ProKidney drops Phase III CKD study to focus on US market and save up to $175m [Yahoo! Finance]
ProKidney Corp. - Class A Ordinary Shares (PROK)
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Source: Yahoo! Finance
The US-based biotech's Phase III program consisted of two studies; the REGEN-006 (PROACT 1) (NCT05099770) study in the US and the REGEN-016 (PROACT 2) (NCT05286853) study in ex-US countries. Both trials are designed to investigate the agent, which is also known as REACT, in type 2 diabetes and CKD. Following discussions to finalise rilparencel's regulatory plans in the US, North Carolina-based ProKidney will drop the REGEN-016 trial, a move which the company says will save between $150m and $175m. The company closed a $140m public offering of class A ordinary shares in June 2024, which would extend its cash runway to mid-2026. Rilparencel, which was granted regenerative medicine advanced therapy (RMAT) designation by the FDA in October 2021, is a regenerative therapy. Administered through intra-renal injection, it utilises autologous renal cells embedded in a gelatin-based hydrogel. These cells are designed to stimulate the regeneration of functional kidney tissue, aiming to rest
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News
- ProKidney Reports Third Quarter 2024 Financial Results along with Regulatory and Clinical Development Updates Following Successful FDA Type B MeetingGlobeNewswire
- ProKidney to Participate in the Guggenheim Inaugural Healthcare Innovation Conference and the Jefferies London Healthcare ConferenceGlobeNewswire
- We're Not Very Worried About ProKidney's (NASDAQ:PROK) Cash Burn Rate [Yahoo! Finance]Yahoo! Finance
- ProKidney Announces Five Abstracts Selected for Presentation at the American Society of Nephrology’s Kidney Week 2024GlobeNewswire
- ProKidney to Participate in the UBS Virtual Organ Restoration DayGlobeNewswire
PROK
Earnings
- 11/12/24 - In-Line
PROK
Sec Filings
- 11/12/24 - Form 10-Q
- 11/12/24 - Form 8-K
- 11/8/24 - Form SC
- PROK's page on the SEC website