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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
Theravance Biopharma Inc.
YUPELRI (NDA)
FDA decision on YUPELRI for moderate to very severe COPD
11/13/2018
FDA approved YUPELRI on Nov.9, 2018
Mylan N.V.
YUPELRI (NDA)
FDA decision on YUPELRI for moderate to very severe COPD
11/13/2018
FDA approved YUPELRI on Nov.9, 2018
Merck & Co Inc.
KEYTRUDA (sBLA)
FDA decision on KEYTRUDA as a treatment for previously treated patients with advanced hepatocellular carcinoma
11/09/2018
FDA approves KEYTRUDA as a treatment for previously treated patients with advanced hepatocellular carcinoma
EyePoint Pharmaceuticals, Inc.
YUTIQ (NDA)
FDA decision on YUTIQt for non-infectious posterior segment uveitis
11/05/2018
FDA Approved YUTIQ on Oct.15, 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
FDA approved DSUVIA on Nov.2, 2018
Coherus Biosciences, Inc.
CHS-1701 (Resubmitted BLA)
FDA decison on CHS-1701, a biosimilar version of Neulasta
11/03/2018
FDA approved CHS-1701, a biosimilar version of Neulasta, under brand name UDENYCA, on Nov.2, 2018
Theratechnologies Inc.
EGRIFTA (sNDA)
FDA decision on EGRIFTA regarding a new single-vial formulation
11/03/2018
FDA Approved EGRIFTA on Nov 5
Trevena, Inc.
OLINVO (NDA)
FDA decision on OLINVO for the management of moderate to severe acute pain
11/02/2018
FDA issues Complete Response Letter for OLINVO
SAGE Therapeutics, Inc.
Brexanolone 5 mg/mL intravenous injection (NDA)
FDA panel to review Brexanolone for postpartum depression
11/02/2018
FDA panel backs Brexanolone (ZULRESSO) for postpartum depression
Bausch Health Companies Inc.
BHC, BHC.TO
BRYHALI Lotion (NDA)
FDA decision on BRYHALI Lotion for plaque psoriasis in adult patients
Early Nov 2018
BRYHALI Lotion secured final approval from FDA on Nov.6, 2018
Alkermes plc
ALKS 5461, a fixed dose combination of Buprenorphine & Samidorphan sublingual tablets (NDA)
FDA panel to review ALKS 5461 for adjunctive treatment of major depressive disorder
11/01/2018
FDA panel votes against approval of ALKS 5461
Pfizer Inc.
lorlatinib (NDA)
FDA decision on lorlatinib for the treatment of patients with ALK-positive metastatic non-small cell lung cancer
Nov 2018
FDA approved lorlatinib on Nov.2, 2018
Novartis AG
Hyrimoz (351(k) BLA)
FDA decision on Hyrimoz as biosimilar version of Humira
Nov 2018
FDA Approved Hyrimoz on Oct 31
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
FDA approves Keytruda in combination with carboplatin-paclitaxel or nab-paclitaxel as a first-line treatment for metastatic squamous NSCLC on Oct.30, 2018
TherapeuticsMD
TX-001HR (NDA)
FDA decision on TX-001HR for vasomotor symptoms due to menopause
10/28/2018
FDA Approved TX-001HR on Oct 29


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