05/11/2019 | Press release | Distributed by Public on 05/11/2019 07:17
Biotech stocks saw a reversal in sentiment as the week saw an earnings deluge from small-, micro- and nano-cap biotechs and some M&A activity.
Here are some key catalysts for the unfolding week that should be on the radar of a biotech investor.
The FDA is set to rule Monday on Regeneron Pharmaceuticals Inc (NASDAQ: REGN)'s sBLA for Eylea in patients with moderately severe to severe non-proliferative diabetic retinopathy without diabetic macular edema.
Sesen Bio Inc (NASDAQ: SESN) is scheduled to release updated preliminary Phase 3 data for Vicinium in non-muscle invasive bladder cancer on Monday.
Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN) will release interim Phase 2 data for ACH-447 in paroxysmal nocturnal hemoglobinuria on Friday.
The Medicines Company (NASDAQ: MDCO) will release Phase 2 data for inclisiran from a study called ORION 3 that is evaluating the pipeline asset for cardiovascular disease. The presentation is scheduled to be made at the National Lipid Association Scientific Sessions on Saturday, May 18.
Amgen, Inc. (NASDAQ: AMGN) - Phase 1 data for AMG 510 in solid tumors
The Oncologic Drugs Advisory Committee will discuss DAIICHI SANKYO/S ADR (OTC: DSNKY)'s NDA for pexidartinib capsule for treating adult patients with giant cell tumor of the tendon sheath. The committee will also vote on the Japanese company's NDA for quizartinib tablets being tested in adults with relapsed or refractory acute myeloid leukemia which is FLT3-ITD positive.
Both meetings are scheduled for Tuesday.