FDA Events for Syros Pharmaceuticals (SYRS)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Syros Pharmaceuticals (SYRS).
Over the past two years, Syros Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Tamibarotene. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Tamibarotene - FDA Regulatory Timeline and Events
Tamibarotene is a drug developed by Syros Pharmaceuticals for the following indication: Myelodysplastic syndrome (MDS).
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:
- Tamibarotene
- Announced Date:
- August 12, 2024
- Indication:
- Myelodysplastic syndrome (MDS)
Announcement
Syros announced that The companywill discontinue enrollment in the SELECT-AML-1 Phase 2 clinical trial evaluating the triplet regimen of tamibarotene in combination with venetoclax and azacitidine compared to the doublet regimen of venetoclax and azacitidine in newly diagnosed, unfit patients with acute myeloid leukemia (AML) and RARA gene overexpression.
AI Summary
Syros Pharmaceuticals announced it will stop enrolling patients in the SELECT-AML-1 Phase 2 clinical trial. The trial compared a triplet regimen of tamibarotene, venetoclax, and azacitidine to the doublet combination of venetoclax and azacitidine in newly diagnosed, unfit AML patients with RARA gene overexpression. An interim analysis of 51 patients revealed nearly identical CR/CRi rates—65% in the triplet arm versus 70% in the doublet arm—after about three months of treatment in the first 40 randomized patients. Based on this non-binding futility assessment, the likelihood of showing superiority for the triplet regimen at the final analysis was considered low, leading to the decision to discontinue further enrollment. The safety profile remained consistent, and current study participants will be allowed to continue treatment at the discretion of their investigators.
Read Announcement- Drug:
- Tamibarotene
- Announced Date:
- April 9, 2024
- Indication:
- Myelodysplastic syndrome (MDS)
Announcement
Syros Pharmaceuticals announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to tamibarotene in combination with azacitidine and venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) with RARA overexpression as detected by an FDA approved test in adults who are over age 75 years or who have comorbidities that preclude the use of intensive induction chemotherapy.
AI Summary
Syros Pharmaceuticals announced that the FDA has granted Fast Track Designation for tamibarotene when used in combination with azacitidine and venetoclax. This treatment is intended for adults over 75 years old or for those with other health issues who are not candidates for intensive chemotherapy. The designation applies to newly diagnosed acute myeloid leukemia (AML) patients showing RARA overexpression, determined by an FDA approved test. Fast Track status is meant to speed up the development and review process for drugs that address serious conditions. Syros believes that this approach may provide a safer and more effective treatment option for AML patients who currently have limited alternatives. The company’s ongoing clinical trial is evaluating the combination’s safety and efficacy, and early data has shown promising results without added toxicity compared to the standard treatment regimen.
Read Announcement
Syros Pharmaceuticals FDA Events - Frequently Asked Questions
As of now, Syros Pharmaceuticals (SYRS) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Syros Pharmaceuticals (SYRS) has reported FDA regulatory activity for Tamibarotene.
The most recent FDA-related event for Syros Pharmaceuticals occurred on August 12, 2024, involving Tamibarotene. The update was categorized as "Provided Update," with the company reporting: "Syros announced that The companywill discontinue enrollment in the SELECT-AML-1 Phase 2 clinical trial evaluating the triplet regimen of tamibarotene in combination with venetoclax and azacitidine compared to the doublet regimen of venetoclax and azacitidine in newly diagnosed, unfit patients with acute myeloid leukemia (AML) and RARA gene overexpression."
Currently, Syros Pharmaceuticals has one therapy (Tamibarotene) targeting the following condition: Myelodysplastic syndrome (MDS).
More FDA Event Resources from MarketBeat
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
This page (NASDAQ:SYRS) was last updated on 7/12/2025 by MarketBeat.com Staff
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