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Sunday, August 12, 2018

Biotech week ahead, August 13


The iShares NASDAQ Biotechnology Index (ETF) IBB 0.55% has experienced volatility amid the release of another spate of earnings reports.
Even as the earnings season winds down, the upcoming week presents a slew of catalysts for biotech investors to watch.

Conferences

  • 33rd International Conference on Dental and Oral Health: Aug. 13-14 in Dubai, UAE
  • 17th Annual Congress on Pediatrics & Neonatology: Aug. 13-14 in Osaka, Japan
  • 2018 Wedbush PacGrow Healthcare Conference: Aug. 14-15 in New York
  • 16th Asia Pacific Biotechnology Congress: Aug. 15-16 in Singapore City, Singapore
  • International Conference on Cancer Research and Diagnostics: Aug. 15-16 in Singapore City, Singapore
  • Asia-Pacific Dermatology and Cosmetology Conference: Aug. 16-17 in Tokyo, Japan

PDUFA Dates

Amicus Therapeutics, Inc. FOLD 1.59% awaits an FDA verdict Monday on its NDA for Migalastat, which is being tested for treating patients 16 years and older with Fabry disease and amenable mutations.
The FDA is set to decide on Vertex Pharmaceuticals Incorporated VRTX 0.13%‘s lumacaftor and ivacaftor combo for cystic fibrosis patients ages 1-2. The PDUFA date for the pipeline candidate is set for Wednesday.
Bristol-Myers Squibb Co BMY 0.35% has a incoming decision from the FDA Thursday, as the agency is set to issue its verdict on the company’s sBLA for Opdivo for treating small-cell lung cancer.
TherapeuticsMD Inc TXMD 0.96%‘s vaginal contraceptive candidate, segesterone acetate/ethinyl estradiol has a PDUFA date of Friday.

Clinical Trial Results

Early Q3 Schedule
  • Altimmune Inc ALT 4% is due to release Phase 1 results for its anthrax treatment candidate Nasoshield.

Earnings

Tuesday
Wednesday
Thursday

IPOs

  • Aridis Pharmaceuticals plans to offer 2 million shares in an IPO, with the pricing expected in the $13-$15 range. The company seeks to list the shares on the Nasdaq under the ticker symbol ARDS.

IPO Quiet Period Expiry

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