Unicycive Therapeutics

Unicycive and ORIC Pharmaceuticals Receive Buy Ratings Based on Promising Clinical Data

4 months ago

• Unicycive Therapeutics' OLC shows promise in treating hyperphosphatemia by reducing pill burden and adverse events, potentially gaining FDA approval by June 2025. • ORIC Pharmaceuticals' ORIC-944, combined with apalutamide, demonstrates significant PSA level decreases in metastatic castration-resistant prostate cancer patients. • Durability of ORIC-944 responses, with some patients maintaining PSA90 responses for 38 weeks, supports confidence in Oric Pharmaceuticals' strategic advancements. • H.C. Wainwright analyst Ed Arce maintains a Buy rating on Unicycive with a $4.00 price target, while Robert Burns reiterates a Buy rating on Oric with a $21.00 target.

FDA Accepts Unicycive's NDA for Oxylanthanum Carbonate to Treat Hyperphosphatemia in CKD Patients

6 months ago

• The FDA has accepted Unicycive Therapeutics' New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) with a PDUFA target action date of June 28, 2025. • OLC aims to reduce the pill burden for chronic kidney disease (CKD) patients on dialysis who suffer from hyperphosphatemia, potentially improving patient adherence. • Unicycive has a long-term manufacturing agreement with Shilpa Medicare for commercial supply of OLC, anticipating a US market launch in the second half of 2025. • Hyperphosphatemia in CKD patients often requires multiple daily pills; OLC offers a simplified, easier-to-swallow treatment option.

Unicycive's OLC Receives FDA Acceptance for Hyperphosphatemia Treatment

6 months ago

• Unicycive's New Drug Application for oxylanthanum carbonate (OLC) has been accepted by the FDA, with a PDUFA target action date set for June 28, 2025. • Clinical trial data indicates OLC's potential as a preferred treatment option, with 79% of patients favoring it over previous phosphate binders. • UNI-494, Unicycive's second asset, successfully completed Phase 1 trial, showing promise for treating acute kidney injury (AKI).

Unicycive's Hyperphosphatemia Drug, Oxylanthanum Carbonate, Awaits FDA Decision in June

6 months ago

• Unicycive Therapeutics' oxylanthanum carbonate (OLC) is under FDA review for treating hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis. • OLC aims to improve patient adherence with fewer, smaller, and easier-to-swallow pills compared to existing phosphate binders like Takeda's Fosrenol. • Clinical trial data showed that 69% of evaluable patients achieved target serum phosphate levels with OLC at a dose of 500mg three times daily. • The FDA is expected to make a decision on OLC by June 28, potentially marking Unicycive's first approved product in a market with significant unmet needs.

FDA Accepts Unicycive's NDA for Oxylanthanum Carbonate in CKD Patients on Dialysis

6 months ago

• The FDA has accepted Unicycive Therapeutics' New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis. • The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025, for the OLC application. • Unicycive is seeking approval via the 505(b)(2) regulatory pathway, supported by data from three clinical studies and preclinical data. • If approved, OLC could significantly improve the treatment burden for hyperphosphatemia in CKD patients on dialysis, with a potential launch in the second half of 2025.

Unicycive's OLC Receives FDA Acceptance for Hyperphosphatemia NDA

6 months ago

• The FDA has accepted Unicycive Therapeutics' New Drug Application for Oxylanthanum Carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease patients on dialysis. • The FDA has set a PDUFA target action date of June 28, 2025, for OLC, a next-generation lanthanum-based phosphate binding agent. • OLC aims to reduce pill burden and improve patient compliance, potentially offering a more convenient treatment option compared to existing therapies. • Clinical data supports OLC's safety and bioequivalence, with Unicycive preparing for a commercial launch in the second half of 2025, pending approval.

FDA Accepts Unicycive's Oxylanthanum Carbonate (OLC) Application for Hyperphosphatemia Treatment

6 months ago

• The FDA has accepted Unicycive Therapeutics' NDA for Oxylanthanum Carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease patients on dialysis. • The FDA has set a PDUFA target action date of June 28, 2025, for OLC, a next-generation lanthanum-based phosphate binding agent. • OLC aims to reduce the pill burden for patients, potentially improving adherence compared to current treatments that often require multiple pills per day. • Unicycive is preparing for the commercial launch of OLC in the second half of 2025, pending FDA approval, targeting a market expected to exceed $2.5 billion globally.

FDA Accepts Unicycive's NDA for Oxylanthanum Carbonate to Treat Hyperphosphatemia in CKD Patients on Dialysis

6 months ago

• The FDA has accepted Unicycive Therapeutics' NDA for Oxylanthanum Carbonate (OLC) with a PDUFA target action date of June 28, 2025. • OLC aims to reduce the high pill burden for hyperphosphatemia patients with chronic kidney disease (CKD) on dialysis. • Unicycive is seeking approval via the 505(b)(2) regulatory pathway, supported by data from three clinical studies and preclinical data. • If approved, OLC could offer a more convenient treatment option due to its lower pill burden and ease of swallowing compared to existing treatments.

UNI-494 Shows Promise in Phase I Trial for Acute Kidney Injury

7 months ago

• Unicycive Therapeutics' UNI-494, a nicorandil pro-drug, demonstrates safety and tolerability in a Phase I trial for acute kidney injury (AKI). • The study showed rapid absorption and metabolism of UNI-494, with plasma concentration increasing proportionally with the dose. • The prevalence of AKI is expected to rise with the aging global population, increasing the demand for effective therapeutic options. • UNI-494 has received orphan drug designation from the FDA for preventing delayed graft function after kidney transplantation.

Unicycive Therapeutics' OLC for Hyperphosphatemia Receives 'Buy' Rating Amidst NDA Submission

9 months ago

• Unicycive Therapeutics' Oxylanthanum Carbonate (OLC) NDA submission for hyperphosphatemia treatment in chronic kidney disease patients on dialysis has garnered a 'Buy' rating. • The FDA waived PDUFA fees for OLC, presenting a cost-saving benefit, and studies suggest favorable tolerability and efficacy in phosphate control. • Analysts anticipate the approval of OLC could unlock a significant revenue opportunity, supported by the company's sound financial position and potential dividend payouts. • Despite a reduced 12-month price target due to TDAPA uncertainties, analysts maintain a positive outlook, expecting resolution and OLC approval.

Unicycive Submits NDA to FDA for Oxylanthanum Carbonate to Treat Hyperphosphatemia in CKD Patients on Dialysis

9 months ago

• Unicycive Therapeutics has submitted an NDA to the FDA for Oxylanthanum Carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis. • The NDA is supported by data from three clinical studies, multiple preclinical studies, and CMC specifications, seeking approval via the 505(b)(2) regulatory pathway. • OLC, a next-generation lanthanum-based phosphate binder, aims to reduce pill burden and improve patient compliance compared to existing treatments. • The FDA granted a waiver for the NDA application Prescription Drug User Fee Act (PDUFA) fees, resulting in significant savings of approximately $4 million.