Senti Biosciences Receives RMAT Designation from FDA
Senti Biosciences announced that the U.S. Food and Drug Administration, FDA, has granted Regenerative Medicine Advanced Therapy, RMAT, designation to SENTI-202, the Company's potential first-in-class Logic Gated off-the-shelf chimeric antigen receptor natural killer, CAR-NK, investigational cell therapy, that is currently in development for the treatment of relapsed/refractory hematologic malignancies, including AML. "This significant FDA designation validates both the tremendous need for better treatments for R/R AML and the promise of SENTI-202 to transform the therapeutic landscape for this notoriously aggressive cancer," Timothy Lu, MD, PhD, Co-Founder and CEO of Senti Biosciences. "We are incredibly pleased with the exciting clinical progress we recently shared at the ASH conference on SENTI-202."
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Senti Bio's SENTI-202 Clinical Data Shows Promising Results
- Clinical Trial Milestone: Senti Bio announced the completion of enrollment in its Phase 1 clinical trial for SENTI-202, marking a significant advancement in treating relapsed or refractory acute myeloid leukemia (R/R AML), which is expected to lay the groundwork for subsequent pivotal registration studies.
- Positive Clinical Data: At the American Society of Hematology (ASH) Annual Meeting, SENTI-202 demonstrated deep, MRD-negative, durable complete remissions with a favorable safety profile in heavily pretreated R/R AML patients, potentially boosting market confidence in this therapy.
- FDA Discussion Preparation: The company plans to engage with the FDA in the first half of 2026 to discuss the pivotal registration program for SENTI-202 in R/R AML and the evaluation of additional indications, including newly diagnosed AML and pediatric AML, indicating the company's focus on future market opportunities.
- RMAT Designation Advantage: SENTI-202 has received Regenerative Medicine Advanced Therapy (RMAT) designation, which may expedite its development and review process, thereby providing patients with faster treatment options and enhancing the company's competitive position in the market.
Senti Biosciences Grants New Employee 13,680 Stock Options at $1.31 Each
- Stock Option Grant: On December 12, 2025, Senti Bio granted stock options for a total of 13,680 shares to a new employee at an exercise price of $1.31 per share, aimed at attracting and retaining talent to enhance the company's competitive edge in the biotechnology sector.
- Incentive Plan Context: This stock option grant was made under the Amended and Restated 2022 Inducement Equity Plan adopted by the company on August 5, 2022, in compliance with NASDAQ Listing Rule 5635(c)(4), reflecting the company's commitment to talent acquisition.
- Biotechnology Development: Senti Bio focuses on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, aiming to provide innovative treatment options for patients with incurable diseases, thereby advancing the company's technological progress in biomedicine.
- Market Potential: By engineering Gene Circuits, Senti Bio's therapies can precisely kill cancer cells while sparing healthy ones, indicating broad application potential in oncology and other diseases, which may lead to long-term market growth opportunities for the company.
Senti Biosciences Grants New Employee 13,680 Stock Options at $1.31 Each
- Employee Incentive Program: On December 12, 2025, Senti Bio granted stock options for 13,680 shares to a new employee at an exercise price of $1.31 per share, aimed at attracting and retaining talent, thereby enhancing the company's competitive edge.
- Plan Background: This grant was made under the Amended and Restated 2022 Inducement Equity Plan adopted on August 5, 2022, in compliance with NASDAQ Listing Rule 5635(c)(4), demonstrating the company's commitment to talent acquisition.
- Biotechnology Development: Senti Bio focuses on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, aiming to provide innovative treatment options for patients with incurable diseases, thus positioning the company at the forefront of biotechnology.
- Market Potential: By engineering Gene Circuits, Senti Bio's therapies have shown potential in preclinical stages for tumor treatment, with future prospects for expansion into other disease areas, further enhancing the company's market value and investment appeal.
Post-Market Surge: Stoke Therapeutics, Alpha Tau Medical, and Compass Pathways Top Biotech Gainers
Biotech Stock Movements: Biotech stocks experienced significant fluctuations in after-hours trading, with several companies rebounding after losses during regular trading hours, driven by clinical data, FDA designations, and financing news.
Stoke Therapeutics Surge: Stoke Therapeutics saw its stock rise to $33.95 (+11.42%) after presenting positive data on zorevunersen for Dravet syndrome in collaboration with Biogen at a recent conference.
Alpha Tau Medical Gains: Alpha Tau Medical's shares surged by 25.26% to $5.30 after announcing the treatment of its first patient in a pilot study for recurrent glioblastoma multiforme using its Alpha DaRT technology.
FDA Designation for Senti Biosciences: Senti Biosciences' stock increased to $1.60 (+3.92%) following the FDA granting RMAT designation to its investigational CAR-NK cell therapy for acute myeloid leukemia and other hematologic malignancies.
What’s Causing the Decline in Senti Bio Stock Focused on Gene Therapy Today?
Senti Biosciences Trial Update: Senti Biosciences presented new data from its trial of SENTI-202, a CAR NK cell therapy for relapsed or refractory Acute Myeloid Leukemia, showing a 50% overall response rate and significant complete remission rates among patients.
FDA Designation: The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to SENTI-202, highlighting its potential in treating a heavily pretreated patient population.
Safety and Efficacy: SENTI-202 demonstrated a favorable safety profile with no serious adverse events or dose-limiting toxicities, and pharmacodynamic data supported its mechanism of action in selectively targeting leukemia cells.
Market Reaction: Despite the promising trial results, Senti Biosciences shares fell by 16.73% to $1.99 following the announcement, indicating investor concerns or market volatility.
Senti Biosciences Obtains FDA RMAT Designation for SENTI-202
FDA Designation: Senti Biosciences has received Regenerative Medicine Advanced Therapy designation from the FDA for its CAR-NK therapy, SENTI-202, aimed at treating relapsed or refractory AML and other hematologic cancers.
Phase 1 Data: New Phase 1 data indicates that SENTI-202 can effectively target leukemic cells while preserving healthy stem cells, supporting its therapeutic potential.
Upcoming Presentation: The company will present updated data on SENTI-202 at the 2025 ASH Annual Meeting and has scheduled an investor webcast for December 9.
Stock Performance: Senti Biosciences' stock (SNTI) is currently trading at $2.6083, reflecting a 9.13% increase on the Nasdaq.
Senti Bio's SENTI-202 Clinical Data Shows Promising Results
- Clinical Trial Milestone: Senti Bio announced the completion of enrollment in its Phase 1 clinical trial for SENTI-202, marking a significant advancement in treating relapsed or refractory acute myeloid leukemia (R/R AML), which is expected to lay the groundwork for subsequent pivotal registration studies.
- Positive Clinical Data: At the American Society of Hematology (ASH) Annual Meeting, SENTI-202 demonstrated deep, MRD-negative, durable complete remissions with a favorable safety profile in heavily pretreated R/R AML patients, potentially boosting market confidence in this therapy.
- FDA Discussion Preparation: The company plans to engage with the FDA in the first half of 2026 to discuss the pivotal registration program for SENTI-202 in R/R AML and the evaluation of additional indications, including newly diagnosed AML and pediatric AML, indicating the company's focus on future market opportunities.
- RMAT Designation Advantage: SENTI-202 has received Regenerative Medicine Advanced Therapy (RMAT) designation, which may expedite its development and review process, thereby providing patients with faster treatment options and enhancing the company's competitive position in the market.
Senti Biosciences Grants New Employee 13,680 Stock Options at $1.31 Each
- Stock Option Grant: On December 12, 2025, Senti Bio granted stock options for a total of 13,680 shares to a new employee at an exercise price of $1.31 per share, aimed at attracting and retaining talent to enhance the company's competitive edge in the biotechnology sector.
- Incentive Plan Context: This stock option grant was made under the Amended and Restated 2022 Inducement Equity Plan adopted by the company on August 5, 2022, in compliance with NASDAQ Listing Rule 5635(c)(4), reflecting the company's commitment to talent acquisition.
- Biotechnology Development: Senti Bio focuses on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, aiming to provide innovative treatment options for patients with incurable diseases, thereby advancing the company's technological progress in biomedicine.
- Market Potential: By engineering Gene Circuits, Senti Bio's therapies can precisely kill cancer cells while sparing healthy ones, indicating broad application potential in oncology and other diseases, which may lead to long-term market growth opportunities for the company.
Senti Biosciences Grants New Employee 13,680 Stock Options at $1.31 Each
- Employee Incentive Program: On December 12, 2025, Senti Bio granted stock options for 13,680 shares to a new employee at an exercise price of $1.31 per share, aimed at attracting and retaining talent, thereby enhancing the company's competitive edge.
- Plan Background: This grant was made under the Amended and Restated 2022 Inducement Equity Plan adopted on August 5, 2022, in compliance with NASDAQ Listing Rule 5635(c)(4), demonstrating the company's commitment to talent acquisition.
- Biotechnology Development: Senti Bio focuses on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, aiming to provide innovative treatment options for patients with incurable diseases, thus positioning the company at the forefront of biotechnology.
- Market Potential: By engineering Gene Circuits, Senti Bio's therapies have shown potential in preclinical stages for tumor treatment, with future prospects for expansion into other disease areas, further enhancing the company's market value and investment appeal.
Post-Market Surge: Stoke Therapeutics, Alpha Tau Medical, and Compass Pathways Top Biotech Gainers
Biotech Stock Movements: Biotech stocks experienced significant fluctuations in after-hours trading, with several companies rebounding after losses during regular trading hours, driven by clinical data, FDA designations, and financing news.
Stoke Therapeutics Surge: Stoke Therapeutics saw its stock rise to $33.95 (+11.42%) after presenting positive data on zorevunersen for Dravet syndrome in collaboration with Biogen at a recent conference.
Alpha Tau Medical Gains: Alpha Tau Medical's shares surged by 25.26% to $5.30 after announcing the treatment of its first patient in a pilot study for recurrent glioblastoma multiforme using its Alpha DaRT technology.
FDA Designation for Senti Biosciences: Senti Biosciences' stock increased to $1.60 (+3.92%) following the FDA granting RMAT designation to its investigational CAR-NK cell therapy for acute myeloid leukemia and other hematologic malignancies.
What’s Causing the Decline in Senti Bio Stock Focused on Gene Therapy Today?
Senti Biosciences Trial Update: Senti Biosciences presented new data from its trial of SENTI-202, a CAR NK cell therapy for relapsed or refractory Acute Myeloid Leukemia, showing a 50% overall response rate and significant complete remission rates among patients.
FDA Designation: The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to SENTI-202, highlighting its potential in treating a heavily pretreated patient population.
Safety and Efficacy: SENTI-202 demonstrated a favorable safety profile with no serious adverse events or dose-limiting toxicities, and pharmacodynamic data supported its mechanism of action in selectively targeting leukemia cells.
Market Reaction: Despite the promising trial results, Senti Biosciences shares fell by 16.73% to $1.99 following the announcement, indicating investor concerns or market volatility.
Senti Biosciences Obtains FDA RMAT Designation for SENTI-202
FDA Designation: Senti Biosciences has received Regenerative Medicine Advanced Therapy designation from the FDA for its CAR-NK therapy, SENTI-202, aimed at treating relapsed or refractory AML and other hematologic cancers.
Phase 1 Data: New Phase 1 data indicates that SENTI-202 can effectively target leukemic cells while preserving healthy stem cells, supporting its therapeutic potential.
Upcoming Presentation: The company will present updated data on SENTI-202 at the 2025 ASH Annual Meeting and has scheduled an investor webcast for December 9.
Stock Performance: Senti Biosciences' stock (SNTI) is currently trading at $2.6083, reflecting a 9.13% increase on the Nasdaq.
