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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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