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The Week Ahead In Biotech: Conferences, PDUFA Dates And Clinical Trials

Shanthi Rexaline

Biotech stocks held their ground in a holiday-shortened week amid a drought of market-moving catalysts.

Looking ahead, the following are catalytic events for biotech investors to watch. 

Conferences

  • Fourth International Conference on Neurological Disorders & Stroke: July 9-10 in Sydney, Australia.
  • 15th International Conference on Digestive Disorders and Gastroenterology: July 11-12 in Sydney, Australia.
  • 13th International Conference on Tissue Engineering & Regenerative Medicine: July 12-13 in Paris, France.
  • Hematologists Global Summit 2018: July 13-14 in Sydney, Australia.
  • Third International Conference on Ophthalmology: July 10-11 in Bangkok, Thailand.
  • 12th International Conference on Pediatric, Perinatal and Diagnostic Pathology: July 13-14 in Toronto, Canada.
  • International Conference on Pediatric Pharmacology and Therapeutics: July 13-14 in Toronto, Canada.
  • Annual Congress on Mental Health: July 9-11 in Paris, France.

PDUFA Dates

Bristol-Myers Squibb Co (NYSE: BMY)'s sBLA for its Opdivo-Yervoy combination for treating adults with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan will come up before the FDA, with the agency set to rule July 10 on the application.

Related Link: Attention Biotech Investors: Mark Your Calendar For These July PDUFA Dates

Adcom Meeting Schedule

FDA's Antimicrobial Drugs Advisory Committee is set to discuss GlaxoSmithKline plc (ADR) (NYSE: GSK)'s NDA for the tafenoquine tablet in a 150-milligram dosage for prevention of relapse of Plasmodium vivax malaria July 12.

Clinical Trials

Zynerba Pharmaceuticals Inc (NASDAQ: ZYNE) is set to present Phase 2 data for ZYN002 in Fragile X syndrome. The data released last September showed that the study met the primary endpoint.

Early Q3 Release

Altimmune Inc (NASDAQ: ALT) is set to release Phase 1 data for its anthrax therapy Nasoshield.

Mid-2018 Releases

GlaxoSmithKline is likely to release Phase 2b data for its anti-SAP mAb, chemically dezamizumab, which is being tested for amyloidosis.

Bellerophon Therapeutics Inc (NASDAQ: BLPH) will release interim analysis of Phase 3 data for its INOpulse delivery device meant to treat pulmonary arterial hypertension.

BIOLINERX Ltd/S ADR (NASDAQ: BLRX) is set to release Phase 3 results from the GENESIS clinical trial, which evaluates its BL-8040 for the mobilization of hematopoietic stem cells used for autologous transplantation in multiple myeloma patients.

Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc (NASDAQ: XLRN) are likely to release Phase 3 data for the b-thalassemia treatment Luspatercept, based on the BELIEVE trial.

IPO Quiet Period Expirations

Verrica Pharmaceuticals Inc (NASDAQ: VRCA), which debuted on Nasdaq June 15 following a 5-million-share IPO at $15 per share, will see its IPO quiet period expire.

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