FDA Calendar

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
Kite Pharma, Inc.
Axicabtagene ciloleucel (KTE-C19) (BLA)
FDA decision on KTE-C19 for Non-Hodgkin Lymphoma
Ultragenyx Pharmaceutical Inc
Recombinant human beta-glucuronidase (BLA)
FDA decision on rhGUS for the treatment of Mucopolysaccharidosis VII
Eagle Pharmaceuticals Inc
Pemetrexed Injection (NDA)
FDA decision on Pemetrexed for the treatment of Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer, and Mesothelioma
PTC Therapeutics Inc.
Translarna (NDA)
FDA decision on Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy
Antares Pharma Inc.
QuickShot Testosterone (NDA)
FDA decision on QST as treatment for low testosterone associated with hypogonadism
AcelRx Pharmaceuticals Inc.
FDA decision on DSUVIA for the treatment of patients with moderate-to-severe acute pain in a medically supervised setting
Mylan N.V.
Pegfilgrastim (BLA)
FDA decision on Pegfilgrastim as a proposed biosimilar to Amgen's Neulasta
Flexion Therapeutics, Inc.
Zilretta (NDA)
FDA decision on Zilretta for treatment of patients with osteoarthritis of the knee
Jazz Pharmaceuticals plc
FDA decision on VYXEOS for the treatment of acute myeloid leukemia
Intellipharmaceutics International
Rexista (NDA under 505(b)(2))
FDA decision on Rexista Rexista™, an abuse- and alcohol-resistant, controlled-release oral oxycodone formulation
Bristol-Myers Squibb Co.
Opdivo (sBLA)
FDA decision on Opdivo for use in patients with hepatocellular carcinoma after prior sorafenib therapy
Merck & Co Inc.
Keytruda (sBLA)
FDA decision on Keytruda for treatment of advanced gastric or gastroesophageal junction adenocarcinoma
Amgen Inc.
ABP 215 (Biosimilar BLA)
FDA decision on ABP 215, a biosimilar candidate to Roche's Avastin
Mylan N.V.
MYL-1401O (BLA)
FDA decision on MYL-1401O as a proposed biosimilar to Roche's Herceptin
Teva Pharmaceutical Industries Limited
SD-809 (NDA)
FDA decision on SD-809 for the treatment of tardive dyskinesia
Pharma-062017.jpg Today's Daily Dose brings you news about Amgen's regulatory catalyst for next February; Axsome's new addition to its Board; Clovis' ARIEL3 results; Exelisis' CABOSUN study; Lipocine's study results of oral testosterone candidate LPCN 1021; FDA approval of Neos' ADHD medication and Seattle Genetics' CASCADE disappointment.
Pharma-061317.jpg Today's Daily Dose brings you news about Celgene's MAGNIFY study results; FDA approval of Ipsen's expanded use of Dysport; Genmab getting milestone payment after FDA approves expanded use of Darzalex and encouraging trial results of Xencor's XmAb5871 in patients with active IgG4-Related Disease.
SageTherapeutics-061517.jpg For SAGE Therapeutics Inc. (SAGE), next quarter is going to be a make-or-break period as an important catalyst is coming its way.
The USDA decision to completely suspend Brazil's imports of fresh meat, announced yesterday, raised market fears over the risk that other relevant buyers will halt the entry of Brazilian protein. The concern is due to the very short timespan between the nonconformities alleged by the Americans and investigations known as "Weak Meat Operation."
The U.S. has suspended all imports of fresh beef from Brazil due to recurring concerns about the safety of the products. The suspension of shipments from Brazil, the fifth largest exporter of beef to the U.S., will remain in place until the Brazilian Ministry of Agriculture takes corrective action, the U.S. Department of Agriculture or USDA said in a statement.
Senate Republicans plan to vote on their bill to repeal and replace Obamacare as soon as next week, although the results of a CBS News poll show the vast majority of Americans are unclear about what the legislation will do. Seventy-six percent of Americans said they have not heard enough about the GOP healthcare plan.
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