Updated hourlyHourly refreshMon, Oct 26, 2026
Finance · Healthcare
Mountain View, CA, 21 Oct, 2026 - Unicycive Therapeutics, Inc. ("Unicycive" or the "Company") (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC), the Company's investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The NDA was resubmitted following a Complete Response Letter (CRL) received in June 2026. The FDA has deemed the OLC resubmission a Class II with a six-month review period from the resubmission date, and set a Prescription Drug User Fee Act (PDUFA) target action date of March 25, 2027.
Unicycive Therapeutics, Inc. is a B2i Digital Featured Company. See the company's in-depth profile at: https://b2idigital.com/unicycive-therapeutics.
"We are pleased that the FDA has accepted the resubmission of our NDA for OLC and assigned a PDUFA date," said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. "This resubmission includes CMC data from a new third-party drug product manufacturing vendor. The new vendor's facility was last inspected by the FDA in March 2024 and received 'No Action Indicated' status. We hope to continue working with the FDA toward potential approval of this important medication to patients with CKD on dialysis who need additional treatment options for managing hyperphosphatemia."
The Company does not know whether the FDA will decide to conduct a pre-approval inspection of the new third-party DP vendor. Additionally, if the original third-party manufacturing vendor is inspected in the near term and finds that its facility complies with current Good Manufacturing Practice (cGMP), the Company plans to seek FDA alignment on a shorter approval timeline.
The Company resubmitted the NDA following the second CRL, which cited deficiencies previously identified at the original third-party manufacturer of the drug product, which the FDA had not been able to re-inspect during the prior submission review.
The timing and outcome of any FDA inspection of the original third-party vendor will be determined solely by the FDA.
The NDA is supported by data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, as well as CMC data. The FDA did not raise any concerns regarding OLC's preclinical or clinical data, including safety data, included in the original NDA submission.
About Oxylanthanum Carbonate
OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden. Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.
About Hyperphosphatemia
Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). Annually there are over 450,000 individuals in the U.S. that require medication to control their phosphate levels.[1] Uncontrolled hyperphosphatemia is strongly associated with increased death and hospitalization for CKD patients on dialysis. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.
[1] Flythe JE. Dialysis-Past, Present, and Future: A Kidney360 Perspectives Series. Kidney360. 2023 May 1;4(5):567-568. doi: 10.34067/KID.0000000000000145.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive's lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com.
Forward-looking statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Unicycive's expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; Unicycive's clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; Unicycive's dependence on third parties for manufacturing; the possibility that FDA may require inspection of any vendor prior to approval, which could delay or prevent approval of its NDA; the risk that the inspection of the original or new third-party manufacturing vendor may not occur within a timeframe that benefits its regulatory timeline, or may result in adverse findings; risks related to business interruptions, which could seriously harm its financial condition and increase its costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; market acceptance of its products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled 'Risk Factors' in Unicycive's Annual Report on Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Investor Contacts:
Kevin Gardner, LifeSci Advisors, kgardner@lifesciadvisors.com
Media Contact:
Unicycive Therapeutics, media@unicycive.com
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David Shapiro, B2i Digital, Inc., +1 212-579-4844, david@b2idigital.com
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SOURCE: Unicycive Therapeutics, Inc.
Oct 22 · 00:00·ACN Newswire
Finance · AI
OKLAHOMA CITY Wednesday Oct 21, 2026 @ 7:00 PM Central —
An active Oklahoma medical marijuana license has never been an absolute guarantee of job security. Starting November 1, 2026, that legal distinction becomes significantly more critical. According to a statewide patient advisory issued by Medical Marijuana Doctor Oklahoma, licensed cardholders face substantial shifts under House Bill 3127, which allows employers to take adverse employment action following a positive marijuana test if the action is carried out under a lawful written drug and alcohol testing policy.
Signed by Governor Kevin Stitt on April 17, 2026, HB 3127 amends 63 O.S. § 427.8 of the Oklahoma Medical Marijuana and Patient Protection Act. While the legislation preserves the foundational rule that employers cannot penalize someone solely for being a registered Oklahoma Medical Marijuana Authority (OMMA) license holder, it substantially narrows the positive-test protections that many working patients currently rely on.
Before November 1: How Existing Law Protected Positive Tests
Under current OMMA patient-rights guidance, an employer generally cannot refuse to hire, discipline, or terminate a licensed patient solely because of a positive drug screen for marijuana components or metabolites.
Existing law permits exceptions only when:
The individual does not hold a valid, active OMMA license;
The employee possesses, consumes, or is under the influence of marijuana at work or during work hours;
The individual holds a position with safety-sensitive job duties; or
State protection is preempted by federal law or where compliance is required to maintain federal funding or contracts.
As detailed in the enrolled HB 3127 legislative history, the amendment does not eliminate all patient safeguards, but it fundamentally rewrites the positive-test exception.
A Compliant Written Policy Becomes the New Dividing Line
Beginning November 1, an employer may act solely on a positive marijuana test result when that action is taken pursuant to a written drug and alcohol testing policy adopted and enforced in accordance with the Oklahoma Standards for Workplace Drug and Alcohol Testing Act.
This statutory change means a valid patient license may no longer defeat an adverse employment decision based on a drug screen. However, Medical Marijuana Doctor Oklahoma emphasizes that employers do not receive unchecked authority simply because they possess an internal document labeled "drug policy."
As noted in recent workplace legal analysis by Crowe & Dunlevy, an employer’s policy and testing workflow must comply strictly with state testing standards, which govern:
advance written notice to employees;
clearly articulated testing criteria (who, when, and what substances are tested);
certified collection and laboratory procedures;
employee rights to explain or rebut a positive result; and
strict statutory confidentiality protections.
Safety-Sensitive Jobs Move to Mandatory Zero Tolerance
HB 3127 creates an explicit statutory rule for safety-sensitive positions: applicants and employees in those roles "shall be subject to a zero-tolerance drug and alcohol standard," even if the employer applies an impairment-based or more flexible rule to non-safety staff.
Crucially, the amendment eliminates the former statutory wording that permitted employers to designate positions as safety-sensitive based merely on what management "reasonably believes" could impact health and safety. Under 63 O.S. § 427.8, the law ties the classification directly to actual performed duties, including:
Handling, storing, disposing of, or transporting hazardous, volatile, flammable, or combustible materials;
Operating a motor vehicle, machinery, equipment, or power tools;
Repairing or monitoring equipment or manufacturing processes whose failure could cause personal injury or property damage;
Firefighting;
Operating or overseeing utilities and critical public infrastructure;
Dispensing pharmaceuticals;
Carrying a firearm; or
Providing direct patient care or direct child care.
While this statutory list is not exhaustive, it restricts employers from applying arbitrary, self-created safety-sensitive labels. Because HB 3127 does not define every operational detail of "zero tolerance," patients in potentially qualifying roles should inspect their formal job descriptions, company policies, and applicable federal regulations.
Core Safeguards and Legal Remedies That Survive Unchanged
Despite the expansion of employer authority, two vital legal protections remain in force:
Status Discrimination Ban: Unless mandated by federal statute or federal funding agreements, an employer may not penalize an applicant or employee solely because they hold an OMMA patient card.
Civil Legal Remedy for Willful Violations: Patients subjected to unlawful adverse actions retain legal recourse. The statute maintains remedies under the Oklahoma workplace testing act, which authorizes civil actions within one year of an alleged willful violation (40 O.S. § 563).
At the same time, state law reiterates that medical cannabis licenses do not authorize workplace consumption. Employers maintain the absolute right to prohibit possession, use, sale, transfer, and impairment on company property or while performing job functions.
What Oklahoma Patients Must Do Before November 1
Medical Marijuana Doctor Oklahoma recommends that cardholders take immediate proactive steps:
Request the Written Policy: Obtain and review your employer's current written drug and alcohol testing policy to verify that it complies with the Oklahoma testing act.
Review Real Job Duties: Compare your daily tasks against the statutory list of safety-sensitive functions to evaluate your risk level.
Never Assume Automatic Protection: Do not assume that off-duty therapeutic use, an active card, or the lack of visible impairment will shield your employment after November 1.
Preserve Documentation: Retain dated copies of testing notices, chain-of-custody documentation, laboratory results, and written employer correspondence.
Seek Timely Counsel: If facing an adverse employment action that appears non-compliant, consult a qualified Oklahoma employment attorney immediately to preserve statutory claims within the one-year limitations window under 40 O.S. § 563.
This advisory provides general educational information, not legal advice. Oklahoma law and workplace policies can change, and federal rules may produce a different result. Verify current requirements through the Oklahoma Legislature, the Oklahoma Medical Marijuana Authority, and qualified legal counsel.
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