Fast Track Group FTRK 深 沪

Can-Fite Secures Japanese Patent Allowance for Namodenoson's Anti-Obesity Technology

Can-Fite BioPharma Ltd. announced that the Japan Patent Office has allowed a patent for Namodenoson, its lead drug candidate, covering its use for fat loss and treating obesity and metabolic disorders. This milestone strengthens Can-Fite's global intellectual property portfolio, which already includes patent protections in major markets like the U.S., Canada, Australia, and Israel. The patent allowance underscores Namodenoson's potential as a dif...

06-26 11:00

NRx Pharmaceuticals Responds to Recent Public Statements Regarding Kadima Dispute

NRx Pharmaceuticals issued a statement addressing unfounded allegations from Kadima Neuropsychiatry Institute regarding the non-acquisition of Kadima by its subsidiary HOPE Therapeutics. NRx initiated arbitration due to Kadima's failure to meet key transaction conditions. Management believes acquiring Kadima would not align with HOPE's strategic goals, which focus on developing new drugs and technologies for treating depression, PTSD, and other c...

06-25 20:01

Incannex wins US patent for IHL-42X obstructive sleep apnea therapy

Incannex wins US patent for IHL-42X obstructive sleep apnea therapy Incannex won a U.S. patent covering the IHL-42X composition and methods to treat obstructive sleep apnea. Baseline patent expiry set for July 9, 2040; patent term extension under review pending potential FDA approval. Move strengthe

06-25 19:31

Candel Therapeutics Appoints Mark Sims as Chief Commercial Officer

Candel Therapeutics appoints Mark Sims as Chief Commercial Officer to lead the commercial strategy and launch readiness for aglatimagene besadenovec in intermediate- to high-risk localized prostate cancer. The company plans to submit a Biologics License Application (BLA) in Q4 2026, with a potential launch in 2027. Aglatimagene is an off-the-shelf adenovirus designed to induce immunogenic cell death and activate anti-tumor immunity. Candel is col...

06-25 12:05

Incannex Secures U.S. Patent Grant for IHL-42X in Obstructive Sleep Apnea

Incannex Healthcare Inc. announced the USPTO has granted a key patent for its IHL-42X composition and therapeutic methods to treat Obstructive Sleep Apnea (OSA). The patent, set to expire in 2040, strengthens the company's intellectual property and supports long-term market exclusivity. IHL-42X, a novel oral therapy, addresses significant unmet needs in OSA treatment, with poor patient adherence to current options. The patent, combined with FDA F...

06-25 12:00

Passage Bio and Remix Therapeutics Announce Merger Agreement

Passage Bio and Remix Therapeutics have agreed to merge in an all-stock transaction, with the combined company operating as Remix Therapeutics. The merger is supported by a $100 million private placement financing, which will fund operations into 2028. Remix’s lead program, REM-422, an mRNA degrader targeting MYB, is in Phase 1/2 trials for cancers like ACC and AML. The transaction is expected to close in Q4 2026, with the combined company led by...

06-24 20:05

INmune Bio Receives MHRA Written Alignment Supporting Planned 2026 UK Conditional Marketing Authorization Application for CORDStrom™ in RDEB

INmune Bio received MHRA alignment on CMC, non-clinical, and clinical strategies for Ebstrocel™ in RDEB, clearing a regulatory path for its 2026 UK MAA submission. MHRA recognized MissionEB Phase 2 data showing significant symptomatic benefits, particularly pain and pruritus, supporting chronic or intermittent therapy positioning. The agency also provided guidance on confirmatory Phase 3 trial design, evidence package, and manufacturing transitio...

06-23 12:00

uniQure Announces Plan for BLA Submission for AMT-130 in Huntington’s Disease

06-17 11:05

Oncolytics Biotech® Secures New U.S. Patent Protecting Commercial Manufacturing of Pelareorep into 2044

Oncolytics Biotech Inc. announced that the USPTO has issued a new patent protecting its proprietary manufacturing process for pelareorep, providing intellectual property protection into 2044. The company also noted that a previously filed method-of-use patent application for pelareorep as an immunotherapy remains under review and, if issued, would provide protection into 2046. Additionally, Oncolytics plans to file further patent applications in ...

06-16 13:00

NovaBridge Biosciences Receives FDA Fast Track Designation for Givastomig in First-Line HER2-Negative Metastatic Gastric Cancer

NovaBridge Biosciences announced that the FDA has granted Fast Track Designation to givastomig, a CLDN18.2 x 4-1BB bispecific antibody, for the treatment of previously untreated HER2-negative advanced or metastatic gastroesophageal adenocarcinomas (GEA) with CLDN18.2 and PD-L1 positive tumors. Phase 1b data showed strong efficacy and tolerability when combined with immunochemotherapy, supporting its potential as a leading CLDN18.2-targeted therap...

06-16 11:00