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Investing.com - H.C. Wainwright has reiterated its Buy rating and $12.00 price target on TuHURA Biosciences (NASDAQ:HURA), following the company’s announcement of its Phase 3 accelerated approval trial initiation. The target represents significant upside from the current price of $2.22, with analyst targets ranging from $9.25 to $15.00, according to InvestingPro data.
The Phase 3 trial will evaluate TuHURA’s lead innate immune agonist, IFx-2.0, as an adjunctive therapy administered weekly for three weeks alongside Keytruda, compared to Keytruda plus placebo in first-line treatment for patients with advanced or metastatic Merkel cell carcinoma (MCC). The $97M market cap company maintains a healthy liquidity position with a current ratio of 3.0, though InvestingPro analysis indicates rapid cash consumption.
The pivotal trial is being conducted under a Special Protocol Assessment with the FDA and will enroll 118 participants across 22 to 25 U.S. sites. Subjects will be randomized on a 1:1 basis and receive Keytruda in both arms for up to two years, or until disease progression or emergence of Keytruda-related toxicities.
The primary endpoint for the trial is objective response rate (ORR), which may allow for accelerated approval, while progression-free survival (PFS) serves as a key secondary endpoint that could support full approval. Keytruda is currently approved in MCC under accelerated approval based on ORR.
H.C. Wainwright maintained its 12-month price target of $12 for TuHURA Biosciences stock following this development in the company’s clinical program for advanced or metastatic MCC treatment. The stock has faced recent headwinds, declining 12.25% over the past week. InvestingPro subscribers can access 10+ additional investment tips and comprehensive financial metrics for HURA.
In other recent news, TuHURA Biosciences has initiated a Phase 3 trial of its lead drug candidate, IFx-2.0, for treating advanced or metastatic Merkel cell carcinoma. This trial, conducted under a Special Protocol Assessment agreement with the FDA, will evaluate IFx-2.0 as an adjunctive therapy alongside Keytruda. Additionally, TuHURA and Kineta stockholders have approved proposals related to their planned merger, which is expected to be completed soon, pending any remaining conditions. Brookline Capital Markets has initiated coverage on TuHURA Biosciences with a buy rating, citing the company’s advancements in immune agonists and checkpoint inhibitors. Furthermore, the FDA has lifted a partial clinical hold on TuHURA’s Phase 3 trial for IFx-2.0, allowing the study to proceed, which has triggered a $2.23 million payment to the company under a private placement agreement. TuHURA has also announced salary increases for its CEO and CFO, reflecting compensation trends within its peer group. These developments come as TuHURA prepares to expand its pipeline following the merger with Kineta, adding new immunotherapy assets.
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