NovaBridge Posts Mature Givastomig Phase 1b Data: 79% ORR, 16.9-Month PFS at 8 mg/kg
NBP is trading near its 52-week low of $1.255 (14% above the low).
Summary
NovaBridge furnished the ESMO 2026 poster and press release with mature givastomig Phase 1b data — 79% ORR, 16.9-month median PFS and 97% disease control at the selected 8 mg/kg dose — one day after announcing the dose selection and FDA alignment.
Key Events · Product Development and Regulatory · NBP
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Mature Phase 1b Efficacy at 8 mg/kg
In 29 efficacy-evaluable patients at the selected 8 mg/kg dose, the objective response rate was 79% (23/29) and the disease control rate 97% (28/29), with a median duration of response of 15.2 months and median progression-free survival of 16.9 months over 17.8 months of median follow-up.
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Activity Across CLDN18.2 Levels
Objective response rate was 82% in tumors with CLDN18.2 expression of at least 75% and 75% in the 1%-74% band — patients not eligible for currently approved CLDN18.2-targeted therapies.
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Manageable Safety, No Grade 4/5
No Grade 4 or Grade 5 treatment-related adverse events were attributed to givastomig; immune-related events were uncommon apart from gastritis, mostly Grade 2.
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Registrational Path and FDA Alignment
The company reports alignment with the FDA on a global registrational study protocol covering patient population, dose and primary endpoints, alongside Orphan Drug and Fast Track designations; no Phase 3 start date or budget is disclosed.
Analysis · NBP · Life Sciences
The headline — 8 mg/kg dose locked, FDA alignment on a global registrational protocol — was already public on October 25, but this filing supplies the actual numbers behind it, and they are strong: a 79% objective response rate and 16.9-month median progression-free survival in first-line metastatic gastroesophageal adenocarcinoma, with responses holding up in tumors expressing as little as 1% CLDN18.2 — a population currently approved CLDN18.2 therapies cannot treat. That breadth is the commercial case, since it widens the addressable market beyond the high-expressors. Safety looks manageable, with no Grade 4/5 treatment-related events attributed to the drug. What is still missing is money and timing: no Phase 3 start date or budget is given, and the company reported a $37.9M first-half 2026 net loss against a $216M cash position as of the August update, so the registrational program will be a funding question as much as a clinical one. The November 2 webcast is the next scheduled disclosure.
How filings like this one have moved
In the 30 days to Oct 26, 2026, 29.9% of the 1374 measured filings Wiseek scored 7 moved their stock by 5% or more by the next session's close. The median move was -0.12%. These are measured outcomes after filings of this importance, not a forecast for this one.
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At the time of this filing, NBP was trading at $1.44 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $158.9M. The 52-week trading range was $1.26 to $5.19. This filing was assessed with positive market sentiment and an importance score of 7 out of 10.