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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PROK
News
- ProKidney Corp. (NASDAQ: PROK) is now covered by analysts at Guggenheim. They set a "buy" rating and a $6.00 price target on the stock.MarketBeat
- ProKidney Corp. (NASDAQ: PROK) had its price target lowered by analysts at Bank of America Co. from $4.00 to $3.00. They now have a "neutral" rating on the stock.MarketBeat
- ProKidney revises Phase 3 program for lead asset [Seeking Alpha]Seeking Alpha
- ProKidney Announces Strategic Updates to its Phase 3 Program to Accelerate Rilparencel's Registrational Path to Potential Approval in the U.S. [Yahoo! Finance]Yahoo! Finance
- ProKidney Announces Strategic Updates to its Phase 3 Program to Accelerate Rilparencel’s Registrational Path to Potential Approval in the U.S.GlobeNewswire
PROK
Earnings
- 8/9/24 - Beat
PROK
Sec Filings
- 9/20/24 - Form 4
- 9/19/24 - Form 144
- 9/16/24 - Form 4
- PROK's page on the SEC website