#USA #HCC #Orphan Drug #Monmouth #J & D Pharmaceuticals

J & D Pharmaceuticals Secures Orphan Drug Designation

In a significant development for cancer therapy, J & D Pharmaceuticals LLC has announced the receipt of Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its innovative treatment targeting Hepatocellular Carcinoma (HCC). Hepatocellular carcinoma, a rare and aggressive form of liver cancer, affects approximately 73,000 individuals in the United States as of 2025. This designation is particularly crucial considering the limited treatment options available for this life-threatening condition.

HCC is notorious for its dismal prognosis, with current FDA-approved medications only extending survival by a mere 2.5 months. This daunting statistic highlights an urgent need for safer and more effective therapeutic solutions. Lenard Lichtenberger, PhD, Chief Scientific Officer of J & D Pharmaceuticals, emphasizes the importance of this milestone: "Receiving Orphan Drug Designation is yet another significant milestone for J & D Pharmaceuticals. This designation not only underscores our commitment to developing solutions that will truly transform patient lives but also reinforces the pressing need for innovative therapies in the realm of HCC."

The FDA's Orphan Drug Designation program incentivizes the development of treatments for rare diseases, offering various advantages, including tax credits for eligible clinical trials, waivers of certain FDA fees, and potentially seven years of market exclusivity upon regulatory approval. With this new designation, J & D Pharmaceuticals aims to propel its HCC program into clinical development swiftly, collaborating closely with the FDA and the HCC community to expedite the delivery of a novel treatment for patients desperately in need.

About J & D Pharmaceuticals LLC:
J & D Pharmaceuticals LLC is a dedicated biopharmaceutical company striving to develop transformative therapies for various cancers and inflammatory diseases, inclusive of both common and rare disorders. The company prioritizes addressing the substantial unmet medical needs in these fields, striving to improve patient outcomes through innovation.

The path forward for J & D Pharmaceuticals appears promising as it embarks on this new chapter in advancing treatment options for a disease that has long been in need of effective interventions. The company remains committed to its mission of enhancing not just the longevity of patients' lives but also the quality of those years. As community and industry stakeholders eagerly await further developments, J & D Pharmaceuticals is poised to make a substantial impact in the global fight against HCC.

For further information, please contact:
Michael Murphy, Business Development Lead, J & D Pharmaceuticals LLC, phone: 732-859-9829.