhibition of glutaminase. In preclinical studies, Calithera showed potent and selective activity of CB-839 against multiple tumor types.
The FDA’s Antiviral Drugs Advisory Committee voted 15 – 0 to recommend approval of Gilead Sciences Inc.’s sofosbuvir for genotype 2 and 3 hepatitis C virus (HCV) patients and for treatment-naïve genotype 1 and 4 patients.
A new underwritten public offering of about 3.25 million shares of common stock by Mirati Therapeutics Inc. will support the company’s Phase I/II push for cancer candidates MGCD265 and MGCD516, as well as an open-label, dose-confirmation trial of its late-stage candidate mocetinostat. Mirati will price the stock at $17.50 per share, and expects gross proceeds of about $56.9 million.
FDA briefing documents appear to be positive in advance of a meeting of the FDA Antiviral Drugs Advisory Committee scheduled for Friday to discuss approval of sofosbuvir in hepatitis C virus (HCV). Questions for the panelists focus on optimal duration of therapy in genotype 2 and 3 patients. The FDA’s documents suggest that the agency is favorably inclined toward approval of the drug, and sees no significant safety issues with it.
