NovaBridge Biosciences (NASDAQ: NBP) experienced an 11.5% increase in premarket trading on Tuesday after announcing that the U.S. Food and Drug Administration has granted Fast Track Designation to givastomig when given in combination with nivolumab and chemotherapy. The designation applies to previously untreated patients with HER2-negative advanced or metastatic gastroesophageal adenocarcinomas whose tumors test positive for both Claudin 18.2 (CLDN18.2) and PD-L1.
Givastomig is described by the company as a novel bispecific antibody that engages CLDN18.2 and 4-1BB. The Fast Track status is intended to accelerate development and review of therapies that address serious conditions with unmet medical needs. The designation permits more frequent communications with the FDA during development and may allow for options such as Rolling Review of regulatory submissions, Priority Review, or Accelerated Approval if applicable criteria are satisfied.
NovaBridge cited Phase 1b results that demonstrated efficacy and tolerability for givastomig in combination with immunochemotherapy. According to the company, responses in the trial were both deep and durable across a broad patient population and represented an improvement relative to historical benchmarks for the current standard of care.
Looking ahead, NovaBridge said it expects to initiate a registrational Phase 3 trial as early as the fourth quarter of 2026. The company also indicated that detailed Phase 1b data will be presented at a major medical conference in the second half of 2026.
Development of givastomig is being carried out through a global partnership with ABL Bio. NovaBridge is identified as the lead party in the collaboration and shares worldwide rights equally with ABL Bio, with the exception of Greater China and South Korea.
The company also noted that the FDA previously confirmed eligibility for the accelerated approval pathway for givastomig.
Market reaction and context
The premarket share rise followed the regulatory update and the company statements about Phase 1b performance and development plans. Fast Track Designation and confirmation of accelerated approval pathway eligibility reflect regulatory progress, while the Phase 3 start target and upcoming detailed data presentations set the near- to mid-term milestones to watch.
What remains to be resolved
While the company has outlined a prospective Phase 3 start window and has said it will present detailed Phase 1b data later in 2026, those timelines and the content of the full data set remain to be confirmed at the scheduled presentations and filings.