MGX-001 Shows Curative Potential, IND Submission Expected in 2026
"I am excited by the direction we are headed as we enter 2026, led by MGX-001, our wholly owned hemophilia A program. MGX-001 recently demonstrated curative factor VIII activity in non-human primates with clear dose-dependent activity and no identifiable off-target editing, representing a therapy with best-in-class treatment potential," said Jian Irish, CEO. "The study informs our anticipated clinical dose regimen and based on recent regulatory engagement, we feel well positioned to file our IND/CTA submissions before year end 2026 and initiate a first-in-human study in 2027. The recent steps we took to strategically reprioritize our pipeline provide us a strengthened balance sheet with runway anticipated into the fourth quarter of 2027. Looking ahead, our new corporate name represents our focus and commitment to delivering curative genetic medicines to patients and accelerating development of these medicines by strategically deploying our most advanced, proprietary technologies built on our foundational science of metagenomics."
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Metagenomi Therapeutics Renames Company, Plans IND Submission for MGX-001 in 2026
- Strategic Evolution: Metagenomi Therapeutics has changed its name to reflect its strategic focus on late-stage preclinical assets, aiming to leverage its advanced gene-editing capabilities to drive the success of therapeutic programs, particularly in hemophilia A.
- Clinical Advancement: MGX-001 has demonstrated curative FVIII activity in non-human primates with no identifiable off-target editing, with plans to submit IND/CTA in Q4 2026 and initiate first-in-human studies in 2027.
- Cash Runway: The company anticipates a cash runway extending through Q4 2027, ensuring financial stability while advancing MGX-001 and other therapeutic projects, thereby enhancing investor confidence.
- Pipeline Prioritization: Through strategic pipeline prioritization, Metagenomi is focusing on MGX-001 and other potential therapies, showcasing its strong competitiveness and market potential in the gene therapy sector.
Metagenomi Therapeutics Renames to Reflect Focus on Gene Therapy, MGX-001 IND Submission Planned for 2026
- Strategic Evolution: Metagenomi Therapeutics has changed its name to reflect its strategic evolution focused on late-stage preclinical assets, particularly the MGX-001 program for hemophilia A, which is expected to submit IND/CTA in 2026, marking a significant advancement in gene therapy.
- Clinical Readiness: MGX-001 demonstrated curative FVIII activity in non-human primates with no identifiable off-target editing, supporting its potential as a best-in-class treatment, with plans to initiate first-in-human studies in 2027 to further advance clinical development.
- Cash Runway: The company anticipates a cash runway extending through Q4 2027, ensuring sufficient funding to support the advancement of MGX-001 and other therapeutic projects, thereby enhancing its competitive position in the market.
- Pipeline Prioritization: Through strategic pipeline prioritization, Metagenomi is focusing on MGX-001 and other secreted protein deficiencies, showcasing the company's strong technological capabilities and promising market outlook in the field of gene editing.
After-Hours Stock Surge: Exicure Leads with 72% Increase, Followed by Wave Life and Assembly Biosciences
Exicure, Inc. Surge: Exicure, Inc. saw a significant after-hours increase of 72.61% to $9.20 following positive Phase 2 trial results for its therapy in multiple myeloma patients, with 90% of participants achieving the primary endpoint.
Artiva Biotherapeutics and iBio Performance: Artiva Biotherapeutics rose 10.39% after hours despite a regular session decline, while iBio advanced 8.38% after hours, continuing its earlier gains without any new announcements.
Cartesian Therapeutics and Metagenomi Gains: Cartesian Therapeutics increased 6.55% after hours, while Metagenomi gained 7.18% after hours, with the latter planning to present preclinical data at an upcoming conference.
Wave Life Sciences and Assembly Biosciences Updates: Wave Life Sciences shares rose 4.97% after hours following a public offering announcement, and Assembly Biosciences gained 5.96% after reporting positive interim results from Phase 1b studies of its investigational HSV inhibitors.
Amazon's Custom Chips Present a New Challenge for Nvidia
Amazon's New AI Chip: Amazon Web Services has launched its Trainium3 custom AI chip, which is claimed to be four times faster than its previous AI chips.
Cost Efficiency: The Trainium3 chip can potentially reduce the costs of training and operating AI models by up to 50% compared to systems using equivalent GPUs.
Biotech Stocks Surge in After-Hours Trading with Gains from BioAtla, Entero, and Sonnet
BioAtla Inc. Gains: BioAtla's shares surged 13.94% in after-hours trading, attributed to investor reactions to recent financing agreements, despite no new company-specific news.
Metagenomi Inc. and PAVmed Inc. Movements: Metagenomi's stock rose 5.71% with no new updates, while PAVmed advanced 5.72% after reporting a significant net loss and a sharp decline in revenue.
Precision BioSciences' Positive Outlook: Precision BioSciences gained 2.94% after announcing it will present Phase 1 trial data at an upcoming conference, boosting investor optimism.
Entero Therapeutics Rebranding: Entero Therapeutics' shares increased 3.68% following its announcement of a rebranding to GridAI Technologies Corp., effective December 1, 2025, along with a new ticker symbol.
Metagenomi (MGX) Posts Q3 Loss, Falls Short of Revenue Projections
Quarterly Performance: Metagenomi reported a quarterly loss of $0.55 per share, slightly better than the expected loss of $0.60, but worse than a loss of $0.45 per share a year ago. The company also posted revenues of $8.66 million, missing estimates by 6.44%.
Stock Performance: Metagenomi shares have declined by approximately 40.4% since the start of the year, contrasting with a 16.2% gain in the S&P 500. The stock currently holds a Zacks Rank #3 (Hold), indicating expected performance in line with the market.
Earnings Outlook: The consensus EPS estimate for the upcoming quarter is -$0.50 on revenues of $9.26 million, while the fiscal year estimate is -$2.39 on $30.44 million in revenues. The mixed trend in earnings estimate revisions could influence future stock performance.
Industry Context: The Medical - Drugs industry, to which Metagenomi belongs, is currently ranked in the top 33% of Zacks industries, suggesting a favorable environment for stocks in this sector. Another company in the same industry, Nutriband Inc., is expected to report a significant loss in its upcoming results.
Metagenomi Therapeutics Renames Company, Plans IND Submission for MGX-001 in 2026
- Strategic Evolution: Metagenomi Therapeutics has changed its name to reflect its strategic focus on late-stage preclinical assets, aiming to leverage its advanced gene-editing capabilities to drive the success of therapeutic programs, particularly in hemophilia A.
- Clinical Advancement: MGX-001 has demonstrated curative FVIII activity in non-human primates with no identifiable off-target editing, with plans to submit IND/CTA in Q4 2026 and initiate first-in-human studies in 2027.
- Cash Runway: The company anticipates a cash runway extending through Q4 2027, ensuring financial stability while advancing MGX-001 and other therapeutic projects, thereby enhancing investor confidence.
- Pipeline Prioritization: Through strategic pipeline prioritization, Metagenomi is focusing on MGX-001 and other potential therapies, showcasing its strong competitiveness and market potential in the gene therapy sector.
Metagenomi Therapeutics Renames to Reflect Focus on Gene Therapy, MGX-001 IND Submission Planned for 2026
- Strategic Evolution: Metagenomi Therapeutics has changed its name to reflect its strategic evolution focused on late-stage preclinical assets, particularly the MGX-001 program for hemophilia A, which is expected to submit IND/CTA in 2026, marking a significant advancement in gene therapy.
- Clinical Readiness: MGX-001 demonstrated curative FVIII activity in non-human primates with no identifiable off-target editing, supporting its potential as a best-in-class treatment, with plans to initiate first-in-human studies in 2027 to further advance clinical development.
- Cash Runway: The company anticipates a cash runway extending through Q4 2027, ensuring sufficient funding to support the advancement of MGX-001 and other therapeutic projects, thereby enhancing its competitive position in the market.
- Pipeline Prioritization: Through strategic pipeline prioritization, Metagenomi is focusing on MGX-001 and other secreted protein deficiencies, showcasing the company's strong technological capabilities and promising market outlook in the field of gene editing.
After-Hours Stock Surge: Exicure Leads with 72% Increase, Followed by Wave Life and Assembly Biosciences
Exicure, Inc. Surge: Exicure, Inc. saw a significant after-hours increase of 72.61% to $9.20 following positive Phase 2 trial results for its therapy in multiple myeloma patients, with 90% of participants achieving the primary endpoint.
Artiva Biotherapeutics and iBio Performance: Artiva Biotherapeutics rose 10.39% after hours despite a regular session decline, while iBio advanced 8.38% after hours, continuing its earlier gains without any new announcements.
Cartesian Therapeutics and Metagenomi Gains: Cartesian Therapeutics increased 6.55% after hours, while Metagenomi gained 7.18% after hours, with the latter planning to present preclinical data at an upcoming conference.
Wave Life Sciences and Assembly Biosciences Updates: Wave Life Sciences shares rose 4.97% after hours following a public offering announcement, and Assembly Biosciences gained 5.96% after reporting positive interim results from Phase 1b studies of its investigational HSV inhibitors.
Amazon's Custom Chips Present a New Challenge for Nvidia
Amazon's New AI Chip: Amazon Web Services has launched its Trainium3 custom AI chip, which is claimed to be four times faster than its previous AI chips.
Cost Efficiency: The Trainium3 chip can potentially reduce the costs of training and operating AI models by up to 50% compared to systems using equivalent GPUs.
Biotech Stocks Surge in After-Hours Trading with Gains from BioAtla, Entero, and Sonnet
BioAtla Inc. Gains: BioAtla's shares surged 13.94% in after-hours trading, attributed to investor reactions to recent financing agreements, despite no new company-specific news.
Metagenomi Inc. and PAVmed Inc. Movements: Metagenomi's stock rose 5.71% with no new updates, while PAVmed advanced 5.72% after reporting a significant net loss and a sharp decline in revenue.
Precision BioSciences' Positive Outlook: Precision BioSciences gained 2.94% after announcing it will present Phase 1 trial data at an upcoming conference, boosting investor optimism.
Entero Therapeutics Rebranding: Entero Therapeutics' shares increased 3.68% following its announcement of a rebranding to GridAI Technologies Corp., effective December 1, 2025, along with a new ticker symbol.
Metagenomi (MGX) Posts Q3 Loss, Falls Short of Revenue Projections
Quarterly Performance: Metagenomi reported a quarterly loss of $0.55 per share, slightly better than the expected loss of $0.60, but worse than a loss of $0.45 per share a year ago. The company also posted revenues of $8.66 million, missing estimates by 6.44%.
Stock Performance: Metagenomi shares have declined by approximately 40.4% since the start of the year, contrasting with a 16.2% gain in the S&P 500. The stock currently holds a Zacks Rank #3 (Hold), indicating expected performance in line with the market.
Earnings Outlook: The consensus EPS estimate for the upcoming quarter is -$0.50 on revenues of $9.26 million, while the fiscal year estimate is -$2.39 on $30.44 million in revenues. The mixed trend in earnings estimate revisions could influence future stock performance.
Industry Context: The Medical - Drugs industry, to which Metagenomi belongs, is currently ranked in the top 33% of Zacks industries, suggesting a favorable environment for stocks in this sector. Another company in the same industry, Nutriband Inc., is expected to report a significant loss in its upcoming results.
