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
Dynavax Technologies Corp
FDA decision on HEPLISAV-B for immunization of adults against hepatitis B infection
Spectrum Pharmaceuticals Inc
EOquin (NDA)
FDA decision on EOquin for the treatment of non-invasive bladder cancer
Lexicon Pharmaceuticals Inc.
Telotristat Etiprate (NDA)
FDA decision on Telotristat Etiprate for the treatment of carcinoid syndrome
Valeant Pharmaceuticals International
Brodalumab (BLA)
FDA decision on Brodalumab for treatment of patients with moderate-to-severe plaque psoriasis.
Gilead Sciences Inc.
Tenofovir Alafenamide (TAF) (NDA)
FDA decision on TAF for treatment of chronic hepatitis B
Amgen Inc.
Enbrel (sBLA)
FDA decision on Enbrel for the expanded use to treat pediatric patients with chronic severe plaque psoriasis.
Regeneron Pharmaceuticals
Sarilumab (BLA)
FDA decision on Sarilumab for the treatment of patients with rheumatoid arthritis
Sarilumab (BLA)
FDA decision on Sarilumab for the treatment of patients with rheumatoid arthritis.
Regeneron Pharmaceuticals
Sarilumab (BLA)
FDA decision on Sarilumab for the treatment of patients with active, moderate-to-severe rheumatoid arthritis
Medivation Inc.
FDA decision on XTANDI in metastatic castration-resistant prostate cancer with data from head-to-head studies of Enzalutamide Vs Bicalutamide
OPKO Health Inc.
RAYALDEE (NDA Resubmission)
FDA decision on RAYALDEE for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 CKD and vitamin D insufficiency.
FDA approved RAYALDEE to treat secondary hyperparathyroidism with Vitamin D Insufficiency in Stage 3-4 CKD on Jun.21, 2016
Roche Holding AG
Atezolizumab (BLA)
FDA decision on Atezolizumab for the treatment of specific type of lung cancer
Allergan Inc.
SER120 (low-dose desmopressin nasal spray) NDA
FDA panel to review SER120 for the treatment of adult onset nocturia
Nicox S.A.
AC-170 (NDA)
FDA decision on AC-170 for the treatment of ocular itching associated with allergic conjunctivitis
Egalet Corp.
FDA decision on ARYMO ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate
Pharma-060716.jpg Shares of Regulus Therapeutics Inc. (RGLS) plunged over 53% in extended trading on Monday, following clinical hold on the company's drug candidate RG-101 for the treatment of chronic hepatitis C virus.
Pharma-061016.jpg Shares of Pluristem Therapeutics Inc. (PSTI) rose over 11% on Wednesday, following positive data from the company's preclinical studies of PLX-PAD cells in the treatment of Duchenne muscular dystrophy.
Pharma-062216.jpg Shares of Prima BioMed Ltd. (PBMD) were up over 10% in extended trading on Tuesday, following encouraging initial safety data from the first cohort of patients in its phase IIb clinical study of IMP321.
Living near an airport could cause a spike in your blood pressure, according to a new study. The study, presented at the European Society of Cardiology meeting in Sophia Antipolis, France, included 201 people between the ages of 40 and 66. Approximately half lived in an area with high levels of aircraft noise for more than three years.
Damage caused by walking or running could promote melanoma on the soles of the feet, a new study shows. The study, published in the New England Journal of Medicine, reviewed the medical data between January 1990 and December 2014 revealed 123 patients at Shinshu University Hospital of people who had been diagnosed with melanoma on the soles of their feet.
There are risks associated with getting a tattoo, according to the U.S. Food and Drug Administration. There are increasing reports of people developing infections from contaminated tattoo inks and having bad reactions to the inks, according to Dr. Linda Katz, director of the FDA's Office of Cosmetics and Colors.
comments powered by Disqus