This section highlights FDA-related milestones and regulatory updates for drugs developed by Mural Oncology (MURA).
Over the past two years, Mural Oncology has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ARTISTRY-7 and nemvaleukin. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ARTISTRY-7 - FDA Regulatory Timeline and Events
ARTISTRY-7 is a drug developed by Mural Oncology for the following indication: pre-treated patients with platinum-resistant ovarian cancer (PROC).
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:
- ARTISTRY-7
- Announced Date:
- April 15, 2025
- Indication:
- pre-treated patients with platinum-resistant ovarian cancer (PROC)
Announcement
Mural Oncology plc announced that following review of data from its phase 2 ARTISTRY-6 trial in melanoma and previously announced results from the phase 3 ARTISTRY-7 trial in platinum-resistant ovarian cancer, the company is discontinuing all clinical development of nemvaleukin alfa and plans to immediately commence the exploration of strategic alternatives focused on maximizing shareholder value. Mural has engaged Lucid Capital Markets, LLC to act as its financial advisor in connection with the exploration of strategic alternatives.
AI Summary
Mural Oncology plc announced it will stop all clinical development of nemvaleukin alfa. This decision comes after the company reviewed data from its phase 2 ARTISTRY-6 trial in melanoma and phase 3 ARTISTRY-7 trial in platinum-resistant ovarian cancer. The results did not meet the expected outcomes, prompting the halt in development.
In response, Mural plans to immediately explore strategic alternatives focused on maximizing shareholder value. These alternatives may include an acquisition, merger, or other business combinations. To assist in this process, the company has engaged Lucid Capital Markets, LLC as its financial advisor. Mural will continue to update investors as further developments occur.
Read Announcement- Drug:
- ARTISTRY-7
- Announced Date:
- September 26, 2024
- Indication:
- pre-treated patients with platinum-resistant ovarian cancer (PROC)
Announcement
Mural Oncology plc announced that it will host a virtual Investor Day today beginning at 10 a.m. ET. Mural leadership will provide new clinical insight into the trial design, statistical assumptions, and progress of the company's late-stage trials of nemvaleukin.
AI Summary
Mural Oncology plc is hosting a virtual Investor Day today at 10 a.m. ET. During the event, Mural’s leadership will share important updates about the company’s late-stage trials of their novel cytokine therapy, nemvaleukin. The management team will provide fresh clinical insights into the trial design and the statistical assumptions behind these studies. They will also discuss the progress made in the clinical development of nemvaleukin, which is being tested in platinum-resistant ovarian cancer and mucosal melanoma—two areas with limited treatment options and unsatisfactory outcomes. Additionally, the session will include discussions with clinicians who will review the treatment landscape for these tough-to-treat cancers. This initiative marks a significant step forward in communicating the company’s clinical strategy and progress, highlighting Mural Oncology’s commitment to advancing promising new cancer treatments.Read Announcement
- Drug:
- ARTISTRY-7
- Announced Date:
- September 26, 2024
- Estimated Event Date Range:
- October 1, 2025 - December 31, 2025
- Target Action Date:
- Q4 2025
- Indication:
- pre-treated patients with platinum-resistant ovarian cancer (PROC)
Announcement
Mural Oncology plc announced that IND submission for Mural's IL-18 program planned for Q4 2025
AI Summary
Mural Oncology plc recently announced plans for its IL-18 program. The company will nominate a development candidate by the end of 2024 and aims to submit an Investigational New Drug (IND) application to the FDA in Q4 2025. This milestone is part of Mural’s ongoing work to develop new cytokine therapies that boost the immune response against cancer.
The redesigned IL-18 program is built to overcome the challenges of the native molecule, which is weakened by a decoy receptor that normally stops it from working well. By eliminating this barrier and extending the treatment’s effects, the program could provide an important new option for patients in need. Mural’s move to seek IND approval is a key step toward showing that this innovative approach may help address unmet needs for cancer patients.
Read Announcement
nemvaleukin - FDA Regulatory Timeline and Events
nemvaleukin is a drug developed by Mural Oncology for the following indication: For 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:
- nemvaleukin
- Announced Date:
- March 25, 2025
- Indication:
- For Solid Tumors
Announcement
Mural Oncology plc announced that the ARTISTRY-7 phase 3 trial of nemvaleukin alfa in combination with Merck's (known as MSD outside the US and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) versus investigator's choice chemotherapy in patients with platinum-resistant ovarian cancer (PROC) will not continue to final analysis and the company will cease development of nemvaleukin for PROC.
AI Summary
Mural Oncology announced that the ARTISTRY-7 phase 3 trial, studying nemvaleukin alfa with KEYTRUDA® (pembrolizumab) in patients with platinum-resistant ovarian cancer, will not move to its final analysis. The decision comes after an interim analysis showed that the combination did not significantly improve overall survival compared to investigator-choice chemotherapy. In the study, the median overall survival was approximately 10.1 months for the combination treatment versus 9.8 months for standard chemotherapy. As a result, the company plans to cease development of nemvaleukin for this indication.
Despite the setback in ovarian cancer, nemvaleukin has been well tolerated in over 800 patients across its clinical program. Mural Oncology remains focused on other areas of development, including a phase 2 trial in mucosal melanoma set to report topline data in the coming months.
Read Announcement- Drug:
- nemvaleukin
- Announced Date:
- October 7, 2024
- Indication:
- For Solid Tumors
Announcement
Mural Oncology plc announced three upcoming poster presentations at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) taking place November 6-10, 2024 in Houston.
AI Summary
Mural Oncology plc has announced three poster presentations at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) scheduled for November 6-10, 2024 in Houston. The company will showcase important new findings related to its immuno-oncology research. One presentation will share data on the tumor microenvironment effects of less frequent dosing of nemvaleukin, an engineered interleukin-2 therapy, from its phase 1/2 ARTISTRY-3 study. Two additional posters will focus on Mural’s preclinical programs, one evaluating enhanced IL-18 fusion proteins that overcome natural inhibition, and the other addressing IL-12 modulation through a novel sequential administration strategy designed to limit systemic toxicity. These presentations aim to highlight Mural Oncology’s innovative approaches designed to improve cancer treatment by optimizing immune responses and reducing side effects.
Read Announcement
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