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-330, WTX-518, WTX-712, and WTX-921. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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:
- 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- Drug:
- WTX-124
- Announced Date:
- May 3, 2024
- Indication:
- Solid Tumors
Announcement
Werewolf continues to focus on the execution of our lead clinical programs WTX-124
AI Summary
Werewolf Therapeutics is continuing to focus on its lead clinical program, WTX-124, which is being developed for the treatment of advanced or metastatic solid tumors. This core initiative remains central to the company’s strategy as it works to deliver conditionally activated therapies that boost the body’s immune response against cancer. At the upcoming ASCO Annual Meeting, Werewolf will present interim data from the dose-escalation portion of its Phase 1/1b trial, where WTX-124 is evaluated both as a single agent and in combination with pembrolizumab. The data presentation is expected to clarify the effective dosing and support further expansion of the clinical program. Meanwhile, the company is also preparing to share first-in-human data for another key asset, WTX-330, reinforcing its commitment to advancing innovative treatments in oncology and immunology.
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WTX-330 - FDA Regulatory Timeline and 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
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 - 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- Drug:
- WTX-330
- Announced Date:
- May 3, 2024
- Indication:
- In multiple tumor types or Non-Hodgkin Lymphoma as a single agent.
Announcement
WTX-330, with updates planned for later in the second quarter.
AI Summary
Werewolf Therapeutics plans to share interim, first-in-human clinical data for WTX-330 later in the second quarter of 2024. WTX-330 is a systemically delivered, conditionally activated Interleukin-12 (IL-12) INDUKINE molecule designed for use as a monotherapy in patients with advanced or metastatic solid tumors, including those resistant or insensitive to immunotherapy and in certain cases of non-Hodgkin lymphoma. The data will come from the ongoing Phase 1 multi-center, open-label clinical trial and is expected to provide important insights into the drug’s safety and clinical potential.
The company is focused on executing its clinical programs and refining its development plan with improved manufacturing processes already aligned with the FDA. These updates reflect Werewolf’s commitment to advancing innovative immunotherapy treatments and building on robust early-stage clinical progress, with further details anticipated later in the second quarter of 2024.
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WTX-518 - FDA Regulatory Timeline and Events
WTX-518 is a drug developed by Werewolf Therapeutics for the following indication: in cancer therapy.
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-518
- Announced Date:
- April 5, 2024
- Indication:
- in cancer therapy.
Announcement
Werewolf Therapeutics, Inc is presenting preclinical data on development candidates WTX-518 in posters at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 5-10 in San Diego, California.
AI Summary
Werewolf Therapeutics, Inc. is showcasing key preclinical data for their development candidate, WTX-518, at the American Association for Cancer Research (AACR) Annual Meeting in San Diego from April 5-10, 2024. WTX-518 is a conditionally activated IL-18 molecule that resists suppression by IL-18BP. In preclinical models, this innovative compound has demonstrated the ability to induce complete tumor regressions by selectively activating the tumor microenvironment. The findings indicate that WTX-518 effectively boosts immune responses by increasing the influx and activity of NK cells and CD8 T cells, which are essential for targeting cancer cells. This new approach, which focuses on the selective release and activation of potent cytokines within tumors, could lead to more effective immunotherapies for cancer patients facing resistant or unresponsive tumors.
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WTX-712 - FDA Regulatory Timeline and Events
WTX-712 is a drug developed by Werewolf Therapeutics for the following indication: in cancer therapy.
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-712
- Announced Date:
- April 5, 2024
- Indication:
- in cancer therapy.
Announcement
Werewolf Therapeutics , is presenting preclinical data on development candidates WTX-712 in posters at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 5-10 in San Diego, California.
AI Summary
At the American Association for Cancer Research (AACR) Annual Meeting in San Diego, Werewolf Therapeutics is showcasing preclinical data on its development candidate WTX-712. WTX-712 is a conditionally activated IL-21 INDUKINETM molecule that has demonstrated strong antitumor activity in preclinical models. According to the data presented in a dedicated poster, WTX-712 works by selectively releasing wild-type IL-21 in the tumor microenvironment, which in turn robustly activates tumor-specific T lymphocytes. This unique mechanism has resulted in tumor regressions in the MC38 mouse tumor model, highlighting the therapeutic potential of WTX-712. The findings suggest that this innovative approach could provide a wider therapeutic window and offer a promising immunotherapy option for tumors that are refractory or resistant to current treatments. Werewolf Therapeutics plans to further develop WTX-712 as part of its expanding portfolio of conditionally activated immunotherapies.
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WTX-921 - FDA Regulatory Timeline and 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.
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