Opna Bio Announces Fast Track Designation for OPN-6602 to Treat Multiple Myeloma

Dual EP300/CBP inhibitor granted FDA Fast Track status for relapsed/refractory multiple myeloma patients

Apr. 16, 2026 at 3:49am

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A highly detailed, translucent X-ray photograph showing the intricate network of cells and vessels within human bone marrow, glowing with an ethereal blue light and symbolizing the complex nature of multiple myeloma.An innovative X-ray imaging technique reveals the intricate cellular architecture of bone marrow, shedding light on the complex biology of multiple myeloma.South San Francisco Today

Opna Bio, a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to OPN-6602, a dual EP300/CBP inhibitor, for the treatment of multiple myeloma (MM). OPN-6602 is currently in a Phase 1 clinical trial evaluating safety, tolerability, pharmacokinetics and preliminary clinical activity in patients with relapsed and/or refractory MM.

Why it matters

Multiple myeloma is a serious blood cancer with an unmet need for new treatment options, as most patients ultimately relapse or become refractory to available therapies. The FDA's Fast Track designation is designed to facilitate development and expedite review of therapies addressing serious conditions with unmet medical need, offering benefits like more frequent FDA interactions and potential eligibility for accelerated approval.

The details

OPN-6602 is an oral, small molecule inhibitor of EP300 and CREB-binding protein (CBP) that is currently being evaluated in a Phase 1 clinical trial for patients with relapsed and/or refractory multiple myeloma. The Fast Track designation applies to patients who have received at least four prior lines of therapy. Opna Bio has been a pioneer in the EP300/CBP inhibitor space, and the company believes OPN-6602 was selected for its potency, selectivity, and optimized pharmacokinetic properties.

  • OPN-6602 was granted Orphan Drug Designation by the FDA in January 2025.
  • The Phase 1 clinical trial for OPN-6602 in multiple myeloma patients is currently ongoing.

The players

Opna Bio

A clinical-stage biopharmaceutical company focused on the discovery and development of novel oncology therapeutics, including OPN-6602, a dual EP300/CBP inhibitor.

OPN-6602

An oral, small molecule inhibitor of EP300 and CREB-binding protein (CBP) that is currently in a Phase 1 clinical trial for the treatment of relapsed and/or refractory multiple myeloma.

U.S. Food and Drug Administration (FDA)

The regulatory agency that has granted Fast Track designation to OPN-6602 for the treatment of multiple myeloma.

Reinaldo Diaz

The chief executive officer of Opna Bio.

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What they’re saying

“Opna Bio has been a pioneer in the EP300/CBP inhibitor space and OPN-6602 was selected for its potency, selectivity, and optimized pharmacokinetic properties. We are encouraged by the progress of the study to date and look forward to reporting emerging clinical data at an upcoming scientific congress.”

— Reinaldo Diaz, Chief Executive Officer, Opna Bio

What’s next

Opna Bio plans to report emerging clinical data for OPN-6602 at an upcoming scientific congress.

The takeaway

The FDA's Fast Track designation for OPN-6602 in the treatment of relapsed/refractory multiple myeloma highlights the unmet need for new therapies in this serious blood cancer and the potential of Opna Bio's dual EP300/CBP inhibitor to address this need.