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FOSTER CITY, Calif. - Terns Pharmaceuticals, Inc. (NASDAQ:TERN), a $321 million market cap biotech company currently trading below its InvestingPro Fair Value, has completed enrollment in its Phase 2 FALCON clinical trial of TERN-601, an oral GLP-1 receptor agonist being developed for obesity, with topline data expected in the fourth quarter of 2025.
The company will present additional data from its completed Phase 1 study of TERN-601 at the American Diabetes Association’s 85th Scientific Sessions in Chicago. The Phase 1 results, initially reported in September 2024, showed statistically significant and dose-dependent weight loss of up to 5.5% over 28 days with once-daily dosing. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 30.89, though it’s currently burning through cash reserves.
According to the company’s press release statement, 67% of patients in the highest dose group lost 5% or more body weight during the 28-day treatment period.
The Phase 1 study also demonstrated that TERN-601 was well-tolerated despite rapid dose titration every three days, with more than 95% of gastrointestinal adverse events classified as mild. The drug showed no treatment-related interruptions, reductions, or discontinuations at any dose level.
The ongoing Phase 2 FALCON trial is evaluating TERN-601 in adults with obesity or who are overweight without diabetes. Participants are randomized to receive one of four active doses (250 mg, 500 mg, 500 mg slow titration, or 750 mg) or placebo. The primary endpoint is percent change in body weight compared to placebo over 12 weeks.
Terns Pharmaceuticals is positioning TERN-601 as having potential advantages over other GLP-1 therapies, including once-daily oral dosing that can be administered with or without food and compatibility with proton pump inhibitors and antacids.
The company’s clinical development program for TERN-601 comes amid growing interest in GLP-1 receptor agonists for weight management, a market currently dominated by injectable medications. While the stock has shown strong returns over the past three months, InvestingPro analysis reveals that three analysts have recently revised their earnings expectations downward, with the company not expected to achieve profitability this year. For deeper insights into TERN’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively on InvestingPro.
In other recent news, Terns Pharmaceuticals has been in the spotlight due to several significant developments. The company reported positive efficacy data for its TERN-701 treatment, with a 50% cumulative MMR rate at 12 weeks in non-T315I patients and a reduction in BCR::ABL1 transcripts in 88% of MR1+ patients. Analyst Silvan Tuerkcan from Citizens JMP reiterated a Market Outperform rating, maintaining a $20 price target based on these results. Meanwhile, BMO Capital Markets adjusted its price target for Terns Pharmaceuticals from $26 to $15, citing recent clinical and patent developments, as well as broader economic factors, while still maintaining an Outperform rating.
In the realm of intellectual property, Terns Pharmaceuticals received favorable updates regarding its TERN-601 treatment, with the USPTO resolving double patenting rejections, paving the way for potential future patents. JMP Securities also reaffirmed a $20 price target, emphasizing the positive safety profile of TERN-601 amid Pfizer’s discontinuation of a similar product due to safety concerns. Mizuho Securities maintained an Outperform rating with a $14 price target, highlighting the competitive advantage gained from Pfizer’s withdrawal of its oral GLP-1 agonist, danuglipron. These developments indicate a strategic position for Terns Pharmaceuticals as it progresses with its pipeline, particularly in the GLP-1RA space.
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