Pathalys Raises $105 Million in Series B to Prepare Renal Disease Drug for FDA Approval

Kidney disease biotech Pathalys Pharma has raised $105 million in a Series B funding round, which the company will use to advance its lead product to the final stages of clinical trials. The company’s primary candidate, upacicalcet, is a calcimimetic designed to enhance the management of secondary hyperparathyroidism (SHPT) in hemodialysis patients. Calcimimetic compounds, including Amgen’s approved SHPT drug Sensipar, are used to treat various conditions associated with calcium receptor activation in tissues.

Pathalys has initiated two nearly identical phase 3 trials, each involving 375 patients with SHPT, to test upacicalcet. SHPT is often seen in patients undergoing maintenance hemodialysis. Upacicalcet is already approved for SHPT in Japan, where the drug “performed exceptionally well” in late-stage trials, Pathalys revealed earlier this year, focusing on the Japanese market.

The newly raised funds will also be used to complete these studies and begin preparing the necessary documentation for FDA approval, as well as to “advance commercialization preparations,” according to the biotech’s August 20th press release.

This significant funding round was led by TCGX, with participation from other investors including J.P. Morgan Life Sciences Private Capital, Samsara BioCapital, Marshall Wace, KB Investment, and JPS Growth Investment Limited Partnership. Additionally, Pathalys’ founding team includes Catalys Pacific and DaVita Venture Group. As part of the financing, three new directors will join Pathalys’ board, including Joe Siletto, the managing partner of J.P. Morgan Life Sciences Private Capital.

Since its inception last September, Pathalys has made substantial progress toward its mission of fundamentally improving the treatment of end-stage kidney disease (ESKD) patients, particularly through the near completion of two phase 3 trials for upacicalcet, as noted by CEO Fowler in the August 20th release.

“We believe that the continued growth of our syndicate with leading life science investors, some of whom are now represented on the board, indicates that Pathalys is on the right path to success,” Fowler said.

Founded in Research Triangle Park, North Carolina, Pathalys had previously raised $150 million in January 2023 through a combination of secured product financing and equity.

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