MedCity News December 5, 2023
Frank Vinluan

Replimune’s lead therapeutic candidate did not meet the two main goals of a study intended to support an FDA submission in cutaneous squamous cell carcinoma. But Replimune’s therapy, an oncolytic virus, has better data in melanoma, and the company plans a 2024 FDA submission in this skin cancer.

Cutaneous squamous cell carcinoma that does not respond to treatment with an immunotherapy called a checkpoint inhibitor has no FDA-approved therapeutic alternatives. Replimune’s lead program, an oncolytic virus, has fallen short in a study hoped to give patients one. The company is still pressing forward with its engineered virus in other types of skin cancer, but not without a pipeline shakeup that means the end for other programs.

Replimune’s lead therapeutic candidate,...

Today's Sponsors

Venturous
Got healthcare questions? Just ask Transcarent

Today's Sponsor

Venturous

 
Topics: Biotechnology, FDA, Govt Agencies, Pharma, Pharma / Biotech
At Current Prices GLP-1s Aren’t Cost-Effective, Limiting Access To Patients
Latigo raises $150M to get non-opioid pain drugs through key tests
AstraZeneca Aims to Make Cell Therapy More Accessible With $425M EsoBiotec Acquisition
CMS doubles down on Medicare drug price negotiations
Drug shortages could surge 25% as AI reshapes specialty pharmacy: Survey

Share This Article