Despite hailing two six-month pivotal studies' successes for Relovair in chronic obstructive pulmonary disease (COPD), South San Francisco-based Theravance Inc. saw its shares dinged by nearly a dollar Thursday as investors focused on the one endpoint that fell short of statistical significance.
After a three-day weekend to digest the news of Optimer Pharmaceuticals Inc.'s approval for macrolide antibiotic Dificid (fidaxomicin), investors jumped on the San Diego-based firm's stock (NASDAQ:OPTR) Tuesday, which, trading at seven times its average volume, gained $1.53, or 11.8 percent, to close at $14.51.
Executives of Optimer Pharmaceuticals Inc. didn't have to wait until after the long weekend for an FDA decision on the company's macrolide antibiotic Dificid (fidaxomicin). Though the PDUFA date was set for May 30, the agency approved the drug Friday afternoon for treating Clostridium difficile-associated diarrhea (CDAD), a common hospital-acquired infection.
Executives of Brisbane, Calif.-based InterMune Inc. disclosed details for the upcoming confirmatory trial needed for U.S. approval of idiopathic pulmonary fibrosis (IPF) drug Esbriet (pirfenidone) and told analysts Thursday that they believe some fine-tuning to the trial design could help the drug finally clear the FDA.
San Diego-based Prometheus Laboratories Inc., a specialty pharma and diagnostics company that has spent nearly four years in the initial public offering (IPO) queue, will become the latest acquisition of Nestle Health Sciences SA, as the Swiss firm expands its efforts in the new area of science-based nutrition.
In an industry riddled with disappointing data, regulatory setbacks and a depressing 90 percent-plus failure rate, biotech companies have learned to be resilient, raising money whenever possible – and sometimes when it almost isn't – and often reinventing themselves in the wake of disastrous pipeline flops.
About two weeks after AstraZeneca plc passed on an option for TC-5619, Targacept Inc. priced a $75 million public offering to move forward with the alpha7 neuronic nicotinic receptor-targeting drug on its own, with plans to launch a Phase IIb study in cognitive dysfunction in schizophrenia (CDS).
The annual abstract release ahead of the American Society of Clinical Oncology (ASCO) meeting – an event simultaneously heralded and dreaded by Wall Street analysts – landed quietly this year, signaling few surprises ahead of Chicago.
Finalizing the design for its planned pivotal trial of cancer vaccine rindopepimut (CDX-110) in glioblastoma multiforme (GBM), slated to start in the second half of this year, Celldex Therapeutics Inc. padded its balance sheet with a $31.5 million public offering.
The latest firm to opt for a reverse merger rather than the more traditional initial public offering, VistaGen Therapeutics Inc. inked a deal to merge with Excaliber Enterprises Ltd., a public shell listed on the Over-the-Counter Bulletin Board.
