logo

FDA Calendar

Share 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.
Date
Company Name
Ticker
Drug
Event
Outcome
Details
10/30/2016
Regeneron Pharmaceuticals
Sarilumab (BLA)
FDA decision on Sarilumab for the treatment of patients with active, moderate-to-severe rheumatoid arthritis
10/30/2016
Regeneron Pharmaceuticals
Sarilumab (BLA)
FDA decision on Sarilumab for the treatment of patients with rheumatoid arthritis
10/30/2016
Sanofi
Sarilumab (BLA)
FDA decision on Sarilumab for the treatment of patients with rheumatoid arthritis.
10/22/2016
Medivation Inc.
XTANDI (sNDA)
FDA decision on XTANDI in metastatic castration-resistant prostate cancer with data from head-to-head studies of Enzalutamide Vs Bicalutamide
10/22/2016
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.
10/19/2016
Roche Holding AG
Atezolizumab (BLA)
FDA decision on Atezolizumab for the treatment of specific type of lung cancer
10/14/2016
Egalet Corp.
ARYMO ER (NDA)
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
09/25/2016
Amgen Inc.
ABP 501 (BLA)
FDA decision on ABP 501 as a biosimilar to AbbVie’s immunosuppressant Humira
09/25/2016
Amgen Inc.
ABP 501 (BLA)
FDA decision on ABP 501 for the treatment of plaque psoriasis, rheumatoid Arthritis
09/25/2016
Pain Therapeutics Inc
REMOXY (Resubmitted NDA)
FDA decision on REMOXY for patients with moderate-to-severe chronic pain
09/25/2016
DURECT Corp.
REMOXY (Resubmitted NDA)
FDA decision on REMOXY for patients with moderate-to-severe chronic pain
09/15/2016
Dynavax Technologies Corp
HEPLISAV-B (BLA)
FDA decision on HEPLISAV-B for immunization against hepatitis B infection in adults 18 years of age and older
FDA decision postponed to December 15, 2016
09/14/2016
Aralez Pharmaceuticals Inc.
YOSPRALA (Resubmitted NDA)
FDA decision on YOSPRALA for secondary prevention of cardiovascular disease
09/12/2016
Roche Holding AG
Atezolizumab (BLA)
FDA decision on Atezolizumab for the treatment of advanced bladder cancer
09/01/2016
Amgen Inc.
BLINCYTO (sBLA)
FDA decision on BLINCYTO for treatment of pediatric and adolescent patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia
Pharma-050416.jpg Prothena Corp. plc (PRTA) has a couple of catalysts to watch out for in the coming months, related to its three lead protein immunotherapy programs - NEOD001, PRX002 and PRX003.
Pharma-050316.jpg Shares of Flamel Technologies (FLML) were up over 7% on Monday, following FDA approval of Akovaz, a drug administered parenterally as a pressor agent to address clinically important hypotension in surgical settings.
Pharma-042916.jpg ACADIA Pharmaceuticals Inc.'s (ACAD) NUPLAZID has been approved by the FDA for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. NUPLAZID, which becomes the first and only medicine to be approved by the FDA for this indication, is expected to be launched in the U.S. next month.
More
Psychotherapy could be the best option for the treatment of chronic insomnia, according to a new study from researchers at the American College of Physicians. In a new report, the group suggested that the practice of cognitive behavioral therapy could be as effective but less risky than the prescription medication. "Sometimes we forget that sleep medications have the potential for serious . . ."
The increasing use of smartphones among teenagers may be the cause of struggle in some family homes, according to a news study from researchers at the Common Sense Media Group. For the study, overseen by Northwestern University, the researchers polled 1,240 parents about teen phone use. The researchers found that about half of the teens' parents described them as addicted to their phones.
Incidents of children sustaining brain injuries while on playgrounds in the U.S. has risen significantly in recent years, according to a new study from researchers at the Centers for Disease Control and Prevention. In their research, the CDC found that about 10 percent of all kids that experience a playground injury end up having a brain injury.
More
comments powered by Disqus