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Saturday, July 3, 2021

Biotech week ahead, July 6

 Biotech stocks advanced for a second week in running, with stocks reacting to pending releases for the second quarter and the first-half of the year.

The week witnessed a few COVID-19 disappointments. CureVac N.V. CVAC 4.55% confirmed the sub-par efficacy data for its first-generation vaccine against the novel coronavirus.

Altimmune, Inc. ALT 6.97% shares fell about 43% for the week after it announced it is rolling up its intranasal COVID-19 vaccine program. The company was also forced to stop enrollment into the phase 1/2 trial for T-COVID, its single dose intranasal therapeutic for treating early COVID-19. Angion Biomedica Corp. ANGN 7.02% decided to shelve its COVID-19 program following a failed Phase 2 study.

Several R&D collaborations and licensing deals were announced during the week. Alector, Inc. 

ALEC 57.12% shares jumped Friday after it announced an out-licensing deal with GlaxoSmithKline plc GSK 0.62% for two monoclonal antibodies being evaluated for the treatment of neurodegenerative diseases.

Among the stocks that made their Wall Street debuts were Acumen Pharmaceuticals, Inc. ABOS 0.9%, medical device maker CVRx, Inc. CVRX 2.34% and Aerovate Therapeutics, Inc. (AVTE), a cardiopulmonary diseases focused biopharma. POINT Biopharma Inc. PNT 11.54% made its debut through a SPAC deal.

Here are the key catalytic events for the unfolding week.

Conferences

  • European Crohn's and Colitis Organization, or ECCO, 16th Annual Congress: July 2-3 & July 8-10
  • Society for Reproductive Investigation, SRI, 68th Annual Meeting: July 6-9
  • European Academy of Allergy and Clinical Immunology, or EAACI, Annual Congress 2021, to be held virtually: July 10-16


PDUFA Dates

The FDA is scheduled to rule on ChemoCentryx, Inc.'s CCXI 0.15% new drug application for avacopan, an orally-administered small molecule being evaluated for the treatment of ANCA-associated vasculitis and other complement-driven autoimmune and inflammatory diseases. An FDA panel that reviewed the NDA in early May issued a split verdict.

Clinical Readouts/Presentations

ObsEva SA OBSV 1.34% is due to present at the SRI annual meeting results from the proof-of-concept trial of ebopiprant for the treatment of spontaneous preterm labor. The oral presentation is scheduled for Wednesday, July 7, at 4-5:30 pm

Morphic Holding, Inc. MORF 1.01% will host a webcast and conference call at 8 am on Friday, July 9 to discuss results from the phase 1 study of MORF-057 in inflammatory bowel disease. The company will also present the data at the ECCO Congress.

Pharvaris N.V. PHVS 6.48% will present clinical data for oral PHA121 that is being evaluated for the treatment of hereditary angioedema, as an e-Poster at the EAACI annual congress. The abstract will be published on the EAACI website on Saturday, July 10. The virtual poster presentation will be on the EAACI website from July 10-16.

IPOs    

IPO Quiet Period Expiry

Janux Therapeutics, Inc. JANX 0.24%
Alzamend Neuro, Inc. ALZN 5.21%   
https://www.benzinga.com/general/biotech/21/07/21832024/the-week-ahead-in-biotech-focus-on-chemocentryx-fda-decision-conference-presentations-in-a-light-

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