This section highlights FDA-related milestones and regulatory updates for drugs developed by Werewolf Therapeutics (HOWL).
Over the past two years, Werewolf Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
WTX-124, WTX-921, and WTX-330. 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.
WTX-124 FDA Regulatory Timeline and Events
WTX-124 is a drug developed by Werewolf 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:
- WTX-124
- Announced Date:
- December 18, 2025
- Indication:
- Solid Tumors
Announcement
Werewolf Therapeutics announced a pipeline update, including a review of recent data for its INDUKINE™ programs, and a business overview of its priorities for 2026 that includes a focus on the Company's highly differentiated INDUCER T cell engager platform.
Read Announcement- Drug:
- WTX-124
- Announced Date:
- October 8, 2025
- Indication:
- Solid Tumors
Announcement
Werewolf Therapeutics, Inc. announced that the Company has received Fast Track Designation for the use of WTX-124 for the potential treatment of patients with locally advanced or metastatic cutaneous melanoma after standard of care immunotherapy.
AI Summary
Werewolf Therapeutics announced that the FDA granted Fast Track Designation to WTX-124 for treating patients with locally advanced or metastatic cutaneous melanoma after standard immunotherapy. WTX-124 is a conditionally activated interleukin-2 (IL-2) INDUKINE therapy designed to deliver IL-2 directly to the tumor microenvironment, which aims to spark a strong anti-tumor immune response while reducing the toxic side effects seen with conventional IL-2 treatments. Fast Track status will allow more frequent interactions with the FDA and could speed up the therapy’s development and review.
WTX-124 is being evaluated in a Phase 1/1b open-label, multicenter study (NCT05479812) as both a standalone treatment and in combination with pembrolizumab for several advanced solid tumors. Daniel J. Hicklin, PhD, President and CEO of Werewolf, emphasized the urgent need for new options in relapsed or refractory melanoma. The company expects to present preliminary Phase 1/1b data, including results for cutaneous melanoma patients, in the fourth quarter and to discuss a registration strategy with the FDA.
Read Announcement- Drug:
- WTX-124
- Announced Date:
- October 3, 2025
- Indication:
- Solid Tumors
Announcement
Werewolf Therapeutics, Inc announced that three posters will be presented at the upcoming Society for Immunotherapy of Cancer's (SITC) 40th Annual Meeting, taking place November 5-9, 2025, in National Harbor, Maryland.
AI Summary
Werewolf Therapeutics, Inc. announced that it will present three posters at the Society for Immunotherapy of Cancer’s 40th Annual Meeting, held November 5–9, 2025, in National Harbor, Maryland. The company’s research focuses on conditionally activated immunotherapies designed to target tumors while limiting toxicity.
The first poster (Abstract 861) covers sequential dosing of WTX-124 and mWTX-330, IL-2 and IL-12 INDUKINE™ molecules. In mouse models with poorly immunogenic EMT6 tumors, this approach boosted antitumor activity without causing systemic side effects. It will be displayed on November 7 in Poster Hall A and B1.
The second poster (Abstract 964) discusses the development of INDUCER™ T cell engagers. A novel masking technique helps prevent dose-limiting cytokine release and reduces off-target toxicity. It will be shown on November 8 in the same poster hall.
The third poster (Abstract 862) offers pharmacokinetic insights into WTX-124 prodrug activation in real time, demonstrating tumor-specific immune modulation. It is also scheduled for November 8 in Poster Hall A and B1.
Read Announcement- Drug:
- WTX-124
- Announced Date:
- January 13, 2025
- Indication:
- Solid Tumors
Announcement
Werewolf Therapeutics, today provided a business update and outlined its strategic outlook and expected milestones for 2025.
AI Summary
Werewolf Therapeutics provided a business update outlining its strategic plans and milestones for 2025. The company plans to release interim data from its WTX-124 monotherapy expansion arms in the first half of 2025. This data is expected to help guide regulatory discussions and explore potential registrational pathways for the treatment. In addition, Werewolf anticipates sharing data from the combination expansion arms, where WTX-124 is used with pembrolizumab, in the fourth quarter of 2025.
Furthermore, the company will kick off a Phase 1/2 dose and regimen-finding clinical trial for WTX-330 in the first quarter of 2025. Werewolf’s update also highlights strong financial positioning, with cash expected to support operations through at least the second quarter of 2026.
Read Announcement
WTX-921 FDA Regulatory Events
WTX-921 is a drug developed by Werewolf Therapeutics for the following indication: for Inflammatory Diseases.
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:
- WTX-921
- Announced Date:
- May 5, 2025
- Indication:
- for Inflammatory Diseases
Announcement
Werewolf Therapeutics, Inc. announced a poster presentation further characterizing its conditionally-activated IL-10 INDUKINE molecule, WTX-921, at IMMUNOLOGY2025, the annual meeting of the American Association of Immunologists (AAI) taking place May 3-7 in Honolulu, Hawaii.
AI Summary
Werewolf Therapeutics, Inc. announced a poster presentation at IMMUNOLOGY2025, the annual meeting of the American Association of Immunologists, held May 3–7 in Honolulu, Hawaii. The company shared new data on WTX-921, its conditionally activated IL-10 INDUKINE molecule aimed at treating inflammatory bowel disease (IBD). The poster, titled “Development of WTX-921, A Conditionally Active IL-10 INDUKINETM Molecule for the Treatment of Inflammatory Bowel Disease” (Board #1230), builds on earlier proof-of-concept findings. It demonstrates that WTX-921 can reduce tissue damage and inflammatory cytokine production in a mouse colitis model. The data also confirm that the molecule effectively masks IL-10 to limit unwanted effects outside inflamed tissues. This targeted approach may overcome the toxicities usually seen with systemic IL-10 treatments, offering a more precise therapy for patients with IBD.
Read Announcement
WTX-330 FDA Regulatory Events
WTX-330 is a drug developed by Werewolf Therapeutics for the following indication: In multiple tumor types or Non-Hodgkin Lymphoma as a single agent.
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:
- WTX-330
- Announced Date:
- June 25, 2024
- Target Action Date:
- Q4 2024
- Estimated Target Date Range:
- October 1, 2024 - December 31, 2024
- Indication:
- In multiple tumor types or Non-Hodgkin Lymphoma as a single agent.
Announcement
Werewolf Therapeutics, Inc announced that additional results anticipated in the fourth quarter of 2024 -
AI Summary
Werewolf Therapeutics, Inc. announced that they expect to share additional results from their Phase 1 WTX-330 study in the fourth quarter of 2024. The company is expanding the trial with arms for patients who have advanced tumors that are either resistant to checkpoint inhibitors or are relapsed/refractory. Early trial data showed that WTX-330, a conditionally activated IL-12 prodrug, reached therapeutically relevant levels with an improved tolerability profile compared to previous IL-12 therapies. Preliminary findings indicate encouraging signs of immune activation and potential clinical activity in heavily pretreated patients. With the ongoing expansion, further safety, biomarker, and antitumor activity data will help clarify WTX-330’s potential benefit for patients with difficult-to-treat tumors. The upcoming data presentation in the fourth quarter of 2024 is highly anticipated by the medical and research communities.
Read Announcement- Drug:
- WTX-330
- Announced Date:
- June 25, 2024
- Indication:
- In multiple tumor types or Non-Hodgkin Lymphoma as a single agent.
Announcement
Werewolf Therapeutics, Inc. announced initial results from the Phase 1 clinical trial evaluating WTX-330, its conditionally activated interleukin-12 (IL-12) INDUKINE™ molecule, as monotherapy in patients with immunotherapy insensitive or resistant locally advanced or metastatic solid tumors or non-Hodgkin lymphoma.
AI Summary
Werewolf Therapeutics, Inc. announced initial Phase 1 clinical trial results for WTX-330, its conditionally activated interleukin-12 (IL-12) INDUKINE™ molecule. The study tested WTX-330 as a monotherapy in patients with advanced solid tumors or non-Hodgkin lymphoma that did not respond to previous immunotherapies. Early data showed that patients reached levels of the IL-12 prodrug that are considered therapeutically effective, with an improved safety profile compared to historical treatments using recombinant human IL-12. One metastatic melanoma patient experienced an unconfirmed partial response, while other patients with colorectal cancer maintained stable disease and showed signs of immune system activation. The results mark encouraging progress in targeting the tumor microenvironment and reducing severe toxicities typically seen with IL-12 therapies. Future updates from the expansion phases of the trial are expected later in 2024.
Read Announcement
