Galecto Expects to Initiate Anti-MutCALR Clinical Development in 2026
The company states: "2026 is expected to be a foundational year for Galecto as the company initiates the clinical development of its anti-mutCALR pipeline candidates. DMR-001 is a potentially best-in-class anti-mutCALR monoclonal antibody demonstrated to have highly potent activity in both Type 1 and Type 2 mutCALR-driven preclinical models, supporting its potential to address the full spectrum of CALR mutations in both essential thrombocythemia and myelofibrosis. DMR-001 is engineered with validated half-life extension technology to enable infrequent low-volume, subcutaneous dosing to maximize target coverage and patient convenience. An Investigational New Drug application ("IND"), or equivalent, submission for DMR-001, with anticipated first-in-human dosing via subcutaneous administration, is expected to occur in mid-2026, with Phase 1 proof-of-concept data anticipated in 2027. DMR-002 is an additional anti-mutCALR antibody. An IND, or equivalent, submission for DMR-002 is planned for the second half of 2026. GB3226 is a dual ENL-YEATS and FLT3 inhibitor for multiple genetic subsets of acute myeloid leukemia. An IND submission is planned for the first quarter of 2026. The Company anticipates that its cash balance, following $285 million raised in the November PIPE, provides operational runway into 2029."
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Galecto Appoints New Executives to Advance DMR-001 Clinical Trials
- Executive Appointments: Galecto has appointed Sherwin Sattarzadeh as COO and Becker Hewes as CMO, both from Blueprint Medicines, leveraging their 20+ years of drug development experience to drive DMR-001 into clinical trials.
- Clinical Advancement: DMR-001, a monoclonal antibody targeting mutant calreticulin, is on track for IND submission in mid-2026, with plans for first-in-human dosing via subcutaneous administration, marking a significant step in blood cancer treatment.
- Financial Position: The company's cash balance, including $285 million raised in a PIPE in November 2025, provides a financial runway into 2029 to support multiple data milestones, including Phase 1 clinical proof-of-concept data for DMR-001 expected in 2027.
- Incentive Plan: The appointments of Sattarzadeh and Hewes come with stock incentive grants of 190,376 and 264,629 restricted stock units respectively, reflecting the company's commitment to its executive team and confidence in future growth.
Aptevo Therapeutics Announces 1-for-18 Reverse Stock Split, Shares Plunge 38.4%
- Reverse Stock Split Announcement: Aptevo Therapeutics has announced a 1-for-18 reverse stock split effective December 29, converting every 18 shares into one, which has led to a significant 38.4% drop in share price to $0.57, indicating a negative market reaction despite prior shareholder approval in July.
- Severe Market Reaction: Following the reverse stock split announcement, Aptevo's shares plummeted sharply during Friday's session, reflecting investor concerns about the company's future prospects, which could adversely affect its financing capabilities and market confidence.
- Shareholder Approval Context: The final ratio for the reverse split was approved by the board in mid-December, despite having received shareholder support at the July annual meeting, yet the market's response raises questions about the company's governance and strategic direction.
- Industry Impact: The sharp decline in Aptevo's stock price may affect its competitive position in the biopharmaceutical sector, particularly regarding financing and partnership opportunities, as investors may reassess its investment value.
