Radiopharmaceutical company POINT Biopharma (Point Biopharma Stock Quote, Charts, News, Analysts, Financials NASDAQ:PNT) recently completed enrolment on a pivotal Phase 3 trial, which amounts to a feather in its cap and a significant de-risking event for investors. That’s according to Raymond James analyst Michael W. Freeman, who updated clients in a Thursday report where he maintained an “Outperform” rating on the stock.
Precision oncology company POINT Biopharma announced on Thursday the enrolment completion for its Phase 3 SPLASH trial on 177Lu-PNT2002 for patients with PSMA-expressing metastatic, castration-resistant prostate cancer who have progressed on androgen receptor pathway inhibitor therapy and refuse or are ineligible for chemotherapy. The trial involves more than 390 participants randomized across 55 sites in North America, Europe and the UK.
POINT Biopharma announced this past November that Lantheus Holdings would license exclusive worldwide rights to both PNT2002 and PNT2003, with a Phase 3 trial of PNT2003 having been already completed.
“We are proud to have reached this important milestone for the PNT2002 program,” said Jessica Jensen, Executive Vice President, Clinical Development of POINT Biopharma, in a press release. “Our success is a testament to both the expertise of our team and the level of enthusiasm for radioligand therapy in the oncology community.”
Freeman called the enrolment a “huge logistical feat,” seeing as it involves supplying a radiopharmaceutical drug product for trial, in this case supplying PHT2002 — with a half-life of 6.6 days — in just-in-time manufacturing fashion and without incident.
“PNT2002’s greatest challenge will come at the point of data analysis and regulatory submission—which we anticipate in 1H23—but we take the opportunity here to acknowledge the significance of PNT’s accomplishment. This is a credibility-building event for this three-year-old company, in our view,” Freeman wrote.
Freeman said anticipated readouts from the Phase 3 PNT2003 trial should be arriving in the coming months, while POINT and Lantheus will be preparing and submitting the regulatory filings in the United States.
“PNT and LNTH have formed joint steering committees to oversee the clinical studies, regulatory filings, manufacturing, and commercial readiness for both PNT2002 and PNT2003. PNT will develop commercial production capacity and manufacture clinical and commercial supply for both PNT2002 and PNT2003 in a COGS-plus-markup arrangement (which, given the complexity of manufacturing radiopharmaceuticals, we expect will be a significant margin),” he said.
With the update, Freeman maintained a 12-month target on PNT of $10.00 per share, which at the time of publication represented a projected return of 38 per cent.