KATP

Unicycive Therapeutics Announces Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 28, 2024
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LOS ALTOS, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the year ended December 31, 2023, and provided a business update.

Key Points: 
  • LOS ALTOS, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the year ended December 31, 2023, and provided a business update.
  • Completed a private placement with new and existing healthcare institutional investors that generated $50 million in gross proceeds to Unicycive.
  • Cash Position: As of December 31, 2023, cash and cash equivalents totaled $9.7 million.
  • Subsequent to year end, in March 2024, Unicycive completed a private placement of preferred stock which generated $50 million in gross proceeds.

Unicycive Therapeutics Announces Orphan Drug Designation Granted for UNI-494 by the U.S. Food and Drug Administration for the Prevention of Delayed Graft Function in Kidney Transplant Patients

Retrieved on: 
Monday, March 4, 2024
DGF, Kidney, KATP, LOS, MD, Critical care, FDA, Food, Conference, Mitochondrion, ODD, Therapy, Patient, AKI, Kidney disease, Diagnosis, CRRT, Kidney transplantation, Pharmaceutical industry

LOS ALTOS, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced that the U.S. Food and Drug Administration has granted orphan drug designation (ODD) to UNI-494 for the prevention of Delayed Graft Function (DGF) in kidney transplant patients.

Key Points: 
  • LOS ALTOS, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced that the U.S. Food and Drug Administration has granted orphan drug designation (ODD) to UNI-494 for the prevention of Delayed Graft Function (DGF) in kidney transplant patients.
  • UNI-494 is a cytoprotective agent that elicits an ischemic preconditioning effect by activating KATP channels in mitochondria to restore mitochondrial function.
  • “We are pleased to announce that the FDA has granted orphan drug designation to UNI-494 for the prevention of delayed graft function after kidney transplantation, an unmet medical need for which there are no FDA-approved drugs,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive.
  • “Obtaining ODD is an important milestone in the development of UNI-494 that may provide certain tax credits for qualified clinical trials, exemption of user fees, and the potential for seven years of market exclusivity after approval.

Human medicines European public assessment report (EPAR): Amglidia, glibenclamide, Date of authorisation: 24/05/2018, Revision: 8, Status: Authorised

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Tuesday, January 2, 2024
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Human medicines European public assessment report (EPAR): Amglidia, glibenclamide, Date of authorisation: 24/05/2018, Revision: 8, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Amglidia, glibenclamide, Date of authorisation: 24/05/2018, Revision: 8, Status: Authorised

Unicycive to Highlight Potential of UNI-494 to Restore Mitochondrial Function and Reduce Oxidative Stress at Two Upcoming Medical and Scientific Meetings

Retrieved on: 
Monday, February 27, 2023
Clinical trial, LOS, AKI, Therapy, Mitochondrion, Kidney, Acute kidney injury, Investigational New Drug, Same, IND, United Kingdom, International Conference on Emerging Infectious Diseases, FDA, KATP, Critical care, Patient, Abstract, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CRRT, Kidney disease, CKD, Drug development, HIV disease progression rates, Conference, Chronic kidney disease, Food, Framework, Pharmaceutical industry, Medical device, Nephrology, SUR2B

LOS ALTOS, Calif., Feb. 27, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that the potential of UNI-494, the Company’s proprietary drug that selectively binds to the SUR2B subunit of the mitochondrial KATP channel, will be the focus of several presentations at two upcoming medical and scientific meetings in March 2023.

Key Points: 
  • Shalabh Gupta, M.D., Chief Executive Officer of Unicycive, will lead a discussion on UNI-494 at the upcoming 5th Annual Chronic Kidney Disease Drug Development Summit taking place in Boston, MA from March 7-9, 2023.
  • Two abstracts were accepted for presentation at the 28th International Conference on Critical Care in Nephrology: the Acute Kidney Injury & CRRT Conference taking place in San Diego, CA from March 29- April 1, 2023.
  • “We are studying UNI-494 in Phase 1 clinical trial in the United Kingdom (UK).
  • We also plan to file a corresponding Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in 2023 for a Phase 2 proof-of-concept trial in acute kidney injury (AKI) patients.”

Qlaris Bio to Present at Glaucoma 360 New Horizons Forum

Retrieved on: 
Friday, January 27, 2023
Health, Other Science, General Health, Research, Science, Biotechnology, MBA, Syndrome, Blood, Channel modulator, Glaucoma, EVP, NTG, KATP, Htoo, ATP, IOP, FDA, Normal tension glaucoma, Bio, MS, Intraocular pressure, Pharmaceutical industry

Qlaris Bio, Inc. , a biotechnology company targeting high unmet needs in debilitating ophthalmic diseases, announced today that Thurein Htoo, MS, MBA, the company’s co-founder and chief executive officer, will present during the 12th Annual Glaucoma 360 New Horizons Forum on Friday, Feb. 3, 2023, at 8:40 a.m. PT (11:40 a.m.

Key Points: 
  • Qlaris Bio, Inc. , a biotechnology company targeting high unmet needs in debilitating ophthalmic diseases, announced today that Thurein Htoo, MS, MBA, the company’s co-founder and chief executive officer, will present during the 12th Annual Glaucoma 360 New Horizons Forum on Friday, Feb. 3, 2023, at 8:40 a.m. PT (11:40 a.m.
  • Htoo will participate in the session titled “Delivering Glaucoma Solutions” and will provide updates on Qlaris Bio’s plans for 2023 and the company’s novel ATP-sensitive potassium (KATP) channel modulator platform currently in development to treat a range of glaucomas, including normal tension glaucoma (NTG), primary open-angle glaucoma (POAG), and glaucoma related to rare diseases such as Sturge-Weber Syndrome.
  • “It is an exciting time for Qlaris and the future of glaucoma therapy,” said Htoo.
  • I am looking forward to sharing updates on Qlaris’ program and our anticipated milestones for the coming year.”
    The Glaucoma 360 New Horizons Forum is hosted by the Glaucoma Research Foundation and brings together clinical, industry, financial, and FDA leaders to discuss research innovation and advances in glaucoma treatment.

Unicycive Reports Key Findings of UNI-494 Efficacy in Preclinical Animal Model of Geographic Atrophy

Retrieved on: 
Monday, November 21, 2022
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LOS ALTOS, Calif., Nov. 21, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with unmet medical needs, today announced key findings of UNI-494 efficacy from a preclinical study in animal models of Geographic Atrophy (GA).

Key Points: 
  • LOS ALTOS, Calif., Nov. 21, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc.(Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with unmet medical needs, today announced key findings of UNI-494 efficacy from a preclinical study in animal models of Geographic Atrophy (GA).
  • The Company evaluated the effect of UNI-494 in preventing visual function loss in a rat model of GA.
  • The study evaluated four groups (n=8 per group): untreated, vehicle control, low dose of UNI-494, and high dose of UNI-494.
  • Further preclinical studies are planned to investigate these promising findings of the effect of UNI-494 in improving visual function.

Unicycive Announces Third Quarter Financial Results and Provides Business Update

Retrieved on: 
Monday, November 14, 2022
Marketing, AKI, Acute kidney injury, Patent, BE, Medication, Safety, Enzyme, LOS, Partnership, Alcoholic hepatitis, Randomized controlled trial, NDA, MHRA, Research, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Dry, Hepatic encephalopathy, Hyperphosphatemia, FDA, United Kingdom, Nephrology, File, CTA, Degenerative disease, Therapy, Dialysis, Pharmacokinetics, IND, Nicorandil, Food, KATP, Liver disease, IgG4-related ophthalmic disease, Oxidative stress, Phosphate binder, Literature, Medicines and Healthcare products Regulatory Agency, New Drug Application, Medicine, Society, Chronic kidney disease, CKD, Kidney disease, Patient, Pharmaceutical industry, Generic drug, Glaucoma, SUR2B

LOS ALTOS, Calif., Nov. 14, 2022 (GLOBE NEWSWIRE) --  Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the third quarter ended September 30, 2022, and provided a business update.

Key Points: 
  • The third quarter of 2022 and recent weeks have been particularly productive as we completed enrollment of our pivotal bioequivalence trial of RENAZORB, with topline results expected by year-end.
  • We remain on track to file a New Drug Application (NDA) in 2023, saidShalabh Gupta, M.D., Chief Executive Officer of Unicycive.
  • Dr. Gupta added, We were delighted to share favorable results from both our product candidates with the nephrology community at this years Kidney Week.
  • General and administrative expenses for the quarter ended September 30, 2022 were $1.7 million, compared with $0.9 million for the same quarter in 2021.

Unicycive Reports Key Findings of UNI-494 Efficacy in Preclinical Animal Model of Acute Kidney Injury (AKI)

Retrieved on: 
Wednesday, September 7, 2022
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LOS ALTOS, Calif., Sept. 07, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced key findings of UNI-494 efficacy from a preclinical study in rodent model of Acute Kidney Injury.

Key Points: 
  • LOS ALTOS, Calif., Sept. 07, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc.(Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced key findings of UNI-494 efficacy from a preclinical study in rodent model of Acute Kidney Injury.
  • The Company evaluated the effect of UNI-494 on ischemia-reperfusion induced acute kidney injury (IR-AKI) in rats.
  • We are excited to report this key finding from the IR-AKI model showing treatment with UNI-494 significantly reduced this key biomarker of kidney injury that is a well-accepted biomarker of proximal renal tubule damage.
  • UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment of acute kidney injury.For more information, please visit www.unicycive.com .

Unicycive Announces Multiple Abstracts Selected for Presentation at American Society of Nephrology’s Kidney Week 2022

Retrieved on: 
Wednesday, August 24, 2022
Literature, Enzyme, IgG4-related ophthalmic disease, Vance DeGeneres, COVID-19, Security (finance), Kidney, Safety, Hepatic encephalopathy, ASN, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Therapy, Chronic kidney disease, Coronavirus, Randomized controlled trial, SUR2, Phosphate binder, Hyperphosphatemia, Decision-making, Degenerative disease, Macular degeneration, Food, KATP, Acute kidney injury, Patent, Alcoholic hepatitis, U.S. Securities and Exchange Commission, Liver disease, FDA, Biotechnology, Nicorandil, Failure, 2021 Essex County Council election, AMD, Private Securities Litigation Reform Act, Oxidative stress, Patient, Pharmaceutical industry

All abstracts for ASNs Kidney Week 2022 will be available via the ASN website ( www.asn-online.org/education/kidneyweek ) by October 14, 2022.

Key Points: 
  • All abstracts for ASNs Kidney Week 2022 will be available via the ASN website ( www.asn-online.org/education/kidneyweek ) by October 14, 2022.
  • Renazorb has been shown to offer unique phosphate binding characteristics, which have the potential to treat hyperphosphatemia in chronic kidney disease patients.
  • Unicycive is preparing a clinical bioequivalence study performed in healthy volunteers in order to submit a 505(b)(2) new drug application to the U.S. Food and Drug Administration.
  • UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment of acute kidney injury.For more information, please visit www.unicycive.com .

Qlaris Bio Reports Phase 2 Clinical Trial Results Demonstrating Favorable Safety and Tolerability Profile and Positive Efficacy Signal for QLS-101

Retrieved on: 
Wednesday, May 18, 2022
Research, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Optical, Science, Other Science, MBA, Adenosine triphosphate, Drainage, ATP, Mayo Clinic, KATP, Patient, Goal, Norwest Venture Partners, Channel modulator, Bio, Severe cognitive impairment, Eye, Adult, Pediatrics, IOP, Duke University Hospital, Hyperaemia, Trabecular meshwork, Glaucoma, SWS, Biotechnology, Sturge–Weber syndrome, Potassium, Ocular hypertension, University, EVP, MIGS, Ophthalmology, Pharmaceutical industry, MD

Study findings demonstrated a favorable safety and tolerability profile for QLS-101, including no evidence of hyperemia (eye redness), as well as a positive efficacy signal, in patients with primary open-angle glaucoma (POAG) or ocular hypertension.

Key Points: 
  • Study findings demonstrated a favorable safety and tolerability profile for QLS-101, including no evidence of hyperemia (eye redness), as well as a positive efficacy signal, in patients with primary open-angle glaucoma (POAG) or ocular hypertension.
  • QLS-101 is a novel adenosine triphosphate (ATP)-sensitive potassium (KATP) channel modulator administered as a topical eyedrop.
  • Unlike currently available therapies for lowering IOP in glaucoma, QLS-101 targets distal outflow resistance and episcleral venous pressure (EVP), a key component of IOP.
  • QLS-101, Qlaris Bios lead product candidate, is a prodrug of levcromakalim, an adenosine triphosphate (ATP)-sensitive potassium (KATP) channel modulator.