FDA ready to review Newron’s resubmitted NDA for Xadago-Newron Pharmaceutical $NWPHF announced that the FDA has accepted to review its resubmitted New Drug Application (NDA) seeking approval of Xadago (safinamide) as add-on therapy in both early to mid-stage Parkinson’s disease (PD) patients who are inadequately managed on their current therapy. The action date is March 21, 2017. The company received a Complete Response Letter (CRL) on March 28, 2016, apropos its original filing.
FDA to review Bristol-Myers Marketing application for Opdivo meant for treating bladder cancer-The FDA accepted to review Bristol-Myers Squibb’s $BMY supplemental Biologic s License Application (sBLA) seeking approval for Opdivo (nivolumab) for the treatment of patients with locally advanced unresectable or or metastatic urothelial carcinoma that has progressed on or after platinum-based chemotherapy, a Breakthrough Therapy indication. The agency's action date is March 2, 2017. The data backing the filing was generated in the Phase 2 clinical trial, Checkmate-275, which demonstrated a 19.6% objective response rate in patients treated with Opdivo.
Analysts bullish on Alkermes following successful late-stage study of antidepressant candidate-Alkermes $ALKS soared on Friday amid heavy trading volume in response to its successful Phase 3 clinical trial, FORWARD-5 of ALKS 5461 for treatment of patients with major depressive disorder (MDD). JP Morgan expects ALKS 5461 to get approved in the U.S. based on FORWARD-5 results and totality of overall data. Leerink also gives the treatment a “reasonable chance” of FDA approval with a 23% upside potential to $70.
Merck's immunotherapy drug succeeds in key bladder cancer trial-A phase 3 study, KEYNOTE-045, evaluating Merck’s $MRK PD-1 inhibitor KEYTRUDA (pembrolizumzb) in treatment –experienced patients with advance urothelial cancer has been concluded early after the independent Data Monitoring Committee determined that the clinical trial met its primary endpoint of overall survival (OS). KEYNOTE-045 is a 542-participant subject randomized study that assessed KEYTRUDA as monotherapy compared to investigator choice chemotherapy (paclitaxel, docetaxel, vinflunine) in patients with metastatic or locally advanced/unresectable urothelial cancer that has progressed following platinum-based chemo.
Moleculin reports ‘positive development’ for Annamycin-Moleculin Biotech $MBRX, in its investor update, said that it observed “positive development” for lead drug candidate Annamycin. Chairman and CEO, Wally Kemp said that the company will be in position to use the Annamycin inventory of licensee Dermin for its clinical trials thereby reducing its planned costs for its mid-stage clinical trials lined-up next year.