MGX

EMERYVILLE, Calif. (AP) — EMERYVILLE, Calif. (AP) — Metagenomi Therapeutics, Inc. (MGX) on Monday reported a loss of $23.1 million in its first quarter. The Emeryville, California-based company said it had a loss of 61 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on MGX at https://www.zacks.com/ap/MGX

On track for regulatory submission of MGX-001 to advance global clinical program, including investigational new drug application (“IND”) in 4Q 2026 Publication in Nature Structural & Molecular Biology highlights potential of MG119-28, a proprietary compact CRISPR nuclease with enhanced genome editing efficiency $140.2 million in cash, cash equivalents, and available-for-sale marketable securities as of March 31, 2026, with runway anticipated to support operations through 4Q 2027 EMERYVILLE, Calif., May 11, 2026 (GLOBE NEWSWIRE) -- Metagenomi Therapeutics, Inc. (Nasdaq: MGX) (the “Company”), an in vivo genome editing company capitalizing on its proprietary technologies to create curative genetic medicines for patients, today reported financial results for the first quarter ended March 31, 2026, and provided business updates. “We remain diligently focused on advancing our core genome-editing technologies, led by our MGX-001 program for hemophilia A, which remains on track for regulatory submission in the fourth quarter of this year and first-in-human studies in 2027,” said Jian Irish, Ph.D., M.B.A., President and Chief Executive Officer of Metagenomi Therapeutics. “The promise of our novel technology, most recently highlighted by a Nature publication, in addition to the encouraging preclinical data and continued IND-enabling execution, gives us confidence in our goal to provide patients an option for one-time, curative treatments, beginning with hemophilia A.” First Quarter 2026 and Subsequent Updates MGX-001 – Hemophilia A Program On track for regulatory submission of MGX-001 to advance global clinical program, including an IND in the fourth quarter of 2026, and subject to regulatory clearance, initiate clinical trials in 2027. During the first quarter, Kapil Saxena, MD joined the Company to spearhead the clinical development program for MGX-001. Prior to joining the Company, Dr. Saxena held leadership positions in clinical development at Autolus, Daiichi Sankyo and Bayer. Prior to joining industry, Dr. Saxena was a practicing hematologist and director of hemophilia treatment centers in Boston and Oklahoma. MGX-001 Large Gene Integration System for Protein Replacement via Gene Insertion Following the demonstration of in vivo proof-of-concept in NHPs via the MGX-001 site-specific genome integration system, the Company is pursuing disease indications which have...

EMERYVILLE, Calif. (AP) — EMERYVILLE, Calif. (AP) — Metagenomi Therapeutics, Inc. (MGX) on Thursday reported a loss of $22.5 million in its fourth quarter. On a per-share basis, the Emeryville, California-based company said it had a loss of 60 cents. The genetic medicines company posted revenue of $3.9 million in the period. For the year, the company reported a loss of $87.9 million, or $2.36 per share. Revenue was reported as $25.2 million. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on MGX at https://www.zacks.com/ap/MGX

Completed pre-IND meeting following MGX-001 preclinical data demonstrating curative FVIII activity in non-human primates (NHPs) and remains on track for global regulatory submission including investigational new drug application (“IND”) in 4Q 2026 Announced corporate name change to Metagenomi Therapeutics, Inc. to reflect Company’s strategic evolution $160.8 million in cash, cash equivalents and available-for-sale marketable securities as of December 31, 2025 with runway anticipated to support operations through 4Q 2027 EMERYVILLE, Calif., March 05, 2026 (GLOBE NEWSWIRE) -- Metagenomi Therapeutics, Inc. (Nasdaq: MGX) (the “Company”), an in vivo genome editing company capitalizing on its proprietary technologies to create curative genetic medicines for patients, today reported financial results for the full year ended December 31, 2025, and provided business updates. “2025 was a pivotal year for Metagenomi as we sharpened our strategic focus, advanced our core genome-editing technologies, and continued to demonstrate the breadth and durability of our technology across multiple therapeutic areas,” said Jian Irish, Ph.D., M.B.A., President and Chief Executive Officer of the Company. “Over the year, we made meaningful progress across our pipeline and collaborations, which reinforce the versatility of our signature technologies and our ability to engineer differentiated genome-editing solutions tailored to specific disease contexts. With our corporate rebranding, we are entering 2026 with a clearer identity and mission centered on unlocking the full potential of precision genetic medicines.” Fourth Quarter 2025 Updates MGX-001 - Hemophilia A Program Announced preclinical data from MGX-001 hemophilia A program that demonstrated curative FVIII activity in NHPs for a therapy with best-in-class treatment potential supporting advancement into clinical development. Completed a pre-IND meeting for MGX-001 and remain on track for regulatory submission to advance global clinical program, including an IND in the fourth quarter of 2026, and subject to regulatory clearance, initiate clinical trials in 2027. Secreted Protein Deficiencies Demonstrated in vivo proof-of-concept in NHPs for Antithrombin (AT-III) Deficiency evidencing the potential to expand the MGX-001 site-specific genome integration system into additional curative therapies for secreted protein disorders. Cardi...

Amphastar Pharmaceuticals (AMPH) came out with quarterly earnings of $0.73 per share, missing the Zacks Consensus Estimate of $0.97 per share. This compares to earnings of $0.92 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -24.49%. A quarter ago, it was expected that this specialty pharmaceutical company would post earnings of $0.77 per share when it actually produced earnings of $0.93, delivering a surprise of +20.78%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Amphastar, which belongs to the Zacks Medical - Generic Drugs industry, posted revenues of $183.11 million for the quarter ended December 2025, missing the Zacks Consensus Estimate by 5.63%. This compares to year-ago revenues of $186.52 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Amphastar shares have added about 4.4% since the beginning of the year versus the S&P 500's gain of 1.5%. While Amphastar has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Amphastar was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of tod...

New MGX-001 preclinical data supports advancement into clinical development; Demonstrated curative FVIII activity in non-human primates Prioritized later-stage preclinical pipeline including wholly-owned MGX-001 hemophilia A program; pre-IND meeting for MGX-001 expected in 4Q 2025 with IND/CTA submissions expected in 4Q 2026 Organizational restructuring reduced workforce by 25%; Capital allocation strategy anticipated to extend cash runway into the 4Q 2027 Jian Irish, Ph.D., M.B.A., currently President and Chief Operating Officer, appointed as Chief Executive Officer; Brian Thomas, Ph.D., former Chief Executive Officer, continuing on Board of Directors and Dr. Willard Dere serving as new Board Chair Conference call today at 4:30 p.m. ET EMERYVILLE, Calif., Nov. 11, 2025 (GLOBE NEWSWIRE) -- Metagenomi, Inc. (Nasdaq: MGX) (the “Company”), an in vivo genome editing company capitalizing on its proprietary technologies to create curative genetic medicines for patients, today reported financial results for the quarter ended September 30, 2025, and announced a strategic evolution focusing capital on the development of its wholly-owned MGX-001 hemophilia A program and later-stage preclinical pipeline while reducing its workforce by 25%. To support the next phase of development, Jian Irish, Ph.D., M.B.A, the Company’s President and former Chief Operating Officer, has been promoted to the role of Chief Executive Officer, and Brian Thomas, Ph.D., the Company’s founder and former Chief Executive Officer, will remain on the Board of Directors (the “Board”) and current Board member Dr. Willard Dere will serve as the Company’s new Board Chair. “In light of the encouraging preclinical MGX-001 hemophilia A results we reported today, we made the decision to strategically reprioritize our pipeline and discovery efforts to focus resources on driving forward our lead program for hemophilia A and pursuing programs that leverage our most advanced, signature gene-editing capabilities. These include programs addressing additional secreted protein deficiencies that deploy the site-specific genome integration system used in MGX-001, and cardiometabolic indications in collaboration with Ionis.” said Jian Irish, Ph.D., M.B.A., President and Chief Executive Officer of Metagenomi. “We are committed to our most compelling programs that have the highest probability of success, and potential...

EMERYVILLE, Calif. (AP) — EMERYVILLE, Calif. (AP) — Metagenomi Inc. (MGX) on Tuesday reported a loss of $20.4 million in its third quarter. The Emeryville, California-based company said it had a loss of 55 cents per share. The results topped Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 60 cents per share. The genetic medicines company posted revenue of $8.7 million in the period. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on MGX at https://www.zacks.com/ap/MGX

Presented three abstracts at American Society of Gene & Cell Therapy (“ASGCT”) demonstrating early proof-of-concept data across multiple gene editing technologies Well capitalized with $205.0 million in cash, cash equivalents and available-for-sale marketable securities as of June 30, 2025 with runway anticipated to support operations into 2027 EMERYVILLE, Calif., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Metagenomi, Inc. (Nasdaq: MGX) (the “Company”), a precision genetic medicines company committed to developing curative therapeutics for patients using its proprietary gene editing toolbox, today reported financial results for the quarter ended June 30, 2025, and provided business updates. “Entering the second half of the year, we continue to advance our MGX-001 wholly-owned program for hemophilia A towards pre-IND and ex-U.S. regulatory meetings in 2025, and our collaboration with Ionis in cardiometabolic indications towards nomination of development candidates in 2025,” said Brian C. Thomas, PhD, CEO and founder of Metagenomi. “Our strong balance sheet and continued focus on operational efficiency are enabling investment in both our pipeline and AI-driven metagenomics platform. At ASGCT, we showcased key advancements of our platform, including compact nucleases for extrahepatic gene editing and CRISPR-associated transposases (“CAST”) for site-specific integration of large therapeutic genes.” Second Quarter 2025 Updates MGX-001 Hemophilia A Program In May 2025, the Company reported additional long-term data from its nonhuman primate (“NHP”) study that demonstrated durable and consistent FVIII activity levels through approximately 19 months. Mean FVIII activity of months 12-19 following lipid nanoparticle dosing was 75%, 8% and 29% in animals 1001, 1002 and 1003, respectively. Emerging data relating to MGX-001 using a bioengineered FVIII construct has, to date, demonstrated FVIII activity higher than expected; the Company has commenced additional studies and may consider alternatives to this construct. Based on the current information, we plan to submit an investigational new drug (“IND”) and clinical trial application (“CTA”) in 2026. Platform Technology Updates Presented three abstracts at the ASGCT 28th Annual Meeting in May 2025 highlighting early proof-of-concept data demonstrating potentially best-in-class compact nucleases for extrahepatic gene editing; and t...

EMERYVILLE, Calif. (AP) — EMERYVILLE, Calif. (AP) — Metagenomi Inc. (MGX) on Tuesday reported a loss of $19.9 million in its second quarter. On a per-share basis, the Emeryville, California-based company said it had a loss of 54 cents. The results topped Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 68 cents per share. The genetic medicines company posted revenue of $8.5 million in the period. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on MGX at https://www.zacks.com/ap/MGX

- Nonhuman primate (NHP) study in hemophilia A demonstrated therapeutically relevant factor VIII (FVIII) activity with durable response through approximately 19 months with an encouraging safety profile - Well capitalized with $226.0 million in cash, cash equivalents and available-for-sale marketable securities as of March 31, 2025 with runway anticipated to support operations into 2027 EMERYVILLE, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Metagenomi, Inc. (Nasdaq: MGX), a precision genetic medicines company committed to developing curative therapeutics for patients using its proprietary gene editing toolbox, today reported financial results for the quarter ended March 31, 2025, and provided business updates. “We are excited about the transformative potential of our AI-driven metagenomics platform across multiple indications in our pipeline,” said Brian C. Thomas, PhD, CEO and founder of Metagenomi. “For our lead program in hemophilia A, we are encouraged by the additional durability of response data demonstrating sustained FVIII activity at therapeutically relevant levels throughout our completed study of approximately 19 months in NHPs. Looking ahead, we plan to leverage these findings to inform the strategy for our MGX-001 program moving forward. Further, we remain well capitalized with cash runway anticipated to support our operations through key milestones into 2027.” First Quarter 2025 Updates Business Updates Hemophilia A Program – approximately 19-month durability results in NHP Results of the NHP study demonstrate that FVIII activity was consistent at therapeutically relevant levels over the approximately 19-month study duration. Mean FVIII activity of months 12-19 following lipid nanoparticle dosing was 75%, 8% and 29% in animals 1001, 1002 and 1003, respectively. At the 19-month or final measured time point, FVIII levels were 80%, 10% and 32% in each of the three animals, respectively. Plasma FVIII activity levels of 80%, 10% and 32% of normal correlated with gene integration frequency of 5.3%, 0.89% and 2.5% in animals 1001, 1002 and 1003, respectively, as measured in the liver at termination. One animal died prematurely from an intussusception of the colon at 17.8 months post LNP, which was assessed to be unrelated to treatment. The FVIII knock-in was achieved with transient elevation of liver transaminases at the time of AAV and LNP administrati...

EMERYVILLE, Calif. (AP) — EMERYVILLE, Calif. (AP) — Metagenomi Inc. (MGX) on Tuesday reported a loss of $25 million in its first quarter. On a per-share basis, the Emeryville, California-based company said it had a loss of 68 cents. The results fell short of Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 62 cents per share. The genetic medicines company posted revenue of $4.1 million in the period. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on MGX at https://www.zacks.com/ap/MGX

Hemophilia A presentation at American Society of Hematology (ASH) 66th Annual Meeting demonstrated sustained Factor VIII (FVIII) activity in nonhuman primate (NHP) study for more than 16 months Leveraged hemophilia A albumin platform to achieve in vivo proof-of-concept in multiple secreted protein deficiencies to support wholly-owned follow-on program Progressed four Wave 1 Ionis targets to lead optimization with plans to declare one to two development candidates (DCs) in 2025 Well capitalized with $248.3 million in cash, cash equivalents and available-for-sale marketable securities at the end of Q4 2024; Cash runway anticipated to support operating plans into 2027 EMERYVILLE, Calif., March 17, 2025 (GLOBE NEWSWIRE) -- Metagenomi, Inc. (Nasdaq: MGX), a precision genetic medicines company committed to developing curative therapeutics for patients using its proprietary gene editing toolbox, today reported financial results for the full year ended December 31, 2024, and provided business updates. “Our diverse and modular AI-driven metagenomics platform is designed to precisely target any site in the human genome, yielding the potential to address the full spectrum of genetic diseases,” said Brian C. Thomas, PhD, CEO and founder of Metagenomi. “In 2024, we made significant progress toward our goal of developing curative genetic medicines for patients. We progressed MGX-001, our potentially transformative treatment for hemophilia A, and leveraged the MGX-001 platform to advance an additional wholly-owned program for an undisclosed secreted protein deficiency disorder. We advanced Wave 1 of our Ionis collaboration, progressing all four targets in cardiometabolic indications. We defined our goals for 2025 and 2026, and remain on track to submit our first IND in hemophilia A in 2026.” 2024 Pipeline Achievements Hemophilia A Program Declared development candidate for wholly-owned program in hemophilia A, MGX-001 Oral presentation at ASH demonstrated sustained FVIII activity in an NHP study for more than 16 months, supporting the durability of our gene editing therapy Nominated a development candidate MGX-001 that includes a bioengineered FVIII construct with higher FVIII activity levels vs wild type construct Completed initial regulatory engagement with FDA and initiated GxP manufacturing activities Secreted Protein Deficiencies Identified targets for wholly-owned th...