Syndax confirms FDA approval of Revuforj for acute leukemia
FDA Approval: Syndax Pharmaceuticals has received FDA approval for Revuforj, the first menin inhibitor for treating relapsed or refractory acute leukemia in patients aged one year and older with a specific gene translocation.
Regulatory Designations: The drug was previously granted Breakthrough Therapy, Fast Track designations, and Priority Review by the FDA, and its approval was facilitated through the Real Time Oncology Review program.
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Syndax Partners with WODA to Expand Access to Revuforj in Multiple Regions
- Global Access Program: Syndax collaborates with WODA to launch a Managed Access Program aimed at expanding access to Revuforj in regions like Eurasia, the Middle East, Latin America, and Africa, potentially benefiting thousands of patients.
- Physician Experience Accumulation: This program not only provides a pathway for patients to access Revuforj but also allows more physicians to gain firsthand experience with the drug, supporting the long-term goal of establishing Revuforj as a standard treatment globally.
- FDA Approval Context: Revuforj is FDA-approved in the U.S. for treating difficult-to-treat acute leukemia, highlighting its significance in blood cancer treatment and expected to enhance Syndax's competitiveness in the global market.
- Role of WODA: WODA will provide Revuforj in over 150 countries, ensuring compliant and patient-focused distribution, further strengthening Syndax's influence in the global drug access landscape.
Syndax Pharmaceuticals Inc. Offers 10.4% Annualized Return on $13 Put Options
- Options Selling Yield: Syndax Pharmaceuticals Inc.'s $13 put option offers a 10.4% annualized return, although the seller only acquires shares if the stock price falls by 39%, illustrating the complex relationship between risk and reward in options trading.
- Cost Basis Analysis: If the contract is exercised, the investor's cost basis would be $10.20 per share after accounting for the $2.80 premium, indicating that investors must carefully assess potential losses against current market price of $21.36.
- Volatility Consideration: With a trailing twelve-month volatility of 68% for Syndax, this provides investors a reference point for evaluating the risks of selling options, and combining this with fundamental analysis can help determine if the risk is worthwhile.
- Market Price Comparison: The current market price of $21.36 compared to the $13 strike price highlights the potential attractiveness of the options selling strategy, especially in a high volatility market, which may offer additional income opportunities for investors.
Syndax's Revuforj® Wins Best New Drug at 2025 Scrip Awards
- Best New Drug Award: Syndax Pharmaceuticals' Revuforj® was recognized as Best New Drug at the 2025 Scrip Awards, highlighting its excellence in drug development and enhancing the company's reputation in the biopharma industry.
- FDA Approval: Revuforj received FDA approval in November 2024 for treating relapsed or refractory acute leukemia, marking a significant milestone in innovative cancer therapies and is expected to drive sales growth.
- Second Indication Approval: In October 2025, Revuforj was approved by the FDA for treating relapsed acute myeloid leukemia, demonstrating its potential across multiple patient populations and likely attracting increased investor interest.
- Ongoing Clinical Trials: Revuforj is undergoing multiple clinical trials to explore its use in combination with standard therapies, which is expected to further validate its efficacy and expand market share.
Syndax's Revuforj® Wins Best New Drug at 2025 Scrip Awards
- Award Recognition: Syndax's Revuforj® was named Best New Drug at the 2025 Scrip Awards, highlighting its excellence in drug development and reinforcing the company's leadership in innovative cancer therapies.
- FDA Approval: Revuforj received FDA approval in November 2024 for treating relapsed or refractory acute leukemia, marking a significant breakthrough in treatment options and expected to greatly enhance patient care.
- Market Potential: The success of Revuforj not only boosts Syndax's reputation but also has the potential to increase its market share in acute leukemia, particularly among patients with no satisfactory alternative treatments.
- Ongoing Research: Syndax is conducting multiple clinical trials to evaluate the combination of Revuforj with standard therapies, indicating future potential for enhanced efficacy and market expansion.
JPMorgan Lowers Price Target for Syndax Pharmaceuticals (SNDX) to $33, Keeps "Overweight" Rating Intact
Syndax Pharmaceuticals Overview: Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX) is recognized as a promising small-cap biotech stock, with analysts highlighting its potential for significant upside.
Recent Financial Performance: In Q3 2025, Syndax reported a 21% revenue increase to $45.9 million, driven by strong sales of its therapies, particularly Revuforj, which gained FDA approval for a broader patient population.
Price Target Adjustment: JPMorgan adjusted its price target for Syndax from $40 to $33 while maintaining an "Overweight" rating, reflecting changes in their models for the SMID-cap biotechnology sector.
Future Projections: The company ended the quarter with $456 million in cash and projected R&D costs of $380 to $385 million for the year, indicating a solid financial position to support ongoing operations and development.
UBS Reiterates Buy Rating for Syndax Pharmaceuticals and Increases Price Target to $38
Real-time Intelligence: Benzinga Pro offers the fastest news alerts for traders to stay updated on market movements.
Exclusive Content: The platform provides exclusive stories and insights generated by Benzinga reporters for its users.
Community Engagement: Over 10,000 serious traders are part of the Benzinga Pro community, enhancing collaboration and information sharing.
Market Winning Tools: Benzinga Pro is designed to help traders gain an edge in the markets with accurate stock market intelligence.
Syndax Partners with WODA to Expand Access to Revuforj in Multiple Regions
- Global Access Program: Syndax collaborates with WODA to launch a Managed Access Program aimed at expanding access to Revuforj in regions like Eurasia, the Middle East, Latin America, and Africa, potentially benefiting thousands of patients.
- Physician Experience Accumulation: This program not only provides a pathway for patients to access Revuforj but also allows more physicians to gain firsthand experience with the drug, supporting the long-term goal of establishing Revuforj as a standard treatment globally.
- FDA Approval Context: Revuforj is FDA-approved in the U.S. for treating difficult-to-treat acute leukemia, highlighting its significance in blood cancer treatment and expected to enhance Syndax's competitiveness in the global market.
- Role of WODA: WODA will provide Revuforj in over 150 countries, ensuring compliant and patient-focused distribution, further strengthening Syndax's influence in the global drug access landscape.
Syndax Pharmaceuticals Inc. Offers 10.4% Annualized Return on $13 Put Options
- Options Selling Yield: Syndax Pharmaceuticals Inc.'s $13 put option offers a 10.4% annualized return, although the seller only acquires shares if the stock price falls by 39%, illustrating the complex relationship between risk and reward in options trading.
- Cost Basis Analysis: If the contract is exercised, the investor's cost basis would be $10.20 per share after accounting for the $2.80 premium, indicating that investors must carefully assess potential losses against current market price of $21.36.
- Volatility Consideration: With a trailing twelve-month volatility of 68% for Syndax, this provides investors a reference point for evaluating the risks of selling options, and combining this with fundamental analysis can help determine if the risk is worthwhile.
- Market Price Comparison: The current market price of $21.36 compared to the $13 strike price highlights the potential attractiveness of the options selling strategy, especially in a high volatility market, which may offer additional income opportunities for investors.
Syndax's Revuforj® Wins Best New Drug at 2025 Scrip Awards
- Best New Drug Award: Syndax Pharmaceuticals' Revuforj® was recognized as Best New Drug at the 2025 Scrip Awards, highlighting its excellence in drug development and enhancing the company's reputation in the biopharma industry.
- FDA Approval: Revuforj received FDA approval in November 2024 for treating relapsed or refractory acute leukemia, marking a significant milestone in innovative cancer therapies and is expected to drive sales growth.
- Second Indication Approval: In October 2025, Revuforj was approved by the FDA for treating relapsed acute myeloid leukemia, demonstrating its potential across multiple patient populations and likely attracting increased investor interest.
- Ongoing Clinical Trials: Revuforj is undergoing multiple clinical trials to explore its use in combination with standard therapies, which is expected to further validate its efficacy and expand market share.
Syndax's Revuforj® Wins Best New Drug at 2025 Scrip Awards
- Award Recognition: Syndax's Revuforj® was named Best New Drug at the 2025 Scrip Awards, highlighting its excellence in drug development and reinforcing the company's leadership in innovative cancer therapies.
- FDA Approval: Revuforj received FDA approval in November 2024 for treating relapsed or refractory acute leukemia, marking a significant breakthrough in treatment options and expected to greatly enhance patient care.
- Market Potential: The success of Revuforj not only boosts Syndax's reputation but also has the potential to increase its market share in acute leukemia, particularly among patients with no satisfactory alternative treatments.
- Ongoing Research: Syndax is conducting multiple clinical trials to evaluate the combination of Revuforj with standard therapies, indicating future potential for enhanced efficacy and market expansion.
JPMorgan Lowers Price Target for Syndax Pharmaceuticals (SNDX) to $33, Keeps "Overweight" Rating Intact
Syndax Pharmaceuticals Overview: Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX) is recognized as a promising small-cap biotech stock, with analysts highlighting its potential for significant upside.
Recent Financial Performance: In Q3 2025, Syndax reported a 21% revenue increase to $45.9 million, driven by strong sales of its therapies, particularly Revuforj, which gained FDA approval for a broader patient population.
Price Target Adjustment: JPMorgan adjusted its price target for Syndax from $40 to $33 while maintaining an "Overweight" rating, reflecting changes in their models for the SMID-cap biotechnology sector.
Future Projections: The company ended the quarter with $456 million in cash and projected R&D costs of $380 to $385 million for the year, indicating a solid financial position to support ongoing operations and development.
UBS Reiterates Buy Rating for Syndax Pharmaceuticals and Increases Price Target to $38
Real-time Intelligence: Benzinga Pro offers the fastest news alerts for traders to stay updated on market movements.
Exclusive Content: The platform provides exclusive stories and insights generated by Benzinga reporters for its users.
Community Engagement: Over 10,000 serious traders are part of the Benzinga Pro community, enhancing collaboration and information sharing.
Market Winning Tools: Benzinga Pro is designed to help traders gain an edge in the markets with accurate stock market intelligence.
