FDA to review ARIAD’s NDA for brigatinib -The FDA accepted to review ARIAD Pharmaceuticals’ $ARIA New Drug Application (NDA) seeking approval of brigatinib for the treatment of patients with ALK-positive non-small cell lung cancer (NSCLC) who have progressed on crizotinib [Pfizer's $PFE XALKORI]. The agency's action date (PDUFA) is scheduled onApril 29, 2017 under Priority Review status.
Capricor’s lead product candidate falls short of clearing early-stage study-Results obtained from a Phase 1 clinical trial labeled as DYNAMIC evaluating Capricor Therapeutics’ $CAPR lead product candidate CAP-1002 in patients with advance heart failure showed mixed treatment effect. The data was shown at the annual scientific symposium of the Cardiovascular Research Foundation called the 28th Transcatheter Cardiovascular Therapeutics in Washington, D.C.
DURECT’s Phase 1b study on NASH treatment yields positive results-DURECT $DRRX soared in afterhours amid heavy trading volume in response to its announcement of encouraging results from its first cohort in a Phase 1b clinical trial evaluating DUR-928 in patients with nonalcoholic steatohepatitis (NASH). The clinical trial is being conducted on successive cohorts assessing single-dose of orally administered DUR-929.
Shire ends a tad lower over Express Scripts comments on hemophilia meds-Shire Plc $SHPG eased on Monday amid increased trading volume in apparent response to comments made by Express Scripts $ESRX Chief Medical Officer, Steven Miller, during a phone call, in which he said that the company is looking at ways to manage increasing costs of hemophilia medicines without forcing patients to switch treatments. Shire is one of the big players in this arena after its merger with Baxalta.
NovaBay fulfills compliance with NYSE listing requirements-NovaBay Pharmaceuticals $NBY announced that it has reclaimed compliance with the NYSE MKT continued listing standards. On April 28th 2015, the drug-maker received notice which said that it was out of compliance with Section 1003 (a) (i) of the NYSE MKT Company Guide pertaining to shareholder equity requirements. Nonetheless, the company, through a series of financings has been able to generate more than $300 million to reclaim compliance and maintain its listings on the exchange.