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FDA Calendar

PDUFA dates and FDA Panel Review dates are very important catalysts because they are ‘make or break events’ for biotech stocks.

The goal date set by the FDA for announcing its decision on a company’s New Drug Application/ Biologics License Application/sBLA/sNDA after reviewing the applications is known as the PDUFA date.

Usually, the stocks experience a run-up going into the scheduled FDA Approval decision/FDA Panel review events. So, having prior knowledge of the key dates goes a long way toward maximizing profit or minimizing loss while investing in the 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 RTT Biotech Investor and our Biotech Home Page.
Company Name
Drug
Event
Outcome
Details
Gilead Sciences Inc.
(GILD)
Tecartus (sBLA)
10/01/2021
FDA decision on Tecartus for the treatment of adult patients with relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia
FDA approves Tecartus for adults with relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia on Oct. 1,2021-
United Therapeutics Corp
(UTHR)
Tyvaso DPI (NDA)
Oct 2021
FDA decision on Tyvaso DPI for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease
FDA issued a Complete Response Letter for Tyvaso DPI for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease on Oct.15, 2021-
MannKind Corp.
(MNKD)
Tyvaso DPI (NDA)
Oct 2021
FDA decision on Tyvaso DPI for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease
FDA issued a Complete Response Letter for Tyvaso DPI for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease on Oct.15, 2021-
ChemoCentryx Inc.
(CCXI)
Avacopan (NDA)
10/07/2021
FDA decision on Avacopan for the Treatment of ANCA-Associated Vasculitis
FDA approves TAVNEOS (avacopan) for ANCA-Associated Vasculitis on Oct. 08, 2021-
Takeda Pharmaceutical Company Limited
(TKPHF.PK, TAK)
Maribavir oral tablets (NDA)
10/07/2021
FDA panel to review Maribavir for the treatment of adults with post-transplant cytomegalovirus infection and/or disease, including infections resistant and/or refractory to ganciclovir, valganciclovir, cidofovir, or foscarnet.
FDA panel unanimously recommended the use of Maribavir for the treatment of adults with post-transplant cytomegalovirus infection and/or disease, including infections resistant and/or refractory to ganciclovir, valganciclovir, cidofovir, or foscarnet on Oct.7, 2021-
Seagen Inc
(SGEN)
Tisotumab Vedotin (BLA)
10/10/2021
FDA decision on Tisotumab Vedotin for the treatment of patients with recurrent or metastatic cervical cancer
FDA granted accelerated approval to TIVDAK (tisotumab vedotin) for the treatment of recurrent or metastatic cervical cancer on Sep.20, 2021-
GENMAB A/S
(GMAB)
Tisotumab Vedotin (BLA)
10/10/2021
FDA decision on Tisotumab Vedotin for the treatment of patients with recurrent or metastatic cervical cancer
FDA granted accelerated approval to TIVDAK (tisotumab vedotin) for recurrent or metastatic cervical cancer on Sep.20, 2021-
AVADEL PHARMACEUTICALS PLC
(AVDL)
FT218 (NDA)
10/15/2021
FDA decision on FT218 for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Adults with Narcolepsy
On Oct.15, 2021, the FDA notified the company that the review of FT218 is still ongoing, and that action will likely not be taken in October. A new target action date is expected to be provided as soon as possible-
Oyster Point Pharma
(OYST)
OC-01 (varenicline) nasal spray (NDA)
10/17/2021
FDA decision on OC-01 for the treatment of signs and symptoms of dry eye disease
FDA approved OC-01, now referred to as TYRVAYA, for the treatment of the signs and symptoms of dry eye disease on Oct.18, 2021-
Omeros Corp.
(OMER)
Narsoplimab (BLA)
10/17/2021
FDA decision on Narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA)
FDA issued CRL for Narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA)on Oct. 18, 2021-

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