Friday, May 01, 2026 8:44:57 PM
The analyst's rationale for this valuation is centered on the commercial potential of the company's lead drug candidate and favorable regulatory timing:Oxylanthanum Carbonate (OLC) Potential:
The investment thesis focuses on OLC, a next-generation phosphate binder for treating hyperphosphatemia in chronic kidney disease patients on dialysis. B. Riley highlights its nanoparticle formulation as a key advantage.
Market Opportunity: OLC is positioned to enter a $1.5 billion U.S. hyperphosphatemia market.
TDAPA Eligibility: B. Riley notes that OLC is the only therapy eligible for the Transitional Add-on Payment Adjustment (TDAPA) at the exact time that class-level TDAPA for six existing bundled binders is set to expire. ( hello ..those who follow this board knew this ...my comments )
FDA Action Date: The FDA has set a PDUFA target action date of June 29, 2026, for OLC, creating a near-term catalyst for the stock.
Commercial Transition: Analysts, including those at H.C. Wainwright (who also hold a $22 target), view the company as successfully transitioning from a clinical-stage developer to a commercial-scale organization.
Note ..re being the only one in TDAPA ( 100% Medicare coverage ) in 2027 .
This assumes the Kidney Care Partners action group fails to extend the existing TDAPA from 2 to 3 yrs ...currently working its way thru Congress.
Kiwi
Recent UNCY News
- Form 8-K - Current report • Edgar (US Regulatory) • 05/12/2026 11:51:50 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/12/2026 10:30:46 AM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 04/30/2026 11:04:02 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 04/30/2026 11:02:10 AM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 04/30/2026 11:00:08 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 04/06/2026 01:11:55 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/30/2026 11:29:20 AM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 03/30/2026 10:32:02 AM
- Unicycive shares gain as FDA accepts resubmitted OLC NDA • IH Market News • 01/29/2026 03:01:58 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/14/2025 10:10:14 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 11/14/2025 10:09:13 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/12/2025 02:12:01 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/12/2025 11:39:29 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/28/2025 11:30:13 AM
- UNCY Investors Have Opportunity to Lead Unicycive Therapeutics, Inc. Securities Fraud Lawsuit • PR Newswire (US) • 10/14/2025 06:55:00 AM
