Fast Track Group FTRK 深 滬

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

Pasithea Therapeutics Announces Exhibit at Children’s Tumor Foundation 2026 NF Conference

Pasithea Therapeutics Corp. will participate in the Children's Tumor Foundation's 2026 NF Conference in Denver, Colorado, to engage with the NF1 community following FDA Fast Track and Rare Pediatric Disease Designations for its lead treatment candidate PAS-004. The company aims to develop safer, long-term therapies for NF1 patients and encourages participants to contact them in advance for meetings. PAS-004 is a next-generation macrocyclic MEK in...

06-15 11:02

Rein Therapeutics Expands Phase 2 RENEW Trial into United Kingdom

Rein Therapeutics has enrolled 16 patients in its Phase 2 RENEW trial for LTI-03 in idiopathic pulmonary fibrosis (IPF), with the first patient randomized in the UK. Trial sites in the US, Australia, and the UK are actively enrolling, and two more countries will join soon. LTI-03 is a first-in-class inhaled peptide targeting lung scarring and promoting healing. The trial aims to evaluate its safety, tolerability, and efficacy, with a primary endp...

06-11 12:00

12 Communication Services Stocks Moving In Wednesday's Pre-Market Session

Gainers VS Media Holdings (NASDAQ:VSME) shares increased by 390.6% to $4.04 during Wednesday's pre-market session. The market value of their outstanding shares is at $2.2 million. HWH Intl (NASDAQ:HWH) shares rose 41.22% to $1.73. The market value of their outstanding shares is at $9.1 million. Vers...

06-10 20:05

BRIEF-Imugene Ltd Says FDA Grants Fast Track Designation To Co's Azer-CEL For CLL/SLL And MZL

BRIEF-Imugene Ltd Says FDA Grants Fast Track Designation To Co's Azer-CEL For CLL/SLL And MZL June 9 (Reuters) - Imugene Ltd IMU.AX : AZER-CEL GRANTED FDA FAST TRACK DESIGNATION FOR CLL AND MZL FDA GRANTS FAST TRACK DESIGNATION TO IMUGENE'S AZER-CEL FOR CLL/SLL AND MZL Further company coverage: IMU.

06-09 09:29

Longeveron to Present at BIO International Convention 2026

Longeveron Inc. will participate in the BIO International Convention 2026 to present its stem cell therapy laromestrocel, focusing on potential partnerships for Hypoplastic Left Heart Syndrome, Alzheimer’s disease, Pediatric Dilated Cardiomyopathy, and Aging-related Frailty. The company aims to leverage strategic collaborations to accelerate development and commercialization, with laromestrocel showing positive results across multiple clinical tr...

06-04 13:15

Johnson & Johnson Reports Lupus Study Results for Nipocalimab

Johnson & Johnson (NYSE:JNJ) today announced nipocalimab met the primary endpoint of decreasing disease activity at 24 weeks as measured by SLE Responder Index 4 (SRI-4)b and continued to demonstrate sustained

06-03 16:13

NRx Pharmaceuticals, Inc. Announces Proposed Public Offering of Common Stock

NRx Pharmaceuticals, Inc. announced plans to offer shares of its common stock in an underwritten public offering, with an option for the underwriter to purchase additional shares. BTIG, LLC is leading the offering, and Lucid Capital Markets, LLC is acting as joint bookrunning manager. The company intends to use proceeds for working capital and general corporate purposes. The offering is subject to market conditions and SEC registration. More deta...

06-02 20:01