Earnings summaries and quarterly performance for TScan Therapeutics.
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Recent press releases and 8-K filings for TCRX.
TScan Therapeutics, Inc. Provides Update on Clinical Programs and Future Milestones
TCRX
New Projects/Investments
Guidance Update
Product Launch
- TScan Therapeutics, Inc. plans to launch a pivotal study for TSC-101 in Q2 2026 for heme malignancies, supported by promising data showing 100% (3/3) of patients 2-years post-HCT had detectable TSC-101 cells and no evidence of disease.
- The company intends to file two Investigational New Drug (IND) applications for TSC-102 (A03:01 and A01:01) in Q1 2026 to expand its heme malignancy program.
- TScan Therapeutics reported $184.5 million in cash as of September 30, 2025, which is projected to fund operations into H2 2027.
- TSC-101 is estimated to generate over $1 billion annually at peak penetration in the U.S., addressing an estimated 2,100 addressable U.S. patients at launch.
Jan 12, 2026, 12:30 PM
TCRX Announces Positive TSC-101 Data and Pivotal Trial Plans
TCRX
Product Launch
New Projects/Investments
Guidance Update
- TScan Therapeutics (TCRX) presented updated positive data from its Phase 1 ALOHA study for TSC-101 in AML and MDS patients at the American Society of Hematology (ASH) conference, showing strong hazard ratios for relapse (0.46), relapse-free survival (0.5), and overall survival (0.61).
- The company has reached an agreement with the FDA on the design for a pivotal trial for TSC-101, which is anticipated to launch in Q2 of next year. The study is expected to include approximately 140 treatment arm subjects and a similar number of control arm subjects, with a top-line readout projected in about two and a half years.
- A new, more efficient commercial-ready manufacturing process for TSC-101 has been introduced, reducing manufacturing time to 12 days from 17 days and lowering costs. This process has been transferred to an external CDMO and will be used in the pivotal trial.
- TScan estimates peak annual U.S. revenues of more than $1.4 billion for TSC-101.
- The company plans to file Investigational New Drug (IND) applications in Q1 of next year for its first two TSC-102 candidates (targeting HLA-A03:01 and HLA-A01:01), expanding its heme program to address other common HLA types.
Dec 8, 2025, 1:00 PM
TScan Therapeutics Provides Update on TSC-101 Program and Pivotal Study Plans
TCRX
Product Launch
New Projects/Investments
Guidance Update
- TScan Therapeutics (TCRX) presented updated data for its lead program, TSC-101, for heme malignancies, highlighting a relapse-free survival hazard ratio of 0.46 and an overall survival hazard ratio of 0.61.
- A pivotal study for TSC-101 is planned for launch in Q2 of next year (2026), following agreement with the FDA on the trial design. This study is expected to enroll approximately 140 treatment arm subjects and a similar number of control arm subjects, with a top-line readout anticipated in about two and a half years.
- TScan has introduced a new, more efficient commercial-ready manufacturing process for TSC-101, which reduces manufacturing time to 12 days from 17 days and requires less ex vivo expansion of T cells.
- The company projects peak annual U.S. revenues for TSC-101 to exceed $1.4 billion.
- TScan also intends to file Investigational New Drug (IND) applications in Q1 of next year (2026) for its first two TSC-102 candidates, aiming to address additional common HLA types and expand the heme program.
Dec 8, 2025, 1:00 PM
TCRX Provides Update on Heme Malignancy Program and TSC-101
TCRX
New Projects/Investments
Guidance Update
Product Launch
- TCRX's TSC-101 TCR-T cell therapy shows promising data in its Heme Malignancy Program, with 100% (3/3) of patients remaining relapse-free two years post-HCT compared to 25% (1/4) in the control arm.
- The company has reached an agreement with the FDA on a pivotal trial design for TSC-101, mirroring the Phase 1 ALLOHATM trial, with relapse-free survival (RFS) as the primary endpoint.
- An optimized, commercial-ready manufacturing process for TSC-101 reduces manufacturing time by 5 days (from 17 to 12 days) and significantly reduces ex vivo expansion.
- TCRX estimates TSC-101 could generate over $1 billion annually at peak penetration in the U.S., with the pivotal study launch expected in Q2 2026.
- As of September 30, 2025, TCRX had $184.5 million in cash, funding operations into H2 2027.
Dec 8, 2025, 1:00 PM
TScan Therapeutics to Launch Pivotal Trial for TSC-101 in Q2 2026, Extends Cash Runway
TCRX
New Projects/Investments
Guidance Update
Product Launch
- TScan Therapeutics' lead program, TSC-101, for heme malignancies (AML/MDS), has demonstrated a 50% reduction in relapse rates in patients treated with the therapy compared to standard of care. Updated data from the ASH abstract indicates 82% of patients remain relapse-free with TSC-101 versus 64% in the control arm.
- The company plans to launch a pivotal trial for TSC-101 in Q2 of next year (2026), with a top-line readout anticipated by the end of 2028 and a filing by mid-2029. The FDA has aligned on an internal control arm design for this trial.
- TScan estimates the addressable market for TSC-101 in the US to be approximately 2,000 patients annually, representing a greater than $1 billion opportunity. The company also plans to expand its heme program with two additional IND filings to cover about 80% of US patients.
- The solid tumor program is pivoting from its current Phase 1 study to an in vivo engineering platform, with data from the ex vivo Plexi-T study expected in Q1 of next year (2026).
- Following a strategic restructuring, TScan has extended its cash runway into the second half of 2027.
Nov 12, 2025, 3:00 PM
TScan Therapeutics Reports Q3 2025 Financial Results and Provides Corporate Update
TCRX
Earnings
Guidance Update
New Projects/Investments
- TScan Therapeutics reported revenue of $2.5 million and a net loss of $35.7 million for the third quarter ended September 30, 2025.
- As of September 30, 2025, the company's cash, cash equivalents, and marketable securities totaled $184.5 million, which are expected to fund operations into the second half of 2027.
- The company reached an agreement with the FDA on the pivotal study design for its lead candidate, TSC-101, with the pivotal trial anticipated to launch in the second quarter of 2026.
- TScan Therapeutics has strategically paused further enrollment in its solid tumor Phase 1 trial (PLEXI-T) to prioritize its heme program and focus preclinical development on in vivo engineering for solid tumors.
Nov 12, 2025, 12:15 PM
TCRX Announces FDA Agreement on TSC-101 Pivotal Trial Design
TCRX
New Projects/Investments
Guidance Update
- TCRX has reached an agreement with the FDA on the pivotal trial design for TSC-101, which mirrors the ALLOHA™ Phase 1 trial.
- The trial design utilizes a biologically assigned control arm to support relapse-free survival (RFS) as the primary endpoint, with overall survival (OS) as a key secondary endpoint.
- The study population for TSC-101 includes patients with AML or MDS who are over 18 years old, undergoing first allo-HCT, and eligible for reduced intensity conditioning (RIC).
- The company expects its existing cash, cash equivalents, and marketable securities to fund its operating plan into the second half of 2027.
Nov 3, 2025, 1:00 PM
TCRX Shifts Focus to HEME Program and Restructures Operations
TCRX
Layoffs
New Projects/Investments
Guidance Update
- TCRX has made a strategic decision to pause further enrollment in its solid tumor trial and will now focus its clinical development efforts on the HEME program.
- The company is undergoing a restructuring that includes a reduction in force of approximately 30% of its employees, which is expected to extend its financial runway into the second half of 2027.
- For its lead HEME program, TSC-101, TCRX anticipates starting the pivotal trial in the second quarter of 2026 and has finalized a new commercial-ready manufacturing process that is five days shorter and has decreased cost of goods.
- TCRX plans to file two Investigational New Drug (IND) applications this year for additional TCRs targeting CD45, aiming to potentially double the addressable market for its HEME program.
Nov 3, 2025, 1:00 PM
TScan Therapeutics reaches FDA agreement for TSC-101 pivotal study and announces strategic prioritization
TCRX
New Projects/Investments
Layoffs
Guidance Update
- TScan Therapeutics has reached an agreement with the FDA on the pivotal study design for TSC-101 for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), with the pivotal trial expected to begin in Q2 2026.
- The company announced a strategic prioritization to advance its heme program, pausing further enrollment in its solid tumor Phase 1 trial and shifting focus to preclinical development of in vivo-engineered TCR-Ts for solid tumors.
- This strategic shift includes a workforce reduction of approximately 30%, or 66 employees, and is expected to result in annual cost savings of approximately $45.0 million in 2026 and 2027, extending the cash runway into the second half of 2027.
- A one-time charge of up to approximately $2.3 million is expected in the fourth quarter of 2025 for severance-related benefits and other costs associated with the workforce reduction.
Nov 3, 2025, 11:35 AM
TScan Therapeutics Provides Updates on Heme Malignancy and Solid Tumor Programs
TCRX
Product Launch
New Projects/Investments
Guidance Update
- TScan Therapeutics (TCRX) is developing TCR-T cell therapies for cancer, with primary clinical programs in heme malignancies and solid tumors.
- The heme malignancies program (TSC-101), for AML, MDS, and ALL, showed strong Phase I results with only 2 out of 26 patients on the treatment arm relapsing, compared to 4 out of 12 on the control arm. TScan plans to launch a pivotal trial in the second half of 2025, with a top-line readout for full approval anticipated in the second half of 2027.
- For solid tumors, TScan is advancing a multiplex therapy approach, combining multiple TCR-T cell therapies. The company has seven different TCRs in a single clinical trial and expects to provide a substantive efficacy readout on multiplex therapy in the second half of 2025.
- Key milestones for 2025 include launching the pivotal trial for the heme program, providing updated Phase I data, introducing a new product (TSC-102) to expand HLA types, and delivering safety and efficacy updates on multiplex therapy for solid tumors.
Feb 25, 2025, 3:00 PM
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