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POINT Biopharma has a 41 per cent upside, says Raymond James

Precision oncology platform POINT Biopharma Global (POINT Biopharma Stock Quote, Charts, News, Analysts, Financials NASDAQ:PNT) continues to get the green light from Raymond James analyst Rahul Sarugaser. In a Wednesday report, Sarugaser said a new FDA Fast Track Designation for its prostate cancer drug should accelerate its timeline for approval.

Indianapolis-headquartered POINT Biopharma focuses on the clinical development and commercialization of radiopharmaceuticals for cancer treatment, i.e., drugs that deliver radiation directly and specifically to cancer cells. The company and its licensor partner, Lantheus Holdings, announced on Monday that PNT2002, which is currently being evaluated for the treatment of advanced prostate cancer, has received Fast Track Designation from the FDA. 

The designation means that there are to be increased interactions with the FDA throughout the drug development and review process, that the drug can be assessed via rolling review and a potentially shorter FDA review time goal, from the standard ten months to six months.

“The FDA Fast Track designation for 177Lu-PNT2002 underscores its potential to address a serious unmet need and serve as a meaningful therapeutic option for patients with mCRPC,” said Dr. Neil Fleshner, M.D., Chief Medical Officer of POINT Biopharma, in a statement.

“We are seeing that radioligand therapy is quickly becoming another pillar of cancer treatment, and, with our continued focus on supply chain excellence, we believe that we are very well positioned to meet market demands post approval,” he said.

With the news, Sarugaser has moved his anticipated date for NDA submission to the FDA to late 2023/early 2024. He noted that the partnership has it that upon approval Lantheus is to take the commercialization reins and POINT to do the manufacturing.

Sarugaser juxtaposed PNT2002 to Novartis’ Pluvicto, another radiopharmaceutical for advanced prostate cancer and PNT2002’s competitor, and Sarugaser said Novartis has been seeing strong demand for Pluvicto but is dealing with supply shortages.

Sarugaser believes it’s the high demand and Pluvicto’s unsteady supply that have likely prompted the FDA’s Fast Track designation for PNT2002.

“We believe PNT2002 has the potential to address the significant unmet need for mCRPC patients. The earlier PNT2002 hits the market, the more easily PNT/LNTH will be able to capture market share from Novartis’ Pluvicto—its most obvious on-market competitor—particularly given NVS’s recent supply woes,” Sarugaser said.

“While a welcoming mCRPC patient population likely awaits PNT2002 regardless its approval timing, NVS is rapidly ramping supply: the production and distribution channel race is on,” he wrote.

With the update, Sarugaser reiterated an “Outperform” rating on POINT Biopharma and $11.00 target price, representing at press time a projected one-year return of 40.7 per cent.

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About The Author /

Jayson is a writer, researcher and educator with a PhD in political philosophy from the University of Ottawa. His interests range from bioethics and innovations in the health sciences to governance, social justice and the history of ideas.
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