FDA Calendar

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
Nektar Therapeutics
NKTR-181 (NDA)
FDA decision on NKTR-181 for chronic low back pain in adult patients new to opioid therapy
Praluent (sBLA)
FDA decision to include the effect of Praluent in reducing overall risk of major adverse cardiovascular events
Regeneron Pharmaceuticals
Praluent (sBLA)
FDA decision to include the effect of Praluent in reducing overall risk of major adverse cardiovascular events
RI-002 (BLA resubmission)
FDA decision on RI-002 to treat primary immune deficiency disease
Evoke Pharma, Inc.
Gimoti (NDA)
FDA decision on Gimoti for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis
Recro Pharma Inc.
Resubmitted IV Meloxicam (NDA)
FDA decision on resubmitted IV Meloxicam for management of moderate to severe pain
Lexicon Pharmaceuticals Inc.
Sotagliflozin (NDA)
FDA decision on Sotagliflozin for type 1 diabetes
Sotagliflozin (NDA)
FDA decision on Sotagliflozin for type 1 diabetes
Jazz Pharmaceuticals plc
Solriamfetol (NDA)
FDA decision on Solriamfetol for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea
SAGE Therapeutics, Inc.
Brexanolone IV (NDA)
FDA decision on Brexanolone IV for the treatment of postpartum depression
Aerie Pharmaceuticals, Inc.
Roclatan (NDA)
FDA decision on Roclatan for patients with open-angle glaucoma, retina diseases
Roche Holding AG
Tecentriq (sBLA)
FDA decision on Tecentriq in Combination with Abraxane for Initial Treatment of People with PD-L1-Positive, Metastatic Triple-Negative Breast Cancer
Novo Nordisk A/S
FDA decision on N8-GP for treatment of people with haemophilia A
Bausch Health Companies Inc.
Loteprednol etabonate ophthalmic gel (NDA)
FDA decision on Loteprednol etabonate ophthalmic gel for post-operative inflammation and pain following ocular surgery
Incyte Corporation
Ruxolitinib (sNDA)
FDA decision on Ruxolitinib for the treatment of steroid-refractory acute GVHD

pharma-021618_17jan19.jpg Today's Daily Dose brings you news about FDA thumbs down on Immunomedics' breast cancer drug; FDA panel vote on Sanofi/Lexicon's diabetes drug; progress in Zymeworks/ Lilly collaboration; and encouraging data from Zafgen's diabetes trial.
pharma-021218_17jan19.jpg Today's Daily Dose brings you news about Alder Biopharma's after-hours stock movement; Mirati's stock offering; FDA panel recommendation of Amgen/UCB's osteoporosis drug Evenity; and Pain Therapeutics' grant award.
pharma-022818_15jan19.jpg Today's Daily Dose brings you news about the approval of the world's first device for treatment of premature babies and newborns with an opening in their hearts; the impact of the U.S. government shutdown on Aimmune Therapeutics; Array's BEACON CRC trial results; and Exelixis' expanded FDA approval for Cabometyx tablets.
Read More
Maryland-based Flying Dog Brewery is partnering with cannabis provider Green Leaf Medical Cannabis on a plan to release Maryland's first THC-infused beer in 2019. Flying Dog said in a press release that the beer, a non-alcoholic India Pale Ale named Hop Chronic, will serve as a medical delivery system...
The societal perception of cannabis has undergone a drastic shift, as can be seen from the number of countries jumping on the marijuana legalization bandwagon. Amid this changing scenario, a new study has found that recreational cannabis use, especially in the adolescent period, can bring about structural differences in the brain.
Governor Andrew Cuomo has revealed details of his proposal to legalize recreational marijuana in New York, during a budget address on Tuesday. Cuomo's $175 billion state budget proposal includes his recreational marijuana plan. The budget proposal is for the new fiscal year, which begins on April...
Read More