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
Immunomedics Inc.
Sacituzumab govitecan (BLA)
FDA decision on Sacituzumab govitecan for treatment of metastatic triple-negative breast cancer
Roche Holding AG
Baloxavir Marboxil (NDA)
FDA decision on Baloxavir Marboxil for the treatment of acute, uncomplicated influenza in people 12 years and older
Jazz Pharmaceuticals plc
Solriamfetol (NDA)
FDA decision on Solriamfetol for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea
SAGE Therapeutics, Inc.
Brexanolone IV (NDA)
FDA decision on Brexanolone IV for the treatment of postpartum depression
Merck & Co Inc.
FDA decision on KEYTRUDA as a treatment for previously treated patients with advanced hepatocellular carcinoma
EyePoint Pharmaceuticals, Inc.
Durasert micro-insert (NDA)
FDA decision on Durasert micro-insert for non-infectious posterior segment uveitis
EyePoint Pharmaceuticals, Inc.
Durasert (NDA)
FDA decision on Durasert for posterior segment uveitis
Coherus Biosciences, Inc.
CHS-1701 (Resubmitted BLA)
FDA decison on CHS-1701, a biosimilar version of Neulasta
Coherus Biosciences, Inc.
CHS-1701 (resubmitted NDA)
FDA decision on CHS-1701 for Neulasta
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
Trevena, Inc.
FDA panel to review OLINVO for management of moderate to severe acute pain
Merck & Co Inc.
FDA decision on Keytruda in combination with carboplatin-paclitaxel or nab-paclitaxel as a first-line treatment for metastatic squamous NSCLC
Regeneron Pharmaceuticals
cemiplimab (BLA)
FDA decision on cemiplimab for metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC
TX-001HR (NDA)
FDA decision on TX-001HR for vasomotor symptoms due to menopause
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
pharma-july-072018.jpg As another week comes to a close, let's take a look back at some of the stories that made headlines in the pharma space, and look ahead to what's in store in the coming week.
pharma-daily-071818.jpg Today's Daily Dose brings you news about the IPO of a cannabis firm; stock offerings of Evolus and Cara, upcoming regulatory catalyst of Immunomedics and an update on CTI Biopharma's Type B meeting with the FDA for its lead product candidate Pacritinib.
pharma-daily-071118.jpg Today's Daily Dose brings you news about IPOs of Crinetics Pharma and Rubius; secondary offerings of Cara, Oragenics and CytomX, and promising efficacy of Cellectar Biosciences' drug candidate CLR 131 observed in a single patient in a phase II trial.
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Can common bacteria like the one that causes strep throat in children cause severe change in a child's behavior overnight?
Women are said to experience a more severe outcome from influenza A virus infection and recover slower than men, even when the viral load is the same in both the genders.
Frequent use of digital media is associated with the development of attention-deficit/hyperactivity disorder (ADHD) symptoms during adolescence, finds a new study conducted by a team of researchers of the University of Southern California.
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