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Shares of ProKidney surged more than 500% on Tuesday following upbeat results from its Phase 2 REGEN-007 study and a price target upgrade from Citi.
The company is developing rilparencel, an autologous cellular therapy aimed at slowing kidney function decline in patients with chronic kidney disease (CKD) and diabetes.
Citi raised its price target to $9 from $6 and maintained a ‘Buy’ rating, saying the early data “exceeded expectations.”
The firm increased the probability of success for the program to 60%, citing statistically significant efficacy seen in Group 1 of the trial, which may support accelerated approval in Phase 3 subject to FDA feedback.
The REGEN-007 study showed that kidney function decline was reduced by 78% in group 1 after rilparencel treatment.
Patients who received two injections approximately three months apart experienced an improvement in their annual eGFR slope from -5.8 to -1.3 mL/min/1.73 m², representing a statistically and clinically meaningful difference.
However, Bank of America was more cautious, reiterating its ‘Underperform’ rating and $1 price target.
The firm flagged the absence of a sham comparator, lack of a conference call to discuss the data, and regulatory ambiguity. It stated that the stock’s sharp rally “looks overdone,” especially given that detailed data are likely to be withheld for a future medical meeting.
ProKidney reported that no serious side effects were observed in the trial, and the safety results were consistent with earlier studies.
Rilparencel already holds RMAT status from the FDA and is also being tested in a larger Phase 3 trial called PROACT 1.
The company noted that early signals from REGEN-007 reinforce previously observed efficacy trends in high-risk patient subgroups.
On Stocktwits, retail sentiment for ProKidney was ‘extremely bullish’ amid ‘extremely high’ message volume.
One user anticipated strong momentum ahead, saying they were “thinking 100% gain tomorrow.”
Another poster struck a more cautious but optimistic tone, noting that while they’d “love for this ticker and its well-deserving product [to have] a double-digit run,” biotech stocks often see profit-taking after big moves.
They said short sellers could enter soon but saw long-term potential, saying, “If Phase III pans out and it gets FDA approval, it could make you a millionaire.”
ProKidney’s stock has more than doubled so far in 2025.
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