Readystate Asset Management LP Takes $714,000 Position in Cogent Biosciences, Inc. $COGT
Readystate Asset Management LP has established a new position in Cogent Biosciences (NASDAQ:COGT), purchasing 49,692 shares valued at approximately $714,000 in the third quarter. While institutional investors like Vanguard have significantly increased their stakes, company insiders have recently been sellers, netting over $136 million in sales over the last 90 days. Analysts maintain a "Moderate Buy" rating for COGT with an average target price of $40.58, despite recent earnings missing consensus estimates.
Assessing Cogent Biosciences (COGT) Valuation After Bezuclastinib NDA Filings Earnings Update And New Shelf Registration
Cogent Biosciences (COGT) is facing valuation scrutiny despite strong past performance, driven by its lead drug candidate bezuclastinib's regulatory filings and recent earnings. The company trades at a high Price-to-Book (P/B) ratio of 29.4x, significantly above its peers and the industry average, largely due to investor focus on its pipeline potential given its zero revenue and loss-making status. While there's upside potential, the high valuation also highlights risks associated with its net loss and the binary nature of clinical trial outcomes.
Piper Sandler raises Cogent stock price target on drug launch outlook
Piper Sandler has increased its price target for Cogent Biosciences (NASDAQ:COGT) to $52 from $39, maintaining an Overweight rating, due to the company's progress towards regulatory approvals and commercial readiness for its drug bezuclastinib. Cogent plans multiple New Drug Applications in 2026 for various indications, backed by positive pivotal data. Other firms like H.C. Wainwright, Raymond James, and UBS also hold positive ratings, forecasting significant market potential for Cogent's pipeline.
Cogent Biosciences (COGT) Reports Strong Cash Position by Year-E
Cogent Biosciences (COGT) reported a strong cash position of $900.8 million by the end of 2025, despite significant non-recurring expenses for debt repayment and equity compensation. The biotechnology company focuses on developing precision therapies for genetically defined diseases and maintains a solid balance sheet with high institutional ownership. Investors are advised to consider the inherent financial and operational risks within the biotechnology sector.
Cogent Biosciences, Inc. (NASDAQ:COGT) Receives Average Recommendation of "Moderate Buy" from Analysts
MarketBeat reports that Cogent Biosciences (NASDAQ:COGT) has received a consensus "Moderate Buy" rating from fifteen brokerages, with an average 12-month price target of $39.55. Despite this positive analyst outlook, company insiders have been significant sellers, offloading over 3.7 million shares totaling $136.6 million in the last three months, and the company also missed its quarterly EPS expectations.
Cogent Biosciences Stock Soars 346% in a Year, but One Fund Just Sold Off $4.5 Million
Rock Springs Capital Management sold 159,278 shares of Cogent Biosciences, an estimated $4.48 million trade, though the fund's overall stake value in the company increased by $15.68 million due to price appreciation. Despite the partial sell-off, Cogent Biosciences has seen its stock price surge 346% in the past year, significantly outperforming the S&P 500, driven by progress in its lead product candidate bezuclastinib and substantial cash reserves. The transaction indicates a portfolio rebalancing rather than a loss of conviction, as the company enters 2026 with strong regulatory momentum for its precision therapies.
Cogent Biosciences Reports Recent Business Highlights and Fourth Quarter and Full Year 2025 Financial Results
Cogent Biosciences reported strong business highlights and financial results for Q4 and full-year 2025, driven by progress in their bezuclastinib program. Key milestones include NDA submissions for bezuclastinib in NonAdvSM and GIST, with an AdvSM NDA submission planned for 1H 2026. The company maintains a robust financial position with $901 million, sufficient to fund operations into 2028, and anticipates launching bezuclastinib in the second half of 2026.
Cogent Biosciences Stock Soars 346% in a Year, but One Fund Just Sold Off $4.5 Million
Rock Springs Capital Management sold 159,278 shares of Cogent Biosciences, a transaction valued at $4.48 million, despite the stock soaring 346% over the past year. The fund's remaining stake represents 1.5% of its reportable assets, indicating continued conviction. The article notes Cogent's strong pipeline momentum with NDA submissions for bezuclastinib and sufficient cash runway into 2028.
Cogent Biosciences, Inc. SEC 10-K Report
Cogent Biosciences, Inc. has released its 2025 Form 10-K report, detailing a net loss of $328.9 million and increased operating expenses, primarily due to research and development. The report highlights progress in its bezuclastinib program, which has received Breakthrough Therapy Designation and is expected to be launched commercially in 2026 pending regulatory approval. The company also outlined its strategic initiatives, future outlook, and potential risks, including its dependence on bezuclastinib's success and market competition.
Cogent Biosciences (NASDAQ:COGT) Posts Earnings Results, Misses Estimates By $0.22 EPS
Cogent Biosciences (NASDAQ:COGT) reported quarterly earnings of ($0.73) per share, missing consensus estimates by $0.22, leading to a 0.5% stock drop. Insider selling has been substantial, with over 3.7 million shares worth $136.6 million sold in the last three months, including significant sales by Jessica Sachs and John Edward Robinson, reducing their stakes by approximately 38-39%. Despite mixed analyst sentiment, the stock holds a "Moderate Buy" consensus rating with an average target price of $39.55, compared to its recent price of $36.53.
Cogent Biosciences Stock Up 346% as Fund Builds $29 Million Stake After November Phase 3 Breakthrough
First Turn Management has disclosed a new $29.28 million position in Cogent Biosciences (NASDAQ:COGT), a clinical-stage biotech company, as of February 13, 2026. This investment comes after Cogent's stock surged 346.6% over the past year, significantly outperforming the S&P 500, driven by positive Phase 3 clinical trial results for its lead drug candidate, bezuclastinib, in November. The company, which focuses on precision therapies for genetically defined diseases, now has roughly $901 million in cash and marketable securities but continues to incur high R&D costs as it pursues multiple regulatory approvals.
BRIEF-Cogent Biosciences Q4 Operating Expenses USD 99.493 Million
Cogent Biosciences reported its Q4 operating expenses, which amounted to USD 99.493 Million. This brief update on the company's financial performance was released by Refinitiv.
Cogent Biosciences announces proposed concurrent public offerings
Cogent Biosciences has announced its intention to launch concurrent public offerings of common stock and pre-funded warrants. The pricing of these offerings will be subject to market conditions.
Cogent Biosciences Announces Multiple SUMMIT Posters at the 2026 AAAAI Annual Meeting
Cogent Biosciences announced that it will present multiple posters at the 2026 American Academy of Allergy Asthma & Immunology Annual Meeting (AAAAI), highlighting results from its SUMMIT trial for bezuclastinib in NonAdvanced Systemic Mastocytosis (NonAdvSM) patients. The company recently submitted a New Drug Application for bezuclastinib in NonAdvSM to the FDA, based on positive clinical data and Breakthrough Therapy Designation. The presentations will cover expanded results, bone formation marker changes, patient experience, symptom burden improvement, correlations with objective disease measures, and subgroup analyses.
Cogent Biosciences, Inc. $COGT Shares Bought by Candriam S.C.A.
Candriam S.C.A. significantly increased its holdings in Cogent Biosciences (NASDAQ:COGT) by 123.3% in the third quarter, now owning 954,209 shares valued at approximately $13.7 million. Despite recent insider selling, analyst consensus rates COGT as a "Moderate Buy" with an average price target of $39.55, and the stock is currently trading around $37.77. Cogent Biosciences is a clinical-stage biopharmaceutical company focused on developing small-molecule therapies for solid tumors by modulating the tumor microenvironment.
Cogent Biosciences Announces Multiple SUMMIT Posters at the 2026 AAAAI Annual Meeting
Cogent Biosciences announced that it will present multiple posters at the 2026 AAAAI Annual Meeting, highlighting results from its SUMMIT trial for bezuclastinib in NonAdvanced Systemic Mastocytosis (NonAdvSM). The company previously submitted a New Drug Application for bezuclastinib in NonAdvSM, based on positive clinical data and Breakthrough Therapy Designation. The presentations will cover expanded results, bone formation marker changes, patient experience, symptom improvement correlations, and subgroup analyses.
Cogent Biosciences Announces Multiple SUMMIT Posters at the 2026 AAAAI Annual Meeting
Cogent Biosciences (Nasdaq: COGT) will present multiple posters featuring bezuclastinib results from the SUMMIT trial at the 2026 AAAAI Annual Meeting. These presentations pertain to NonAdvanced Systemic Mastocytosis (NonAdvSM) patients and follow Cogent's New Drug Application submission for bezuclastinib to the U.S. FDA in December 2025. The posters will cover expanded results, bone formation marker changes, patient experience, symptom burden improvement, and subgroup analyses.
Cogent Biosciences Announces Multiple SUMMIT Posters at the 2026 AAAAI Annual Meeting
Cogent Biosciences (Nasdaq: COGT) will present multiple posters at the 2026 AAAAI Annual Meeting, highlighting bezuclastinib results from the SUMMIT trial in NonAdvanced Systemic Mastocytosis (NonAdvSM) patients. The company previously submitted a New Drug Application for bezuclastinib in NonAdvSM to the U.S. FDA in December 2025, based on positive clinical data and its Breakthrough Therapy Designation. These presentations will cover expanded results, evaluation of bone formation marker changes, patient experience, symptom improvement, and subgroup analyses for patients with unmet needs.
New bezuclastinib data in systemic mastocytosis to debut at AAAAI
Cogent Biosciences announced it will present multiple posters detailing results from its bezuclastinib SUMMIT trial in nonadvanced systemic mastocytosis (NonAdvSM) at the 2026 AAAAI Annual Meeting. These presentations, scheduled for February 28, 2026, will cover expanded data, patient experience, and correlations with objective measures, further supporting the New Drug Application submitted in December 2025. The company also noted that bezuclastinib has Breakthrough Therapy Designation for this indication.
(COGT) as a Liquidity Pulse for Institutional Tactics
The article provides an AI-generated analysis of Cogent Biosciences Inc. (NASDAQ: COGT), highlighting weak near-term sentiment but strong long-term prospects. It outlines three institutional trading strategies (Position, Momentum Breakout, Risk Hedging) with specific entry, target, and stop-loss points. The analysis points to an exceptional 86.7:1 risk-reward setup for long-term gains.
Is FDA Breakthrough Status And Rapid Review For Bezuclastinib Reshaping The Case For Cogent Biosciences (COGT)?
The FDA has granted Breakthrough Therapy Designation to bezuclastinib plus sunitinib for previously imatinib-treated GIST, a decision that could accelerate its path to market. This regulatory interest, combined with the Real-Time Oncology Review program, significantly impacts Cogent Biosciences' investment narrative, especially given the company currently generates no revenue. Investors are now closely watching upcoming NDA filings and trial data, with the potential for both rapid upside and significant risk depending on regulatory outcomes and market sentiment.
Federated Hermes Inc. Purchases 93,223 Shares of Cogent Biosciences, Inc. $COGT
Federated Hermes Inc. significantly increased its stake in Cogent Biosciences, Inc. by purchasing 93,223 shares in the third quarter, bringing its total ownership to 93,225 shares. Despite recent insider selling totaling approximately $136.6 million, analysts maintain a "Moderate Buy" consensus with a price target of $39.55 for the company, which has a market cap of $5.08 billion. Cogent Biosciences, a clinical-stage biopharmaceutical company, focuses on developing small-molecule therapies targeting the tumor microenvironment.
Is FDA Breakthrough Status And Rapid Review For Bezuclastinib Reshaping The Case For Cogent Biosciences (COGT)?
Cogent Biosciences received FDA Breakthrough Therapy Designation and Real-Time Oncology Review for bezuclastinib plus sunitinib for previously imatinib-treated GIST, based on positive PEAK trial data. This dual recognition significantly enhances the investment narrative for COGT, highlighting regulatory interest and potential fast-tracking for a drug critical to its future revenue generation. While the stock has seen a sharp re-rating, investors must consider the execution risks and potential dilutions associated with a company still generating no revenue.
Optimize Financial Inc Buys New Position in Cogent Biosciences, Inc. $COGT
Optimize Financial Inc initiated a new stake in Cogent Biosciences (NASDAQ:COGT) during the third quarter, acquiring 32,552 shares valued at approximately $467,000. Other institutions like Principal Financial Group and Federated Hermes also increased their holdings. Despite significant insider selling totaling over $136 million in the last quarter, analysts maintain a "Moderate Buy" consensus rating with a target price of $39.55 for Cogent Biosciences.
Assessing Cogent Biosciences (COGT) Valuation After FDA Breakthrough Therapy And Real Time Oncology Review News
Cogent Biosciences (COGT) recently received two FDA milestones, Breakthrough Therapy Designation and Real-Time Oncology Review, for its lead cancer therapy, leading to significant stock momentum with a 303.03% total shareholder return over the past year. Despite this, the company's Price-to-Book ratio of 29.2x is considerably higher than industry averages, suggesting it may be overvalued given its current losses and pre-profitability stage, though forecasts anticipate profitability within three years. Investors are paying a substantial premium for its growth profile and pipeline potential, which remains contingent on successful trial outcomes and further FDA decisions.
Cogent Biosciences (COGT) Advances Bezuclastinib-Sunitinib Combination With Breakthrough Therapy Designation (BTD)
Cogent Biosciences (COGT) received Breakthrough Therapy Designation (BTD) from the FDA for its bezuclastinib-sunitinib combination to treat Gastrointestinal Stromal Tumors (GIST). This designation followed positive PEAK trial results showing a 50% reduction in disease progression risk and improved progression-free survival. The FDA is also accelerating its New Drug Application review for the treatment through its Real-Time Oncology Review program.
Cogent Biosciences (COGT) Advances Bezuclastinib-Sunitinib Combination With Breakthrough Therapy Designation (BTD)
Cogent Biosciences, Inc. received Breakthrough Therapy Designation (BTD) from the FDA for its bezuclastinib-sunitinib combination to treat Gastrointestinal Stromal Tumors (GIST) in patients previously treated with imatinib. This designation follows promising results from the PEAK trial, showing a 50% reduction in disease progression risk and improved progression-free survival. The FDA has also accepted Cogent Biosciences' New Drug Application for accelerated review.
Cogent Biosciences (NASDAQ:COGT) Cut to Sell at Wall Street Zen
Wall Street Zen downgraded Cogent Biosciences (NASDAQ:COGT) from a "hold" to a "sell" rating, despite a mixed-to-positive broker consensus of "Moderate Buy" and a target price of $39.55. The downgrade follows significant insider selling totaling $136.6 million over the past 90 days, with two insiders selling shares worth millions in late December. Cogent Biosciences, a clinical-stage biopharmaceutical company, reported negative earnings and has a market capitalization of $5.11 billion, though its lead CSF1R inhibitor is in early clinical trials.
Strs Ohio Has $596,000 Position in Cogent Biosciences, Inc. $COGT
Strs Ohio significantly increased its stake in Cogent Biosciences, Inc. (NASDAQ:COGT) by 591.7% in the third quarter, bringing its total holdings to $596,000. Other institutional investors also made substantial moves in COGT stock. The article also details recent analyst ratings, with a consensus "Moderate Buy," and insider selling activities, highlighting key financial metrics for the company.
Fairmount Funds Management LLC Increases Stake in Cogent Bioscie
Fairmount Funds Management LLC has increased its stake in Cogent Biosciences Inc by adding 384,500 shares, bringing its total holdings to 16,261,918 shares. This transaction, executed at $39.52 per share, reflects Fairmount's strong confidence in the biotechnology company, which specializes in precision therapies for genetically defined diseases. Despite Cogent Biosciences' current financial challenges and low GF Score, Fairmount Funds Management LLC sees potential for future growth through its innovative approach.
Why Is Pfizer Stock Rising Tuesday?
Pfizer (NYSE: PFE) stock is rising on Tuesday after Cantor Fitzgerald increased its price forecast for the company from $24 to $27. This positive analyst action comes amidst the broader healthcare sector's decline and follows several recent developments for Pfizer, including a licensing agreement with Novavax and a Breakthrough Therapy Designation for a combination therapy involving one of its drugs. Investors are also anticipating Pfizer's upcoming earnings report on February 3rd.
Cogent Biosciences Gains Breakthrough Therapy Designation For Bezuclastinib Combination In GIST
Cogent Biosciences Inc. (COGT) has received Breakthrough Therapy Designation from the U.S. FDA for its drug Bezuclastinib when used in combination with Sunitinib for patients suffering from Gastrointestinal Stromal Tumors (GIST) who have previously been treated with Imatinib. This designation is based on strong phase 3 PEAK trial data showing a significant improvement in progression-free survival. The company plans to submit the New Drug Application (NDA) in April 2026 and expects a commercial launch in the latter half of 2026, pending FDA approval.
Cogent Biosciences announcse U.S. BTD for bezuclastinib
Cogent Biosciences received Breakthrough Therapy Designation (BTD) from the U.S. FDA for bezuclastinib combined with sunitinib to treat Gastrointestinal Stromal Tumors (GIST) in patients previously treated with imatinib. This designation recognizes the therapy's potential to significantly improve treatment options for imatinib-resistant GIST, a patient population that has not seen new treatments in over two decades. The company plans to collaborate further with the FDA to bring this new treatment to market.
Cogent Biosciences Gains Breakthrough Therapy Designation For Bezuclastinib Combination In GIST
Cogent Biosciences has received Breakthrough Therapy Designation from the U.S. FDA for its Bezuclastinib and Sunitinib combination in patients with Gastrointestinal Stromal Tumors (GIST) previously treated with Imatinib. This designation is supported by phase 3 PEAK trial data showing a significant improvement in progression-free survival. The company plans to submit the NDA in April 2026 and anticipates a commercial launch in the second half of 2026.
Cogent Biosciences Announces Breakthrough Therapy
Cogent Biosciences has announced that the FDA granted Breakthrough Therapy Designation for bezuclastinib in combination with sunitinib for GIST patients previously treated with imatinib. This designation is based on the PEAK trial results, which showed a significant improvement in progression-free survival, reducing the risk of disease progression or death by 50% compared to current standard care. The company plans to complete the New Drug Application (NDA) submission in April 2026 under the FDA's Real-Time Oncology Review (RTOR) program.
Cogent Biosciences stock rises after FDA grants breakthrough therapy status By Investing.com
Cogent Biosciences Inc. (NASDAQ:COGT) stock increased by 3.4% after the FDA granted Breakthrough Therapy Designation for its bezuclastinib treatment combined with sunitinib for Gastrointestinal Stromal Tumors. This designation, based on positive results from the PEAK trial showing a 50% reduction in disease progression or death risk, aims to expedite the review process. The company expects to complete its New Drug Application submission by April 2026 and plans to initiate a Phase 2 trial for first-line GIST patients in mid-2026.
Cogent's New Stomach Cancer Treatment Cuts Progression Risk In Half, Gets Breakthrough Therapy Tag
Cogent Biosciences' bezuclastinib, combined with sunitinib, has received Breakthrough Therapy Designation from the FDA for Gastrointestinal Stromal Tumors (GIST), cutting the risk of disease progression or death by 50%. This designation was granted based on strong results from the PEAK trial, which showed a significant improvement in progression-free survival. Cogent plans to complete the New Drug Application submission in April 2026 and initiate a Phase 2 trial for first-line GIST patients.
New GIST combo cuts progression risk by 50% in Cogent trial
Cogent Biosciences announced that the FDA granted Breakthrough Therapy Designation for bezuclastinib in combination with sunitinib for patients with imatinib-resistant Gastrointestinal Stromal Tumors (GIST). This designation is based on PEAK trial results showing a 50% reduction in the risk of progression or death and a median Progression-Free Survival (PFS) of 16.5 months, significantly better than sunitinib monotherapy. The company is on track to complete its PEAK NDA submission under RTOR in April 2026 and plans further data presentations and a Phase 2 trial for first-line exon 9 GIST.
Cogent Biosciences Announces Breakthrough Therapy Designation for Bezuclastinib in Combination with Sunitinib for Patients with Gastrointestinal Stromal Tumors (GIST)
Cogent Biosciences has received Breakthrough Therapy Designation (BTD) from the U.S. FDA for bezuclastinib in combination with sunitinib for GIST patients previously treated with imatinib. This designation follows positive results from the PEAK trial, which demonstrated a significant improvement in progression-free survival and a 50% reduction in risk of disease progression or death compared to standard care. The company plans to submit its New Drug Application (NDA) in April 2026 under the FDA’s Real-Time Oncology Review (RTOR) program, aiming to accelerate the availability of this new treatment option.
Cogent Biosciences, Inc. (NASDAQ:COGT) Given Average Recommendation of "Moderate Buy" by Brokerages
Brokerages have given Cogent Biosciences (NASDAQ:COGT) an average recommendation of "Moderate Buy" based on ratings from fifteen firms, with an average one-year target price of $39.55. Despite insider selling activity, the company, a clinical-stage biopharmaceutical firm focusing on small-molecule therapies, reported a quarterly EPS that exceeded estimates. Several analysts have recently updated their ratings and price targets for COGT.
Real-Time FDA Review Of Bezuclastinib Combo In GIST Might Change The Case For Investing In Cogent Biosciences (COGT)
Cogent Biosciences announced that the FDA agreed to review its New Drug Application for bezuclastinib plus sunitinib for Gastrointestinal Stromal Tumor (GIST) under the Real-Time Oncology Review program, a significant development as the combination could be the first new treatment option in this GIST setting in over two decades. This accelerated review tightens timelines for a key opportunity, potentially expediting revenue but also increasing execution risk. Investors must consider this against Cogent's existing challenges, including substantial losses and past dilution, especially given the stock's sharp rise over the past year.
Cogent Biosciences, Inc. (COGT) Stock Analysis: A 28% Upside Potential in the Biotech Sector
Cogent Biosciences (COGT) is a Waltham, Massachusetts-based biotechnology company focusing on precision therapies for genetically defined diseases. Analysts project a 28.17% upside potential for the stock, with an average target price of $50.67. Despite the company not yet being profitable, its lead product, bezuclastinib, is in Phase 3 trials, and positive analyst sentiment suggests strong confidence in its growth trajectory.
Real-Time FDA Review Of Bezuclastinib Combo In GIST Might Change The Case For Investing In Cogent Biosciences (COGT)
Cogent Biosciences announced that the FDA would review its New Drug Application for bezuclastinib plus sunitinib in GIST under the Real-Time Oncology Review program, a significant development for the company. This accelerated review, supported by positive Phase 3 data, could potentially bring the first new GIST treatment in over two decades to market sooner, impacting Cogent's path to revenue but also increasing execution risks. Investors need to consider this alongside the company's financial burn rate and past dilution, especially given the recent sharp rise in share price.
Emerald Mutual Fund Advisers Trust Grows Position in Cogent Biosciences, Inc. $COGT
Emerald Mutual Fund Advisers Trust increased its stake in Cogent Biosciences (NASDAQ:COGT) by 14.2% in the third quarter of 2025, now owning 1,022,858 shares valued at $14.69 million. Despite significant insider selling totaling over $136 million in the last 90 days, analysts have become more bullish, with several firms raising price targets and the stock holding a "Moderate Buy" consensus rating with an average target of $39.55. Cogent Biosciences reported earnings of ($0.50) per share for the last quarter, beating analyst estimates.
Emerald Advisers LLC Increases Stock Position in Cogent Biosciences, Inc. $COGT
Emerald Advisers LLC significantly increased its stake in Cogent Biosciences during Q3, buying an additional 133,722 shares to own 1.39% of the company. Despite insider selling, analysts maintain a "Moderate Buy" rating with a consensus price target of $39.55, indicating positive sentiment for the stock. Cogent Biosciences, a clinical-stage biopharmaceutical company, focuses on developing therapies for the tumor microenvironment.
Cogent Biosciences (NASDAQ:COGT) Earns Outperform Rating from Wedbush
Wedbush has reissued an "outperform" rating for Cogent Biosciences (NASDAQ:COGT) with a $55 price target, suggesting a 36.6% upside. The company also holds a "Moderate Buy" consensus rating from analysts with an average price target of $39.55. Despite positive analyst sentiment, company insiders have recently sold a significant amount of stock, totaling approximately $9.2 million.
Wedbush Reiterates "Outperform" Rating for Cogent Biosciences (C
Wedbush has reiterated its "Outperform" rating for Cogent Biosciences (COGT) with a price target of $55.00, reflecting continued confidence in the company's market potential. This rating aligns with other positive sentiments from analysts like HC Wainwright & Co. and JP Morgan, which have also recently raised price targets for COGT. Cogent Biosciences, a biotechnology company, focuses on developing precision therapies for genetically defined diseases, with its program CGT9486 targeting conditions like Systemic Mastocytosis.
A Look At Cogent Biosciences (COGT) Valuation After FDA Accepts Bezuclastinib NDA Under RTOR Program
Cogent Biosciences (COGT) stock is under scrutiny following FDA acceptance of its New Drug Application for bezuclastinib plus sunitinib under the Real Time Oncology Review program, which has led to significant share price increases. Despite strong market momentum and analyst targets, the company's valuation with a P/B ratio of 31.2x appears very high compared to industry peers, largely reflecting future pipeline expectations rather than current fundamentals for the pre-revenue biotech firm. Key considerations for investors include clinical and regulatory risks, the company's net loss, and lack of current revenue.
Cancer drug combo cuts GIST progression risk by 50% in key trial
Cogent Biosciences announced that the FDA has agreed to accept its New Drug Application (NDA) for bezuclastinib in combination with sunitinib for imatinib-resistant Gastrointestinal Stromal Tumors (GIST) under the Real-Time Oncology Review (RTOR) program. The Phase 3 PEAK trial demonstrated a 50% reduction in the risk of progression or death, with a median Progression-Free Survival (mPFS) of 16.5 months compared to 9.2 months for sunitinib monotherapy. The company expects to complete the NDA submission in April 2026, with full PEAK results to be presented in H1 2026.
Cogent Biosciences to Initiate New Drug Application (NDA) Submission for Bezuclastinib Under Real-Time Oncology Review (RTOR)
Cogent Biosciences announced that the FDA has agreed to accept its New Drug Application (NDA) for bezuclastinib in combination with sunitinib for GIST patients under the Real-Time Oncology Review (RTOR) program. This decision follows positive results from the PEAK trial, which demonstrated significant clinical benefit and an unprecedented overall response rate for the bezuclastinib combination in imatinib-resistant GIST patients. Cogent is expected to initiate the RTOR process immediately, with full NDA submission anticipated in April 2026.
