COGT

- Planning for dual launches of bezuclastinib in Systemic Mastocytosis and Gastrointestinal Stromal Tumors (GIST) - Pivotal data from Phase 3 PEAK trial in GIST patients selected for oral presentation at 2026 ASCO annual meeting - Ended 1Q 2026 with $866.4 million in cash, sufficient to fund operations into 2028 WALTHAM, Mass. and BOULDER, Colo., May 05, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and announced financial results for the first quarter ended March 31, 2026. “2026 is shaping up to be a pivotal year for Cogent,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “We have two NDAs for bezuclastinib under FDA review and expect to submit a third in the first half of this year. These milestones highlight the breadth of bezuclastinib’s potential across GIST and KIT-driven diseases. With a strong balance sheet, we are focused on completing our commercial build and preparing for multiple potential launches.” Recent Business Highlights Announced details for an oral presentation on May 30 at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting featuring pivotal data from the Phase 3 PEAK trial in patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib Presented updated preclinical data from the company’s KRAS and ErbB2 candidates at the American Association of Cancer Research (AACR) annual meeting Announced submission of the company’s New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in patients with GIST who have received prior treatment with imatinib. Based on the positive results from the PEAK trial, the bezuclastinib NDA was submitted under the FDA’s Real-Time Oncology Review (RTOR) program, which is intended to enable a more streamlined review process. Bezuclastinib was also granted Breakthrough Therapy Designation as a treatment for GIST earlier in 2026. Announced the FDA accepted its NDA for bezuclastinib in patients with NonAdvanced Systemic Mastocytosis (NonAdvSM) and assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2026 Presented six posters with bezuclastinib in patients with NonAdvSM at the 2026 AAAAI annual meeting Initiated Phase 1 st...

On February 17, 2026, Superstring Capital Management reported selling 345,869 shares of Terns Pharmaceuticals (NASDAQ:TERN) in the fourth quarter, an estimated $7.99 million trade based on quarterly average pricing. According to a February 17, 2026, SEC filing, Superstring Capital Management reduced its position in Terns Pharmaceuticals by 345,869 shares during the fourth quarter of 2025. The estimated value of the trade, derived from the average closing price for the quarter, was $7.99 million. The fund’s quarter-end position in Terns Pharmaceuticals decreased in value by approximately $12.00 million, reflecting both share sales and stock price moves. Top holdings after the filing: NASDAQ:CDTX: $18.80 million (10.1% of AUM) NASDAQ:TERN: $17.93 million (9.6% of AUM) NASDAQ:URGN: $16.82 million (9.0% of AUM) NASDAQ:COGT: $13.01 million (7.0% of AUM) NASDAQ:DVAX: $8.08 million (4.3% of AUM) As of Wednesday, Terns shares were priced at $45.56, up a staggering 1,300% over the past year and vastly outperforming the S&P 500’s roughly 19% gain in the same period. Terns develops small-molecule therapies targeting chronic myeloid leukemia (CML), non-alcoholic steatohepatitis (NASH) and obesity, with lead candidates including TERN-101, TERN-201, TERN-501, and TERN-601 in various stages of clinical development. The firm operates a clinical-stage biopharmaceutical business model focused on advancing proprietary drug candidates through early- and mid-stage trials, aiming for eventual regulatory approval and commercialization or strategic partnerships. It has targeted patients with NASH and metabolic diseases, addressing unmet needs in the global healthcare and biotechnology markets. Even after trimming Terns, the stock remains one of the largest holdings in Superstring’s portfolio, which tells you this is not a loss of conviction but a recalibration after an extraordinary move. A 1,300% gain in a single year is staggering, and it certainly creates some expectations, which matter in biotech, where outcomes hinge on trial execution and regulatory milestones rather than steady revenue growth. The underlying story, however, is still compelling. Terns has repositioned around oncology, with its lead program for chronic myeloid leukemia showing strong early efficacy and a slate of catalysts expected this year, including dose selection and pivotal trial progress. Meanwhile, roug...

SUMMIT NDA for bezuclastinib in patients with NonAdvSM submitted in December 2025; APEX NDA submission for bezuclastinib in patients with AdvSM on track for 1H 2026 PEAK NDA initiated for bezuclastinib in patients with 2L GIST under Real-Time Oncology Review (RTOR) and Breakthrough Therapy Designation (BTD); completion of NDA on track for April 2026 Six abstracts from SUMMIT trial of bezuclastinib in patients with NonAdvSM accepted for presentation at 2026 AAAAI annual meeting Strong financial position with $901 million sufficient to fund operations into 2028 WALTHAM, Mass. and BOULDER, Colo., Feb. 17, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and reported financial results for the fourth quarter and full year of 2025. “Following three positive pivotal trials in 2025, we have entered 2026 with tremendous momentum and multiple value-creating regulatory catalysts underway,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “We have submitted our SUMMIT NDA for bezuclastinib in patients with NonAdvSM, initiated our PEAK NDA under the FDA’s RTOR program for bezuclastinib in patients with second-line GIST, and remain on track to submit our APEX NDA for bezuclastinib in patients with AdvSM in the first half of this year. These recent and upcoming milestones underscore the breadth of bezuclastinib’s best-in-class potential across KIT-mutant driven diseases. With a very strong balance sheet entering 2026, we will soon finish building our commercial organization and will be ready to launch bezuclastinib in the second half of 2026.” Recent Company Highlights In February 2026, announced that six abstracts from the SUMMIT trial of bezuclastinib in patients with NonAdvanced Systemic Mastocytosis (NonAdvSM) have been accepted for presentation at the 2026 AAAAI annual meeting. In January 2026, announced that the U. S. Food and Drug Administration (FDA) agreed to accept the PEAK NDA for bezuclastinib in patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib under the Real-Time Oncology Review (RTOR) program. Shortly thereafter Cogent initiated the NDA submission to the FDA under this program. Based on the results from the PEAK trial, in January 2026 bezucl...

-- Bezuclastinib demonstrated rapid and deep clinical benefit in AdvSM patients resulting in an objective response rate (CR+CRh+PR+CI) of 57% per mIWG criteria and 80% per PPR criteria -- -- Bezuclastinib demonstrated a powerful effect on mast cell burden with 89% of patients achieving ≥50% reduction in bone marrow mast cells or clearance of aggregates – -- Bezuclastinib was very well tolerated with only 14.8% of patients requiring dose reduction and no patients requiring discontinuation due to treatment related adverse events -- -- APEX NDA submission expected in 1H 2026 – -- Cogent to host investor conference call and webcast today at 8:00 a.m. ET -- WALTHAM, Mass. and BOULDER, Colo., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (NASDAQ: COGT) today announced positive top-line results from the registration-directed APEX Part 2 clinical trial of bezuclastinib in patients with advanced systemic mastocytosis (AdvSM) demonstrating clinically meaningful results as measured by consensus criteria used to assess patient response. This is the third positive pivotal trial result for bezuclastinib in 2025, following positive announcements from the SUMMIT trial in NonAdvSM patients and the PEAK trial in GIST patients earlier this year. Based on these top-line data, Cogent expects to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in AdvSM during the first half of 2026. In addition, Cogent plans to present detailed data from the APEX trial at an upcoming scientific meeting in the first half of 2026. “We are excited to announce the third positive pivotal trial for bezuclastinib this year. The results from the APEX trial demonstrate the clear benefit that a highly selective, highly potent KIT mutant inhibitor is capable of providing to patients with AdvSM,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “Coupling rapid, deep, durable responses with the safety and tolerability profile demonstrated by bezuclastinib provides these patients with a new choice to fight their disease without compromising their quality of life. With positive results from APEX, taken together with data from SUMMIT and PEAK, Cogent is preparing for multiple commercial launches in the second half of 2026.” In Part 2 of the APEX trial, 81 AdvSM patients were treated with 150 mg of bezuclastinib, including 57 pat...

-- Bezuclastinib achieves clear clinical benefit across all symptom domains including significant improvements on 11 individual symptoms plus the most severe symptom at baseline -- -- Bezuclastinib demonstrates that reducing objective measures of disease, including serum tryptase, correlates with improvement in symptom severity; the first time this has been shown in NonAdvSM patients -- -- New 48-week data demonstrate a clear, continued deepening of symptomatic improvement over time -- -- Bezuclastinib demonstrated a favorable safety and tolerability profile supporting chronic use -- -- Granted Breakthrough Therapy Designation for bezuclastinib in October 2025; New Drug Application (NDA) on track for submission in December 2025 -- -- Cogent to host investor conference call and webcast on Monday, December 8, at 8:00 a.m. ET -- WALTHAM, Mass. and BOULDER, Colo., Dec. 06, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (NASDAQ: COGT) today announced complete results from the registration-directed Part 2 of the SUMMIT clinical trial of bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM). As previously reported, bezuclastinib demonstrated clinically meaningful and highly statistically significant improvements across the primary and all key secondary endpoints. New results further highlight the benefit of bezuclastinib on patient-reported symptoms and objective measures of mast cell burden and demonstrate significant correlation between improvement in disease pathology and patient-reported symptom severity. “We are excited to present additional data from the SUMMIT trial that support our conviction that bezuclastinib will be the best-in-class treatment option for patients with nonadvanced systemic mastocytosis,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “We remain on track to submit our first New Drug Application for bezuclastinib in NonAdvSM with the FDA this month and are encouraged by the increased interest in our Expanded Access Program.” “Nonadvanced systemic mastocytosis patients currently have very limited treatment options, and the benefit bezuclastinib demonstrated in the SUMMIT trial across measures of disease pathology and symptomatic improvement is very exciting for this patient population,” said Lindsay Rein, MD, Associate Professor of Medicine in the Division of Hematologic Malignancies and Cellula...

Cogent Biosciences (COGT) is attracting fresh attention after announcing positive Phase 3 PEAK trial data for its lead therapy, bezuclastinib combined with sunitinib, in patients with gastrointestinal stromal tumors resistant to imatinib. See our latest analysis for Cogent Biosciences. Cogent Biosciences’ strong momentum over the past month has caught the market’s eye, with a staggering 154.7% one-month share price return following positive Phase 3 data and another clinical conference appearance. This has helped fuel an exceptional year-to-date share price return of 394%, while its total shareholder return over the past year stands at 319%. Recent milestones are clearly building optimism for the future. If innovative biotech stories like Cogent’s spark your interest, you’ll want to check out the latest names gaining traction through our See the full list for free. With the stock up nearly 400% this year and analysts lifting price targets, investors now face a pivotal question: is Cogent Biosciences still undervalued, or is the market already pricing in future growth? With a current Price-to-Book Ratio of 30.1x, Cogent Biosciences is trading at a far higher valuation than both its industry and peer averages, suggesting the recent rally has pushed valuation beyond typical levels seen in biotech. The price-to-book ratio measures how much investors are willing to pay for each dollar of book value. It is often used to benchmark early-stage or pre-revenue biotech stocks with little or no earnings. For a company in Cogent’s situation, which is currently unprofitable with no meaningful revenue, this ratio is often a proxy for growth optimism and confidence in the pipeline. At 30.1x, Cogent’s price-to-book is not only 12 times the US biotech industry average of 2.6x, but also more than triple its peer group average of 8.8x. This premium implies the market sees transformative potential in its upcoming therapies. However, it also signals much of that future promise is already built into the current price. See what the numbers say about this price — find out in our valuation breakdown. Result: Price-to-Book Ratio of 30.1x (OVERVALUED) However, continued lack of revenue and ongoing net losses could limit future upside if pipeline milestones take longer than expected to materialize. Find out about the key risks to this Cogent Biosciences narrative. For those who want to e...

Phase 3 PEAK results in 2nd-line GIST patients expected in November; pivotal APEX results in AdvSM patients expected in December Breakthrough Therapy Designation granted for bezuclastinib; New Drug Application (NDA) filing for NonAdvSM remains on track for year-end 2025 Multiple bezuclastinib abstracts selected for presentation at the 67th Annual Meeting of the American Society of Hematology (ASH); SUMMIT data in NonAdvSM selected for two oral presentations Plan to showcase novel JAK2 V617F mutant-selective candidate at ASH 2025 Strong pro forma cash position of $430 million expected to fund operations through anticipated launch of bezuclastinib and into 2027 WALTHAM, Mass. and BOULDER, Colo., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today reported recent business highlights and financial results for the third quarter ended September 30, 2025. “Cogent had a very productive and busy third quarter and we now find ourselves weeks away from reporting top-line results from our Phase 3 PEAK trial of bezuclastinib plus sunitinib in Gastrointestinal Stromal Tumor (GIST) patients and our registration-directed APEX trial in Advanced Systemic Mastocytosis (AdvSM) patients. In addition, we are pleased to announce we will have three bezuclastinib presentations at ASH 2025, including two oral presentations focused on the results from the SUMMIT trial in NonAdvanced Systemic Mastocytosis (NonAdvSM) patients,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “On top of this progress, we recently presented updated preclinical data from our research pipeline that demonstrated potential best-in-class attributes of our pan-KRAS inhibitor and plan to describe for the first time at ASH 2025 our highly potent, highly selective JAK2 V617F mutant-selective inhibitor. Both of these programs are on track for IND in 2026. Our continued financial discipline and business execution position us well as we head into pivotal data readouts and prepare for our first NDA filing for NonAdvSM later this year.” Recent Business Highlights Announced alignment with the U.S. Food and Drug Administration (FDA) on the SUMMIT New Drug Application (NDA) submission plan for broad NonAdvSM patient population following a productive pre-NDA meeting, as well...

Reported positive top-line results from SUMMIT evaluating bezuclastinib in patients with NonAdvanced Systemic Mastocytosis, achieving statistical significance across all primary and key secondary endpoints On track to share pivotal trial results from PEAK in GIST and APEX in AdvSM in 2H 2025 $453 million in pro-forma cash sufficient to fund operations through anticipated launch and into 2027; includes proceeds from upsized $230 million public offering in July 2025 WALTHAM, Mass. and BOULDER, Colo., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today reported financial results for the second quarter ended June 30, 2025. “We were thrilled to announce bezuclastinib’s impressive performance in the SUMMIT trial, demonstrating clinically meaningful and statistically significant results across all primary and key secondary endpoints,” said Andrew Robbins, the Company’s President and Chief Executive Officer. “These positive data along with the favorable safety profile give us confidence that bezuclastinib has the potential to become the new standard-of-care for NonAdvSM patients. Supported by our recent upsized public offering, Cogent is advancing our mission from a position of strength as we prepare to report top-line results from two additional pivotal trials in GIST and AdvSM in the second half of this year, submit our first New Drug Application by the end of 2025 and make continued progress toward the anticipated commercial launch of bezuclastinib in 2026.” Recent Business Highlights Announced positive top-line results from the registration-directed Part 2 of the SUMMIT clinical trial in NonAdvanced Systemic Mastocytosis (NonAdvSM) patients. The SUMMIT trial, which was designed to assess the clinical benefit of bezuclastinib versus placebo, achieved its primary endpoint with a highly statistically significant difference in the mean change in Total Symptom Score (TSS) at 24 weeks (p=0.0002). TSS was assessed by the Mastocytosis Symptom Severity Daily Diary (MS2D2). The bezuclastinib arm had a mean reduction of 24.3 points in TSS at 24 weeks, versus the placebo arm which had a mean reduction of 15.4 points in TSS, resulting in a placebo-adjusted TSS improvement of 8.91 points. In addition, the SUMMIT trial demonstrated highly statistical...

-- Patients treated with bezuclastinib showed a superior mean change in total symptom score at 24 weeks (-24.3 points vs. -15.4 points, -8.91 point placebo-adjusted difference; p=0.0002), compared to patients treated with placebo, establishing new benchmarks for placebo-adjusted and absolute symptomatic improvement for this patient population -- -- Bezuclastinib demonstrated a powerful effect on mast cell burden, with 87.4% of patients treated with bezuclastinib achieving at least 50% reduction in serum tryptase compared to 0% of patients treated with placebo -- -- Bezuclastinib demonstrated a favorable safety and tolerability profile supporting chronic use in this patient population -- -- Bezuclastinib NDA submission to FDA expected by end of 2025; strong financial position with $237 million current cash balance and access up to an additional $350 million via recently announced debt facility with SLR Capital Partners -- -- On track to share pivotal trial results from PEAK in GIST and APEX in AdvSM in 2H 2025 -- -- Cogent to host investor conference call and webcast today at 8:00 a.m. ET -- WALTHAM, Mass. and BOULDER, Colo., July 07, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (NASDAQ: COGT) today announced positive top-line results from the registration-directed Part 2 of the SUMMIT clinical trial of bezuclastinib in patients with non-advanced systemic mastocytosis (NonAdvSM) demonstrating clinically meaningful and highly statistically significant improvements across the primary and all key secondary endpoints, including patient-reported symptoms and objective measures of mast cell burden. Based on these data, Cogent is on track to submit its first new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in NonAdvSM by the end of 2025. In addition, Cogent plans to present detailed results from the SUMMIT trial at an upcoming medical meeting later this year. “We have been eagerly awaiting this day and are thrilled to announce bezuclastinib’s performance in the SUMMIT trial, demonstrating clinically meaningful and statistically significant results across all trial endpoints,” said Andrew Robbins, Cogent’s President and CEO. “Our team is already at work on our first New Drug Application for bezuclastinib that we expect to file with the FDA later this year. We are committed to providing bezuclastinib access to the thousa...

Three Registration-Directed Top-line Data Readouts Remain on Track in 2025: SUMMIT in NonAdvanced SM expected in July, APEX in Advanced SM expected in second half of the-year and PEAK in GIST expected by end of year Ended 1Q 2025 with $245.7 million in cash, sufficient to fund operations into late 2026 WALTHAM, Mass. and BOULDER, Colo., May 06, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and announced financial results for the first quarter ended March 31, 2025. “The first quarter of 2025 was very productive for Cogent as our team focused on executing across our portfolio in preparation for three transformative data readouts this year. We look forward to reporting top-line results from our registration-directed SUMMIT trial with bezuclastinib in patients with nonadvanced systemic mastocytosis in July, followed later in the year with top-line results from our APEX and PEAK trials,” said Andrew Robbins, the Company’s President and Chief Executive Officer. “While we are preparing for a potential launch of bezuclastinib in 2026, we are also very proud of the progress we have made with our early-stage pipeline, including presentations from four distinct programs recently at the annual AACR conference.” Recent Business Highlights Announced expanded clinical results from the Open Label Extension (OLE) portion of the Company’s ongoing SUMMIT trial evaluating bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM) at the 2025 American Academy of Allergy Asthma & Immunology Annual Meeting (AAAAI) meeting. Bezuclastinib showed a 65% mean improvement in Total Symptom Score (TSS) at 48 weeks, including 88% of patients achieving at least a 50% reduction in TSS. The safety profile for bezuclastinib remains favorable, with adverse events reported primarily as low-grade and reversible. No treatment-related bleeding or cognitive impairment was observed. The most common treatment-related adverse events were hair discoloration and transient elevations in liver transaminases. All cases of elevated transaminases were asymptomatic and fully reversible. Presented updated preclinical data from the company’s KRAS, PI3Kα, FGFR2/3 and ErbB2 candidates at the American Association of Cancer Research (AACR) annual me...