Hepion Pharmaceuticals, Inc. (HEPA) Gets FDA Feedback Backing 505(b)(2) Path for GV104

Hepion Pharmaceuticals' subsidiary Gravitas Life Sciences received FDA feedback on GV104, a drug for gambling disorder. The FDA confirmed a 505(b)(2) pathway and deemed nonclinical studies sufficient for a Phase 2 study. Gravitas plans to file a full IND in 2027. Gambling disorder affects 2 million U.S. adults, with no approved treatments.

Hepion Pharmaceuticals (OTCQB:HEPA) received FDA feedback on its GV104 treatment for gambling disorder. The FDA deemed the Phase 2 study design appropriate and provided guidance on the regulatory pathway. Hepion plans to file an IND for GV104 in 2027, aiming to bring the first approved medicine for gambling disorder, which currently has no approved pharmacotherapy.

AnaptysBio (ANAB) and GSK (GSK) announced FDA approval for Jemperli to treat a type of rectal cancer. The approval was granted under the FDA's accelerated pathway, and ANAB's stock price increased following the news.

GSK announced US FDA approval for Jemperli (dostarlimab) to treat a form of locally advanced rectal cancer. The immunotherapy is the first of its kind for this indication, offering an alternative to standard treatments like chemotherapy, radiation, and surgery. GSK shares closed 0.4% lower at 1,854.89 pence on Monday.

GSK announced FDA accelerated approval for Jemperli as an immunotherapy for certain rectal cancer types, based on trial data showing no detectable cancer in some patients after one year. The treatment may help avoid chemotherapy, radiation, and surgery for eligible patients, according to the company.

The U.S. CFTC argues CME Group lacks legal standing to challenge its perpetual futures policy, stating CME hasn't shown financial harm. CME claims perps are swaps, not futures, and disputes the policy's impact. The CFTC's stance could affect the future of perpetual futures in the U.S. CME's volume in crypto futures has risen since the policy shift, according to the CFTC.