New FDA fast track status for Medicinova Inc.'s phase II nonalcoholic steatohepatitis (NASH) drug MN-001 (tipelukast) invigorated the company's U.S.-listed shares (NASDAQ:MNOV), pushing them 41.3 percent higher to $4.96 in heavy trading Thursday as investors warmed to the company's chances for gaining FDA approval to treat the chronic liver condition, for which no drug is currently approved.
Ampio Pharmaceuticals Inc. shares fell sharply Monday, hitting a 52-week low after the company revealed that one of its lead candidates, Ampion, failed to provide better pain relief that a placebo injection in a phase III study of people suffering from osteoarthritis of the of the knee (OAK).
About a year after its IPO, Akebia Therapeutics Inc. is raising $60 million in a follow-on offering to support phase III testing of its lead candidate, the renal anemia drug AKB-6548, and phase I development of the cancer-focused AKB-6899.
New FDA fast track status for Medicinova Inc.'s phase II nonalcoholic steatohepatitis (NASH) drug MN-001 (tipelukast) invigorated the company's U.S.-listed shares (NASDAQ:MNOV), pushing them 41.3 percent higher to $4.96 in heavy trading Thursday as investors warmed to the company's chances for gaining FDA approval to treat the chronic liver condition, for which no drug is currently approved.
Shares of Aduro Biotech Inc. (NASDAQ:ADRO) rose 147 percent to $42 in the company's Nasdaq debut Wednesday as investors clamored to get a piece of the cancer immunotherapy company's upsized 7 million share offering.
Inmed Pharmaceuticals Ltd., a Canadian-listed start-up mixing cannabinoids and noncannabis elements for the treatment of glaucoma, pain and inflammation is working to move into the clinic this year and attract the kind of big pharma backers that have rallied to support high-profile cannabinoid drugmaker GW Pharmaceuticals plc.
One of two major assets from Shire plc's multimillion-dollar Lumena Pharmaceuticals Inc. buy, SHP625 (LUM001), is shining a little less brightly after missing both primary and secondary endpoints in a small phase II study called IMAGO, which tested its ability to lower bile acid levels and minimize itching vs. placebo for children with Alagille syndrome (ALGS), a rare genetic disorder.
Washington-based gene therapy developer Regenxbio Inc. has shored up key intellectual property rights and relationships supporting its preclinical therapies for the rare genetic diseases Hurler and Hunter syndromes, executing two exclusive new license and research agreements with the universities of Pennsylvania and Minnesota.
Arvinas LLC, a Yale University spinout creating new drugs to degrade pathogenic proteins, has inked its first collaboration deal with Merck & Co. Inc. with the goal of creating new therapies for multiple diseases, most likely including cancer, the company's area of core expertise and the focus of its own initial development work.
Perosphere Inc., a private company focused on bringing a broadly applicable anticoagulant reversal agent to market, has won FDA fast track status for the synthetic small molecule ahead of planned phase III studies.
