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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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Company Name
Ticker
Drug
Event
Date
Outcome
Details
Akcea Therapeutics Inc.
Inotersen
FDA decision on Inotersen for hereditary TTR amyloidosis (hATTR)
07/06/2018
Dermira Inc.
Glycopyrronium tosylate (NDA)
FDA decision on Glycopyrronium tosylate for primary axillary hyperhidrosis
06/30/2018
Merck & Co Inc.
KEYTRUDA (sBLA)
FDA decision on Keytruda for treatment of advanced cervical cancer
06/28/2018
GW Pharmaceuticals PLC
GWPH, GWP.L
Epidiolex (NDA)
FDA decision on Epidiolex for treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome
06/27/2018
Achaogen Inc.
Plazomicin (NDA)
FDA decision on Plazomicin for the treatment of complicated urinary tract infections, and bloodstream infections
06/25/2018
scPharmaceuticals Inc.
Furoscix (505(b)(2) NDA)
FDA decision on Furoscix for treatment of worsening, or decompensated, heart failure outside of the inpatient setting
06/23/2018
Teva Pharmaceutical Industries Limited
Fremanezumab (BLA)
FDA decision on Fremanezumab for the treatment of migraine
06/16/2018
Recro Pharma Inc.
IV Meloxicam (NDA)
FDA decision on IV Meloxicam for the management of moderate to severe pain
05/26/2018
Insys Therapeutics, Inc.
Buprenorphine Sublingual Spray (NDA)
FDA panel to review Buprenorphine Sublingual Spray for moderate-to-severe acute pain
05/22/2018
Dova Pharmaceuticals, Inc.
Avatrombopag (NDA)
FDA decision on Avatrombopag for the treatment of thrombocytopenia in patients with chronic liver disease
05/21/2018
Amgen Inc.
Aimovig (BLA)
FDA decision on Aimovig for the prevention of migraine
05/17/2018
Valeant Pharmaceuticals International
VRX, VRX.TO
PLENVU (NDA)
FDA decision on PLENVU for cleansing of the colon in preparation of colonoscopy
05/13/2018
Akcea Therapeutics Inc.
Volanesorsen (NDA)
FDA panel to review Volanesorsen for the treatment of familial chylomicronemia syndrome
05/10/2018
Lipocine Inc
TLANDO (NDA resubmission)
FDA decision on TLANDO for the proposed indication of testosterone replacement therapy in adult males for hypogonadism
05/08/2018
Achaogen Inc.
Plazomicin (NDA)
FDA panel to review NDA of Plazomicin for complicated urinary tract infections
05/02/2018
pharma-april23to29-042018.jpg The biotech sector witnessed a couple of hurrahs and heartaches this week. Now, let's take a look at the pharma/biotech stocks and upcoming events to keep an ear out for in the coming week.
pharma-daily-041918.jpg Today's Daily Dose brings you news about Rigel Pharma's stock offering; FDA panel support for GW Pharma's New Drug Application for Epidiolex; FDA approval of expanded use of AstraZeneca's TAGRISSO and Argos' decision to pull the plug on its ADAPT phase III trial.
pharma-041318.jpg Today's Daily Dose brings you news about an agreement between Pfenex and China NT Pharma; Bristol-Myers' near-term regulatory catalyst; Eloxx Pharma's progress with cystic fibrosis drug candidate and FDA clearance of Cantel Medical's ADVANTAGE PLUS Pass-Thru automated endoscope reprocessor.
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