Dynavax Technologies Corporation (NASDAQ: DVAX) today said that top-line data from its Phase 3 trial comparing HEPLISAV, an investigational hepatitis B virus (HBV) vaccine, to a currently marketed HBV vaccine, Engerix-B, demonstrated non-inferiority, superiority and the safety of HEPLISAV. However, it crucially FAILED to reach its primary endpoint of consistency criteria at 8 weeks with the Geometric Mean Antibody Concentration (GMC) in one lot higher than the other lots.
Capstone Therapeutics (Nasdaq: CAPS) said today it received notice from Nasdaq saying it will be delisted from the end of today and will trade on the OTC market from the start of trading on July 21.
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) and Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced that they have entered into a definitive merger agreement under which the companies will combine in an all-stock merger with a total equity value of approximately $686 million. The transaction is expected to result in annual cost savings synergies of between $55 million and $60 million, the majority of which are expected to be realized in the first fiscal year after closing. Allos stockholders will receive a fixed ratio of 0.1282 shares of AMAG common stock for each share of Allos common stock they own. AMAG stockholders will own approximately 61 percent of the combined company and Allos stockholders will own approximately 39 percent of the combined company. The transaction is expected to close in the fourth quarter of 2011.
VIVUS, Inc. (NASDAQ: VVUS) said today that data from its birth defect FORTRESS study, required for its NDA resubmission of Qnexa for obesity, will be released during 4Q 2011.
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today maintained previous guidance of an interim analysis by the Data Safety Monitoring Board of its Phase 3 trial of vosaroxin in combination with cytarabine in first relapsed or refractory AML, in mid-2012.
Synta Pharmaceuticals Corp. (NASDAQ: SNTA), today announced that the first patient has been treated in a Phase 2b-3 clinical trial of ganetespib in combination with docetaxel in non-small cell lung cancer (NSCLC). Interim results from the Phase 2b portion of the trial are expected early in 2012.
Pfizer Inc. (NYSE:PFE) and Icagen, Inc. (Nasdaq:ICGN) today announced that they have entered into a definitive merger agreement. Pfizer, which currently owns approximately 11% of Icagen, will acquire the remaining 8.3 million shares at a price of $6.00 per share. The companies are targeting closing before the end of the year.