FDA Events for Keen Vision Acquisition (KVAC)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Keen Vision Acquisition (KVAC).
Over the past two years, Keen Vision Acquisition has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
SRD-001. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
SRD-001 - FDA Regulatory Timeline and Events
SRD-001 is a drug developed by Keen Vision Acquisition for the following indication: For Heart Failure with Reduced Ejection Fraction.
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:
- SRD-001
- Announced Date:
- March 20, 2025
- Indication:
- For Heart Failure with Reduced Ejection Fraction
Announcement
Medera Inc. announced that the independent Data and Safety Monitoring Board (DSMB) has completed its planned review of the MUSIC-HFrEF Phase 1b/2 clinical trial data, recommending the completion of the Phase 1b portion and clearance to initiate the Phase 2 portion of the trial evaluating the gene therapy candidate SRD-001 in patients with heart failure with reduced ejection fraction (HFrEF).
AI Summary
Medera Inc. announced that its independent Data and Safety Monitoring Board (DSMB) has completed the planned review of the MUSIC-HFrEF trial data. Based on the review, which included data from nine patients in the open-label Phase 1 study, the DSMB recommended completing the Phase 1b part of the trial and gave clearance to start Phase 2. The trial evaluates the gene therapy candidate SRD-001 in patients with heart failure with reduced ejection fraction (HFrEF), a common and challenging condition affecting millions worldwide. The Phase 2 portion will be a placebo-controlled study designed to further assess the therapy’s safety and effectiveness. This progression represents an important step in Medera’s mission to develop innovative treatments for patients with advanced heart failure who currently have limited options.
Read Announcement- Drug:
- SRD-001
- Announced Date:
- March 11, 2025
- Indication:
- For Heart Failure with Reduced Ejection Fraction
Announcement
Medera Inc announced that patient dosing has been completed in its MUSIC-HFrEF Phase 1/2a clinical trial of the gene therapy candidate SRD-001 in patients with heart failure with reduced ejection fraction (HErEF).
AI Summary
Medera Inc. announced that patient dosing has been completed in its MUSIC-HFrEF Phase 1/2a clinical trial for the gene therapy candidate SRD-001. This trial targets patients with heart failure with reduced ejection fraction (HFrEF), a common form of advanced heart disease affecting millions worldwide. In this open-label, uncontrolled study, six patients received a low dose while three patients were given a higher dose of SRD-001. Preliminary data presented at a recent scientific meeting showed an acceptable safety profile and promising improvements in heart function and overall patient health at six and 12 months after treatment. The completion of patient dosing marks an important milestone for Medera, offering hope for a novel therapeutic option for those with few current treatments for advanced HFrEF.
Read Announcement
Keen Vision Acquisition FDA Events - Frequently Asked Questions
As of now, Keen Vision Acquisition (KVAC) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Keen Vision Acquisition (KVAC) has reported FDA regulatory activity for SRD-001.
The most recent FDA-related event for Keen Vision Acquisition occurred on March 20, 2025, involving SRD-001. The update was categorized as "review," with the company reporting: "Medera Inc. announced that the independent Data and Safety Monitoring Board (DSMB) has completed its planned review of the MUSIC-HFrEF Phase 1b/2 clinical trial data, recommending the completion of the Phase 1b portion and clearance to initiate the Phase 2 portion of the trial evaluating the gene therapy candidate SRD-001 in patients with heart failure with reduced ejection fraction (HFrEF)."
Currently, Keen Vision Acquisition has one therapy (SRD-001) targeting the following condition: For Heart Failure with Reduced Ejection Fraction.
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:KVAC) was last updated on 7/11/2025 by MarketBeat.com Staff
