Orchestra BioMed (OBIO) FDA Approvals

Orchestra BioMed's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Orchestra BioMed (OBIO). Over the past two years, Orchestra BioMed has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as BACKBEAT. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

BACKBEAT FDA Regulatory Events

BACKBEAT is a drug developed by Orchestra BioMed for the following indication: AVIM therapy in pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medications. 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.

FDA approved - August 8,2025

• Drug: BACKBEAT
• Announced Date: August 8, 2025
• Indication: AVIM therapy in pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medications.

Orchestra BioMed Holdings, announced the roll out of a protocol update, approved by the U.S. Food and Drug Administration ("FDA"), that significantly expands patient eligibility criteria for enrollment of the BACKBEAT study evaluating AVIM therapy in pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medications.

Orchestra BioMed Holdings announced a protocol update, approved by the U.S. FDA, that expands patient eligibility for the global BACKBEAT study. This trial evaluates AVIM therapy, a new treatment to lower blood pressure in patients with a dual-chamber pacemaker and uncontrolled hypertension despite medication.

The updated criteria now include any hypertensive patient with a Medtronic Azure or Astra dual-chamber pacemaker—first implant or replacement—with sufficient battery life. It also adds patients with mild to moderate heart failure (NYHA class I or II).

Orchestra BioMed estimates these changes increase the potential patient pool by more than 24-fold compared to the original protocol. Rollout began in the third quarter of 2025, with full implementation in the fourth quarter, aiming to complete enrollment by mid-2026.

This update better aligns the study group with older, higher-risk patients who need both a pacemaker and better blood pressure control.

Orchestra BioMed FDA Events - Frequently Asked Questions

Has Orchestra BioMed received FDA approval?

As of now, Orchestra BioMed (OBIO) has not received any FDA approvals for its therapy in the last two years.

What drugs has Orchestra BioMed submitted to the FDA?

In the past two years, Orchestra BioMed (OBIO) has reported FDA regulatory activity for BACKBEAT.

What is the most recent FDA event for Orchestra BioMed?

The most recent FDA-related event for Orchestra BioMed occurred on August 8, 2025, involving BACKBEAT. The update was categorized as "FDA approved," with the company reporting: "Orchestra BioMed Holdings, announced the roll out of a protocol update, approved by the U.S. Food and Drug Administration ("FDA"), that significantly expands patient eligibility criteria for enrollment of the BACKBEAT study evaluating AVIM therapy in pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medications."

What conditions do Orchestra BioMed's current drugs treat?

Currently, Orchestra BioMed has one therapy (BACKBEAT) targeting the following condition: AVIM therapy in pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medications..