Aldosterone

Mineralys Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 21, 2024
Research, American Heart Association, Administration, Conference call, Conference, Target, Obesity, Prevalence, CKD, Part, Patient, SGLT2, G&A, Pivotal, Insurance, Investment, Research and development, AHA, Therapy, EGFR, Senior management, Safety, Chronic kidney disease, Hypertension, Leptin, BMI, Aldosterone, Pharmaceutical industry

RADNOR, Pa., March 21, 2024 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today announced financial results for the fourth quarter and full year ending December 31, 2023, and provided a corporate update.

Key Points: 
  • R&D expenses for the quarter ended December 31, 2023 were $23.7 million, compared to $7.8 million for the quarter ended December 31, 2022.
  • G&A expenses were $4.0 million for the quarter ended December 31, 2023, compared to $2.2 million for the quarter ended December 31, 2022.
  • Total other income, net was $3.3 million for the quarter ended December 31, 2023, compared to $0.9 million for the quarter ended December 31, 2022.
  • Net loss was $24.4 million for the quarter ended December 31, 2023, compared to $9.1 million for the quarter ended December 31, 2022.

Mineralys Therapeutics Appoints Minji Kim, Ph.D. as Chief Business Officer

Retrieved on: 
Thursday, January 4, 2024
Seoul National University, Business, National university, Hypertension, Yale School of Management, MBA, License, Min-ji, Aldosterone, Therapy, Chronic kidney disease, Business development, Roche, Doctor of Philosophy, Patient, Corporation, Harvard Medical School, Neurology, Yale school, CKD

Adam Levy will remain in his role as Chief Financial Officer.

Key Points: 
  • Adam Levy will remain in his role as Chief Financial Officer.
  • “With our expanding operations, we have decided to split the functions of Chief Financial Officer and Chief Business Officer into two roles, and we are excited to have Minji join our team.
  • She brings a solid track record of generating value for multiple companies by identifying and executing strategic opportunities,” stated Jon Congleton, Chief Executive Officer of Mineralys.
  • Prior to joining Mineralys, she held the role of Chief Business Officer at Affamed Therapeutics and General Manager at Affamed Digital, and brought multiple products into their pipeline.

Mineralys Therapeutics Announces First Subject Dosed in Launch-HTN, the Second Pivotal Trial of Lorundrostat for the Treatment of Hypertension

Retrieved on: 
Thursday, December 21, 2023
Hypertension, Safety, Chronic kidney disease, Aldosterone, CKD, Therapy, Pharmaceutical industry

RADNOR, Pa., Dec. 21, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today announced that the first subject has been dosed in the Launch-HTN (NCT06153693) pivotal trial to evaluate the safety and efficacy of lorundrostat for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), when used as an add-on therapy to prescribed background treatment.

Key Points: 
  • “Initiating this second pivotal trial demonstrates the continued progress we’re making towards introducing a targeted approach to care in hypertension by identifying and profiling potential responders to lorundrostat,” stated Jon Congleton, Chief Executive Officer of Mineralys.
  • This trial is designed to model real world treatment of uHTN and rHTN in the primary care setting.
  • Previously, in May 2023, the Company announced the first subject dosed in the first pivotal trial, Advance-HTN.
  • The Company expects to announce topline data from the Advance-HTN trial in the second half of 2024.

Mineralys Therapeutics Further Defines Endotype-Specific, Targeted Approach to Treatment of Uncontrolled or Resistant Hypertension with Lorundrostat Data at AHA Scientific Sessions 2023

Retrieved on: 
Saturday, November 11, 2023
Chronic kidney disease, Blood pressure, Hypertension, Therapy, AHA, BP, Patient, CKD, Obesity, American Heart Association, Aldosterone, Leptin, BMI, Risk, Poster, Target, Pharmaceutical industry

RADNOR, Pa., Nov. 11, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today presented data from the Target-HTN Phase 2 trial that further defines an endotype-specific targeted approach for treating uncontrolled or resistant hypertension with lorundrostat, a highly selective aldosterone synthase inhibitor. The data were presented in a poster at the American Heart Association (AHA) Scientific Sessions 2023, which is being held in Philadelphia from November 11th –13th.

Key Points: 
  • The data were presented in a poster at the American Heart Association (AHA) Scientific Sessions 2023, which is being held in Philadelphia from November 11th –13th.
  • Data previously presented from Target-HTN showed that elevated body mass index (BMI) was predictive of an enhanced reduction in systolic blood pressure (BP) from lorundrostat treatment.
  • Target-HTN trial results support the transition to late-stage development of lorundrostat as a treatment for uncontrolled or resistant hypertension.
  • The poster at AHA Scientific Sessions 2023 titled, “Lorundrostat for Treatment of Obesity-Related, Aldosterone-Dependent Hypertension - An Endotype-Specific, Targeted Approach to the Treatment of Uncontrolled Hypertension,” can be accessed on the publications page of the Mineralys corporate website.

Boehringer Ingelheim achieves major milestone in chronic kidney disease: aldosterone synthase inhibitor on top of empagliflozin delivers promising results in Phase II trial

Retrieved on: 
Friday, November 3, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Standard of care, University of Washington School of Medicine, Hyperkalemia, Oxford, Pressure, Albuminuria, SGLT2, Kidney, HIV disease progression rates, Society, American Society of Nephrology, Population 1 (album), Chronic kidney disease, Phase, Boehringer Ingelheim, Clinical trial, ASN, Hypertension, Aldosterone, Risk, Kidney disease, University, Serum, ASI, CKD, Safety, End organ damage, Patient, Ingelheim am Rhein, Pharmaceutical industry, UACR, Medicine

Boehringer Ingelheim today announced promising 14-week Phase II data for BI 690517, a novel selective aldosterone synthase inhibitor (ASi).

Key Points: 
  • Boehringer Ingelheim today announced promising 14-week Phase II data for BI 690517, a novel selective aldosterone synthase inhibitor (ASi).
  • “With over 1 billion people worldwide affected by these conditions, the potential to help reduce the pressure on healthcare systems and patients is immense.
  • We are proud to be leading the way in this field and are excited to move forward with the upcoming Phase III trial to further investigate the potential of this novel compound on top of standard of care including empagliflozin."
  • Hyperkalemia occurred at a rate typical for a CKD population,1 and most episodes did not require medical treatment or BI 690517 discontinuation.1

COMPASS Pathways appoints Daphne Karydas to its Board of Directors

Retrieved on: 
Monday, September 18, 2023
JPMorgan Chase, BS, Depression, Goldman, Chronic kidney disease, Senior, Health, Goldman Sachs, Biotechnology, Allergan, Cancer, MBA, Infection, COMPASS, Merck & Co., AstraZeneca, MS, Massachusetts Institute of Technology, Hypertension, Anorexia nervosa, Aldosterone, Acquisition, Post-traumatic stress disorder, AbbVie, Flare, Patient, Chemical engineering, Corporation, Factorization of polynomials, Harvard Business School, Merck, CMPS, Treasurer, Therapy, Mental health, Pharmaceutical industry, Nursing

LONDON, Sept. 18, 2023 (GLOBE NEWSWIRE) -- COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the appointment of Daphne Karydas to its Board of Directors, effective September 18, 2023.

Key Points: 
  • LONDON, Sept. 18, 2023 (GLOBE NEWSWIRE) -- COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the appointment of Daphne Karydas to its Board of Directors, effective September 18, 2023.
  • Ms. Karydas is President and Chief Financial Officer at Flare Therapeutics Inc., a privately held biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases.
  • “Daphne is an ideal match for the COMPASS Pathways Board of Directors as we progress our phase 3 COMP360 psilocybin program in treatment-resistant depression and our phase 2 programs in anorexia nervosa and post-traumatic stress disorder,” said George Goldsmith, Chairman of the COMPASS Pathways Board of Directors.
  • We are delighted to welcome her.”
    “I am excited to join the COMPASS board as the company advances its pioneering COMP360 psilocybin program,” said Ms. Karydas.

Mineralys Therapeutics Announces JAMA Publication of Full Target-HTN Phase 2 Trial Results for Lorundrostat in Uncontrolled and Treatment-Resistant Hypertension

Retrieved on: 
Sunday, September 10, 2023
Blood pressure, SBP, Male, JAMA, Cleveland Clinic, Obesity, Chronic kidney disease, Heart, Urinary tract infection, Glomerular filtration rate, Hyponatremia, Female, QD, Target, American Medical Association, Hypertension, Plasma protein binding, Aldosterone, Journal, Patient, Disease, Mortality, BMI, Therapy, Safety, Pharmaceutical industry

RADNOR, Pa., Sept. 10, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease and other diseases driven by abnormally elevated aldosterone, today announced that full results from the Target-HTN Phase 2 trial of lorundrostat, a highly selective aldosterone synthase inhibitor, in individuals with uncontrolled hypertension (uHTN) and treatment-resistant hypertension (rHTN) were published in the Journal of the American Medical Association (JAMA).

Key Points: 
  • “Despite the multitude of currently available treatments, half of all patients treated for hypertension are not able to reach their blood pressure goal.
  • “We are gratified that JAMA chose to highlight our Target-HTN Phase 2 trial results.
  • "We believe this trial confirms the link between obesity, excess aldosterone production and hypertension.
  • The Target-HTN (NCT05001945) Phase 2 proof-of-concept trial was a randomized, double-blind, placebo-controlled, dose-ranging, multicenter trial conducted in the U.S.

Mineralys Therapeutics Selected for Oral Poster Presentation of Target-HTN Phase 2 Trial Results at 2023 AHA Hypertension Scientific Sessions

Retrieved on: 
Tuesday, September 5, 2023
Aldosterone, Target, Hypertension, Uncontrolled, Therapy, Chronic kidney disease, Treatment, American Heart Association, AHA, Pharmaceutical industry

RADNOR, Pa., Sept. 05, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease and other diseases driven by abnormally elevated aldosterone, today announced it has been selected to present the full results from the Target-HTN Phase 2 trial of lorundrostat in individuals with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) in an oral poster presentation at the 2023 American Heart Association (AHA) Hypertension Scientific Sessions, which is being held in Boston from September 7–10.

Key Points: 
  • RADNOR, Pa., Sept. 05, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease and other diseases driven by abnormally elevated aldosterone, today announced it has been selected to present the full results from the Target-HTN Phase 2 trial of lorundrostat in individuals with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) in an oral poster presentation at the 2023 American Heart Association (AHA) Hypertension Scientific Sessions, which is being held in Boston from September 7–10.
  • Aldosterone Synthase Inhibition with Lorundrostat for the Treatment of Uncontrolled Hypertension: The Target-HTN Randomized Clinical Trial

Mineralys Therapeutics Reports Second Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, August 7, 2023
Insurance, ARB, Chronic kidney disease, Conference call, EGFR, G&A, Glomerular filtration rate, Part, SGLT2, Medicare Part D, Hypertension, Research and development, Proteinuria, Aldosterone, Patient, Investment, Administration, ACE, R, Therapy, CKD, Conference, Safety, Pharmaceutical industry, Video game

RADNOR, Pa., Aug. 07, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone, today announced financial results for the quarter ending June 30, 2023, and provided a corporate update.

Key Points: 
  • ET –
    RADNOR, Pa., Aug. 07, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone, today announced financial results for the quarter ending June 30, 2023, and provided a corporate update.
  • Research and Development (R&D) expenses were $11.9 million for the quarter ended June 30, 2023, compared to $5.6 million for the quarter ended June 30, 2022.
  • General and Administrative (G&A) expenses were $3.9 million for the quarter ended June 30, 2023, compared to $0.9 million for the quarter ended June 30, 2022.
  • Net loss was $12.1 million for the quarter ended June 30, 2023, compared to $6.5 million for the quarter ended June 30, 2022.

Mineralys Therapeutics Announces Expansion of Planned Phase 2 Trial of Lorundrostat Alone and in Combination with SGLT2 Inhibitor to Treat Patients with Chronic Kidney Disease (CKD)

Retrieved on: 
Monday, July 17, 2023
Enzyme inhibitor, ARB, Optimism, Chronic kidney disease, Terminal, EGFR, Part, SGLT2, Alveolar soft part sarcoma, ASI, Hypertension, Proteinuria, Aldosterone, Patient, FAHA, Risk, ACE, Therapy, CKD, Safety, Pharmaceutical industry

RADNOR, Pa., July 17, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone, today announced details of an expanded two-part Phase 2 clinical trial for lorundrostat as a potential therapy to treat patients with Stage 2 to 4 chronic kidney disease (CKD), which is expected to start enrolling patients in the second half of 2023.

Key Points: 
  • “We are excited to move ahead with this trial to evaluate lorundrostat as a treatment for CKD.
  • This trial builds upon the amelioration of aldosterone-mediated uncontrolled hypertension we observed in our Target-HTN trial of lorundrostat.
  • “There is a growing consensus for the use of an SGLT2 inhibitor as a component of CKD treatment.
  • Subjects will receive either once daily combination treatment of lorundrostat 50 mg plus dapagliflozin 10 mg or placebo for 12 weeks.