This section highlights FDA-related milestones and regulatory updates for drugs developed by TScan Therapeutics (TCRX).
Over the past two years, TScan Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TSC-102-A01, TSC-101, and TSC-100. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
TSC-102-A01 FDA Regulatory Events
TSC-102-A01 is a drug developed by TScan Therapeutics for the following indication: for Heme Candidates.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TSC-102-A01
- Announced Date:
- February 26, 2026
- Indication:
- for Heme Candidates
Announcement
TScan Therapeutics, Inc. announced completion of enrollment into Cohort C of the ALLOHA™ study. Patients in Cohort C are being treated using the new commercial-ready manufacturing process.
AI Summary
TScan Therapeutics announced it has completed enrollment of Cohort C in the Phase 1 ALLOHA™ trial. Patients in this cohort are being treated using the company’s new commercial-ready manufacturing process, marking a shift from early-stage production methods to a process designed for larger-scale, consistent manufacturing.
Treating a clinical cohort with a commercial-ready process lets the company assess not only safety and early signs of benefit but also manufacturing consistency, scalability, and supply-chain performance under real-world trial conditions. Data from Cohort C will help refine production parameters and support decisions about later-stage trials and broader patient access as the program advances. This step aims to reduce manufacturing risk as TScan develops its TCR-T therapies for hematologic malignancies.
Read Announcement
TSC-101 FDA Regulatory Timeline and Events
TSC-101 is a drug developed by TScan Therapeutics for the following indication: Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TSC-101
- Announced Date:
- December 7, 2025
- Indication:
- Solid Tumors
Announcement
TScan Therapeutics, Inc. announced updated results from the ongoing ALLOHA™ Phase 1 trial (NCT05473910) of TSC-101 in patients with heme malignancies undergoing allogeneic hematopoietic cell transplantation (HCT).
AI Summary
TScan Therapeutics reported updated results from the ALLOHA Phase 1 trial (NCT05473910) of TSC-101 given after allogeneic HCT in patients with blood cancers. As of the data cut, 42 patients were evaluable (23 treated, 19 control). The treatment arm showed improved relapse-free survival (HR=0.50; p=0.23) and overall survival (HR=0.61; p=0.52). Four of 19 (21%) treated patients relapsed versus 6 of 18 (33%) controls. All three TSC-101 patients who reached two years of follow-up remained relapse-free versus 1 of 4 (25%) in the control arm. One treated patient who relapsed responded to a third dose and regained complete donor chimerism.
TSC-101 was well tolerated with no dose-limiting toxicities. Among 37 patients with molecular data, 8 (22%) had TP53 mutations; only 1 of 6 mutated patients in the treatment arm relapsed, while both mutated controls relapsed and died. The company linked greater ex vivo TCR-T expansion to mixed chimerism or relapse and introduced a manufacturing process that shortens production from 17 to 12 days and reduces expansion. The data were presented at ASH, and a virtual KOL event is scheduled for Dec. 8.
Read Announcement- Drug:
- TSC-101
- Announced Date:
- December 7, 2025
- Indication:
- Solid Tumors
Announcement
TScan Therapeutics, Inc. announced updated results from the ongoing ALLOHA™ Phase 1 trial (NCT05473910) of TSC-101 in patients with heme malignancies undergoing allogeneic hematopoietic cell transplantation (HCT).
AI Summary
TScan Therapeutics reported updated results from the ALLOHA Phase 1 trial of TSC-101 given after allogeneic hematopoietic cell transplantation (HCT) for blood cancers. As of the data cut, 42 patients were in the safety set (23 treated, 19 control). Treatment-arm patients showed improved relapse-free survival (HR=0.50; p=0.23) and overall survival (HR=0.61; p=0.52). Four of 19 treated patients relapsed versus 6 of 18 controls. Notably, all three TSC-101 patients who reached two years of follow-up remained relapse-free compared with 1 of 4 in the control arm.
TSC-101 was well tolerated with no dose-limiting toxicities. One relapsed patient achieved a complete response after a third dose. Patients with TP53 mutations appeared to benefit in the treatment arm. The company also reported a faster, commercial-ready manufacturing process that shortens production time and reduces ex vivo T cell expansion, which may affect durability and consistency of responses.
Read Announcement- Drug:
- TSC-101
- Announced Date:
- December 3, 2025
- Indication:
- Solid Tumors
Announcement
TScan Therapeutics, Inc. announced the Company will host a virtual key opinion leader (KOL) event to discuss updated data from the ALLOHA™ Phase 1 trial being presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition and the future market opportunity for its heme program.
AI Summary
TScan Therapeutics will host a virtual key opinion leader (KOL) event on Monday, December 8 at 8:00 a.m. ET to review updated data from the ALLOHA™ Phase 1 trial presented at the 67th ASH Annual Meeting. The company will give an in-depth look at the poster and highlight two-year relapse outcomes from initial patients treated with TSC-101 after allogeneic hematopoietic cell transplantation (HCT).
Speakers will discuss an improved, commercial-ready manufacturing process now used in the ALLOHA trial and planned for the pivotal trial that is scheduled to begin in the second quarter of 2026. The event will also cover the unmet medical need in hematologic malignancies and the potential market opportunity for TSC-101 and follow-on heme program candidates.
Featured presenters include Dr. Ran Reshef, TScan CEO Gavin MacBeath, and SVP Stephen Camiolo. Registration is available online, and a replay will be posted in the “Events and Presentations” section at ir.tscan.com.
Read Announcement- Drug:
- TSC-101
- Announced Date:
- November 3, 2025
- Indication:
- Solid Tumors
Announcement
TScan Therapeutics, Inc announced regulatory and clinical program updates, implementation of a workforce reduction of approximately 30%, and extension of its cash runway into the second half of 2027.
AI Summary
TScan Therapeutics announced important regulatory and clinical updates. The company received positive feedback at its End-of-Phase 1 meeting with the FDA and reached agreement on a pivotal study design for TSC-101 in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
To focus resources, TScan paused further enrollment in its solid tumor Phase 1 trial and will advance clinical work on its heme program. It also plans preclinical development of an in vivo-engineered TCR-T therapy for solid tumors and continues to explore new targets for autoimmune diseases.
As part of this strategic shift, TScan reduced its workforce by about 30%, cutting 66 positions. These measures, along with a more efficient manufacturing process, are expected to save $45 million annually and extend the company’s cash runway into the second half of 2027.
Read Announcement- Drug:
- TSC-101
- Announced Date:
- May 29, 2024
- Indication:
- Solid Tumors
Announcement
TScan Therapeutics, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to TSC-100 and TSC-101, the Company's two lead TCR-T therapy candidates for the treatment of heme malignancies (NCT05473910)..
AI Summary
TScan Therapeutics, Inc. announced that the FDA has granted RMAT designation to its two lead TCR-T therapy candidates, TSC-100 and TSC-101, for treating hematologic malignancies. The therapies are being developed to help patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS) who receive allogeneic hematopoietic cell transplants. RMAT designation is a special FDA program that speeds up the review and development of promising regenerative medicine therapies for serious conditions. The designation supports TScan’s strategy to use engineered T cell receptors to target and eliminate residual malignant cells after a transplant while keeping donor cells intact. This milestone reflects the potential of TSC-100 and TSC-101 to address significant unmet needs in the treatment of these challenging blood cancers, and TScan looks forward to continued collaboration with the FDA.
Read Announcement
TSC-100 FDA Regulatory Timeline and Events
TSC-100 is a drug developed by TScan Therapeutics for the following indication: Solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TSC-100
- Announced Date:
- March 5, 2025
- Indication:
- Solid tumors
Announcement
TScan Therapeutics, provided a business update.
AI Summary
TScan Therapeutics provided a business update highlighting progress in its clinical programs and financial strength. The company presented updated data from its ALLOHA™ Phase 1 heme trial at the 66th ASH Annual Meeting, showing promising results with only 2 of 26 treated patients relapsing compared to 4 of 12 in the control group. Additional two-year relapse data is expected by the end of the year, reinforcing the potential of this therapy. In its solid tumor program, the IND application for TSC-202-A0201 targeting MAGE-A4 on HLA-A*02:01 was cleared by the FDA, now contributing to a total of seven TCR-T therapy candidates in the PLEXI-T Phase 1 trial. TScan also completed a $30 million registered direct offering at a 37% premium, ensuring that cash and marketable securities will fund operations into the first quarter of 2027.
Read Announcement- Drug:
- TSC-100
- Announced Date:
- December 9, 2024
- Indication:
- Solid tumors
Announcement
TScan Therapeutics, Inc. announced that updated results from the ongoing ALLOHA™ Phase 1 trial of TSC-100 and TSC-101 will be presented during an oral session at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition.
AI Summary
TScan Therapeutics, Inc. announced that updated results from its ongoing ALLOHA™ Phase 1 trial of TSC-100 and TSC-101 will be presented during an oral session at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. The trial focuses on patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS) who have undergone allogeneic hematopoietic cell transplantation with reduced intensity conditioning. Early data show that event-free survival significantly favors the treatment arm, and there is a trend toward a lower probability of relapse when compared to control patients.
The treatments, designed to eliminate residual disease and prevent relapse, were well-tolerated at all studied dose levels with no dose-limiting toxicities observed. These encouraging results suggest TSC-100 and TSC-101 could offer a promising new approach for addressing relapse in high-risk transplant patients.
Read Announcement- Drug:
- TSC-100
- Announced Date:
- May 29, 2024
- Indication:
- Solid tumors
Announcement
TScan Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to TSC-100 and TSC-101, the Company's two lead TCR-T therapy candidates for the treatment of heme malignancies (NCT05473910).
AI Summary
TScan Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its two leading T cell receptor (TCR)-engineered therapy candidates, TSC-100 and TSC-101. This designation aims to accelerate the development and review of these promising treatments for hematologic malignancies such as acute myeloid leukemia, acute lymphoblastic leukemia, and myelodysplastic syndrome. The RMAT program offers intensive FDA guidance, enabling early discussions on surrogate endpoints and potential pathways for accelerated approval. By targeting specific antigens, TSC-100 and TSC-101 are designed to eliminate residual malignant or pre-malignant cells post-transplant while sparing donor cells, addressing a critical need in transplant patients who face high relapse rates. This milestone reflects TScan’s commitment to advancing innovative therapies that could significantly improve outcomes in hard-to-treat blood cancers.
Read Announcement
