Unicycive Therapeutics (Nasdaq: UNCY) – Preparing for a Second Shot at Bringing a New Kidney Treatment to Market (TEST)

Key Takeaways 

• Unicycive has completed clinical development of its lead asset, Oxylanthanum Carbonate (OLC).
• OLC is designed to improve on current phosphate binders by offering better efficacy, fewer pills, and improved tolerability for dialysis patients with hyperphosphatemia.
• The FDA’s June 2025 rejection was solely due to manufacturing deficiencies at a third-party vendor, not concerns about the drug itself.
• With a new manufacturer in place, Unicycive plans to resubmit its New Drug Application (NDA) in December 2025, with potential FDA approval by mid-2026.
• The U.S. market opportunity for OLC is estimated at $500M+, and Unicycive intends to commercialize the drug through its own targeted sales force.

About Unicycive Therapeutics

Unicycive Therapeutics is a clinical-stage biotechnology company headquartered in Los Altos, California. The company focuses on kidney-related conditions, with its main development program centered on Oxylanthanum Carbonate, a next-generation phosphate binder for patients with chronic kidney disease (CKD) on dialysis.

OLC has reached the end of its clinical development pathway, but the FDA issued a Complete Response Letter (CRL) in June 2025 due to manufacturing issues at a third-party vendor. The company has since moved to a new manufacturer and expects to resubmit the New Drug Application (NDA) in December 2025, keeping it on track for potential approval in mid-2026.

Unicycive is also advancing UNI-494, a mitochondrial-protective compound in Phase 1 for acute kidney injury.

FDA Approval of OLC Could Be a Major Catalyst for the Company

Hyperphosphatemia is a common and serious issue for dialysis patients. Because their kidneys cannot remove excess phosphorus, levels can rise dangerously high, increasing risks of heart disease, bone problems, and mortality.

OLC represents a significant improvement on older drugs. Lanthanum carbonate, the active ingredient behind OLC, has been FDA-approved since 2004 and is currently sold as Fosrenol. OLC uses proprietary nanoparticle technology to improve phosphate binding, which allows patients to take far fewer pills. While many dialysis patients must swallow 8 to 12 phosphate-binder pills per day, OLC requires just one tablet three times daily, a meaningful improvement for adherence and quality of life.

OLC is a safe drug. Under America's 505(b)(2) regulatory pathway, OLC can gain approval using data from previous developers which established safety. Unicycive's New Drug Application (NDA) submission package is based on a Phase 1 and a bioequivalence study in healthy volunteers and a tolerability study in dialysis patients.

OLC is an effective drug. In its pivotal UNI-OLC-201 trial, only 6% of patients discontinued treatment due to adverse events, compared with a 14% discontinuation rate for Fosrenol. Importantly, just 1.4% of patients in the evaluable group stopped treatment due to treatment-related side effects, meeting the trial’s primary endpoint with a wide margin.

OLC is a patient-preferred drug. A survey of patients taking OLC in Unicycive's clinical work found that 79% of patients preferred OLC over their current medication, a massive 98% of patients said OLC was easy to take versus 55% with the current medication, and 89% of patients were satisfied with OLC versus only 49% with the current medication.

OLC's NDA resubmission is a significant catalyst. After switching to a new manufacturing partner, Unicycive held a Type A meeting with the FDA in October 2025, the agency’s highest-priority meeting category. The discussion focused solely on resolving the manufacturing issue raised in the earlier Complete Response Letter, and no new concerns were identified. As a result, Unicycive expects to resubmit its NDA in December 2025, which could lead to FDA approval as early as mid-2026.

OLC is protected by a strong patent position, with issued patents covering the drug through 2031, and the potential for patent term extensions that could extend protection into the mid-2030s.

Unicycive will run its own sales force for OLC, since in this market a relatively small sales force can allow the company to reach all the relevant physicians treating dialysis patients. This allows the company to capture significant value from OLC.

OLC US sales can potentially be over half a billion US dollars a year. It's estimated that around 75% of all dialysis patients have excessive phosphate levels. Around 450,000 individuals in the US take phosphate binders without getting good outcomes. US$30,000 per patient per year for a 5% market share would mean US$675m in sales annually for OLC.

Unicycive is funded to get to its first sales, with a cash runway into 2027 expected to support resubmission, potential FDA approval, and the launch of OLC.

The market size for OLC

There are more than 450,000 patients in the US alone, with 550,000 US dialysis patients in 2020, growing about 3% p.a., and around 80% of these patients receiving phosphate binders for hyperphosphatemia. This large and steadily growing patient population creates a sizable and durable demand for phosphate-lowering treatments, making the dialysis market an important long-term opportunity.

The US market is currently a billion-dollar opportunity, with the typical patient on phosphate binders costing an average of US$2,500 per patient per year across brand-only and generic products. On a global basis, the market is even larger at around US$2.5 billion, and is growing at roughly 5% per year, highlighting the scale of the commercial opportunity for new and improved treatments.

Most patients don't take their pills, with more than 60% self-reported to be non-adherent due in large measure to the currently marketed phosphate binders being unpalatable. This poor adherence is largely driven by high pill burden and gastrointestinal side effects, making lower pill burden the biggest unmet need in nephrology and a key area where new therapies can stand out.

The existing pills often don't work very well. There are only a handful of phosphate binders currently on patent, including Renvela from Sanofi and Auryxia from Akebia Therapeutics. Alongside these, there are several older treatments still used, such as Fosrenol, PhosLo, and Velphoro.

Despite having these options available, most of them don’t work well enough in real-world use. In fact, around 75% of patients still fail to get their phosphate levels under control, even while taking these medications. This gap in effectiveness highlights why a better, easier-to-take option like OLC could have strong appeal for both patients and doctors.

The reimbursement outlook for the US is strong. Under Medicare’s TDAPA program, new dialysis drugs such as OLC could be reimbursed at 100% of cost for the first two years starting in 2026, which may support faster adoption and higher early usage before pricing pressure increases after 2028. Unicycive believes that the 'best in class' nature of OLC means that it can enjoy higher volumes once price pressure kicks in after TDAPA ends in 2028.

Xphozah shows the potential pricing.  Xphozah (tenapanor), a drug from Ardelyx that gained FDA approval in 2023, is currently priced around US$3,000 per month. Other drugs are priced less expensively, at more like US$1,700 a month.

Commercial Strategy: A Focused Sales Approach

Unicycive plans to commercialize OLC on its own, rather than partnering with a larger pharmaceutical company. While many small biotech companies rely on partners with large sales teams, Unicycive believes the U.S. market for phosphate binders is highly concentrated, making a focused in-house launch feasible.

Company research shows that around half of all phosphate-binder prescriptions in the U.S. are written by just 2,100 doctors, out of roughly 31,000 prescribers nationwide. Because of this concentration, Unicycive believes it can effectively reach the core market with a targeted sales force of about 50 representatives.

Looking ahead, 2026 could be a pivotal year. Unicycive expects a potential FDA approval for OLC in the first half of the year, followed by a commercial launch in the second half. If approved, OLC may also qualify for TDAPA reimbursement, which could support early adoption and accelerate sales.

What OLC Could Achieve by 2029

Unicycive can potentially be a US$500m drug in 2029. Take the analysis we used above of 450,000 patients where OLC gets 4% to 5% market share in the third year after launch, but where the drug is priced at only US$2,000 per month. This suggests a US$500m revenue level. We think the US$500m assumption is conservative and accounts for the post-2028 market environment that would see lower pricing pressure, but higher patient uptake given the clinical effectiveness.

Assume the ~20% net profit margin typical of US biotech companies. We believe that OLC can potentially enjoy a 70% gross margin. The drug has multiple manufacturing steps and is not a biological drug, but it is reasonable to expect gradually reduced production costs. The sales force will be the most significant expense for Unicycive but there is also R&D related to the company's pipeline and the company's corporate overhead. All things considered, it's reasonable to think a 20% profit margin expectation by 2029 is conservative if OLC can achieve that 4-5% market share.

Discount rate. We assume a discount rate of 10%, which is around 6% higher than the US ten year bond rate and reflects the risks related to OLC's commercial experience from 2026.

Unicycive is significantly undervalued given the potential. Should the company achieve a US$500m sales figure for 2029 and a 20% net profit rate US$100.19m, it is reasonable to expect a significantly higher value for Unicycive. Typically, in late 2025 US-listed biotechs trade on a PE ratio of around 27, which would capitalise the company on Nasdaq at US$2.8bn. Should Unicycive still have 79.8m shares on issue in 2030, a reasonable price for the stock would be US$34.68. Discounted to 2025 at 10% that suggests a fair value today of $21.53.

Risks

While the opportunity is meaningful, key risks include:

• Timing risk. FDA approval could be delayed.
• Regulatory risk. Another CRL or additional requests from FDA.
• Commercial risk. Slower-than-expected adoption/sales.
• Dilution risk. Future capital raises may be necessary, diluting existing shareholders.
• Key personnel risk. Retaining the company’s key personnel is critical. If Unicycive were to lose important team members and struggle to replace their expertise, it could impact execution and slow progress.

Early-stage biotech risk: Like many life science companies that are pre-revenue, Unicycive should be considered a higher-risk investment. The share prices of pre-revenue biotech companies can be volatile, as their value often depends on scientific progress, regulatory outcomes, and future commercialization. In addition, the underlying science and intellectual property can be complex, which makes it harder for non-specialist investors to assess risk.

Peer Comparisons

Ardelyx (Nasdaq: ARDX) is a commercial-stage biotech that sells Xphozah (tenapanor), a treatment for kidney-related conditions. The company is also developing RDX10531, a next-generation drug that could be used across multiple therapeutic areas. Ardelyx has partnered with other companies to commercialize tenapanor outside the U.S., and today the company is valued at around US$1.4 billion.

Akebia Therapeutics (Nasdaq: AKBA) is focused on kidney disease treatments. Its products include Auryxia, a phosphate binder, and Vafseo, a once-daily oral drug approved by the FDA in March 2024 for anemia in dialysis patients with chronic kidney disease. Akebia currently has a market capitalization of approximately US$420 million.

Conclusion

Unicycive is nearing a key regulatory event with the planned New Drug Application resubmission for OLC. With strong clinical data, a clear FDA path forward, and a billion-dollar addressable market, the company is positioned for a potentially meaningful commercial launch in 2026. If OLC performs as expected, it could drive substantial growth and shareholder value through 2029 and beyond.