MAZE

Positive topline data from Phase 2 HORIZON trial of MZE829 in patients with broad AMKD provide proof-of-concept and support advancement into pivotal trial; additional HORIZON data expected in late 2026 or early 2027 Phase 2 proof-of-concept clinical trials evaluating MZE782 in PKU and CKD on track to initiate in 2026 Strong balance sheet with $528 million in cash, cash equivalents and marketable securities; inclusive of net proceeds from the $150 million registered offering and $20 million MZE001 milestone payment in April 2026; cash runway expected to extend into 2029 SOUTH SAN FRANCISCO, Calif., May 12, 2026 (GLOBE NEWSWIRE) -- Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company developing small molecule precision medicines for patients with kidney and metabolic diseases, today reported financial results for the first quarter ended March 31, 2026, highlighting recent progress and business updates. “We continue to execute across our clinical pipeline in 2026, and with positive topline data reported from our Phase 2 HORIZON trial of MZE829 in broad AMKD in the first quarter, we are more confident than ever in our potential to harness the power of genetics to transform the lives of patients,” said Jason Coloma, Ph.D., chief executive officer of Maze. “Looking ahead to the rest of the year, we remain on track to initiate a Phase 2 trial of MZE782 in PKU around the middle of this year with topline data expected in 2027, and an additional Phase 2 study is expected to initiate in CKD in the second half of this year. We also look forward to reporting additional results from the HORIZON study in late 2026 or early 2027, and to advancing MZE829 into a pivotal trial in moderate AMKD patients without diabetes, including those with FSGS. With a strong balance sheet and expected cash runway into 2029, we continue to focus on clinical execution and pivotal study preparation.” Program Progress and Anticipated Milestones MZE829 for APOL1-Mediated Kidney Disease (AMKD) MZE829 is an oral, small molecule, dual-mechanism APOL1 inhibitor that Maze is advancing as a potential treatment for patients with AMKD, a subset of chronic kidney disease (CKD) estimated to affect over one million people in the United States alone. In March 2026, Maze announced positive topline data from the Phase 2 HORIZON trial evaluating MZE829 in patients with broad AMKD,...

Atul Dandekar, Chief Strategy and Business Officer of Maze Therapeutics (NASDAQ:MAZE), reported the exercise and immediate sale of 7,500 shares of common stock for a transaction value of approximately $190,000 on April 29, 2026, as disclosed in this SEC Form 4 filing. Transaction value based on SEC Form 4 weighted average purchase price ($25.37); post-transaction value based on April 29, 2026, market close ($25.68). How does this transaction affect Dandekar's ongoing exposure to Maze Therapeutics? Dandekar's direct common stock holdings were reduced by 41.66%, but he maintains 44,143 stock options that can be exercised for future equity exposure or liquidity events. What was the nature of the shares disposed in this filing? All 7,500 shares were acquired via option exercise and immediately sold in the open market, reflecting a derivative-driven liquidity event rather than a discretionary open-market sale. Does this sale represent a change in Dandekar's trading cadence? The 7,500-share event is consistent with prior administrative transactions in 2026, with declining trade sizes explained by the reduced available share count after prior exercises and sales. What are the implications for future insider activity? While direct holdings are now modest, the sizable remaining option position provides capacity for additional similar transactions, supporting ongoing liquidity scheduling under the existing Rule 10b5-1 plan. 1-year price change calculated using April 29, 2026, as the reference date. Develops small molecule precision medicines targeting renal, cardiovascular, metabolic diseases, and obesity, with lead programs MZE829 (APOL1 inhibitor, phase 2) and MZE782 (SLC6A19 inhibitor, phase 1). Operates a clinical-stage biopharmaceutical model focused on advancing proprietary drug candidates through early- and mid-stage clinical trials. Develops small-molecule precision medicines for renal and metabolic diseases in the United States. Maze Therapeutics, Inc. is a clinical-stage biotechnology company leveraging genetic insights to develop targeted therapies for complex renal and metabolic diseases. The company’s strategy centers on advancing a focused pipeline of oral small-molecule drugs with the potential to address significant unmet medical needs. With a lean workforce and a strong emphasis on precision medicine, Maze Therapeutics seeks to differentiate itself th...

Positive topline data from Phase 2 HORIZON trial of MZE829 demonstrating first clinical proof-of-concept in patients with broad AMKD to support advancement into pivotal program; Maze to host conference call today at 8:00 am EDT Two Phase 2 proof-of-concept clinical trials evaluating MZE782 in PKU and CKD expected to initiate in 2026 Industry leader Neil Kumar, Ph.D., Founder and CEO of BridgeBio, appointed to Maze Board of Directors Strong balance sheet with $360.0 million in cash, cash equivalents and marketable securities; expected cash runway into 2028 SOUTH SAN FRANCISCO, Calif., March 25, 2026 (GLOBE NEWSWIRE) -- Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company developing small molecule precision medicines for patients with kidney and metabolic diseases, today reported financial results for the fourth quarter and year ended December 31, 2025, highlighting recent progress and business updates. “We are proud of the progress that Maze achieved in 2025 and have already carried our strong record of execution into the new year, as evidenced by today’s positive topline data from our Phase 2 HORIZON trial of MZE829 in broad AMKD,” said Jason Coloma, Ph.D., chief executive officer of Maze. “We look forward to advancing MZE829 into a pivotal program and to initiating our two Phase 2 trials of MZE782 in PKU and CKD. As we continue on our mission to deliver potential first- or best-in-class precision medicines to patients with kidney and metabolic diseases, we are grateful to have the support of both the patient and investor communities behind us.” Dr. Coloma continued, “We are also thrilled to announce the addition of Neil Kumar to our Board of Directors. Neil’s experience building BridgeBio into the fully-integrated, commercial-stage, patient-centric organization it is today will be invaluable to the team at Maze as we work to grow our company and transform the lives of patients.” Program Progress and Anticipated Milestones MZE829 for APOL1-Mediated Kidney Disease (AMKD) MZE829 is an oral, small molecule, dual-mechanism APOL1 inhibitor that Maze is advancing as a potential treatment for patients with AMKD, a subset of chronic kidney disease (CKD) estimated to affect over one million people in the United States alone. Today, Maze announced positive topline data from the Phase 2 HORIZON trial evaluating MZE829 in patients with broa...

First-in-human data from Phase 1 trial of MZE782 support best- and first-in-class potential; two Phase 2 proof-of-concept trials in phenylketonuria (PKU) and chronic kidney disease (CKD) expected to initiate in 2026 Enrollment ongoing in Phase 2 HORIZON trial of MZE829 in broad APOL1-mediated kidney disease (AMKD); topline data for initial patients expected by the end of Q1 2026 Strong balance sheet with $383.9 million in cash, cash equivalents and marketable securities following oversubscribed private placement; cash runway into 2028 SOUTH SAN FRANCISCO, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company developing small molecule precision medicines for patients with kidney and metabolic diseases, today reported financial results for the third quarter ended September 30, 2025, highlighting recent progress and business updates. “We are proud to have delivered another strong quarter marked by continued execution across our pipeline and business. We are particularly thrilled with the positive first-in-human results from our Phase 1 trial of MZE782, which support the continued advancement of MZE782 in two Phase 2 trials in both PKU and CKD, and we look forward to initiating those planned trials in 2026,” said Jason Coloma, Ph.D., chief executive officer of Maze. “We continue to actively enroll patients in our Phase 2 HORIZON trial of MZE829 and anticipate reporting topline proof-of-concept data on initial patients by the end of Q1 2026. These data, from a broad AMKD population, are expected to inform potential advancement into Phase 2b/3 planning. With a strong balance sheet, bolstered by our recently announced oversubscribed private placement, we are well-positioned for multiple milestones ahead.” Program Progress and Anticipated Milestones MZE829 for APOL1-Mediated Kidney Disease (AMKD) MZE829 is an oral, small molecule, dual-mechanism APOL1 inhibitor that Maze is advancing as a potential treatment for patients with AMKD, a subset of chronic kidney disease (CKD) estimated to affect over one million people in the United States alone. Maze continues to enroll patients in the Phase 2 HORIZON trial of MZE829. The trial includes patients with broad AMKD, including diabetic and non-diabetic patients and patients with severe focal segmental glomerulosclerosis (FSGS). Maze expects to report top...

Maze Therapeutics catapulted Thursday after its experimental treatment for a rare, genetic disease blew past the company's own expectations.

Maze Therapeutics has shared positive outcomes from the randomised Phase I study of the oral SLC6A19 inhibitor, MZE782, for treating phenylketonuria (PKU) and chronic kidney disease (CKD). The placebo-controlled, double-blind trial, which involved 112 healthy adult volunteers, is aimed at assessing single ascending doses (SAD) and multiple ascending doses (MAD) of the therapy. It included 56, 40, and 16 subjects in the SAD, MAD, and the food effect cohorts, respectively. Each SAD and MAD cohort included eight subjects who were randomised in a 6:2 ratio. The single doses ranged from 30mg to 960mg while multiple doses were administered once or twice a day over a week, ranging from 120mg to 720mg. In addition, the impact of a high-fat meal and a low-fat meal on the therapy’s absorption was evaluated. The primary goals of the trial focused on the safety and tolerability of SAD and MAD doses of the therapy while the secondary and exploratory objectives included assessing the impact of food, pharmacokinetic (PK) analysis, and pharmacodynamic (PD) evaluations of the therapy’s target interaction. This included the measurement of urinary excretion levels of phenylalanine (Phe) and glutamine (Gln), which serve as indicative biomarkers for the inhibition of SLC6A19 and the management of the disease. In addition, the study measured the estimated glomerular filtration rate (eGFR) to estimate kidney function. Results were positive, with MZE782 showing good tolerance across all dosage levels. It exhibited a consistent absorption pattern, reaching a maximum concentration in six hours and having a half-life of 11 hours. In terms of PD, MZE782 increased the urinary excretion of phenylalanine (Phe) and glutamine (Gln) across the MAD and SAD cohorts. The study also observed an initial decrease in the estimated glomerular filtration rate (eGFR), a measure of kidney function. The eGFR reduction was reversed after the dosing period ended at day 11. Maze Therapeutics chief medical officer and research and development president Harold Bernstein said: “The rapid and profound increase in urinary phenylalanine excretion confirms SLC6A19 inhibition in healthy individuals that we anticipate will translate to meaningful reductions in plasma phenylalanine levels in patients with PKU, based on the biology of this transporter.” In February 2025, Maze dosed the first subject in the Phase II H...

Phase 1 data in healthy volunteers exceed expectations and support best-in-class potential, enabling Phase 2 advancement for both intended indications of PKU and CKD Dose-dependent urinary amino acid excretion demonstrated across all SAD and MAD cohorts, including up to a 42-fold increase in urinary phenylalanine (Phe) excretion, a well-validated biomarker for PKU and predictive for CKD Dose-dependent initial eGFR dip similar to SGLT2 inhibitors observed, supporting a potential kidney protective effect in CKD Well tolerated across all doses with an excellent safety profile and no serious adverse events observed Phase 2 trials in both PKU and CKD expected to initiate in 2026 Maze to host investor conference call and webcast today at 8:30 am EDT SOUTH SAN FRANCISCO, Calif., Sept. 11, 2025 (GLOBE NEWSWIRE) -- Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company developing small molecule precision medicines for patients with kidney and metabolic diseases, today announced positive clinical results from the Phase 1 healthy volunteer study of MZE782, an oral small molecule targeting the solute transporter, SLC6A19. MZE782 has potential to be a best-in-class therapy for patients with PKU, an inherited metabolic disorder, and a first-in-class therapy for patients with CKD. “These first-in-human results for MZE782 mark an important milestone, demonstrating an excellent safety profile, robust target engagement and compelling pharmacodynamic effects, consistent with our therapeutic hypothesis,” said Harold Bernstein, M.D., Ph.D., president of R&D and chief medical officer of Maze. “The rapid and profound increase in urinary phenylalanine excretion confirms SLC6A19 inhibition in healthy individuals that we anticipate will translate to meaningful reductions in plasma phenylalanine levels in patients with PKU, based on the biology of this transporter.” “We also observed dose-dependent changes in eGFR in healthy individuals with MZE782, similar to those seen with SGLT2 inhibitors, suggesting a potential beneficial effect on kidney physiology in CKD patients. We look forward to advancing MZE782 into Phase 2 studies in both PKU and CKD in 2026,” Dr. Bernstein continued. “These findings also serve as important clinical validation of our Compass platform. MZE782 is the third clinical program to come out of our Compass platform, further demonstratin...

MZE782 Phase 1 Trial in Healthy Volunteers to Provide Proof of Mechanism Data for Phenylketonuria (PKU) and Chronic Kidney Disease (CKD) Expected in Q3 2025 MZE829 Phase 2 HORIZON Trial Actively Enrolling Patients with APOL1-Mediated Kidney Disease; Initial Data Expected in Q1 2026 Strong Balance Sheet with $264.5 Million in Cash and Cash Equivalents, Expected to Provide Cash Runway into H2 2027 SOUTH SAN FRANCISCO, Calif., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company developing small molecule precision medicines for patients with kidney and metabolic diseases, today reported financial results for the second quarter ended June 30, 2025, highlighting recent progress and business updates. “With two clinical-stage programs advancing, Maze continues to execute with focus and discipline,” said Jason Coloma, Ph.D., chief executive officer of Maze. “We remain on track to report key mechanistic biomarker data from our Phase 1 study of MZE782 in Q3, a significant milestone toward initiating Phase 2 trials in PKU and CKD. In addition, we continue to enroll our Phase 2 HORIZON trial of MZE829 in APOL1-mediated kidney disease, keeping us on track for an initial proof-of-concept readout in Q1 2026. With a strong balance sheet and cash runway into the second half of 2027, we’re well-positioned to deliver meaningful impact for patients and value for shareholders.” Program Progress and Anticipated Milestones MZE829 for APOL1-Mediated Kidney Disease (AMKD) MZE829 is an oral, small molecule APOL1 inhibitor that Maze is advancing as a potential treatment for patients with AMKD, a subset of CKD estimated to affect over one million people in the United States alone. Maze continues to enroll patients in the Phase 2 HORIZON trial of MZE829. The trial includes a broad population of patients with AMKD, including those with diabetes, those with non-diabetic kidney disease, and patients with severe focal segmental glomerulosclerosis (FSGS). Maze expects to announce initial proof-of-concept data from the Phase 2 HORIZON trial in the first quarter of 2026. MZE782 in CKD and Phenylketonuria (PKU) MZE782 is an oral, small molecule targeting the solute transporter, SLC6A19, with potential to be a first-in-class treatment for the approximately five million U.S. patients with CKD who inadequately respond to currently ava...

MZE829 Phase 2 HORIZON Trial Enrolling Patients with APOL1 Kidney Disease; Initial Data Expected in Q1 2026 MZE782 Phase 1 Healthy Volunteer Trial Ongoing; Initial Data Expected in Q3 2025 Strong Balance Sheet with $294.4 Million in Cash and Cash Equivalents, Expected to Provide Cash Runway into H2 2027 SOUTH SAN FRANCISCO, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company developing small molecule precision medicines for patients with renal, metabolic and cardiovascular diseases, today reported financial results for the first quarter ended March 31, 2025, and reiterated upcoming milestones. “With two clinical programs underway – an important milestone that underscores the strength of our Compass platform and drug development expertise – Maze is entering a new phase of growth,” said Jason Coloma, Ph.D., chief executive officer of Maze. “We’re particularly excited about MZE782, a genetically informed therapy that we believe could be best-in-class for PKU and first-in-class for CKD. We expect to report Phase 1 healthy volunteer data, including biomarker results, later this year to support Phase 2 trials in both indications. In addition, our Phase 2 HORIZON trial of MZE829 continues to actively enroll, on track for a readout in Q1 2026. With a strong balance sheet following our IPO, we’re well-positioned to deliver on our pipeline and mission.” Key Anticipated Milestones MZE829 for APOL1 Kidney Disease (AKD) MZE829 is an oral, small molecule APOL1 inhibitor that Maze is advancing as a potential treatment for patients with AKD, a subset of chronic kidney disease (CKD) estimated to affect over one million people in the United States (U.S.) alone. Maze continues to enroll patients in the Phase 2 HORIZON trial of MZE829. The trial includes a broad population of patients with AKD, including those with diabetes, those with non-diabetic kidney disease, and patients with severe focal segmental glomerulosclerosis (FSGS). Maze expects to announce initial proof-of-concept data from the Phase 2 HORIZON trial in the first quarter of 2026. MZE782 in CKD and Phenylketonuria (PKU) MZE782 is an oral, small molecule targeting the solute transporter, SLC6A19, with potential to be a first-in-class treatment for the approximately five million U.S. patients with CKD who inadequately respond to currently availa...

MZE829 Phase 2 HORIZON Trial Enrolling Patients with APOL1 Kidney Disease (AKD); Initial Data Expected in Q1 2026 MZE782 Phase 1 Healthy Volunteer Trial Ongoing; Initial Data Expected in H2 2025 Raised $140 Million in Gross Proceeds in Upsized IPO in February 2025, Providing Expected Cash Runway into H2 2027 SOUTH SAN FRANCISCO, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company developing small molecule precision medicines for patients with renal, cardiovascular and metabolic diseases, today reported financial results for the fourth quarter and year ended December 31, 2024, highlighted recent progress and reiterated upcoming milestones. “Maze has reached a pivotal moment in our journey. On the heels of a successful IPO and with two ongoing clinical-stage programs - MZE829 for AKD and MZE782 for both chronic kidney disease (CKD) and phenylketonuria (PKU) - we are making meaningful progress towards advancing genetic-based medicines with the potential to transform patient care,” said Jason Coloma, Ph.D., chief executive officer of Maze. “We look forward to reporting initial Phase 1 data for MZE782 in healthy volunteers in the second half of 2025, which will enable us to prepare to initiate Phase 2 trials in CKD and PKU. We also expect to report initial data from the Phase 2 HORIZON trial of MZE829 in patients with AKD in the first quarter of next year. With a strong financial foundation, highly accomplished team and clear mission, we are well-positioned to execute our milestones and deliver breakthrough medicines to patients.” Pipeline Accomplishments and Upcoming Milestones MZE829 for AKD MZE829 is an oral, small molecule APOL1 inhibitor that Maze is advancing as a potential treatment for patients with AKD, a subset of CKD estimated to affect over one million people in the United States alone. In February 2025, Maze dosed the first patient in the Phase 2 HORIZON Study of MZE829 in patients with AKD. The trial is enrolling a broad population of AKD patients, including those with more severe disease who have nephrotic range proteinuria, focal segmental glomerulosclerosis (FSGS), patients with lower levels of proteinuria and hypertensive nephropathy and patients with proteinuria and diabetic kidney disease. Maze expects to announce topline data from the Phase 2 trial in the first quarter...