FDA Grants Orphan Drug Designation to 9MW2821
“Mabwell (688062.SH) announced that its self-developed novel Nectin-4-targeting ADC (R&D code: 9MW2821) has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA), for the treatment of esophageal cancer. 9MW2821 was previously given Fast Track Designation (FTD) by the FDA for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma. It is the first therapeutic drug candidate targeting Nectin-4 in the world to reveal clinical effectiveness data for an esophageal cancer indication.”
Share:
More News
“The eNRGy study highlights that NRG1 fusions are an actionable therapeutic target and the importance of developing biomarker-driven therapies like zenocutuzumab,” said Debasish Roychowdhury, MD, Chief Technology Officer at Partner Therapeutics. “We are deeply grateful to the Merus team that designed, researched and developed zenocutuzumab, the eNRGy trial investigators, and
Pnina Fishman, CSO & Chairperson of Can-Fite BioPharma, commented: “We are pleased to offer this compassionate use program with Namodenoson for eligible patient in the US to address the unmet medical needs for pancreatic cancer. Initiating this program is another milestone achieved for Namodenoson, and concurrently to our ongoing Phase
“We are deeply disappointed by these results from our Phase 1 trial. Despite continuing to demonstrate differentiated safety as a more combinable ADC, updated efficacy data suggest that treatment with EO-3021 does not meet our bar for success and is insufficient to provide patients a competitive benefit-risk profile compared to
Søren Bregenholt, CEO of Alligator, commented: “The FDA’s recognition of HLX22/AC101’s potential with Orphan Drug Designation is a notable recognition. While Alligator’s is not directly involved in the development of HLX22/AC101, we continue to follow its progress as it potentially represents future income to Alligator.”
