""Unfortunately, for patients and physicians in the melanoma community, we have had no choice but to stop our compassionate use program and adjust the planned expansion of our Phase 3 clinical program.""
""This decision has not only put much-needed therapies at risk, including RP1 and RP2, but it has also put the company at risk.""
""Patients and caregivers pleaded for urgency. All of it was met with inconsistent communication and a fragmented and slow-moving regulatory process, which clearly puts U.S. innovations at risk.""
Replimune is cutting 223 jobs due to the FDA's rejection of its advanced melanoma treatment, RP1. The layoffs include 63 positions from the commercial organization and 160 from the headquarters and manufacturing facility. This reduction represents nearly half of the company's workforce. The FDA cited insufficient data for efficacy in its decision. The company expressed concern over the impact on patients and the future of its experimental treatments, RP1 and RP2, which utilize modified viruses to combat tumors.
Read at Boston.com
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