5 Biotech Stocks to Monitor Before Key Clinical Trial Results in September 2025
Biotech Stocks to Watch: September 2025 is crucial for several biotech companies as they prepare to release important clinical trial data that could significantly impact their stock prices.
KALA Bio Inc. (KALA): KALA is set to announce topline results from its CHASE trial of KPI-012, a treatment for persistent corneal epithelial defect, which could lead to FDA submission if results are positive.
Kairos Pharma Ltd. (KAPA): KAPA will report interim efficacy data from its Phase 2 trial of ENV-105 for advanced prostate cancer, following positive safety results from initial patients.
Other Companies: Rapport Therapeutics (RAPP) and Metsera Inc. (MTSR) are also expected to release significant trial results in September, while Cullinan Therapeutics (CGEM) will present data on Zipalertinib for lung cancer at an upcoming conference.
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Growth Prospects for the EGFR-NSCLC Market Analyzed
- Market Size Forecast: The EGFR-NSCLC market is projected to reach $6 billion by 2024, with the U.S. accounting for approximately 56% of the total market, indicating strong demand for new therapies and significant economic potential in this region.
- Rising Patient Numbers: In 2024, nearly 117,000 new cases of EGFR-NSCLC are expected, and as testing rates increase, more patients with EGFR mutations are identified, driving the demand for targeted therapies and signaling ongoing market expansion.
- Active Drug Development: Several new drugs, including Zipalertinib and Firmonertinib, are in clinical trials and are anticipated to introduce new treatment options, which not only diversify the therapeutic landscape but also have the potential to redefine existing treatment standards and improve patient survival rates.
- Evolving Competitive Landscape: The convergence of TKIs, ADCs, and gene therapies is intensifying competition in the EGFR-NSCLC market, where future winners will depend on efficacy, resistance coverage, and combination therapy potential, driving innovation and growth in the industry.
Major Stocks on the Rise Monday: Paramount Skydance, Wave Life Sciences, Ocular Therapeutix, Carvana, and More
U.S. Stock Market Performance: U.S. stocks declined, with the Dow Jones dropping over 200 points on Monday, while several companies saw significant gains in their share prices.
Paramount's Acquisition Move: Paramount Skydance Corporation's shares surged nearly 10% after announcing a $30 per share all-cash tender offer to acquire Warner Bros. Discovery, valuing the deal at $108.4 billion.
Biotech Stock Gains: Wave Life Sciences and Structure Therapeutics experienced remarkable increases of 129.1% and 100.5%, respectively, following positive clinical trial results for their obesity treatments.
Other Notable Stock Movements: Companies like Fulcrum Therapeutics and Kymera Therapeutics also saw substantial share price increases due to promising clinical trial data, while Carvana announced its inclusion in the S&P 500, boosting its stock by 11.6%.
Cullinan Therapeutics' CLN-049 Shows 31% Complete Response Rate in R/R AML Patients
- Clinical Trial Results: Among 45 patients treated with CLN-049, a complete response (CR/CRh) rate of 31% was observed at the highest dose of 12 µg/kg, indicating the therapy's efficacy in heavily pretreated acute myeloid leukemia (AML) patients and potentially offering new treatment options in this area.
- Favorable Tolerability: CLN-049 demonstrated a favorable safety profile across all assessed doses, with 35.6% of patients experiencing cytokine release syndrome (CRS), primarily Grade 1 or 2, which did not lead to treatment discontinuation, suggesting its potential for clinical application.
- FDA Fast Track Designation: CLN-049 has recently received Fast Track designation from the U.S. FDA, underscoring its potential in treating relapsed/refractory AML patients and likely accelerating its clinical development timeline.
- Future Development Plans: Cullinan Therapeutics will host an investor event on December 8, 2025, to share the latest clinical data on CLN-049, further enhancing communication with investors and boosting market confidence.
Cullinan Therapeutics' CLN-049 Shows 31% Complete Response Rate in R/R AML Patients
- Clinical Data Update: Cullinan Therapeutics reported a 31% complete response (CR) rate in its Phase 1 study of CLN-049 for relapsed/refractory acute myeloid leukemia (R/R AML) patients, indicating significant potential for this therapy in heavily pretreated populations and the possibility of introducing new treatment options in the field.
- FDA Fast Track Designation: CLN-049 has recently received Fast Track designation from the U.S. FDA, highlighting the therapy's promising prospects in treating R/R AML, which is expected to expedite its clinical development process to meet the urgent needs of patients requiring new therapies.
- Favorable Safety Profile: Among the 45 patients, CLN-049 demonstrated a favorable safety profile, with the most common treatment-emergent adverse events being cytokine release syndrome (35.6%), predominantly Grade 1 or 2, indicating the therapy's feasibility and patient tolerability in clinical applications.
- Future Development Plans: Cullinan Therapeutics plans to expand its study cohorts in early 2026, continuing dose escalation studies to further validate the efficacy and safety of CLN-049, aiming to provide more treatment options for AML patients.
Cullinan Secures FDA Fast Track Designation for CLN-049 in Relapsed/Refractory AML
FDA Fast Track Designation: Cullinan Therapeutics' CLN-049, a bispecific T cell engager for treating relapsed/refractory acute myeloid leukemia (AML), has received Fast Track Designation from the U.S. FDA, highlighting the urgent need for effective treatments in this area.
AML Statistics: Acute myeloid leukemia is the most common acute leukemia in adults, with approximately 22,000 new diagnoses and 11,000 deaths annually in the U.S., and a global impact of 144,000 cases and 130,000 deaths each year.
Clinical Trial Results: In Phase 1 trials, CLN-049 showed promising efficacy and safety, including complete responses in heavily pre-treated patients, and is currently being evaluated in two ongoing studies.
Future Presentations: Data from the Phase 1 trial will be presented at the 67th American Society of Hematology Annual Meeting on December 8, 2025, as part of the FDA's initiative to expedite the development of therapies for serious conditions.
Cullinan Receives FDA Fast Track Designation for CLN-049 in AML Treatment
- Fast Track Designation: Cullinan Therapeutics announced that its CLN-049 has received FDA Fast Track designation aimed at providing new treatment options for relapsed/refractory acute myeloid leukemia (AML) patients, highlighting the drug's potential to address unmet medical needs.
- Clinical Trial Results: Initial Phase 1 trial data shows that CLN-049 demonstrates significant efficacy in heavily pre-treated patients, including complete responses, indicating its broad applicability in treating AML patients with limited effective options.
- Upcoming Data Presentation: Data from the CLN-049 clinical trial will be presented in an oral session at the 67th American Society of Hematology Annual Meeting on December 8, which is expected to further propel the drug's development and attract investor interest.
- Strategic Implications: The FDA's Fast Track designation not only accelerates the development timeline for CLN-049 but also provides Cullinan Therapeutics with a crucial competitive edge in the oncology market, underscoring its commitment to innovation in cancer treatment.
Growth Prospects for the EGFR-NSCLC Market Analyzed
- Market Size Forecast: The EGFR-NSCLC market is projected to reach $6 billion by 2024, with the U.S. accounting for approximately 56% of the total market, indicating strong demand for new therapies and significant economic potential in this region.
- Rising Patient Numbers: In 2024, nearly 117,000 new cases of EGFR-NSCLC are expected, and as testing rates increase, more patients with EGFR mutations are identified, driving the demand for targeted therapies and signaling ongoing market expansion.
- Active Drug Development: Several new drugs, including Zipalertinib and Firmonertinib, are in clinical trials and are anticipated to introduce new treatment options, which not only diversify the therapeutic landscape but also have the potential to redefine existing treatment standards and improve patient survival rates.
- Evolving Competitive Landscape: The convergence of TKIs, ADCs, and gene therapies is intensifying competition in the EGFR-NSCLC market, where future winners will depend on efficacy, resistance coverage, and combination therapy potential, driving innovation and growth in the industry.
Major Stocks on the Rise Monday: Paramount Skydance, Wave Life Sciences, Ocular Therapeutix, Carvana, and More
U.S. Stock Market Performance: U.S. stocks declined, with the Dow Jones dropping over 200 points on Monday, while several companies saw significant gains in their share prices.
Paramount's Acquisition Move: Paramount Skydance Corporation's shares surged nearly 10% after announcing a $30 per share all-cash tender offer to acquire Warner Bros. Discovery, valuing the deal at $108.4 billion.
Biotech Stock Gains: Wave Life Sciences and Structure Therapeutics experienced remarkable increases of 129.1% and 100.5%, respectively, following positive clinical trial results for their obesity treatments.
Other Notable Stock Movements: Companies like Fulcrum Therapeutics and Kymera Therapeutics also saw substantial share price increases due to promising clinical trial data, while Carvana announced its inclusion in the S&P 500, boosting its stock by 11.6%.
Cullinan Therapeutics' CLN-049 Shows 31% Complete Response Rate in R/R AML Patients
- Clinical Trial Results: Among 45 patients treated with CLN-049, a complete response (CR/CRh) rate of 31% was observed at the highest dose of 12 µg/kg, indicating the therapy's efficacy in heavily pretreated acute myeloid leukemia (AML) patients and potentially offering new treatment options in this area.
- Favorable Tolerability: CLN-049 demonstrated a favorable safety profile across all assessed doses, with 35.6% of patients experiencing cytokine release syndrome (CRS), primarily Grade 1 or 2, which did not lead to treatment discontinuation, suggesting its potential for clinical application.
- FDA Fast Track Designation: CLN-049 has recently received Fast Track designation from the U.S. FDA, underscoring its potential in treating relapsed/refractory AML patients and likely accelerating its clinical development timeline.
- Future Development Plans: Cullinan Therapeutics will host an investor event on December 8, 2025, to share the latest clinical data on CLN-049, further enhancing communication with investors and boosting market confidence.
Cullinan Therapeutics' CLN-049 Shows 31% Complete Response Rate in R/R AML Patients
- Clinical Data Update: Cullinan Therapeutics reported a 31% complete response (CR) rate in its Phase 1 study of CLN-049 for relapsed/refractory acute myeloid leukemia (R/R AML) patients, indicating significant potential for this therapy in heavily pretreated populations and the possibility of introducing new treatment options in the field.
- FDA Fast Track Designation: CLN-049 has recently received Fast Track designation from the U.S. FDA, highlighting the therapy's promising prospects in treating R/R AML, which is expected to expedite its clinical development process to meet the urgent needs of patients requiring new therapies.
- Favorable Safety Profile: Among the 45 patients, CLN-049 demonstrated a favorable safety profile, with the most common treatment-emergent adverse events being cytokine release syndrome (35.6%), predominantly Grade 1 or 2, indicating the therapy's feasibility and patient tolerability in clinical applications.
- Future Development Plans: Cullinan Therapeutics plans to expand its study cohorts in early 2026, continuing dose escalation studies to further validate the efficacy and safety of CLN-049, aiming to provide more treatment options for AML patients.
Cullinan Secures FDA Fast Track Designation for CLN-049 in Relapsed/Refractory AML
FDA Fast Track Designation: Cullinan Therapeutics' CLN-049, a bispecific T cell engager for treating relapsed/refractory acute myeloid leukemia (AML), has received Fast Track Designation from the U.S. FDA, highlighting the urgent need for effective treatments in this area.
AML Statistics: Acute myeloid leukemia is the most common acute leukemia in adults, with approximately 22,000 new diagnoses and 11,000 deaths annually in the U.S., and a global impact of 144,000 cases and 130,000 deaths each year.
Clinical Trial Results: In Phase 1 trials, CLN-049 showed promising efficacy and safety, including complete responses in heavily pre-treated patients, and is currently being evaluated in two ongoing studies.
Future Presentations: Data from the Phase 1 trial will be presented at the 67th American Society of Hematology Annual Meeting on December 8, 2025, as part of the FDA's initiative to expedite the development of therapies for serious conditions.
Cullinan Receives FDA Fast Track Designation for CLN-049 in AML Treatment
- Fast Track Designation: Cullinan Therapeutics announced that its CLN-049 has received FDA Fast Track designation aimed at providing new treatment options for relapsed/refractory acute myeloid leukemia (AML) patients, highlighting the drug's potential to address unmet medical needs.
- Clinical Trial Results: Initial Phase 1 trial data shows that CLN-049 demonstrates significant efficacy in heavily pre-treated patients, including complete responses, indicating its broad applicability in treating AML patients with limited effective options.
- Upcoming Data Presentation: Data from the CLN-049 clinical trial will be presented in an oral session at the 67th American Society of Hematology Annual Meeting on December 8, which is expected to further propel the drug's development and attract investor interest.
- Strategic Implications: The FDA's Fast Track designation not only accelerates the development timeline for CLN-049 but also provides Cullinan Therapeutics with a crucial competitive edge in the oncology market, underscoring its commitment to innovation in cancer treatment.
