PROK Surges More Than 500% on Upbeat Data From Kidney Cell Therapy Study

Shares of ProKidney Corp. PROK skyrocketed 515% yesterday after the company reported encouraging top-line data from the phase II REGEN-007 study evaluating its lead pipeline drug, rilparencel, in patients with diabetes and chronic kidney disease (CKD).

Results from the study showed that treatment with this experimental therapy exhibited statistically significant and clinically meaningful improvement in the rate of kidney function decline in one of the two dosing groups.

More on ProKidney’s REGEN-007 Study Results

The study randomized patients into two groups — Group 1 and Group 2. While patients in Group 1 received two rilparencel injections three months apart, those in Group 2 initially received a single dose and were given a second one only if they experienced a sustained decline in kidney function.

The prespecified primary endpoint for REGEN-007 was the difference in annual estimated glomerular filtration rate (eGFR) slope, comparing the pre-injection period to the period following the last rilparencel injection. The eGFR slope measures how quickly kidney function declines over time.

Results from the REGEN-007 study showed that the annual decline in eGFR slope improved by 78% in Group 1, which ProKidney claimed was “statistically and clinically meaningful.”

In contrast, Group 2 demonstrated a 50% reduction in annual eGFR decline. Though this result did not reach statistical significance, ProKidney noted that it suggests “evidence of a dose response.”

ProKidney plans to present full results from the REGEN-007 study at the American Society of Nephrology (“ASN”) 2025 Kidney Week as a late-breaking clinical trial.

PROK Share Price Performance

Year to date, the stock has surged 121% compared with the industry’s 4% growth.

What Makes ProKidney’s REGEN-007 Study Results Encouraging?

The FDA had previously communicated to the company that rilparencel would be eligible for approval under the accelerated pathway, provided an accepted surrogate endpoint is used. Since the eGFR slope is a well-established predictor of progression to kidney failure, a significant improvement in this marker could support accelerated approval, pending validation in a late-stage study.

ProKidney plans to meet with the FDA this summer to confirm the use of eGFR slope as the primary surrogate endpoint in the ongoing Phase III PROACT 1 study on rilparencel in subjects with advanced CKD and type 2 diabetes. Additional details from this regulatory dialogue are expected in mid-2025.

The REGEN-007 results have raised the probability of success for rilparencel, given the encouraging efficacy observed in Group 1 as a potential basis for accelerated approval, pending regulatory feedback. This was likely the reason behind the significant jump in PROK stock.

PROK’s Zacks Rank

ProKidney currently carries a Zacks Rank #2 (Buy).

ProKidney Corp. Price

 

ProKidney Corp. price | ProKidney Corp. Quote

Other Key Picks Among Biotech Stocks

Some other top-ranked stocks from the sector are Amarin Corporation AMRN and Agenus AGEN. While AMRN sports a Zacks Rank #1 (Strong Buy) at present, Agenus carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, Amarin's 2025 loss per share estimates have improved from $3.85 to $2.30. Loss per share estimates for 2026 have narrowed from $3.59 to $1.50 during the same period. AMRN stock has surged 74% year to date.

Amarin’s earnings beat estimates in two of the trailing four quarters, met the mark once and missed in the other, delivering an average surprise of 29.11%.

In the past 60 days, Agenus’ bottom-line estimates for 2025 have significantly improved from a loss of $3.46 per share to earnings of $1.56. During the same timeframe, estimates for 2026 loss per share have narrowed from $3.91 to $1.99. AGEN stock has soared 89% so far this year.

Agenus’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 22.71%.

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