Coronavirus vaccine developer Inovio Pharmaceuticals Inc INO's stock, which was rocked in September by the partial clinical hold imposed on the planned Phase 2/3 study of the company's DNA vaccine INO-4800, is facing further pressure Monday.
What Happened: Inovio shares are reacting to announcements from rival vaccine developers Novavax, Inc. NVAX and the Pfizer Inc. PFE and BioNTech SE – ADR BNTX partnership.
Pfizer and BioNTech announced results Monday from the first interim analysis of the Phase 3 study of their mRNA vaccine candidate, showing over 90% efficacy.
The companies indicated that emergency use filing in the U.S. could occur when the required safety milestone is achieved, which is expected in the third week of November.
The FDA has granted fast track designation to Novavax's vaccine candidate NVX-CoV2373. The designation translates to an expedited development timeline.
Related Link: The Week Ahead In Biotech: Supernus, Sanofi Await FDA Decisions
What's Next: Inovio told Benzinga last week that it responded to the FDA regarding the partial clinical hold in October, and expects to hear from the agency in November to set the ball rolling on the Phase 2/3 trial.
Since the company announced the regulatory setback, its shares have pulled back by about 38%.
The positive news from Pfizer/BioNTech and Novavax has only served to aggravate the weakness.
Inovio is scheduled to report third-quarter results after the market close Monday. The consensus estimates call for a loss of 19 cents per share on revenue of $3.05 million.
Any positive update by the company either in the earnings report or on the earnings call could help the shares bounce back.
Other players such as Vaxart Inc VXRT, Sorrento Therapeutics Inc SRNE and Heat Biologics Inc HTBX were also seeing stock weakness Monday.
INO Price Action: At last check, Inovio shares were slumping 20.66% to $8.36.
Related Link: Attention Biotech Investors: Mark Your Calendar For These November PDUFA Dates
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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