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Replimune shares plummet as skin cancer therapy fails mid-stage study

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Replimune Group said on Tuesday its experimental combination therapy to treat a common form of skin cancer failed to significantly remove or reduce cancerous lesions in a mid-stage study, sending its shares tumbling 52.2% to a record low.
The company was testing its lead therapy, RP1, in combination with Regeneron’s antibody drug, Libtayo, in patients with cutaneous squamous cell carcinoma, compared to Libtayo alone.
“RP1 works, but the statistics did not,” said BMO Capital Markets analyst Evan Seigerman. The data, which had been delayed by the company earlier this year, will add to investor frustration, he said in a note to clients.
Replimune, however, said the combination therapy showed that the rate of complete disappearance of tumors, also known as the complete response rate (CRR), was “just short” of statistical significance.
The study mainly looked for improvements in CRR and overall response rate (ORR), which measures the percentage of patients who achieve either complete disappearance of tumors or reduction in tumor size following the treatment.
The trial, conducted under a research and supply agreement with Regeneron, will continue as planned, Replimune said.
The Massachusetts-based drug developer also said it would stop development of its therapies RP2 and RP3 to treat cancers of the head and neck as well as colon, while discontinuing RP3.
An ongoing study for a common form of liver cancer will continue with RP2 alone.
The company’s shares were last down 47.24% at $6.5. The stock has lost more than half of its value so far this year.


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