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The Week Ahead In Biotech: Conferences, PDUFA Dates And IPOs

Shanthi Rexaline

Earnings is providing a much-needed boost to the biotech sector last week, with big-name companies like Eli Lilly And Co (NYSE: LLY) and Pfizer Inc. (NYSE: PFE) all trading at fresh 52-week highs in the aftermath of their respective earnings reports.

With the earnings season continuing in full swing, there's likely to be no dearth of catalysts, and these are some a biotech investor needs to be mindful about.


  • 14th Annual Congress on Gastroenterology & Hepatology – Aug. 6-7 in Osaka, Japan
  • 10th International Conference on Clinical and Cellular Immunology - Aug. 6-7 in Madrid, Spain
  • 8th Global Summit on Neuroscience and Neuroimmunology - Aug. 6-7 in Madrid, Spain
  • 26th European Neurology Congress - Aug. 6-8 in Madrid, Spain
  • Canaccord Genuity 38th Annual Growth Conference – Aug. 8-9 in Boston, Massachusetts

See Also: Attention Biotech Investors: Mark Your Calendar For These August PDUFA Dates


Pain Therapeutics, Inc. (NASDAQ: PTIE) awaits Tuesday an FDA decision on its pain medication Remoxy, which it has licensed from DURECT Corporation (NASDAQ: DRRX).

The FDA is set to rule Tuesday on Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX)'s lumacaftor/ivacaftor, combo treatment candidate for cystic fibrosis for patients aged 2 to 5.

Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY)'s NDA for Patisiran hereditary ATTR, or hATTR, amyloidosis, is pending before the FDA, with the agency expected to rule on the application on Saturday. Alnylam uses Arbutus Biopharma Corp (NASDAQ: ABUS)'s intellectual property in RNAi therapeutic products using LNP technology.

The FDA will rule Saturday on Regeneron Pharmaceuticals Inc (NASDAQ: REGN)'s sBLA Eylea to treat wet age-related maculae degeneration.

Adcom Meetings

FDA's Antimicrobial Drugs Advisory Committee on Tueday will discuss the NDA for Insmed Incorporated (NASDAQ: INSM)'s NDA for mikacin liposome inhalation suspension, indicated to treat nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex in adults as part of a combination antibacterial drug regimen.

The Antimicrobial Drugs Advisory Committee is also scheduled to meet Wednesday to discuss the NDAs for omadacycline tablets and omadacycline injection submitted by Paratek Pharmaceuticals Inc (NASDAQ: PRTK). The candidate is being considered for treating community-acquired bacterial pneumonia as well as for acute bacterial skin and skin structure infections.


Vaccinex, a clinical-stage biotech company developing biotherapeutics to treat cancer, neurodegenerative diseases and autoimmune disorders, is set to offer 3.333 million shares in an IPO. The company seeks to list its shares on the Nasdaq under the ticker symbol VCNX.

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