Chimerix's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Chimerix (CMRX).
Over the past two years, Chimerix has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
dordaviprone. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Dordaviprone FDA Regulatory Timeline and Events
Dordaviprone is a drug developed by Chimerix for the following indication: treatment for recurrent H3 K27M-mutant diffuse glioma.
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:
- dordaviprone
- Announced Date:
- February 18, 2025
- Indication:
- treatment for recurrent H3 K27M-mutant diffuse glioma
Announcement
Chimerix announced the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) seeking accelerated approval for dordaviprone as a treatment for patients with recurrent H3 K27M-mutant diffuse glioma.
AI Summary
Chimerix has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for dordaviprone. The company is seeking accelerated approval for this drug to treat patients with recurrent H3 K27M-mutant diffuse glioma—a form of high-grade brain tumor with very few treatment options. The NDA has been granted Priority Review, and the FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 18, 2025. Notably, the FDA does not currently plan to host an advisory committee meeting for further discussion of the application.
This acceptance is a significant milestone for Chimerix. It not only highlights progress towards providing a new treatment option for a challenging disease, but it also underscores the company’s commitment to expediting access to care for patients facing dire prognoses.
Read Announcement- Drug:
- dordaviprone
- Announced Date:
- February 18, 2025
- Estimated Event Date Range:
- August 18, 2025 - August 18, 2025
- Target Action Date:
- August 18, 2025
- Indication:
- treatment for recurrent H3 K27M-mutant diffuse glioma
Announcement
Chimerix announced that PDUFA Target Action Date of August 18, 2025
AI Summary
Chimerix announced that the FDA has accepted its New Drug Application for dordaviprone, a potential treatment for patients with recurrent H3K27M-mutant diffuse glioma. The drug has been granted Priority Review and has a PDUFA Target Action Date of August 18, 2025. This decision highlights a major step forward for the company as it works to bring a new treatment option to patients who face very few choices beyond palliative care.
The application is backed by special designations such as Rare Pediatric Disease, Fast Track, and Orphan Drug status. Although the FDA will not hold an advisory committee meeting for this application, Chimerix is preparing for a potential commercial launch. The company is committed to accelerating access and improving the lives of patients dealing with this aggressive brain tumor.
Read Announcement- Drug:
- dordaviprone
- Announced Date:
- December 30, 2024
- Indication:
- treatment for recurrent H3 K27M-mutant diffuse glioma
Announcement
Chimerix today confirms that the Company has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking accelerated approval for dordaviprone as a treatment for patients with recurrent H3 K27M-mutant diffuse glioma in the United States.
AI Summary
Chimerix has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for dordaviprone as a treatment for patients with recurrent H3 K27M-mutant diffuse glioma in the United States. This submission marks an important milestone for the company as it moves closer to making the potentially life-changing drug available to patients. Chimerix is preparing for a commercial launch next year and has upgraded its commercial capabilities, including market access, distribution, reimbursement, patient services, and manufacturing, to ensure widespread availability of the treatment if it is approved. The NDA includes a request for Priority Review, which could result in a six-month FDA review process and a potential action date in the third quarter of 2025. Additionally, dordaviprone has received a Rare Pediatric Disease Designation, supporting its development for this serious condition.
Read Announcement- Drug:
- dordaviprone
- Announced Date:
- December 9, 2024
- Indication:
- treatment for recurrent H3 K27M-mutant diffuse glioma
Announcement
Chimerix announced that, following extensive dialogue with the U.S. Food and Drug Administration (FDA), the Company plans to submit a complete New Drug Application (NDA) seeking accelerated approval for dordaviprone as a treatment for recurrent H3 K27M-mutant diffuse glioma in the United States before year-end.
AI Summary
Chimerix announced that after extensive discussions with the U.S. FDA, the company will submit a complete New Drug Application (NDA) before the end of the year. The NDA seeks accelerated approval for dordaviprone as a treatment for recurrent H3 K27M-mutant diffuse glioma, a lethal form of brain cancer with very limited treatment options. The accelerated pathway aims to address an urgent, unmet medical need, potentially making dordaviprone the first FDA-approved therapy for this disease. Chimerix has focused on generating robust clinical data to support the application, including results from a Phase 2 study and other supportive analyses. Alongside this, the company has strengthened its commercial team to prepare for an anticipated U.S. launch possibly in the third quarter of 2025, should the regulatory review progress favorably.
Read Announcement
Chimerix FDA Events - Frequently Asked Questions
As of now, Chimerix (CMRX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Chimerix (CMRX) has reported FDA regulatory activity for dordaviprone.
The most recent FDA-related event for Chimerix occurred on February 18, 2025, involving dordaviprone. The update was categorized as "FDA Accepted," with the company reporting: "Chimerix announced the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) seeking accelerated approval for dordaviprone as a treatment for patients with recurrent H3 K27M-mutant diffuse glioma."
Currently, Chimerix has one therapy (dordaviprone) targeting the following condition: treatment for recurrent H3 K27M-mutant diffuse glioma.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:CMRX) was last updated on 7/18/2025 by MarketBeat.com Staff
