Terns Pharma Shares Soar on 'Unprecedented' Leukemia Drug Data
FDA & Biotech

Terns Pharma Shares Soar on 'Unprecedented' Leukemia Drug Data

Phase 1 trial for TERN-701 shows a 64% response rate in hard-to-treat CML patients, setting the stage for a pivotal presentation at the upcoming ASH annual meeting.

Shares of Terns Pharmaceuticals (NASDAQ: TERN) surged in trading Monday, climbing toward 52-week highs after the company announced highly promising data for its experimental leukemia drug, TERN-701. The biotech firm revealed an “unprecedented” response rate in a Phase 1 trial for patients with resistant forms of Chronic Myeloid Leukemia (CML), a significant development for what could become the company’s flagship oncology asset.

The data, released in an abstract ahead of the 67th American Society of Hematology (ASH) Annual Meeting, showed that 64% of heavily pretreated and refractory CML patients achieved a Major Molecular Response (MMR) by the 24-week mark. This high efficacy rate in a difficult-to-treat population signals a potential breakthrough for patients who have exhausted other therapeutic options and positions TERN-701 as a formidable future player in a competitive market.

A New Challenger in CML Treatment

TERN-701 is an oral, allosteric inhibitor of the BCR-ABL gene fusion that drives CML. While several tyrosine kinase inhibitors (TKIs) are on the market, many patients develop resistance or cannot tolerate existing treatments. Terns' drug targets a different binding site on the BCR-ABL protein, potentially offering a powerful new mechanism to overcome this resistance.

The 64% MMR is a critical benchmark indicating a significant reduction of the leukemia-causing gene to very low levels. Achieving this in patients who have previously failed multiple lines of therapy is a noteworthy clinical outcome that has captured investor and analyst attention. The data has been selected for an oral presentation at the ASH meeting on December 8, 2025, a prestigious slot that guarantees a wide audience of clinicians, researchers, and industry competitors.

"The high rate of MMR by 24 weeks in this heavily pretreated, refractory CML population is truly unprecedented," the company stated in its official announcement. The release also highlighted a favorable safety and tolerability profile, a key factor for drugs intended for long-term use.

Market Reaction and Analyst Outlook

The market’s reaction was swift. The stock price for Terns, a company with a market capitalization of approximately $723 million, pushed toward its 52-week high of $9.03 per share. The positive data provides fundamental support for Wall Street’s bullish stance on the company. The consensus target price among analysts sits at $15.83, implying significant upside from its current levels.

This optimism was echoed in earlier analyst commentary. Oppenheimer, for instance, reiterated an "Outperform" rating and a $20 price target late last year, noting that the market had yet to fully appreciate TERN-701's potential. Today's data release appears to be closing that valuation gap.

The drug is entering a CML market projected to reach nearly $8.9 billion in 2025. It will compete with established therapies, including Novartis's Scemblix (asciminib), which is also an allosteric inhibitor. However, Terns has previously presented preclinical data suggesting TERN-701 has superior potency against a wide range of resistance mutations, potentially carving out a best-in-class profile.

Strategic Pivot to Oncology

This clinical success marks a pivotal moment for Terns Pharmaceuticals, which has historically been known for its work in liver diseases like nonalcoholic steatohepatitis (NASH). The remarkable progress of TERN-701, which was granted Orphan Drug Designation by the FDA in March 2024, solidifies the company's strategic expansion into the highly valuable oncology space.

With the dose-expansion phase of the CARDINAL trial underway since April 2025, all eyes will now turn to the full data presentation at the ASH conference in December. Investors and the medical community will be looking for further details on the durability of patient responses, long-term safety data, and activity across various mutation types. A strong showing could pave the way for a pivotal Phase 2/3 trial and further solidify TERN-701's path toward becoming a cornerstone therapy for CML.