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
Aquestive Therapeutics Inc.
Libervant Buccal Film (NDA)
FDA decision on Libervant Buccal Film for management of seizure clusters
09/27/2020
MorphoSys AG
MOR, MPSYY.PK
Tafasitamab (BLA)
FDA decision on Tafasitamab for the treatment of relapsed or refractory diffuse large B cell lymphoma.
08/30/2020
Lipocine Inc
TLANDO (resubmitted NDA)
FDA decision on TLANDO as testosterone replacement therapy in adult males for conditions associated with hypogonadism
08/28/2020
Tricida, Inc.
Veverimer (NDA)
FDA decision on Veverimer for treatment of patients with chronic kidney disease
08/22/2020
Seattle Genetics Inc.
Tucatinib (NDA)
FDA decision on Tucatinib for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer
08/20/2020
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
08/17/2020
Jazz Pharmaceuticals plc
Lurbinectedin (NDA)
FDA decision on lurbinectedin for patients with SCLC who have progressed after prior platinum-containing therapy
08/16/2020
Deciphera Pharmaceuticals, Inc.
Ripretinib (NDA)
FDA decision on Ripretinib for advanced gastrointestinal stromal tumors
08/13/2020
Gilead Sciences Inc.
KTE-X19 (BLA)
FDA decision on KTE-X19 for the treatment of adult patients with relapsed or refractory mantle cell lymphoma
08/10/2020
Trevena, Inc.
IV Oliceridine (Resubmitted NDA)
FDA decision on IV Oliceridine for the management of moderate-to-severe acute pain
08/07/2020
DBV Technologies S.A. -
Viaskin Peanut (BLA)
FDA decision on Viaskin Peanut for treatment of peanut allergy
08/05/2020
Ultragenyx Pharmaceutical Inc
UX007 (triheptanoin) (NDA)
FDA decision on for UX007 for treatment of Long-chain Fatty Acid Oxidation Disorders
07/31/2020
Verrica Pharmaceuticals Inc.
VP-102 (cantharidin 0.7% Topical Solution) (NDA)
FDA decision on VP-102 for the Treatment of Molluscum Contagiosum
07/13/2020
Endo International plc
Collagenase clostridium histolyticum (BLA)
FDA decision on collagenase clostridium histolyticum (CCH) for cellulite in buttocks
07/06/2020
Heron Therapeutics Inc.
HTX-011 (Resubmitted NDA)
FDA decision on HTX-011 for the management of postoperative pain
06/26/2020
Buy this Content


pharma 051017 01apr20 Today's Daily Dose brings you news about AVEO's NDA submission for Tivozanib in renal cell carcinoma; EyeGate's encouraging data in a pilot study of dry eye; Kiniksa's progress in COVID-19 program; delay in the timeline of ProQR Therapeutics' clinical trial read-outs, near-term catalysts of Trevi; and the launch of VIVUS telemedicine portal.
pharma 010919 31mar20 Today's Daily Dose brings you news about Akero's big day; Immunovant's Thyroid Eye Disease trial results; Court ruling in Amarin's patent suit related to Vascepa, Savara's update on its ongoing clinical trials in light of the coronavirus crisis; Johnson & Johnson's progress in its COVID-19 vaccine program.
biotech march27 Today's Daily Dose brings you news about BioSig Technologies' foray into COVID-19 drug development, FDA approval of Bristol-Myers' multiple sclerosis drug, delay in FDA panel review of Intercept Pharma's NASH drug candidate, and positive results of VBL Therapeutics' ovarian cancer trial.
Read More
Drugstore chain Walgreens and courier services provider Postmates said they have expanded on-demand delivery to more than 7,000 Walgreens stores nationwide. The companies expect the service will help capitalize on the rising need for home delivery amid the coronavirus pandemic. The expansion will enable consumers in cities across the country to get home delivery of health and wellness items.
As the coronavirus continues to rage across the world killing thousands and infecting more, three countries - Spain, the United Kingdom and France - reported their biggest overnight jump in deaths since the start of the pandemic. Spain's coronavirus death toll rose by 849 cases overnight to 8,189. Britain's Health Ministry reported a record daily coronavirus toll of 381, more than double the n
Shares of Tanger Factory Outlet Centers, Inc. (SKT) are sinking 14 percent in Wednesday's trading at $4.29. The shares have traded in a range of $4.05 to $20.66 in the past 52 weeks. Tuesday, Tanger said it is withdrawing its financial outlook for fiscal 2020 due to the uncertainty regarding the...
Read More
>