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