H.C. Wainwright keeps Buy on Unicycive Therapeutics , says CRL ‘anticipated’

H.C. Wainwright analyst Swayampakula Ramakanth notes that Unicycive has announced the receipt of a complete response letter from the FDA for the use of oxylanthanum carbonate to treat hyperphosphatemia in dialysis patients. Recall, earlier in June the company announced that the FDA has identified a cGMP compliance-related deficiency with the company’s third-party manufacturing vendor, who is a subcontractor to Unicycive’s CDMO. Therefore, the firm points out that the CRL was not unexpected, and according to management, issues raised by the FDA in the CRL relate solely to a failed cGMP inspection rather than any concerns with the drug’s safety or efficacy. To alleviate the issues raised by the agency, management has identified a second vendor that has produced OLC and plans to seek a Type A meeting with the FDA in the coming days. Wainwright expects the company to provide additional details once the meeting has taken place, which it believes could take 4-6 weeks. The firm has a Buy rating on the shares with a price target of $9.