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Unicycive (UNCY) Up on Positive Hyperphosphatemia Study Update
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Unicycive Therapeutics, Inc. (UNCY - Free Report) , a clinical-stage company, issued a letter to its shareholders providing corporate updates and key upcoming milestones for the company in 2024. Following the issuance, shares of the company surged 18.3% on Jan 23, as the investors cheered the encouraging pipeline progress. Shares of the company gained 6.8% in the after-market hours.
The company is currently evaluating its lead candidate, Oxylanthanum Carbonate (OLC), in a pivotal clinical study to evaluate the tolerability of OLC in chronic kidney disease (CKD) patients on dialysis. Top-line results from the study are expected in the second quarter of 2024.
OLC is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology. UNCY is developing OLC for hyperphosphatemia associated with kidney diseases.
In the past year, shares of Unicycive have rallied 61.2% against the industry’s 5.5% fall.
Image Source: Zacks Investment Research
The pivotal study was initiated after Unicycive aligned with the FDA regarding the overall data package required to file a New Drug Application (NDA) for OLC for the hyperphosphatemia indication. The regulatory body had also agreed with the company regarding the clinical study design, including sample size, duration of treatment and the primary endpoint of the study.
In 2022, Unicycive reported results from a previous bioequivalence study that measured OLC’s efficacy in healthy volunteers. It was observed that the drug was equivalent to the already approved reference drug, Fosrenol (lanthanum carbonate).
UNCY is looking to address a significant unmet medical need with its investigational hyperphosphatemia candidate, OLC.
Per the company, the novel characteristics of OLC are expected to reduce the pill burden volume of dialysis patients by more than four-fold compared with the most prescribed phosphate binder. OLC is also an easier-to-use formulation as the tablets are swallowed whole with water and not chewed.
UNCY believes that OLC has the potential to be a best-in-class treatment in the multibillion-dollar hyperphosphatemia market.
In the press release, Unicycive stated that the ongoing phase III pivotal study is the last major component to complete the data package required to file an NDA for OLC with the FDA. The NDA submission is anticipated around mid-year 2024.
Additionally, the company also continues to advance its second compound UNI-494, which is currently being developed for the treatment of acute kidney injury and CKD. UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator.
Unicycive is currently evaluating UNI-494 in an early-stage study dose-ranging safety study in healthy volunteers in the U.K. The phase I study is expected to be completed in 2024.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has increased from 72 cents to 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 64 cents to 69 cents. Over the past year, shares of PBYI have gained 9.2%.
PBYI beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for CytomX’s 2023 EPS has remained constant at 2 cents. During the same time frame, the consensus estimate for CytomX’s 2024 loss per share is pegged at 6 cents. Over the past year, shares of CTMX have plunged 38.5%.
CTMX beat estimates in three of the trailing four quarters and missed the mark on one occasion, delivering an average earnings surprise of 45.44%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has remained constant at 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 22 cents. Over the past year, shares of ADMA have rallied 47.2%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
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Unicycive (UNCY) Up on Positive Hyperphosphatemia Study Update
Unicycive Therapeutics, Inc. (UNCY - Free Report) , a clinical-stage company, issued a letter to its shareholders providing corporate updates and key upcoming milestones for the company in 2024. Following the issuance, shares of the company surged 18.3% on Jan 23, as the investors cheered the encouraging pipeline progress. Shares of the company gained 6.8% in the after-market hours.
The company is currently evaluating its lead candidate, Oxylanthanum Carbonate (OLC), in a pivotal clinical study to evaluate the tolerability of OLC in chronic kidney disease (CKD) patients on dialysis. Top-line results from the study are expected in the second quarter of 2024.
OLC is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology. UNCY is developing OLC for hyperphosphatemia associated with kidney diseases.
In the past year, shares of Unicycive have rallied 61.2% against the industry’s 5.5% fall.
Image Source: Zacks Investment Research
The pivotal study was initiated after Unicycive aligned with the FDA regarding the overall data package required to file a New Drug Application (NDA) for OLC for the hyperphosphatemia indication. The regulatory body had also agreed with the company regarding the clinical study design, including sample size, duration of treatment and the primary endpoint of the study.
In 2022, Unicycive reported results from a previous bioequivalence study that measured OLC’s efficacy in healthy volunteers. It was observed that the drug was equivalent to the already approved reference drug, Fosrenol (lanthanum carbonate).
UNCY is looking to address a significant unmet medical need with its investigational hyperphosphatemia candidate, OLC.
Per the company, the novel characteristics of OLC are expected to reduce the pill burden volume of dialysis patients by more than four-fold compared with the most prescribed phosphate binder. OLC is also an easier-to-use formulation as the tablets are swallowed whole with water and not chewed.
UNCY believes that OLC has the potential to be a best-in-class treatment in the multibillion-dollar hyperphosphatemia market.
In the press release, Unicycive stated that the ongoing phase III pivotal study is the last major component to complete the data package required to file an NDA for OLC with the FDA. The NDA submission is anticipated around mid-year 2024.
Additionally, the company also continues to advance its second compound UNI-494, which is currently being developed for the treatment of acute kidney injury and CKD. UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator.
Unicycive is currently evaluating UNI-494 in an early-stage study dose-ranging safety study in healthy volunteers in the U.K. The phase I study is expected to be completed in 2024.
Unicycive Therapeutics, Inc. Price and Consensus
Unicycive Therapeutics, Inc. price-consensus-chart | Unicycive Therapeutics, Inc. Quote
Zacks Rank and Stocks to Consider
Unicycive currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the same industry worth mentioning are Puma Biotechnology, Inc. (PBYI - Free Report) , CytomX Therapeutics (CTMX - Free Report) and ADMA Biologics (ADMA - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has increased from 72 cents to 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 64 cents to 69 cents. Over the past year, shares of PBYI have gained 9.2%.
PBYI beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for CytomX’s 2023 EPS has remained constant at 2 cents. During the same time frame, the consensus estimate for CytomX’s 2024 loss per share is pegged at 6 cents. Over the past year, shares of CTMX have plunged 38.5%.
CTMX beat estimates in three of the trailing four quarters and missed the mark on one occasion, delivering an average earnings surprise of 45.44%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has remained constant at 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 22 cents. Over the past year, shares of ADMA have rallied 47.2%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.