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The Week Ahead In Biotech (June 28- July 4): Pending Clinical Readouts In Focus During A Short Holiday Week

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The Week Ahead In Biotech June 28- July 4: Pending Clinical Readouts In Focus During A Short Holiday Week

Biotech stocks went on a seesaw ride along with the broader markets in the week ended June 26. Yet there were some encouraging developments on the COVID-19 vaccine development front. Vaccine companies are going all out, forging alliances and adding personnel that could help them be successful in their quest.

Translate Bio Inc (NASDAQ: TBIO) rallied strongly earlier in the week on the back of news concerning an expansion of its vaccine development partnership with Sanofi SA (NASDAQ: SNY) but eventually gave back some of the gains following a secondary offering. Vaxart Inc (NASDAQ: VXRT), another COVID-19 vaccine play, rallied during the week.

The FDA review machinery worked overtime, ruling on a host of investigational therapies. Three biopharma companies went public this week, raising a combined $485 million in gross proceeds.

The following are key catalysts in the unfolding week:

Conferences

  • Cantor Fitzgerald's Virtual Symposium: "Winning Ways to Treat Infections and COVID-19: Tuesday, June 30

Clinical Readouts/Presentations

Q2 Releases

  • Intra-Cellular Therapies Inc (NASDAQ: ITCI) is scheduled to release top-line results from Phase 1/2 clinical trial of ITI-214, its phosphodiesterase 1 inhibitor, in patients with chronic systolic heart failure.
  • Obseva SA (NASDAQ: OBSV) will release Phase 3 PRIMROSE 1, 6-month primary endpoint results and PRIMROSE 2 twelve-month data for Linzagolix in uterine fibroids.
  • Novavax, Inc. (NASDAQ: NVAX) is scheduled to release top-line data from Matrix M vaccine adjuvant, which is a key component of Serum Institute of India's malaria vaccine candidate.
  • Revance Therapeutics Inc (NASDAQ: RVNC) is due to release Phase 2 top-line data for DAXI in forehead lines and crow's feet.
  • Zynerba Pharmaceuticals Inc (NASDAQ: ZYNE) is expected to release topline data from the pivotal CONNECT-FX trial that is evaluating Zygel in Fragile X syndrome.
  • Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) will release interim results from Phase 2 studies of ALXN2040 in C3 Glomerulopathy.
  • Iterum Therapeutics PLC (NASDAQ: ITRM) is due to release Phase 3 topline results from sulopenem clinical trials in uncomplicated urinary tract infections.

See also: Novavax Gains Over 50% In June: What's Driving The Rally?

First-Half Releases

  • Cerecor Inc (NASDAQ: CERC) is due to release initial data readout from the Phase 1 trial of CERC-802 in healthy volunteers.
  • Novartis AG (NYSE: NVS) will release Phase 2 data for LJN452 in non-alcoholic steatohepatitis.
  • Regenxbio Inc (NASDAQ: RGNX) is due to give a program update from the Phase 1/2 trial of RGX-501 for the treatment of Homozygous Familial Hypercholesterolemia.
  • BioNTech SE – ADR (NASDAQ: BNTX) will release Phase 1 data for BNT111 in advanced melanoma.

June Releases

  • Inovio Pharmaceuticals Inc (NASDAQ: INO) will release interim Phase 1 data for its coronavirus vaccine candidate INO-4800.

Earnings

 

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