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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
Antares Pharma Inc.
QuickShot Testosterone (NDA)
FDA decision on QST as treatment for low testosterone associated with hypogonadism
10/20/2017
AcelRx Pharmaceuticals Inc.
DSUVIA (NDA)
FDA decision on DSUVIA for the treatment of patients with moderate-to-severe acute pain in a medically supervised setting
10/12/2017
Mylan N.V.
Pegfilgrastim (BLA)
FDA decision on Pegfilgrastim as a proposed biosimilar to Amgen's Neulasta
10/09/2017
Flexion Therapeutics, Inc.
Zilretta (NDA)
FDA decision on Zilretta for treatment of patients with osteoarthritis of the knee
10/06/2017
Jazz Pharmaceuticals plc
VYXEOS (NDA)
FDA decision on VYXEOS for the treatment of acute myeloid leukemia
10/01/2017
FDA approved VYXEOS for the treatment of acute myeloid leukemia on Aug.3, 2017
PTC Therapeutics Inc.
Translarna (NDA)
FDA panel to review Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy
09/28/2017
Intellipharmaceutics International
Rexista (NDA under 505(b)(2))
FDA decision on Rexista Rexista™, an abuse- and alcohol-resistant, controlled-release oral oxycodone formulation
09/25/2017
Bristol-Myers Squibb Co.
Opdivo (sBLA)
FDA decision on Opdivo for use in patients with hepatocellular carcinoma after prior sorafenib therapy
09/24/2017
Johnson & Johnson
Sirukumab (BLA)
FDA decision on Sirukumab for the treatment of adult patients with moderately to severely active rheumatoid arthritis
09/23/2017
Merck & Co Inc.
Keytruda (sBLA)
FDA decision on Keytruda for treatment of advanced gastric or gastroesophageal junction adenocarcinoma
09/22/2017
GlaxoSmithKline PLC
GSK.L, GSK
Trelegy Ellipta
FDA decision on Trelegy Ellipta for appropriate patients with COPD
09/21/2017
Pfizer Inc.
SUTENT(sNDA)
FDA panel to review SUTENT for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy
09/19/2017
FDA panel voted 6 in favor and 6 against recommending approval of SUTENT for new indication
Neos Therapeutics, Inc.
NT-0201 (NDA)
FDA decision on NT-0201, an extended-release liquid suspension amphetamine formulation, for ADHD
09/15/2017
FDA approves Adzenys ER, formerly referred to as NT-0201, for ADHD
Amgen Inc.
ABP 215 (Biosimilar BLA)
FDA decision on ABP 215, a biosimilar candidate to Roche's Avastin
09/14/2017
FDA approves MVASI (Avastin biosimilar)
GlaxoSmithKline PLC
GSK.L, GSK
Shingrix(BLA)
FDA panel to review Shingrix for the prevention of herpes zoster (shingles) in people aged 50 years or over.
09/13/2017
FDA panel unanimously recommends approval of Shingrix
Flexion-092217.jpg Shares of Flexion Therapeutics Inc. (FLXN) are up 40% so far this year, well ahead of the iShares NASDAQ Biotech Index ETF (IBB), which has returned only 25% during the same period.
pharma-092117.jpg Today's Daily Dose brings you news about Acceleron Pharma's public offering; pre-market approval of Abiomed's Impella RP heart pump; FDA panel review of Aerie's Rhopressa; NASDAQ notification for Intellipharmaceutics; positive data from Karyopharm's phase II/III SEAL study and Pfizer's suit against Johnson & Johnson.
Pharma-091417.jpg Today's Daily Dose brings you news about Biohaven's collaboration with Alzheimer's Disease Cooperative Study; CHMP positive opinion on GlaxoSmithKline's Trelegy Ellipta and TESARO's ZEJULA; Orphan Drug designated Motif's investigational drug candidate, Iclaprim, and FDA approval of Neos' third extended release product for the treatment of ADHD.
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Vitamin World, a retailer of vitamins and health supplements, filed for bankruptcy protection and said it has identified 51 stores for closure during the bankruptcy process. The company filed for Chapter 11 reorganization in Delaware Bankruptcy Court on Tuesday. It has listed liabilities of more than $43.6 million and estimated assets in a range of $50 million to $100 million.
CVS Pharmacy will be launching health and wellness vending machines across the country to offer healthy snacks, personal care items as well as over-the-counter products to the customers on the go. The automated machines will be placed in airports, hotels, transportation hubs etc. and can be accessed using credit and debit cards.
Drug maker AstraZeneca (AZN) announced the full results of Phase III FLAURA trial, which support TAGRISSO's clear potential as a new standard of care (SoC) in the 1st-line treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung...
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