NovaBridge Announces Productive FDA Type B Meeting on Potential Accelerated Approval Pathway for Givastomig in Gastric Cancer
NovaBridge Biosciences - American Depositary Shares (NBP)
Company Research
Source: GlobeNewswire
FDA confirmed givastomig’s potential eligibility for an accelerated approval pathwayNovaBridge expects to initiate a registrational Phase 3 combination trial as early as Q4 2026, using objective response rate (ORR) as a primary endpoint for accelerated approvalGivastomig, a bispecific Claudin 18.2 X 4-1BB antibody, has the potential to be a first-in-class and best-in-class first line (1L) Claudin 18.2 (CLDN 18.2) therapeutic in Her-2 negative (Her2-), CLDN 18.2 positive (CLDN 18.2+), PD-L1-positive (PD-L1+) gastroesophageal cancer (GEC) ROCKVILLE, Md., March 16, 2026 (GLOBE NEWSWIRE) -- NovaBridge Biosciences (Nasdaq: NBP) (“NovaBridge” or the “Company”), a global biotechnology platform company committed to accelerating access to innovative medicines, today announced that based on a productive Type B meeting with the U.S. Food and Drug Administration (the “FDA”) and receipt of written minutes, NovaBridge has secured FDA alignment on givastomig’s potential eligibility for an accele
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News
- I-Mab (NBP) had its "buy" rating reaffirmed by HC Wainwright. They now have a $9.00 price target on the stock.MarketBeat
- NovaBridge Announces Productive FDA Type B Meeting on Potential Accelerated Approval Pathway for Givastomig in Gastric Cancer [Yahoo! Finance]Yahoo! Finance
- Everest Medicines' Licensing Partner NovaBridge and Visara Announce Positive Results from VIS-101 Phase 2a Wet AMD StudyPR Newswire
- NovaBridge Biosciences (NBP) Discusses Phase 2a Clinical Data and Development Plan for VIS-101 in Wet Age-Related Macular Degeneration Transcript [Seeking Alpha]Seeking Alpha
- NovaBridge and Visara Announce Positive Results from VIS-101 Phase 2a Wet AMD Study [Yahoo! Finance]Yahoo! Finance
NBP
Sec Filings
- 3/16/26 - Form 6-K
- 3/9/26 - Form 6-K
- 3/3/26 - Form 6-K
- NBP's page on the SEC website