FDA Removes Manufacturing-Related Partial Clinical Hold On TuHURA's Phase 3 Accelerated Approval Trial For IFx-2.0, Allowing Trial To Proceed As Agreed To Under Previously Announced SPA Agreement With FDA

Benzinga·06/09/2025 12:11:11

Listen to the news

Company anticipates initiating its Phase 3 accelerated approval trial of IFx-Hu2.0 as adjunctive therapy with Keytruda® (pembrolizumab) as first-line treatment for advanced and metastatic Merkel cell carcinoma (MCC), conducted under Special Protocol Assessment (SPA) Agreement with U.S. Food and Drug Administration (FDA), later in June 2025

Resolution of partial clinical hold unlocks second tranche of funds from $12.5 million PIPE financing announced on June 3, 2025

TAMPA, Fla., June 9, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced that the FDA has removed the manufacturing-related partial clinical hold on the Company's Phase 3 accelerated approval trial for IFx-2.0, thereby allowing the trial to proceed as agreed to under the previously announced SPA Agreement with the FDA.

FAQ

Fee Schedule Open Account Deposit & Withdrawal Trading

Terms & Conditions

Client Agreement Privacy Policy Data Disclaimer Security Tips

About Webull

About us Webull Promotions Contact information Announcements

Service Email : service@webull.hkBusiness Cooperation : marketinghk@webull.hk

Risk Disclosure: The content of this page is not an investment advice and does not constitute any offer or solicitation to offer or recommendation of any investment product. It is for general purposes only and does not take into account your individual needs, investment objectives and specific financial circumstances. All investments involve risk and the past performance of securities, or financial products does not guarantee future results or returns. Keep in mind that while diversification may help spread risk it does not assure a profit, or protect against loss, in a down market. There is always the potential of losing money when you invest in securities, or other financial products. Investors should consider their investment objectives and risks carefully before investing. For more details, please refer to risk disclosure.
① During the campaign period, US stocks, US stocks short selling, US stock options, Hong Kong stocks, and A-shares trading will maintain at $0 commission, and no subscription/redemption fees for mutual fund transactions. $0 fee offer has a time limit, until further notice. For more information, please visit: https://www.webull.hk/pricing
Webull Securities Limited is licensed with the Securities and Futures Commission of Hong Kong (CE No. BNG700) for carrying out Type 1 License for Dealing in Securities, Type 2 License for Dealing in Futures Contracts and Type 4 License for Advising on Securities.

Language

English