Cogent Submits Bezuclastinib NDA to Support 2026 Launch
"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."
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Funding Announcement: COGENT SECURITY has secured funding led by Bain Capital Ventures, indicating strong investor confidence in the company's potential.
Investor Participation: The funding round also saw participation from existing investor Greylock Partners, highlighting ongoing support from established venture capital firms.
- New Investment Disclosure: On February 13, 2026, First Turn Management disclosed the acquisition of 824,283 shares of Cogent Biosciences for $29.28 million, indicating strong confidence in the company's future prospects.
- Significant Ownership: This new position represents 3.35% of First Turn Management's reportable U.S. equity assets as of December 31, 2025, highlighting its strategic importance within the portfolio.
- Outstanding Market Performance: As of February 13, 2026, Cogent's shares were priced at $36.53, reflecting a remarkable 346.6% increase over the past year, significantly outperforming the S&P 500 by 334.8 percentage points, showcasing its robust market performance.
- Strong Financial Position: Cogent enters 2026 with approximately $901 million in cash and marketable securities, providing a runway into 2028, although it reported a net loss of $328.9 million for 2025, which is typical for late-stage biotech firms, underscoring execution risks.
- Stake Reduction Details: Rock Springs Capital Management disclosed a reduction of 159,278 shares in Cogent Biosciences during Q4 2026, with an estimated transaction value of $4.48 million, indicating that despite the reduction, confidence in the company remains intact.
- Market Performance Analysis: As of February 16, 2026, Cogent's share price stood at $36.53, reflecting a remarkable 346.6% increase over the past year, significantly outperforming the S&P 500 by 334.8 percentage points, showcasing its strong position in the biotech sector.
- Financial Overview: Cogent boasts a market capitalization of $5.82 billion, and despite a net loss of $294.37 million over the past twelve months, it holds approximately $901 million in cash and marketable securities, ensuring operational funding through 2028.
- Future Growth Potential: Cogent is advancing multiple new drug applications, including bezuclastinib for non-advanced systemic mastocytosis, with an APEX NDA submission expected in the first half of 2026, demonstrating its ongoing innovation in oncology.
- Sale Overview: On January 22, 2026, Fairmount Funds Management LLC indirectly sold 3.5 million shares of Cogent at $36.40 per share, generating approximately $127.4 million in transaction value, which represented 38.87% of its total indirect holdings, reducing its stake from 9,003,418 to 5,503,418 shares.
- Stock Surge Context: Cogent's stock skyrocketed over 342% in 2025, and this significant share sale has sparked speculation about management taking profits, although Fairmount's exact motives remain unclear; nonetheless, the over $120 million gain from this transaction is substantial.
- Holding Structure Analysis: Despite the large sale of common shares, Fairmount still holds approximately 67,414 units of Series A Convertible Preferred Stock, which could convert to about 16.85 million common shares, but due to a 9.9% ownership limit, they would need to sell some common shares first to facilitate this conversion.
- Investment Strategy and Market Performance: Fairmount Funds focuses heavily on biotech investments, with Cogent being a key part of its portfolio, showcasing potential in targeted therapies for rare diseases, and combined with its strong market performance, it may present long-term profit opportunities for investors.
- Transaction Overview: On January 22, 2026, Fairmount Funds Management LLC indirectly sold 3.5 million shares of Cogent Biosciences for approximately $127.4 million, highlighting its investment strategy in the biotech sector.
- Change in Holdings: This transaction reduced Fairmount's indirect holdings by 38.87%, leaving 5,503,418 shares, which may indicate a potential shift in confidence regarding Cogent's future prospects.
- Market Context Analysis: At the time of the sale, Cogent's shares were priced at $36.40, lower than the closing price of $39.53 that day, suggesting a cautious market sentiment that could impact investor confidence.
- Investor Implications: Although Fairmount still holds about 67,414 units of Series A Convertible Preferred Stock, which could convert to approximately 16.85 million common shares, the 9.9% ownership limit will restrict future sales, affecting liquidity management.
- Forecast Upgrade: Cantor Fitzgerald raised Pfizer's price forecast from $24 to $27, providing a positive catalyst for the pharmaceutical giant despite a 1.6% decline in the broader healthcare sector.
- Licensing Agreement: Pfizer entered a non-exclusive licensing agreement with Novavax for its Matrix-M adjuvant technology, granting Novavax a $30 million upfront payment and potential milestones up to $500 million, indicating Pfizer's proactive approach in product development.
- FDA Breakthrough Therapy: Pfizer's Sutent, in combination with Cogent Biosciences' bezuclastinib, received FDA Breakthrough Therapy Designation after showing a 50% reduction in disease progression risk, enhancing Pfizer's competitive edge in oncology treatments.
- Leadership Warning: At the World Economic Forum, CEO Albert Bourla warned that reduced funding for U.S. universities has weakened America's position in global health research, highlighting China's dominance in health research rankings.









