CKPT stock gains on key regulatory milestone in Europe (NASDAQ:CKPT) – Seeking Alpha

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The shares of clinical-stage biotech Checkpoint Therapeutics (NASDAQ:CKPT) are trading sharply higher on Friday as H.C. Wainwright welcomes the Pediatric Investigation Plan (PIP) product-specific waivers granted for the company’s cancer candidate cosibelimab in the EU and U.K.

On Friday, Checkpoint (CKPT) announced the PIP product-specific waivers issued by the European Medicines Agency (EMA) and the U.K. Medicines & Healthcare products Regulatory Agency (MHRA) for the drug in cutaneous squamous cell carcinoma, a form of skin cancer.

The regulators in the EU and U.K. request the companies to submit a PIP detailing the strategy for investigating a product candidate in children. Sometimes, PIPs are requested when the tests for pediatric medications are not feasible or appropriate, as is the case with cosibelimab, the company said.

“Such PIP waivers enable us to proceed more quickly and cost-effectively when advancing our marketing approval applications with the EMA and MHRA,” Checkpoint (CKPT) Chief Executive James Oliviero noted.

The issuance of PIP waivers is a key regulatory milestone to launch the product in Europe, H.C. Wainwright analysts led by Joseph Pantginis remarked in response.

“The granted waiver should, in our opinion, support future regulatory review (in both the U.S. and abroad), reduce development costs and expenses, and increase the overall value” of the program, especially in Europe, they added.

H.C. Wainwright has a Buy recommendation and a $26.00 per share target Checkpoint (CKPT) compared to the Strong Buy rating and $19.80 average per share target on Wall Street, currently.

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