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

Shanthi Rexaline

Biotech shares saw further momentum last week, following up on the gains of the previous two weeks.

Will the momentum continue in the upcoming week? Here are the catalytic events that could drive the sector.

Conferences

  • American Society for Bone and Mineral Research, or ASBMR, 2018 Annual Meeting – Sept. 28 – Oct. 1 in Montréal, Québec, Canada
  • 12th International Conference on Endocrinology,Diabetes and Metabolism – Oct. 1-2, in Osaka, Japan
  • 12th International Conference on Allergy, Asthma & Clinical Immunology – Oct. 1-2, in Moscow, Russia
  • 3rd World Congress on Pediatric Neurology and Pediatric Surgery – Oct. 1-2, in Osaka
  • 13th World Conference on Neurology and Neuromuscular Disorders - Oct. 1-2, in London
  • Cantor Global Healthcare Conference – Oct. 1-3, in New York City
  • Ladenburg Thalmann 2018 Healthcare Conference – Oct. 2, in New York City
  • 3rd International conference on Neuroscience, Neuroradiology & Imaging – Oct. 3-4, in Osaka
  • 2nd International Conference on Cancer Biology, Therapeutics and Drug Discovery & Delivery – Oct. 3-4, in Los Angeles
  • 10th Annual Congress on Biomarkers, Clinical Research & Therapeutics – Oct. 3-4, in Los Angeles
  • American Heart Congress - CVD – Oct. 5-6, in Los Angeles
  • 4th International Conference on Wound Care, Wound Nursing, Tissue Repair & Regenerative Medicine - Oct. 5-6, in Los Angeles
  • World Congress on Fetal and Maternal Medicine - Oct. 5-6, in Osaka

PDUFA Dates

Roche Holdings AG Basel ADR (OTC: RHHBY)'s Genentech unit awaits FDA nod for an expanded indication for its Hemlibra. Hemlibra has already been approved for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with haemophilia A with factor VIII inhibitor. This time around the company is seeking clearance for treating adults and children with haemophilia A without factor VIII inhibitors. The PDUFA date is set for Thursday, Oct. 4.

The FDA is set to rule on Bausch Health Companies Inc (NYSE: BHC)'s NDA for its plaque psoriasis treatment IDP-122 lotion Friday, Oct. 5.

Ionis Pharmaceuticals Inc (NASDAQ: IONS), and its affiliate Akcea Therapeutics Inc (NASDAQ: AKCA) look ahead to FDA approval of their Inotersen, a RNA-targeted therapeutic for hATTR amyloidosis. PTC Therapeutics, Inc. (NASDAQ: PTCT) has a collaboration agreement to market Inotersen in Latin America. The PDUFA date for Inotersen, which has already been approved in the EU, is set for Saturday, Oct. 6.

Paratek Pharmaceuticals Inc (NASDAQ: PRTK)'s broad spectrum antibiotic Omadacycline is being evaluated by the FDA for two indications, namely Community-acquired pneumonia, or CAB, and acute bacterial skin and skin structure infections, or ABSSSI. The company indicated the PDUFA date is likely to be in early October.

See Also: Aldeyra's Dry Eye Disease Aces Mid-Stage Trial, Stock Soars

Clinical Trial Results

Unum Therapeutics Inc (NASDAQ: UMRX) is set to present Sept. 30 initial Phase 1 data for its ACTR707 in combination with Roche's Rituxan for treating non-Hodgkin lymphoma.

Viking Therapeutics Inc (NASDAQ: VKTX) is due to present already-released Phase 2 data for its acute hip fracture treatment VK5211 at the ASBMR 2018 annual meeting on Sept. 30. Recently, the company reported positive results for its non-alcoholic fatty liver disease candidate.

Protalix Biotherapeutics Inc (NYSE: PLX) will present preliminary Phase 3 open label data for its Fabry disease treatment Pegunigalsidase alfa on Oct. 5.

Audentes Therapeutics Inc (NASDAQ: BOLD) is due to release updated Phase 1/2 data for AT132, its treatment candidate for X-linked myotubular myopathy on Oct. 5.

IPO

Guardant Health, which develops non-invasive blood-based cancer diagnostics tests, is set to offer 12.5 million shares in an IPO, with an estimated price range of $15 to $17. The shares are to be listed on the Nasdaq under the ticker symbol GH.

Kodiak Sciences will offer 9 million shares priced between $13 and $15 in an IPO. The company, which develops anti-VEGF inhibitors for wet AMD, plans to list the shares on the Nasdaq under the ticker symbol KOD.

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