ProKidney revises Phase 3 program for lead asset [Seeking Alpha]
ProKidney Corp. - Class A Ordinary Shares (PROK)
Company Research
Source: Seeking Alpha
The company said it has decided to discontinue its Phase 3 REGEN-016 (PROACT 2) trial for the candidate, noting that the trial, which was based on overseas patients, will not be required for the drug's initial U.S. approval. The decision follows feedback from former FDA officials and regulatory experts, ProKidney ( PROK ) added. Given the Regenerative Medicine Advanced Therapy (RMAT) designation for rilparencel, the company said that results from its ongoing Phase 3 REGEN-006 (PROACT 1) trial will be enough for it to seek initial FDA approval for the candidate under an expedited approval pathway. The company expects its current cash runway to extend through Q1 2027 and reduce its expenses by $150M-$175M following revisions. The revised Phase 3 program is for topline data by Q3 2027. Recommended For You More Trending News Recommended For You More Trending News About PROK Stock Related Stocks Trending Analysis Trending News
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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 drops Phase III CKD study to focus on US market and save up to $175m [Yahoo! Finance]Yahoo! Finance
- 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 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