Q32 Bio (QTTB) FDA Approvals

Upcoming FDA Events for Q32 Bio

Q32 Bio (QTTB) has upcoming FDA regulatory milestones for Bempikibart. The table below outlines estimated target dates and event types for these pending regulatory actions.

Q32 Bio's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Q32 Bio (QTTB). Over the past two years, Q32 Bio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Bempikibart. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Bempikibart FDA Regulatory Timeline and Events

Bempikibart is a drug developed by Q32 Bio for the following indication: For Severe Alopecia Areata. 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.

Enrollment Update - October 21,2025

Phase 2a

• Drug: Bempikibart
• Announced Date: October 21, 2025
• Indication: For Severe Alopecia Areata

Q32 Bio Inc announced that it has completed enrollment in Part B of its SIGNAL-AA Phase 2a clinical trial evaluating bempikibart in patients with severe or very severe AA.

Q32 Bio Inc. has finished enrolling patients in Part B of its SIGNAL-AA Phase 2a trial for bempikibart, a fully human antibody against IL-7Rα. Strong patient demand led the company to increase enrollment from about 20 to 33 people with severe or very severe alopecia areata (AA). This milestone highlights both patient interest and the company’s ability to execute its clinical plan.

In Part B, participants receive a loading dose of 200 mg of bempikibart each week for four weeks, then 200 mg every other week through week 36, with safety and effects tracked through week 52. The trial will measure changes in the Severity of Alopecia Tool (SALT) score to see how well hair regrowth responds to treatment.

Early signs of clinical activity and faster steady-state drug levels have been observed. Q32 Bio expects topline data in mid-2026, which could support moving bempikibart into larger, pivotal trials if results are positive.

Data Presentation - April 30,2025

Fast Track

• Drug: Bempikibart
• Announced Date: April 30, 2025
• Indication: For Severe Alopecia Areata

Q32 Bio Inc. announced that the United States Food and Drug Administration ("FDA") has granted Fast Track designation (FTD) to Q32 Bio's bempikibart (ADX-914) for the treatment of AA.

Q32 Bio Inc. recently announced that the FDA has granted Fast Track designation to its investigational drug bempikibart (ADX‑914) for treating alopecia areata (AA). This designation recognizes the serious nature of AA and the significant unmet medical need in treating the condition. Bempikibart, a fully human anti‑IL‑7Rα antibody, works by blocking IL‑7 and TSLP signaling to help re-regulate the immune system. Its potential as a novel and differentiated treatment option is backed by promising clinical data observed in the ongoing Phase 2 SIGNAL‑AA trial.

The Fast Track status is designed to speed up the development and review process by allowing more frequent interactions with the FDA, which could ultimately lead to faster approval. This milestone underscores the commitment of Q32 Bio to deliver a potentially transformative therapy for patients suffering from AA.

Data readout - April 16,2025

• Drug: Bempikibart
• Announced Date: April 16, 2025
• Target Action Date: H1 2026
• Estimated Target Date Range: January 1, 2026 - June 30, 2026
• Indication: For Severe Alopecia Areata

Q32 Bio Inc. announced that SIGNAL-AA Part B topline data readout on-track for 1H'26 --

Q32 Bio Inc. announced that it is on track to report the SIGNAL-AA Part B topline data in the first half of 2026. This signal-phase trial is an important step in the clinical development of bempikibart, a fully human anti-IL-7Rα antibody designed to treat patients with alopecia areata. In Part B, approximately 20 patients with severe or very severe alopecia areata will be enrolled in an open-label study.

The dosing plan includes an initial loading regimen of 200mg given weekly for four weeks, followed by a maintenance dose of 200mg every other week over 32 weeks, for a total treatment period of 36 weeks, with a follow-up period extending to 52 weeks. The topline data readout is expected to provide insights into the efficacy and safety of bempikibart and help pave the way for future pivotal trials aimed at offering a new treatment option for patients.

Dosing Update - April 16,2025

Phase 2a

• Drug: Bempikibart
• Announced Date: April 16, 2025
• Indication: For Severe Alopecia Areata

Q32 Bio Inc. announced that the Company has dosed the first patients in both the Part A open-label extension (OLE) and Part B of the SIGNAL-AA Phase 2a clinical trial evaluating bempikibart in patients with alopecia areata (AA).

Q32 Bio Inc. announced a key milestone in the SIGNAL-AA Phase 2a clinical trial for its experimental drug, bempikibart, targeting alopecia areata (AA). The company has dosed the first patients in both the Part A open-label extension (OLE) and Part B portions of the study. The updated trial builds on earlier encouraging results from Part A, where patients demonstrated sustained responses and improvements in their Severity of Alopecia Tool (SALT) scores. In Part B, approximately 20 patients with severe AA will receive a treatment regimen that starts with a loading dose followed by a maintenance dose over 36 weeks, with follow-up continuing through 52 weeks. Q32 Bio believes that the favorable clinical activity and the well-tolerated safety profile of bempikibart could offer a new, differentiated treatment option for AA, potentially transforming care for patients if approved.

Provided Update - March 11,2025

• Drug: Bempikibart
• Announced Date: March 11, 2025
• Indication: For Severe Alopecia Areata

Q32 Bio Inc. provided recent corporate updates.

Q32 Bio Inc., a clinical-stage biotechnology company, recently provided corporate updates focused on its bempikibart program for treating alopecia areata (AA). At the 2025 American Academy of Dermatology Annual Meeting, the company presented late-breaking Phase 2a Part A data showing encouraging clinical activity. Patients experienced continued hair growth responses even months after completing treatment, and bempikibart demonstrated a strong safety profile with durable results.

Building on these positive results, Q32 Bio is set to advance bempikibart in two additional studies: an open-label extension (OLE) of the SIGNAL-AA trial and Phase 2a Part B. The company plans to dose patients in the first half of 2025, with topline data from Part B expected in the first half of 2026. Financially, Q32 Bio reported $78 million in cash and cash equivalents as of December 31, 2024, providing runway into the second half of 2026.

Results - March 8,2025

Phase 2a

• Drug: Bempikibart
• Announced Date: March 8, 2025
• Indication: For Severe Alopecia Areata

Q32 Bio Inc. announced additional results from Part A of its SIGNAL-AA Phase 2a clinical trial of bempikibart in patients with alopecia areata (AA) at the 2025 American Academy of Dermatology (AAD) Meeting in Orlando, FL.

Q32 Bio Inc. presented promising findings from Part A of its SIGNAL-AA Phase 2a trial for bempikibart at the 2025 American Academy of Dermatology Meeting. The trial focused on patients with severe alopecia areata and demonstrated significant improvements in hair loss, measured by a reduction in Severity of Alopecia Tool (SALT) scores. At week 24, patients treated with bempikibart experienced notable decreases in their SALT scores compared to the placebo group. Remarkably, many patients maintained or even deepened their hair regrowth after dosing ended at week 24, with continued positive results observed through week 36 and up to week 55 in some cases. The data further indicated that bempikibart is safe and well-tolerated, with supportive pharmacokinetic and receptor engagement results, emphasizing its potential as a long-lasting treatment option for alopecia areata.