Biotech week ahead, June 29

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 21.04% rallied strongly earlier in the week on the back of news concerning an expansion of its vaccine development partnership with Sanofi SA SNY 1.83% but eventually gave back some of the gains following a secondary offering. Vaxart Inc VXRT 28.43%, 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 1.11% 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 4.03% 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 7.36% 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 2.67% is due to release Phase 2 top-line data for DAXI in forehead lines and crow’s feet.
• Zynerba Pharmaceuticals Inc ZYNE 0.47% is expected to release topline data from the pivotal CONNECT-FX trial that is evaluating Zygel in Fragile X syndrome.
• Alexion Pharmaceuticals, Inc. ALXN 0.12% will release interim results from Phase 2 studies of ALXN2040 in C3 Glomerulopathy.
• Iterum Therapeutics PLC ITRM 0.66% is due to release Phase 3 topline results from sulopenem clinical trials in uncomplicated urinary tract infections.

First-Half Releases

• Cerecor Inc CERC 6.23% is due to release initial data readout from the Phase 1 trial of CERC-802 in healthy volunteers.
• Novartis AG NVS 2.8% will release Phase 2 data for LJN452 in non-alcoholic steatohepatitis.
• Regenxbio Inc RGNX 0.91% 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 4.05% will release Phase 1 data for BNT111 in advanced melanoma.

June Releases

• Inovio Pharmaceuticals Inc INO 4.06% will release interim Phase 1 data for its coronavirus vaccine candidate INO-4800.

Earnings

• Avid Bioservices Inc CDMO 2.63% (Tuesday after the close)

• IPO Quiet Period Expiration

• Pliant Therapeutics Inc PLRX 2.06%
• Legend Biotech Corp LEGN 1.23%
• Applied Molecular Transport Inc. AMTI 6.61%
• CALLIDITAS THER/S ADR CALT 6.53%

https://www.benzinga.com/general/biotech/20/06/16408983/the-week-ahead-in-biotech-june-28-july-4-pending-clinical-readouts-in-focus-during-a-short-holida