Biotech Catalyst


20-Jun-2018 17:25 PM



   One of the best trade strategies with high reward and low risk for a biotech trader is the catalyst trade. The trader can trade on the run-up upcoming biotech data, corporate earnings report and pending FDA approval for Prescription Drug User Fee Act (PDUFA). For the traders and investors looking for the biotech catalyst, our site provided this information. For biotech upcoming data quarter by quarter of phase II and III

   Investor and trader that look for the temporary run-up to FDA decision for PDUFA, our calendar here

    Furthermore, there is six biotech with pending FDA approval for June and one pending CHMP approval. Let's take a look at these seven biotech companies.

  1. Achaogen Inc (AKAO)-  priority review for Plazomicin date is June 25, 2018.  Back on May 02, 2018 the FDA Advisory Committee voted unanimously in favor of Plazomicin for treatment of adults with Complicated Urinary Tract Infections (UTI), the result (15-0). But the second vote for treatment of bloodstream infections in patients, the result was (4-11-0).  As a result, stock down -24.76% for the next day trading. Here is the company press release
  2. Merk & Co, Inc (MRK)- FDA accepted and Grant Priority review to Merck's Supplemental Biologics License Application (sBLA) for KEYTRUDA® for the treatment of Advanced Cervical Cancer. Date of June 28, 2018
  3.  Puma Biotechnology (PBYI) on June 12, the company 8-k announced that the Committee for Medicinal Products for Human Use (CHMP) will be conducting an oral hearing to discuss the reexamination for neratinib Marketing Authorization Application (MAA) on June 26, 20018.
  4. Pain Therapeutics, Inc (PTIE)- Advisory Committee Meeting for Remoxy ER, June 26th
  5. GW Pharmaceuticals plc (GWPH)-  ON April 19, 2018, unanimous positive results of FDA Advisory Committee meeting for first plant-based pharmaceuticals Cannabidiol treatment for seizures in patients with two rare, severe form of epile. The PDUFA goal date for completion of NDA review of cannabidiol oral solution is June 27, 2018. 
  6. Array Biopharma Inc (ARRY)-  June 30, 2018, PDUFA date for encorafenib and binimetinib NDAs in BRAF-mutant melanoma.
  7. Dermira, Inc (DERM)-  FDA decision on glycopyrronium tosylate New Drug Application expected by June 30, 2018. 

   All of these biotechs are with catalyst just a week away, one of the side note is Achaogen, Inc (AKAO) short float interest is 56.39% or about 14.02M shares sold short. This is the highest. Will this stock have an epic short squeeze if FDA approve? or did the short know something? 

   What are your opinions of the FDA approval chances on these biotechs? We love to hear your opinions. 

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