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FDA Calendar

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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.

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Date
Company Name
Ticker
Drug
Event
Outcome
Details
11/30/2015
Repros Therapeutics Inc.
Enclomiphene citrate product candidate ( formerly known as Androxal)
FDA decision on Androxal for secondary hypogonadism
11/30/2015
Repros Therapeutics Inc.
Enclomiphene (formerly Androxal) (NDA)
FDA decision on Enclomiphene for secondary hypogonadism in overweight men
11/27/2015
Bristol-Myers Squibb Co.
Opdivo (sBLA)
FDA decision on Opdivo for expanded use in treating previously untreated patients with unresectable or metastatic melanoma
11/11/2015
Roche Holding AG
Cobimetinib (NDA)
FDA decision on Cobimetinib for advanced melanoma
11/11/2015
EXELIXIS INC
Cobimetinib (NDA)
FDA decision on Cobimetinib for treatment of patients with BRAF V600 mutation-positive advanced melanoma
11/04/2015
GlaxoSmithKline PLC
GSK.L, GSK
Mepolizumab (BLA)
FDA decision on Mepolizumab as an add-on maintenance treatment for severe asthma with eosinophilic inflammation.
11/03/2015
Repros Therapeutics Inc.
Enclomiphene (formerly Androxal) (NDA)
FDA panel to review Enclomiphene for secondary hypogonadism in overweight men
10/27/2015
Amgen Inc.
Talimogene laherparepvec (NDA)
FDA decision on Talimogene laherparepvec for advanced melanoma
10/27/2015
Amgen Inc.
Talimogene Laherparepvec (BLA)
FDA decision on Talimogene Laherparepvec in combination with Keytruda for advanced melanoma
10/24/2015
MERRIMACK PHARMACEUTICALS, INC.
MM-398 (NDA)
FDA decision on MM-398 for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy
10/21/2015
Relypsa Inc
Patiromer for Oral Suspension (NDA)
FDA decision on Patiromer for the treatment of hyperkalemia
10/12/2015
Collegium Pharmaceutical, Inc
Xtampza ER (NDA)
FDA decision on Xtampza ER, an abuse-deterrent analgesic, for chronic pain
10/02/2015
Merck & Co Inc.
Keytruda (sBLA)
FDA decision on Keytruda for the treatment of patients with advanced non-small cell lung cancer
09/11/2015
Collegium Pharmaceutical, Inc
Xtampza ER (NDA)
FDA panel to review Xtampza ER, an abuse-deterrent analgesic, for chronic pain
09/08/2015
Synageva BioPharma Corp.
Kanuma (BLA)
FDA decision on Kanuma for the treatment of lysosomal acid lipase deficiency
PharmaReport-090115.jpg Nevro Corp. has submitted its preliminary response to the Patent Trial and Appeals Board, or PTAB, in response to two petitions for inter partes review filed by a unit of Boston Scientific Corp., challenging the validity of Nevro's patent no. 8,359,102. A decision by the PTAB to either institute or deny review of the petition is expected by December 1st, 2015.
PharmaReport-090115.jpg TiGenix NV's (TGXSF.OB) lead compound Cx601 has met the primary endpoint in a phase III trial in Crohn's disease patients with complex perianal fistulas. Based on the positive phase III results, the company plans to submit a Marketing Authorisation Application to EMA early 2016.
PharmaReport-083015.jpg Telesta Therapeutics Inc's (TST.TO) Biologics License Application for MCNA for non-muscle invasive bladder cancer has been accepted by the FDA for priority review, and the decision date has been set for February 27, 2016.
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Those who routinely take midday naps may enjoy lower overall blood pressure, according to a new study from researchers at the European Society of Cardiology Congress. For the study the researchers examined 200 men and 186 women with an average age of 61.4 years old. Each of the participants had previously been diagnosed with arterial hypertension.
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