logo

FDA Calendar

Share
PDUFA dates and FDA Panel Review dates are very important because they are make or break events for biostocks when the decisions are announced. Also, usually biostocks experience a run-up going into the scheduled decision/review dates. So having prior knowledge of the catalysts goes a long way toward maximizing profit or minimizing loss while trading volatile biotech stocks.
Listed below are large cap, mid cap and small cap stocks with pending regulatory catalysts.

Get in-depth analysis and insight on investing in the high-stakes biotech and pharma sectors. Check out our premium biotech research product and our biotech home page.
Company Name
Ticker
Drug
Event
Date
Outcome
Details
Bausch Health Companies Inc.
BHC, BHC.TO
Loteprednol etabonate ophthalmic gel (NDA)
FDA decision on Loteprednol etabonate ophthalmic gel for post-operative inflammation and pain following ocular surgery
02/25/2019
Incyte Corporation
Ruxolitinib (sNDA)
FDA decision on Ruxolitinib for the treatment of steroid-refractory acute GVHD
02/24/2019
Stemline Therapeutics Inc
ELZONRIS (BLA)
FDA decision on ELZONRIS for the treatment of blastic plasmacytoid dendritic cell neoplasm
02/21/2019
FDA approved ELZONRIS on Dec.21, 2018
Alexion Pharmaceuticals Inc.
ALXN1210 (BLA)
FDA decision on ALXN1210 for the treatment of patients with paroxysmal nocturnal hemoglobinuria
02/18/2019
FDA approved Ultomiris (also known as ALXN1210) on Dec.21
Merck & Co Inc.
KEYTRUDA (sBLA)
FDA decision on KEYTRUDA in the treatment of resected, high-risk stage III melanoma
02/16/2019
Bausch Health Companies Inc.
BHC, BHC.TO
DUOBRII (Resubmitted NDA)
FDA decision on DUOBRII for the topical treatment of plaque psoriasis.
02/15/2019
MOTIF BIO PLC
Iclaprim (NDA)
FDA decision on Iclaprim for acute bacterial skin and skin structure infections
02/13/2019
FDA declines to approve Iclaprim for ABSSSI
Johnson & Johnson
Esketamine (NDA)
FDA panel to review Esketamine for the treatment of treatment-resistant depression.
02/12/2019
FDA panel backs Esketamine for the treatment of treatment-resistant depression.
Evolus Inc.
DWP-450(Resubmitted BLA)
FDA decision on DWP-450 for treatment of moderate to severe glabellar lines
02/02/2019
FDA approved Jeuveau (DWP-450) for treatment of moderate to severe glabellar lines on Feb.1, 2019
Alkermes plc
ALKS 5461 (NDA)
FDA’s final decision on ALKS 5461 for adjunctive treatment of major depressive disorder
01/31/2019
FDA rejected ALKS 5461 for adjunctive treatment of major depressive disorder on Feb.1, 2019
Aquestive Therapeutics Inc.
APL-130277 (NDA)
FDA decision on APL-130277 to overcome episodic off periods in Parkinson's disease
01/29/2019
FDA issued a Complete Response Letter for APL-130277 on Jan.30, 2019
Sanofi
Fluzone Quadrivalent (sBLA)
FDA decision on flu vaccine Fluzone Quadrivalent of 0.5-mL dose to include children 6 through 35 months of age
01/28/2019
FDA approved Fluzone Quadrivalent of 0.5-mL dose on Jan.23, 2019
Immunomedics Inc.
Sacituzumab govitecan (BLA)
FDA decision on Sacituzumab govitecan for treatment of metastatic triple-negative breast cancer
01/18/2019
FDA issued Complete Response Letter for Sacituzumab govitecan on Jan.17, 2019
Lexicon Pharmaceuticals Inc.
Zynquista (sotagliflozin) (NDA)
FDA panel to review Zynquista for adults with type 1 diabetes
01/17/2019
FDA panel voted eight to eight on approval of Zynquista
Amgen Inc.
EVENITY (Resubmission BLA)
FDA panel to review EVENITY for osteoporosis in postmenopausal women at high risk for fracture
01/16/2019
FDA panel votes 18 of 19 in favor of EVENITY for postmenopausal women with osteoporosis at high risk for fracture


bank-feb04.jpg Historically, biotech stocks have performed reasonably well in the month of January, and this year too, it has been no different. The iShares Nasdaq Biotechnology ETF (IBB) a bellwether of investor sentiment, has so far gained nearly 16%. Listed below are some of the biotech stocks that made triple-digit gains in January, and their near-term catalysts to watch out for.
pharmacalendar-feb01.jpg Here are some of the pharma/biotech stocks to watch out for in the week starting February 4.
Read More