H.C. Wainwright Reiterates Buy Rating on NovaBridge Biosciences (NBP) following FDA meeting feedback

H.C. Wainwright analyst Andres Maldonado reiterated a Buy rating and $9.00 price target on NovaBridge Biosciences (NASDAQ: NBP)

The analyst commented, "Today NovaBridge shared productive FDA feedback from their Type B meeting, including confirmation of lead asset givastomig’s potential eligibility for an accelerated approval pathway. In our view, this update signals growing regulatory confidence in givastomig’s clinical significance as a potential best-in-class CLDN18.2 X 4-1BB antibody in frontline immune chemotherapy combinations for HER2-, CLDN18.2+, and PD-L1+ gastroesphageal cancer. Topline Phase1b data demonstrated a 77% ORR (n=52 evaluable, 8 mg/kg) and 73% ORR (n=52 evaluable, 12 mg/kg) when givastomig was combined with opdivo (BMS, not rated) and chemotherapy in 1L HER2-negative metastatic gastric cancer patients with a broad range of PD-L1 and CLDN18.2 expression levels. Median PFS at 8 mg/kg was 16.9 months with the 6 month PFS for 8 mg/kg 73% and 91% for 12 mg/kg cohorts. Importantly, the combination therapy maintained an acceptable tolerability profile with no Grade 5 TRAEs and the most common low-grade TRAEs being nausea, vomiting and fatigue. Immune-related gastritis was observed in 33% of patients at Grade 3 in 4% of patients at 8 mg/kg and 15% of patients at 12 mg/kg. The company expects to release updated Phase 1b expansion data in 2H26 and plans to initiate a registrational Phase 3 combination trial as early as 4Q26 using ORR as a primary endpoint for accelerated approval. We reiterate our Buy rating and $9 PT."

For an analyst ratings summary and ratings history on NovaBridge Biosciences click here. For more ratings news on NovaBridge Biosciences click here.

Shares of NovaBridge Biosciences closed at $2.83 yesterday.

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