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

Shanthi Rexaline

Biotech stocks staged a recovery this week after being in the red in the previous two weeks.

AbbVie Inc (NYSE: ABBV)'s psoriasis drug Skyrizi received FDA nod. The week also saw the release of strong quarterly earnings by big European pharma giants such as Novartis AG (NYSE: NVS), Sanofi SA (NASDAQ: SNY) and Roche Holdings AG Basel ADR (OTC: RHHBY).

Here are a few key catalysts a biotech investor should stay focused on in the unfolding week.

Conferences

  • 2019 The Association for Research In Vision and Ophthalmology annual meeting – April 28- May 2, in Vancouver, British Columbia
  • 17th International Conference on Pharmaceutical Microbiology and Biotechnology - April 29-30, in London
  • 4th World Heart Congress - April 29 - May 1 in Kyoto, Japan
  • 22nd American Society of Gene and Cell Therapy annual meeting – April 29- May 2, in Washington D.C.
  • 3rd International Conference on Medical and Clinical Microbiology - May 1-2, in Kyoto
  • 2019 American Academy of Neurology annual meeting – May 4-10, in Philadelphia, Pennsylvania

PDUFA Dates

Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and Sanofi await FDA verdict on their sBLA for Praluent injection. The company is seeking label expansion for the drug to include effect of the drug in reducing the overall risk of major adverse cardiovascular events, or MACE. The PDUFA date has been scheduled for Sunday, April 28.

The FDA is set to rule on Heron Therapeutics Inc (NASDAQ: HRTX)'s HTX-011, a fixed-dose combination of the local anesthetic bupivacaine and nonsteroidal anti-inflammatory drug meloxicam, for application into the surgical site to reduce postoperative pain. The decision date is April 30.

The FDA will announce its decision April 30 on Nabriva Therapeutics PLC – ADR (NASDAQ: NBRV)'s Contepo for complicated urinary tract infections.

Sanofi's dengue vaccine Dengvaxia will come before the FDA scanner, with the regulatory agency scheduled to announce its verdict on May 1.

Clinical Trial Readouts

Orchard Therapeutics PLC – ADR (NASDAQ: ORTX) is scheduled to release Phase 1/2 data for OTL-300 which is being evaluated for transfusion-dependent beta-thalassemia on April 29.

The Association For Research In Vision And Ophthalmology Meeting Presentations

Akari Therapeutics PLC (NASDAQ: AKTX) – interim update of Phase 1/2 study of Coversin (Atopic keratoconjunctivitis).

View more earnings on IBB

Aldeyra Therapeutics Inc (NASDAQ: ALDX) – Phase 2 data for ADX-102 (dry eye syndrome) on May 1.

BioTime, Inc. (NYSE: BTX) – updated Phase 1/2 data for OpRegen (dry age-related macular degeneration) on May 2.

American Society Of Gene And Cell Therapy Meeting Presentations

Audentes Therapeutics Inc (NASDAQ: BOLD) – Phase 1/2 data for AT132 (X-linked myotubular myopathy) on May 1.

Adaptimmune Therapeutics PLC – ADR (NASDAQ: ADAP) – Full summary of SPEAR program evaluating MAGE-A4 (solid tumors) on May 2.

Abstracts Of American Academy Of Neurology Meeting Presentations (to be made public May 3)

GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) – Phase 3 data for Epidiolex (Dravet Syndrome).

Ionis Pharmaceuticals Inc (NASDAQ: IONS) & Biogen Inc (NASDAQ: BIIB) – Phase 1/2 data for IONIS-SOD1Rx/BIIB067 (Amyotrophic lateral sclerosis).

Biohaven Pharmaceutical Holding Co Ltd (NYSE: BHVN) – Phase 3 data for Zydis ODT formulation of rimegepant (migraine).

Ovid Therapeutics Inc (NASDAQ: OVID) - Phase 2 data for OV101 (for adolescents with Angelman syndrome).

IPOs

TransMedics, a medical device company supplying a system for organ transplants, is set to offer 4.7 million shares, with the price estimated in a range of $14 to $16. The shares will be listed on the Nasdaq under the ticker symbol "TMDX."

Trevi Therapeutics has planned a 4.67 million offering likely to be priced between $14 and $16. The company, which develops an extended-release version of an opioid for new indications, is seeking to list its shares on the Nasdaq under the ticker symbol "TRVI."

IPO Quiet Period Expiry

  • Silk Road Medical Inc (NASDAQ: SILK)
  • NGM Biopharmaceuticals Inc (NASDAQ: NGM)
  • Guardion Health Sciences Inc (NASDAQ: GHSI)

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