Why Is Tenaya Therapeutics Stock Up Today?

Tenaya Therapeutics stock is up today after the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to TN-401, its gene therapy for arrhythmogenic right ventricular cardiomyopathy caused by PKP2 mutations. The designation crossed MoveSurge's tape at 08:30:00 ET; the stock was 1.070% lower ten minutes later, and at 12:29 ET it traded at $0.6970, up 8.91% on the session.

What RMAT designation gives TN-401

RMAT is an FDA expedited program for regenerative medicine therapies aimed at serious conditions. It brings more contact with the agency on clinical development, manufacturing and the regulatory path, and it can make a therapy eligible for accelerated approval, priority review and rolling review. TN-401 already has Orphan Drug and Fast Track designations from the FDA and PRIME designation from the European Medicines Agency for the same disease.

TN-401 is an AAV9-based gene therapy given as a single intravenous infusion. Mutations in the PKP2 gene are the most common genetic cause of the disease, found in about 40% of patients with ARVC, and Tenaya estimates more than 70,000 people in the U.S. have the PKP2 form.

The RIDGE-1 data so far

RIDGE-1 is an open-label, dose-escalation Phase 1b/2 trial. Tenaya presented interim results for its first two cohorts on May 15, 2026:

Premature ventricular contractions, the extra heartbeats that mark electrical instability in ARVC, fell in all six patients, by a mean of 64% from baseline. Two patients who entered with high rates of non-sustained ventricular tachycardia had substantial reductions as early as week 20, and no dose-limiting toxicities occurred at either dose. Tenaya expects more data and an update on its regulatory talks about pivotal plans for TN-401 and TN-201 in the fourth quarter of 2026.

How the stock traded, measured minute by minute

In the 08:30 minute the price touched $0.6700, 3.88% above the last print of $0.6450, then closed the minute at $0.6409 on 17,560 shares. By the ten-minute mark 12,808 more shares had traded and the price had drifted to $0.6381, 1.070% below the pre-release print. Friday's close was $0.6400, so the session gain came after that first premarket window.

Cash and listing status

Tenaya had $78.1 million in cash and cash equivalents at June 30, 2026, including a $10.0 million upfront payment from a collaboration with Alnylam that also carries up to $1.1 billion in potential milestones. The company said the cash funds planned operations through the third quarter of 2027.

On January 28, 2026, Nasdaq told Tenaya that its shares had closed below the $1.00 minimum bid price for 30 consecutive business days. The notice set an initial compliance period ending July 27, 2026, with a possible second 180-day period if the company transferred to the Nasdaq Capital Market. The shares traded at $0.6970 at 12:29 ET.

TN-401 and Tenaya timeline

1. January 28, 2026 — Nasdaq minimum bid price notice.
2. April 2026 — $10.0 million upfront payment received under the Alnylam collaboration.
3. May 15, 2026 — interim RIDGE-1 data for cohorts 1 and 2 at the ASGCT annual meeting.
4. August 5, 2026 — second-quarter results, $78.1 million in cash, runway through the third quarter of 2027.
5. September 14, 2026 — FDA grants RMAT designation to TN-401.
6. Fourth quarter of 2026 — more data and an update on pivotal trial plans expected.