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On Monday, H.C. Wainwright analyst Robert Burns adjusted the price target on Nuvation Bio Inc (NYSE:NUVB) to $10.00 from the previous $11.00, while maintaining a Buy rating on the stock. Currently trading at $2.02, InvestingPro data shows the stock has gained nearly 11% over the past week, though it remains undervalued according to Fair Value analysis. The adjustment comes as Nuvation Bio awaits a significant regulatory decision on its lead drug candidate, taletrectinib.
Taletrectinib is currently under review by the FDA for the treatment of advanced ROS1-positive non-small cell lung cancer (NSCLC), with a Prescription Drug User Fee Act (PDUFA) approval decision date set for June 23, 2025. The submission for approval was supported by pooled data from the Phase 2 TRUST-I and TRUST-II studies, which demonstrated strong clinical outcomes in both TKI-naive and TKI-pretreated ROS1+ NSCLC patients. With a strong current ratio of 9.04, InvestingPro analysis indicates the company has ample liquidity to support its development programs.
The efficacy of taletrectinib was highlighted by an 88.8% confirmed overall response rate (cORR) and a median duration of response (mDOR) of 44.2 months in TKI-naive patients. In the TKI-pretreated population, the drug achieved a cORR of 55.8% and an mDOR of 16.6 months. Additionally, taletrectinib showed robust confirmed intracranial response rates in both patient groups.
Comparatively, Bristol-Myers Squibb (NYSE:BMY)’s Augtyro, a competing drug, demonstrated lower cOR rates in its pivotal Phase 1/2 TRIDENT-1 trial. The safety profile of taletrectinib was also favorable, with fewer patients requiring dose reductions or discontinuing treatment compared to those in the TRIDENT-1 trial.
Burns expressed optimism about the approval process for taletrectinib, citing the drug’s promising trial results. Furthermore, he noted that Nuvation Bio has secured non-dilutive financing to support the commercialization of taletrectinib in the U.S., which influenced the revised price target. InvestingPro data reveals strong analyst consensus with a 1.4 rating (where 1 is Strong Buy), with price targets ranging from $5 to $11. Subscribers can access 8 additional ProTips and comprehensive financial analysis in the Pro Research Report.
In other recent news, Nuvation Bio Inc. has secured a significant financing agreement with Sagard Healthcare Partners, obtaining up to $250 million to support the launch of its cancer drug, taletrectinib, in the U.S. This financial package includes $150 million in royalty interest financing and up to $100 million in senior term loans, contingent on FDA approval of the drug. The company has also launched an Expanded Access Program (EAP) in the U.S. for taletrectinib, targeting patients with ROS1-positive non-small cell lung cancer who have exhausted other treatment options. Additionally, the FDA has accepted Nuvation Bio’s New Drug Application for taletrectinib, granting it Priority Review with a decision expected by June 23, 2025. This comes after promising results from the TRUST-I and TRUST-II studies, which demonstrated high response rates and prolonged progression-free survival. Meanwhile, H.C. Wainwright reaffirmed a Buy rating for Nuvation Bio, citing the drug’s potential market opportunity and strong clinical data. In another development, Dr. Jerry Wang, CEO of subsidiary AnHeart Therapeutics, has departed following the achievement of key milestones, including regulatory advancements for taletrectinib. These recent developments highlight the company’s strategic progress in advancing its oncology portfolio.
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