NovaBridge Announces Productive FDA Type B Meeting on Potential Accelerated Approval Pathway for Givastomig in Gastric Cancer [Yahoo! Finance]
NovaBridge Biosciences - American Depositary Shares (NBP)
Company Research
Source: Yahoo! Finance
NovaBridge 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 approval Givastomig, 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 accelerated approval pathway in 1L Her2-, CLDN 18.2+, PD-L1+ GEC patients, building on p
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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 CancerGlobeNewswire
- 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