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 TBIO rallied strongly earlier in the week on the back of news concerning an expansion of its vaccine development partnership with Sanofi SA SNY but eventually gave back some of the gains following a secondary offering. Vaxart Inc 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 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 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. 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 RVNC is due to release Phase 2 top-line data for DAXI in forehead lines and crow's feet.
• Zynerba Pharmaceuticals Inc ZYNE is expected to release topline data from the pivotal CONNECT-FX trial that is evaluating Zygel in Fragile X syndrome.
• Alexion Pharmaceuticals, Inc. ALXN will release interim results from Phase 2 studies of ALXN2040 in C3 Glomerulopathy.
• Iterum Therapeutics PLC 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 CERC is due to release initial data readout from the Phase 1 trial of CERC-802 in healthy volunteers.
• Novartis AG NVS will release Phase 2 data for LJN452 in non-alcoholic steatohepatitis.
• Regenxbio Inc 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 BNTX will release Phase 1 data for BNT111 in advanced melanoma.

June Releases

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

Earnings

• Avid Bioservices Inc CDMO (Tuesday after the close)

  IPO Quiet Period Expiration

  • Pliant Therapeutics Inc PLRX
  • Legend Biotech Corp LEGN
  • Applied Molecular Transport Inc. AMTI
  • CALLIDITAS THER/S ADR CALT
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