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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
Roche Holding AG
Baloxavir Marboxil (NDA)
FDA decision on Baloxavir Marboxil for the treatment of acute, uncomplicated influenza in people 12 years and older
12/24/2018
Jazz Pharmaceuticals plc
Solriamfetol (NDA)
FDA decision on Solriamfetol for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea
12/20/2018
SAGE Therapeutics, Inc.
Brexanolone IV (NDA)
FDA decision on Brexanolone IV for the treatment of postpartum depression
12/19/2018
Merck & Co Inc.
KEYTRUDA (sBLA)
FDA decision on KEYTRUDA as a treatment for previously treated patients with advanced hepatocellular carcinoma
11/09/2018
EyePoint Pharmaceuticals, Inc.
Durasert micro-insert (NDA)
FDA decision on Durasert micro-insert for non-infectious posterior segment uveitis
11/05/2018
EyePoint Pharmaceuticals, Inc.
Durasert (NDA)
FDA decision on Durasert for posterior segment uveitis
11/05/2018
Coherus Biosciences, Inc.
CHS-1701 (Resubmitted BLA)
FDA decison on CHS-1701, a biosimilar version of Neulasta
11/03/2018
AcelRx Pharmaceuticals Inc.
DSUVIA (Resubmitted NDA)
FDA decision on DSUVIA for the management of acute moderate to severe pain in adults in medically monitored settings
11/03/2018
Trevena, Inc.
OLINVO (NDA)
FDA panel to review OLINVO for management of moderate to severe acute pain
11/02/2018
Merck & Co Inc.
KEYTRUDA (sBLA)
FDA decision on Keytruda in combination with carboplatin-paclitaxel or nab-paclitaxel as a first-line treatment for metastatic squamous NSCLC
10/30/2018
Regeneron Pharmaceuticals
cemiplimab (BLA)
FDA decision on cemiplimab for metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC
10/28/2018
TherapeuticsMD
TX-001HR (NDA)
FDA decision on TX-001HR for vasomotor symptoms due to menopause
10/28/2018
Jazz Pharmaceuticals plc
Xyrem oral solution, CIII (sNDA)
FDA decision on Xyrem oral solution, CIII, to treat cataplexy and excessive daytime sleepiness in pediatric narcolepsy patients
10/27/2018
Merck & Co Inc.
Doravirine (NDA)
FDA decision for use of Doravirine with lamivudine and tenofovir disoproxil fumarate for HIV
10/23/2018
Regeneron Pharmaceuticals
DUPIXENT (sBLA)
FDA decision on DUPIXENT for moderate-to-severe asthma
10/20/2018
pharma-july2-071318.jpg Here are some of the pharma/biotech stocks and upcoming events to keep an ear out for in the coming week.
pharma-daily-071118.jpg Today's Daily Dose brings you news about stock offering of Assembly Biosciences, AcelRx Pharmaceuticals and Myovant Sciences; anticipated milestones of Ovid Therapeutics for the second half of this year; European Commission's approval of Akcea's TEGSEDI; Achieve Life Sciences' progress with Cytisine as an aid to smoking cessation and a regulatory event to watch out for today.
lethalinjection-july1.jpg Pharmaceutical company Alvogen has accused the state of Nevada and the department of corrections for illegally acquiring Midazolam in the upcoming execution of Scott Raymond Dozier, slated to take place on Wednesday, July 11, 2018, at the Ely State Prison in Ely, Nevada.
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