Terns Pharmaceuticals Gains FDA Breakthrough Status for TERN-701

Terns Pharmaceuticals ( (TERN) ) has provided an announcement.

On April 27, 2026, Terns Pharmaceuticals announced that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to its investigational drug TERN-701 for adults with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase without the T315I mutation who have been treated with at least two tyrosine kinase inhibitors. The designation, based on encouraging Phase 1/2 CARDINAL trial data showing promising molecular responses and a largely low-grade safety profile, underscores the drug’s potential to meaningfully improve outcomes for heavily pretreated CML patients and could strengthen Terns’ position in oncology as its acquisition by Merck moves forward.

TERN-701’s Breakthrough Therapy Designation is based on early clinical data demonstrating promising efficacy and tolerability in difficult-to-treat CML patients.

This regulatory milestone, coinciding with Merck’s deal to acquire Terns, may accelerate TERN-701’s path toward pivotal trials and enhance Terns’ strategic value in oncology.

The most recent analyst rating on (TERN) stock is a Hold with a $52.89 price target. To see the full list of analyst forecasts on Terns Pharmaceuticals stock, see the TERN Stock Forecast page.

Spark’s Take on TERN Stock

According to Spark, TipRanks’ AI Analyst, TERN is a Neutral.

Score is held back primarily by weak financial performance (no meaningful revenue, widening losses, and sustained cash burn), partially offset by a very strong low-debt balance sheet. Technicals are supportive with a strong uptrend, though momentum is stretched. Valuation is constrained by negative earnings, while the Merck acquisition announcement is a major positive corporate event that lifts the overall score.

To see Spark’s full report on TERN stock, click here.

More about Terns Pharmaceuticals

Terns Pharmaceuticals, Inc. is a clinical-stage oncology company focused on reimagining known cancer biology to develop high-impact medicines. Its lead program, TERN-701, is a highly selective, oral allosteric BCR::ABL1 inhibitor aimed at improving the efficacy, safety and convenience of existing treatments for chronic myeloid leukemia.

Average Trading Volume: 5,719,361

Technical Sentiment Signal: Buy

Current Market Cap: $6.1B

For a thorough assessment of TERN stock, go to TipRanks’ Stock Analysis page.