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
Alnylam Pharmaceuticals Inc.
FDA decision on expanded use OXLUMO for the reduction of plasma oxalate in the treatment of patients with advanced primary hyperoxaluria type 1 (PH1)
FDA approved OXLUMO for expanded use in advanced primary hyperoxaluria Type 1 on Oct.6, 2022-
scPharmaceuticals Inc.
FUROSCIX (Resubmitted NDA)
FDA decision on FUROSCIX for the treatment of congestion in patients with worsening heart failure,
FDA approved FUROSCIX for the at-home treatment of congestion in Chronic Heart Failure on Oct.10, 2022-
AMP-100 (NDA)
FDA decision on AMP-100 for ocular surface anesthesia and intraoperative pain management during ocular surgery.
FDA approved AMP-100, under brand name IHEEZO, for ocular surface anesthesia on Sep.27, 2022 -
FDA decision on BRUKINSA in the expanded use of treating adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma
On Jun.13,2022, the FDA notified the company that the decision date has been extended to Jan.20, 2023-
GSK plc
Daprodustat (NDA)
FDA panel to review Daprodustat for the potential treatment of anaemia due to chronic kidney disease (CKD) in adult patients on dialysis and not on dialysis.
FDA panel voted 13 to 3, supporting the use of Daprodustat only in adult dialysis patients with anaemia of chronic kidney disease -
Y-mAbs Therapeutics, Inc.
OMBLASTYS (Resubmitted BLA)
FDA panel to review OMBLASTYS for Neuroblastoma
FDA panel unanimously gave thumbs down to Omburtamab on Oct. 28, 2022.-
Amicus Therapeutics Inc.
Cipaglucosidase alfa, a component of AT-GAA (BLA)
FDA decision on Cipaglucosidase alfa, a component of AT-GAA, for Pompe disease
On Oct.28, 2022, the FDA issued Deferred Action Letter on AT-GAA as the required manufacturing site inspection hasn't been completed yet -
Ipsen SA
Palovarotene (Resubmitted NDA)
FDA panel to review Palovarotene for the prevention of heterotopic ossification in adults and children with fibrodysplasia ossificans progressiva
On Oct.25, 2022, the FDA informed its decision to postpone the planned Endocrinologic and Metabolic Drugs Advisory Committee meeting-
AstraZeneca PLC
PT027. (NDA)
FDA panel to review PT027 in proposed indication of as-needed treatment or prevention of bronchoconstriction and for the prevention of exacerbations in patients with asthma 4 years of age and older
FDA panel voted 16 to 1 that the data support a favorable benefit risk assessment for the use of PT027 for the treatment of asthma in people aged 18 years and older. In children aged 4 to 11 years, the panel voted 16 to 1 against its approval. In adolescents aged 12 to 17 years, the panel voted 9 to 8 that the data do not support a favorable benefit risk assessment for the use of PT027 for the treatment of asthma. -
Sabizabulin (EUA)
FDA panel to discuss Emergency Use Authorization of Sabizabulin for hospitalized COVID-19 patients who are at high risk for ARDS.
FDA panel voted 8-5 that the known and potential benefits of Sabizabulin for the treatment of adult patients hospitalized with COVID-19 at high risk of ARDS do not outweigh its known and potential risks, on Nov. 10, 2022.-

ALSO READ - COVID-19 Drugs In Development Calendar which lists Companies that are in Race to find a Treatment or Vaccine for the Novel Coronavirus.

Buy this Content

Spectrum Pharmaceuticals Inc.'s (SPPI) Poziotinib, proposed for the treatment of patients with previously treated locally advanced or metastatic non-small cell lung cancer harboring HER2 exon 20 insertion mutations, has been denied FDA approval as expected. In September, the FDA Oncologic Drugs...
BioMarin Pharmaceutical Inc. (BMRN) said the company was recently notified by the FDA that, at this time, the Agency no longer plans to hold an advisory committee meeting to discuss the BLA for ROCTAVIAN that is currently under review for adults with severe Hemophilia A. The FDA granted Regenerative...
AbbVie (ABBV) announced Wednesday that the European Commission approved SKYRIZI (risankizumab) for the treatment of moderate to severe active Crohn's disease. It is the first specific interleukin-23 or IL-23 inhibitor in the European Union for the treatment of adults with moderately to severely active...
Read More
After a recent lull, U.S. Covid cases and casualties are rising again. A 4 percent increase in Covid-related casualties has been reported in the United States in the last two weeks, according to the New York Times. New cases of coronavirus infection have increased by five percent in the same period.
A new study conducted by researchers at the University of Colorado Cancer Center has revealed that the frequency with which certain cancers come back can be brought down to a certain degree by irradiating certain set of lymph nodes near the tumour rather than all of them together. The study was published...
After a recent lull, U.S. Covid cases and casualties are rising again. 4 percent fall in Covid-related casualties has been reported in the United States in the last two weeks, according to the New York Times. New cases of coronavirus infections have increased by seven percent in the same period. The United States on Wednesday reported 111386 new cases of coronavirus infections. With this, the
Read More