Biotech Stocks Rise After Hours: Clene Jumps Ahead of ALS Update; Werewolf, Biomea, and Dyne Also Gain
Clene Inc. Gains: Clene Inc. shares rose 8.53% in after-hours trading after announcing an upcoming investor call regarding its CNM-Au8 program for ALS, despite a regular session decline.
Werewolf Therapeutics Update: Werewolf Therapeutics saw a 6.12% increase after hours, likely influenced by investor reactions to its recent presentation at a cancer immunotherapy conference, despite no new news.
Biomea Fusion Presentation: Biomea Fusion's stock climbed 7.31% after hours following its announcement of an upcoming presentation on icovamenib data at a major diabetes and cardiovascular disease congress.
General Market Trends: Other biotech companies like Denali Therapeutics, TScan Therapeutics, and Nyxoah also experienced after-hours gains, reflecting ongoing investor interest and positioning ahead of regulatory milestones and presentations.
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- Market Size Forecast: The global oncology market is projected to reach $279.98 billion in 2026 and grow to $748.17 billion by 2035, indicating a structural shift from single-agent treatments to combination therapies and next-generation cell therapies.
- Immuno-Oncology Expansion: The immuno-oncology segment is expected to expand from $65.22 billion in 2025 to $170.19 billion by 2032, as approvals of combination therapies convert previously resistant tumors into viable treatment targets, driving market demand.
- Oncolytics Biotech New Data: Oncolytics Biotech will present new data at the 2026 American Association for Cancer Research Annual Meeting, indicating that its lead drug pelareorep can make tumors more susceptible to immunotherapy, particularly showing positive results in breast and gastrointestinal cancer trials.
- Clinical Trial Progress: Oncolytics' REO 033 trial demonstrated a total survival of 27 months in second-line RAS-mutant, microsatellite-stable metastatic colorectal cancer patients, with the FDA granting Fast Track Designation, which is expected to enhance the company's position in high-value markets.
- Market Growth Potential: The global oncology market is valued at $279.98 billion in 2026 and is projected to reach $748.17 billion by 2035, indicating a strong trend towards a shift from single-agent treatments to combination platforms and next-generation cell therapies, potentially creating significant market opportunities for related companies.
- Immuno-Oncology Expansion: The immuno-oncology segment is expected to grow from $65.22 billion in 2025 to $170.19 billion by 2032, as the approval of combination therapies transforms previously resistant tumors into viable treatment targets, driving rapid industry growth.
- Oncolytics Biotech New Data: Oncolytics Biotech is set to present new mechanistic and translational data at the 2026 American Association for Cancer Research Annual Meeting, indicating that its lead drug pelareorep can enhance tumor sensitivity to immunotherapy, potentially providing crucial scientific support for the company in a competitive market.
- Clinical Trial Progress: Oncolytics' REO 033 trial for KRAS-mutant metastatic colorectal cancer shows an overall survival of 27 months and a 33% objective response rate, with the FDA granting Fast Track Designation, which is expected to create significant market opportunities for the company.
- Earnings Performance: TScan Therapeutics reported a Q4 GAAP EPS of -$0.18, beating market expectations by $0.06, indicating a positive trend in the company's profitability improvement.
- Significant Revenue Growth: The company achieved Q4 revenue of $2.57 million, representing a 283.6% year-over-year increase, which not only surpassed expectations by $0.15 million but also reflects strong demand for its products and improved market acceptance.
- Positive Market Reaction: The market reacted positively to the earnings report exceeding expectations, which may drive the stock price up, enhancing investor confidence and attracting more capital inflow.
- Optimistic Future Outlook: With ongoing R&D and market expansion efforts, the company is expected to continue achieving revenue growth in the coming quarters, further solidifying its competitive position in the biopharmaceutical sector.
- Trial Enrollment Completion: TScan Therapeutics announced the completion of enrollment in Cohort C of the ALLOHA™ trial, with over 10 patients treated using the new commercial-ready manufacturing process, which is expected to significantly enhance treatment outcomes and lay the groundwork for subsequent clinical data sharing.
- FDA IND Approval: The company received FDA clearance for IND applications for TSC-102-A01 and TSC-102-A03 targeting patients with HLA types A01:01 and A03:01, respectively, which is anticipated to nearly double the addressable U.S. patient population for its therapies.
- Future Research Plans: TScan plans to initiate Phase 1 trials for both TSC-102 candidates in the second half of 2026, aiming to assess their safety and initial efficacy, thereby advancing the company's strategic positioning in the hematologic malignancies sector.
- Key Data Sharing: The company is set to share safety and early chimerism data from Cohort C in the second quarter of 2026, which is expected to provide a foundation for the pivotal study of TSC-101 and facilitate market expansion in acute myeloid leukemia and myelodysplastic syndromes.

- Clinical Advancement: GT Biopharma has advanced its GTB-3650 clinical trial to Cohort 4, where patients are receiving a dosing of 10μg/kg/day, indicating potential efficacy against resistant blood cancers, with further results expected in Q1 2026.
- Safety Confirmation: Six patients across Cohorts 1, 2, and 3 have successfully completed treatment with GTB-3650, establishing the therapy's safety profile at escalating doses without any dose-limiting toxicities, thereby enhancing confidence in the clinical trial.
- Dose Escalation Plan: The trial is designed to include seven cohorts, with plans to enroll two patients per cohort, escalating doses from 1.25μg/kg/day to potentially 100μg/kg/day, demonstrating the company's ongoing commitment to efficacy and patient care.
- Therapeutic Prospects: GT Biopharma is also advancing GTB-5550, with regulatory submission for human trials expected in late December 2025 or January 2026, further expanding its market opportunities in cancer treatment.

- Clinical Trial Progress: GT Biopharma has advanced its GTB-3650 clinical trial to Cohort 4, where patients are receiving a dosing of 10μg/kg/day, indicating enhanced safety and potential efficacy in combating resistant blood cancers.
- Treatment Protocol Optimization: The therapy follows a continuous infusion schedule structured as two-week treatment periods followed by two-week rest intervals, which is expected to improve patient adherence and treatment outcomes over a four-month duration.
- Market Potential: Targeting CD33-positive acute myeloid leukemia and high-risk myelodysplastic syndrome, GTB-3650 represents a significant complement to traditional therapies, potentially unlocking substantial market opportunities for the company.
- Future Outlook: The company plans to share its next trial update in Q1 2026, and as dosing escalates, GTB-3650 is expected to approach higher efficacy ranges, further advancing its clinical development trajectory.







