Damora Therapeutics, Inc. Common Stock's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Damora Therapeutics, Inc. Common Stock (DMRA).
Over the past two years, Damora Therapeutics, Inc. Common Stock has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
DMR-001. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
DMR-001 FDA Regulatory Events
DMR-001 is a drug developed by Damora Therapeutics, Inc. Common Stock for the following indication: Patients with Mutant Calreticulin-Driven Essential Thrombocythemia and Myelofibrosis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- DMR-001
- Announced Date:
- August 5, 2026
- Indication:
- Patients with Mutant Calreticulin-Driven Essential Thrombocythemia and Myelofibrosis
Announcement
Damora Therapeutics, Inc. announced the initiation of the global Phase 1/1b CLARITY-101 clinical trial of DMR-001, an investigational monoclonal antibody therapy designed to selectively target mutant calreticulin (mutCALR), in patients with mutCALR-driven essential thrombocythemia (ET) and myelofibrosis (MF), based on receipt of health authority approval.
AI Summary
Damora Therapeutics, Inc. announced the start of the global Phase 1/1b CLARITY-101 clinical trial after receiving health authority approval. The open-label, multicenter study will evaluate DMR-001, an experimental monoclonal antibody, in patients with essential thrombocythemia (ET) and myelofibrosis (MF) driven by mutant calreticulin (mutCALR).
DMR-001 is designed to target both Type 1 and non-Type 1 mutCALR mutations, including Type 2 mutations. The therapy is being developed for once-monthly under-the-skin dosing. In preclinical studies, it showed up to 30 times greater potency and about five times longer half-life than a reference anti-mutCALR antibody. Its Fc-null design is intended to support a favorable safety profile.
The trial will begin with dose escalation and expansion. A planned Phase 1b portion will study earlier-line treatment and combinations with other therapies. Damora expects initial results beginning in mid-2027. DMR-001 remains investigational and is not approved for any use.
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Damora Therapeutics, Inc. Common Stock FDA Events - Frequently Asked Questions
As of now, Damora Therapeutics, Inc. Common Stock (DMRA) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Damora Therapeutics, Inc. Common Stock (DMRA) has reported FDA regulatory activity for DMR-001.
The most recent FDA-related event for Damora Therapeutics, Inc. Common Stock occurred on August 5, 2026, involving DMR-001. The update was categorized as "Clinical Trial," with the company reporting: "Damora Therapeutics, Inc. announced the initiation of the global Phase 1/1b CLARITY-101 clinical trial of DMR-001, an investigational monoclonal antibody therapy designed to selectively target mutant calreticulin (mutCALR), in patients with mutCALR-driven essential thrombocythemia (ET) and myelofibrosis (MF), based on receipt of health authority approval."
Currently, Damora Therapeutics, Inc. Common Stock has one therapy (DMR-001) targeting the following condition: Patients with Mutant Calreticulin-Driven Essential Thrombocythemia and Myelofibrosis.
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:DMRA last updated on 8/5/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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