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 ending 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 the Phase 1/2 clinical trial of ITI-214, its phosphodiesterase 1 inhibitor for patients with chronic systolic heart failure.
• Obseva SA (OBSV) will release Phase 3 PRIMROSE 1 six-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 the Serum Institute of India's malaria vaccine candidate.
• Revance Therapeutics Inc. (RVNC) is due to release Phase 2 top-line data for DAXI, a treatment for 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 for Fragile X syndrome.
• Alexion Pharmaceuticals, Inc. (ALXN) will release interim results from Phase 2 studies of ALXN2040 for C3 Glomerulopathy.
• Iterum Therapeutics PLC (ITRM) is due to release Phase 3 topline results from sulopenem clinical trials for uncomplicated urinary tract infections.

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 for non-alcoholic steatohepatitis.
• Regenxbio Inc. (RGNX) is due to give a program update from the Phase 1/2 trial of RGX-501, which is for the treatment of Homozygous Familial Hypercholesterolemia.
• BioNTech SE – ADR (BNTX) will release Phase 1 data for BNT111 for 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​) will report earnings on Tuesday, June 30, 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).