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.

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Company Name
Aquestive Therapeutics Inc.
Libervant Buccal Film (NDA)
FDA decision on Libervant Buccal Film for management of seizure clusters
MorphoSys AG
Tafasitamab (BLA)
FDA decision on Tafasitamab for the treatment of relapsed or refractory diffuse large B cell lymphoma.
Lipocine Inc
TLANDO (resubmitted NDA)
FDA decision on TLANDO as testosterone replacement therapy in adult males for conditions associated with hypogonadism
Tricida, Inc.
Veverimer (NDA)
FDA decision on Veverimer for treatment of patients with chronic kidney disease
Seattle Genetics Inc.
Tucatinib (NDA)
FDA decision on Tucatinib for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer
Bristol-Myers Squibb Co.
Lisocabtagene maraleucel (BLA)
FDA decision on Lisocabtagene maraleucel for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies
Jazz Pharmaceuticals plc
Lurbinectedin (NDA)
FDA decision on lurbinectedin for patients with SCLC who have progressed after prior platinum-containing therapy
Deciphera Pharmaceuticals, Inc.
Ripretinib (NDA)
FDA decision on Ripretinib for advanced gastrointestinal stromal tumors
Gilead Sciences Inc.
FDA decision on KTE-X19 for the treatment of adult patients with relapsed or refractory mantle cell lymphoma
Trevena, Inc.
IV Oliceridine (Resubmitted NDA)
FDA decision on IV Oliceridine for the management of moderate-to-severe acute pain
DBV Technologies S.A. -
Viaskin Peanut (BLA)
FDA decision on Viaskin Peanut for treatment of peanut allergy
Ultragenyx Pharmaceutical Inc
UX007 (triheptanoin) (NDA)
FDA decision on for UX007 for treatment of Long-chain Fatty Acid Oxidation Disorders
Verrica Pharmaceuticals Inc.
VP-102 (cantharidin 0.7% Topical Solution) (NDA)
FDA decision on VP-102 for the Treatment of Molluscum Contagiosum
Endo International plc
Collagenase clostridium histolyticum (BLA)
FDA decision on collagenase clostridium histolyticum (CCH) for cellulite in buttocks
Heron Therapeutics Inc.
HTX-011 (Resubmitted NDA)
FDA decision on HTX-011 for the management of postoperative pain
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