Nuvation Bio’s Strategic Positioning and Potential FDA Approval: Analyst Recommends Buy Rating

JonesTrading analyst Soumit Roy has maintained their bullish stance on NUVB stock, giving a Buy rating on May 16.

Soumit Roy has given his Buy rating due to a combination of factors surrounding Nuvation Bio’s potential FDA approval and strategic positioning in the market. The upcoming presentation of Phase 2 post-hoc data at ASCO is crucial, as it aims to demonstrate consistent efficacy of taletrectinib in ROS1+ NSCLC across different patient demographics, which is particularly important given the recent negative ODAC vote on a competitor’s trial.
Nuvation Bio’s taletrectinib is on track for potential FDA approval by June 23, with the FDA granting a priority review and completing all planned inspections without the need for an advisory committee meeting. The drug’s NDA is supported by robust global and Chinese Phase 2 trials, and the company is well-prepared for a potential mid-2025 launch. Additionally, while competitors like Nuvalent are also advancing in the same space, Nuvation Bio is ahead in the race for line-agnostic approval, strengthening its market position.

Roy covers the Healthcare sector, focusing on stocks such as Precision BioSciences, Elicio Therapeutics, and Chimerix. According to TipRanks, Roy has an average return of -26.9% and a 16.90% success rate on recommended stocks.

In another report released on May 16, Wedbush also maintained a Buy rating on the stock with a $5.00 price target.