Unicycive Therapeutics Inc (UNCY) News & EventsUNCYNews & EventsUnicycive Therapeutics Inc

Unicycive CEO Says OLC Application Progressing Well

"We are focused on securing approval of oxylanthanum carbonate and remain confident in the efficacy and safety of OLC and in its potential to improve care for patients with hyperphosphatemia on dialysis," said Shalabh Gupta, Chief Executive Officer of Unicycive. "The latest update from our third-party manufacturing vendor is that the U.S. Food and Drug Administration has assigned a facility inspection. This marks a positive step forward, and our dialogue with the FDA on OLC labeling and packaging has been productive and continuous throughout this process. We are optimistic about a successful inspection of the third-party manufacturing facility, which would enable us to promptly resubmit the NDA. In the meantime, we are well positioned to launch OLC as quickly as possible following potential approval, and we are utilizing this time to continue to expand market awareness in preparation for the commercial success of OLC."

Markets End Cautiously, Semiconductor Stocks Drive Gains

Markets are ending the second quarter on a cautious note, with the indexes pointing slightly lower as investors weigh strong year-to-date gains against growing questions about valuations and the path of interest rates. The S&P 500 and Nasdaq are coming off a rebound session, while the Dow recently pushed above the 52,000 level. Despite geopolitical tensions, an oil-price shock earlier in the quarter, and persistent inflation concerns, major indexes are still on track for one of their strongest quarterly performances in years.Semiconductor stocks have driven much of the market's gains this year, with the Philadelphia Semiconductor Index nearly doubling in the first half as hyperscaler spending on AI infrastructure accelerated. However, recent volatility has revived debate over whether parts of the market are beginning to show signs of excess enthusiasm. Investors increasingly appear to be asking not whether AI spending is real, but whether current stock prices already reflect years of future growth.Investors are watching today's JOLTS job openings report and consumer confidence data for clues about the health of the labor market and the consumer. Those readings could influence expectations for Federal Reserve policy, particularly as traders continue to debate whether additional rate increases will be needed later this year.In pre-market trading, S&P 500 futures were flat, Nasdaq futures fell 0.04% and Dow futures fell 0.05%.Check out this morning's top movers from around Wall Street, compiled by The Fly.HIGHER -Abivaxup 33% after announcing topline results from ABTECT Maintenance Part 2, the supplemental portion of its Phase 3 UC maintenance program evaluating obefazimodAevexup 11% after securing a $50M contract from the United States Air Force to continue expanding unmanned mission-support capabilities for current operationsLCI Industriesup 2% after Patrick Industriesand the company agreed to combine in an all-stock mergerBlockup 1% after Piper Sandler upgraded the stock to Overweight from Underweight with a price target of $100, up from $58UP AFTER EARNINGS -AeroVironmentup 28%DOWN AFTER EARNINGS -Concentrixdown 21%LOWER -Unicycive Therapeuticsdown 37% after receiving a complete response letter from the FDA regarding the resubmitted new drug application for oxylanthanum carbonatePatrick Industriesdown 8% after the company and LCI Industries announced an agreement to combine in an all-stock mergerDigital Realtydown 4% after agreeing to purchase from Blackstone-affiliated funds a stake in three fully leased data centers containing 288 megawatts of total IT capacity in Northern Virginia at a gross value of $7.8B

Unicycive Receives Complete Response Letter from FDA

Unicycive Therapeutics announced that it has received a complete response letter, or CRL, from the FDA regarding the resubmitted new drug application, or NDA, for oxylanthanum carbonate, or OLC, for the treatment of hyperphosphatemia in patients with chronic kidney disease, or CKD, on dialysis. The FDA has not raised any concerns regarding clinical efficacy or safety data, and no additional data was requested from Unicycive. The CRL is based on the same third-party manufacturing deficiencies that were identified in the previous CRL issued in June 2025. Unicycive understands that the FDA has not yet conducted its inspection of that third-party manufacturing vendor as part of the review process of the resubmitted NDA. The NDA for OLC had been resubmitted based on Unicycive's belief of continued progress by the original third-party manufacturing vendor in resolving FDA-cited deficiencies and demonstrating inspection readiness. Unicycive previously discussed these milestones during a Type A meeting with the FDA in September 2025, which was held to obtain feedback and alignment on resolving the deficiencies identified in the company's CRL related to the compliance status of the vendor. The FDA did not express any concerns about the third-party manufacturer's progress and no additional issues were raised by the FDA at the Type A meeting.