J & D Pharmaceuticals LLC Receives Orphan Drug Designation for Treatment of Hepatocellular Carcinoma (HCC)

MONMOUTH, N.J., Dec. 4, 2025 /PRNewswire/ -- J & D Pharmaceuticals LLC announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company's investigational therapy for the treatment of Hepatocellular Carcinoma (HCC) a rare and life-threatening disorder that is estimated to occur in approximately 73,000 individuals in the United States in 2025.

HCC is a devastating disorder that has a very poor prognosis. With FDA approved medications the amount of time extended in patient with HCC is only 2.5 months. There is a need for a safer and more effective medication for HCC.

"Receiving Orphan Drug Designation is yet another significant milestone for J & D Pharmaceuticals," said Lenard Lichtenberger, PhD, Chief Scientific Officer. "This designation adds to the two previous orphan drug designations we received and continues to underscore the urgent need for innovative therapies for HCC patients and strengthens our commitment to developing solutions that we expect to transform the lives of those affected by this debilitating condition not just by adding years to their lives but life to those years."

The FDA's Orphan Drug Designation program provides incentives to encourage the development of treatments for rare diseases, including tax credits for qualified clinical testing, exemption from certain FDA fees, and the potential for seven years of market exclusivity upon regulatory approval.

J & D Pharmaceuticals plans to advance its HCC program into clinical development and will continue working closely with the FDA and the HCC community to accelerate progress toward delivering a novel treatment option to patients in need.

About J & D Pharmaceuticals LLC
J & D Pharmaceuticals LLC is a biopharmaceutical company dedicated to developing innovative therapies for cancer as well as inflammatory diseases including common, rare as well as serious disorders. The company's mission is to bring forward transformative treatments that address high unmet medical needs and improve patient outcomes.

Michael Murphy
Business Development Lead
J & D Pharmaceuticals LLC
732 859 9829
405733@email4pr.com 

View original content to download multimedia:https://www.prnewswire.com/news-releases/j--d-pharmaceuticals-llc-receives-orphan-drug-designation-for-treatment-of-hepatocellular-carcinoma-hcc-302632020.html

SOURCE J & D Pharmaceuticals LLC