Wall Street Analysts Downgrade Thermo Fisher Scientific, Norfolk Southern, T-Mobile, PVH Corp., and Ball Corporation.

US indices ended mixed on Tuesday, with Dow Jones slipping 0.4% and S&P 500 down 0.1%. Top stocks gaining attention include ProKidney Corp (PROK) up 515%, SoundHound AI (SOUN) up 11.69%, QuantumScape Corp (QS) up 16.69%, Intel (INTC) up 7.23%, and Nvidia (NVDA) up 1.11%. These stocks were driven by positive announcements and partnerships, including ProKidney's Phase 2 trial results, SoundHound AI's rally after Nvidia's exit, QuantumScape's production announcement, Intel's restructuring efforts, and Nvidia's partnership with OpenAI.

US indices ended mixed on Tuesday, with the Dow Jones slipping 0.4% and the S&P 500 down 0.1%. Top performers included ProKidney Corp (PROK), which surged by 515%, SoundHound AI (SOUN) up 11.69%, QuantumScape Corp (QS) up 16.69%, Intel (INTC) up 7.23%, and Nvidia (NVDA) up 1.11%. These gains were driven by positive announcements and partnerships, including ProKidney's Phase 2 trial results.

ProKidney Corp (PROK), a North Carolina-based biotech company focused on treating kidney disease with cellular therapeutics, saw its shares skyrocket by over 500% on Tuesday. The catalyst for this stunning gain was the announcement of statistically significant and clinically meaningful positive topline results from the full Group 1 modified intent-to-treat (MITT) population of the Phase 2 REGEN-007 trial. The trial evaluated rilparencel, an autologous cellular therapy, in patients with chronic kidney disease (CKD) and diabetes [1].

Rilparencel is an autologous cellular therapy that has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food & Drug Administration (FDA). It is currently being evaluated in the ongoing Phase 3 REGEN-006 (PROACT 1) trial to demonstrate its potential to preserve kidney function in patients with advanced CKD and type 2 diabetes. Autologous cell therapies work by harvesting cells from a patient, which are then genetically engineered to fight a particular disease before being reinfused back into the patient. This approach has proven successful in the field of oncology, with several FDA-approved therapies, such as Bristol Myers Squibb's Abecma and Breyanzi, Gilead Sciences' Tecartus and Yescarta, and Legend Biotech's Carvykti, treating hematological cancers [1].

The Phase 2 REGEN-007 trial results showed that in Group 1 (n=24), kidney function stabilized after receiving rilparencel. The annual decline in estimated glomerular filtration rate (eGFR) slope improved by 78% from -5.8 mL/min/1.73m2 in the pre-injection period to -1.3 mL/min/1.73m2 in the period following the last rilparencel injection. This 4.6 mL/min/1.73m2 per year difference was statistically significant (p0.001) and clinically meaningful. Of the 24 patients in Group 1, 15 (63%) met key Phase 3 PROACT 1 inclusion criteria, and similar efficacy results were observed in this subgroup compared to the full Group 1 results [1].

The Phase 3 PROACT 1 protocol was amended in the first half of 2024 after a similar eGFR efficacy signal was observed in the Phase 2 RMCL-002 study subgroup analysis. This amendment means ProKidney is now focused on more severe disease, as the company has acknowledged the threat of GLP-1 receptor agonist drugs, such as Novo Nordisk's semaglutide, which is better known under its brand names Ozempic and Wegovy. Ozempic has been approved to treat CKD and has a more palatable treatment regime than rilparencel, which requires two injections over three months [1].

The statistically significant and clinically meaningful results from Group 1, if repeated in the Phase 3 PROACT 1 study, ought to be sufficient to garner an accelerated approval for rilparencel. The FDA's accelerated approval pathway permits the use of a surrogate endpoint, such as eGFR slope, to expedite the approval process. However, the Group 2 data, where patients received a single injection, did not achieve statistical significance, with a relative benefit of 50% compared to 78% in Group 1 [1].

Looking ahead, ProKidney is due to meet with the FDA in a matter of weeks to confirm its approach to eGFR slope as a surrogate endpoint for accelerated approval. The FDA has faced criticism around accelerated approvals in the past, with less than half of the oncology drugs granted such an approval being successful in their post-confirmatory studies. ProKidney's Phase 3 study is not expected to read out data until Q3 2027, and management has suggested that there may be a long wait for the data [1].

In summary, ProKidney Corp's Phase 2 trial results have driven a significant surge in the company's stock price. The market is optimistic about the potential of rilparencel, an autologous cellular therapy, to treat more severe forms of CKD. However, the long wait for Phase 3 data and potential dilution from fundraising efforts may temper the share price's momentum.

References:
[1] https://seekingalpha.com/article/4800123-prokidney-study-win-send-shares-soaring-500-percent-new-valuation-feels-fair