De-Risked NDA Resubmission and TDAPA Tailwinds Support Buy Rating on Unicycive and OLC Commercial Upside

Analyst Jason McCarthy from Maxim Group maintained a Buy rating on Unicycive Therapeutics and keeping the price target at $30.00.

Jason McCarthy has given his Buy rating due to a combination of factors tied to both regulatory visibility and commercial potential. He views the resubmission of the NDA for oxylanthanum carbonate (OLC) as de-risked because the prior FDA setback was limited to a third‑party manufacturing issue, with no concerns raised about the drug’s clinical, preclinical, or safety data. With the manufacturing deficiency reportedly addressed and the FDA review cycle expected to conclude around late 2Q26, he sees a clear path toward a potential approval decision. In parallel, Unicycive’s balance sheet is described as sufficient to fund operations into 2027, which should allow the company to execute on launch and commercialization without near‑term financing pressure.
McCarthy also emphasizes the strategic timing relative to the TDAPA reimbursement window for phosphate binders, which he believes could accelerate early uptake of OLC and support premium pricing during the remaining years before TDAPA expires in 2027. Even after that period, he expects the product to remain competitive due to its favorable dosing profile and expected reimbursement dynamics for innovative therapies. Additional Phase 2 data showing markedly lower pill burden, improved adherence, and strong patient preference versus existing phosphate binders reinforce his view that OLC can address key barriers to treatment compliance identified in dialysis patients. Taken together, these regulatory, clinical, and market advantages underpin his conviction that Unicycive’s shares offer attractive upside at current levels, supporting a Buy rating.

McCarthy covers the Healthcare sector, focusing on stocks such as Actinium Pharmaceuticals, Annovis Bio, and Coherus Biosciences. According to TipRanks, McCarthy has an average return of -13.8% and a 32.60% success rate on recommended stocks.