This section highlights FDA-related milestones and regulatory updates for drugs developed by Vor Biopharma (VOR).
Over the past two years, Vor Biopharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
telitacicept and VBP101. 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.
Telitacicept FDA Regulatory Events
Telitacicept is a drug developed by Vor Biopharma for the following indication: Sjögren's Disease.
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:
- telitacicept
- Announced Date:
- September 29, 2025
- Indication:
- Sjögren's Disease
Announcement
Vor Bio announced that clinical data from the Phase 3 study in China evaluating telitacicept in adults with primary Sjögren's disease, a study sponsored by Vor's collaborator RemeGen Co., Ltd (HKEX: 9995, SHA: 688331), will be presented as a late-breaking poster presentation at ACR Convergence 2025, being held October 24-29, 2025, at McCormick Place in Chicago, Illinois.
AI Summary
Vor Bio announced that clinical data from the Phase 3 study in China evaluating telitacicept in adults with primary Sjögren’s disease will be presented as a late-breaking poster at ACR Convergence 2025. The study was sponsored by Vor’s collaborator RemeGen Co., Ltd. This showcase will take place October 24–29, 2025, at McCormick Place in Chicago, Illinois.
The poster, titled “Efficacy and Safety of Telitacicept in Patients with Sjögren’s Disease: Results from a Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Clinical Study,” is scheduled for Tuesday, October 28 from 10:30 AM to 12:30 PM CT as part of the Late-Breaking Posters session. Telitacicept is a dual-target fusion protein that blocks two key cytokines driving B cell activity and autoantibody production. In early September, RemeGen announced that China’s NMPA accepted its Biologics License Application for telitacicept in primary Sjögren’s disease, which would become its fourth approved indication in China.
Read Announcement
VBP101 FDA Regulatory Events
VBP101 is a drug developed by Vor Biopharma for the following indication: Study of patients with relapsed/refractory AML receiving trem-cel followed by Mylotarg™.
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:
- VBP101
- Announced Date:
- March 20, 2025
- Indication:
- Study of patients with relapsed/refractory AML receiving trem-cel followed by Mylotarg™.
Announcement
Vor Bio provided a business update.
AI Summary
Vor Bio provided a business update highlighting progress in its cell and genome engineering programs. The company shared that the next clinical data update for its VCAR33 trial is expected in the first half of 2025. This update is part of their ongoing efforts to develop therapies for patients with blood cancers. The VCAR33 trial is a Phase 1/2 study that involves a novel anti-CD33 CAR-T cell therapy, aimed at helping patients with relapsed AML after standard treatments or trem-cel transplants. The update comes as the company continues to strengthen its financial position following a $55.6 million private placement led by Reid Hoffman and RA Capital Management. This enhanced financial backing will support upcoming clinical trials, including the anticipated Phase 1 trial for the combined trem-cel+VCAR33 Treatment System scheduled for the second half of 2025.
Read Announcement- Drug:
- VBP101
- Announced Date:
- September 6, 2024
- Indication:
- Study of patients with relapsed/refractory AML receiving trem-cel followed by Mylotarg™.
Announcement
Vor Bio announced new clinical data from its ongoing Phase 1/2 VBP101 study of patients with relapsed/refractory AML receiving trem-cel followed by Mylotarg™.
AI Summary
Vor Bio recently shared encouraging new clinical data from its ongoing Phase 1/2 VBP101 study in patients with relapsed/refractory AML. In this study, patients received the cell therapy trem‐cel followed by the chemotherapy drug Mylotarg™, and the results were promising. The data showed that all patients achieved reliable engraftment, with primary neutrophil recovery in a median of 9 days and robust platelet recovery by around 16.5 days. Additionally, the treatment provided shielding from Mylotarg’s on-target toxicity, which allowed for a broadened therapeutic window. Early signs of patient benefit were observed, including improved relapse-free survival compared to historical high-risk AML outcomes. These findings support the potential of combining trem-cel with Mylotarg to better manage AML and justify discussions with the FDA to design a pivotal trial.
Read Announcement
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