Chimerix (CMRX) FDA Approvals

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.

Abstract - November 11,2025

• Drug: dordaviprone
• Announced Date: November 11, 2025
• Indication: treatment for recurrent H3 K27M-mutant diffuse glioma
• Other Companies Involved: NASDAQ:JAZZ

Jazz Pharmaceuticals plc announced that the company will present five abstracts at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting taking place November 19-23 in Honolulu, Hawaii.

Provided Update - September 9,2025

• Drug: dordaviprone
• Announced Date: September 9, 2025
• Indication: treatment for recurrent H3 K27M-mutant diffuse glioma
• Other Companies Involved: NASDAQ:JAZZ

Jazz Pharmaceuticals plc announced that Modeyso™ (dordaviprone) is recommended by the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a category 2A single-agent treatment option for pediatric and adult patients with recurrent or progressive diffuse high-grade glioma harboring an H3 K27M mutation.

Jazz Pharmaceuticals plc today announced that Modeyso™ (dordaviprone) has been added to the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology as a category 2A single-agent treatment option. The recommendation covers both pediatric and adult patients whose diffuse high-grade glioma has returned or worsened and carries the H3 K27M mutation.

This guideline update marks the first time a targeted therapy is endorsed for these patients, reflecting an urgent need for new options against this aggressive brain tumor. The NCCN Guidelines are widely used by doctors, nurses, pharmacists and payers to guide cancer care and help improve patient outcomes. Modeyso is now commercially available in the United States for those with recurrent or progressive H3 K27M-mutant diffuse high-grade glioma, offering hope to patients and families facing limited treatment choices.

FDA GRANT - August 6,2025

• Drug: dordaviprone
• Announced Date: August 6, 2025
• Indication: treatment for recurrent H3 K27M-mutant diffuse glioma
• Other Companies Involved: NASDAQ:JAZZ

Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Modeyso™ (dordaviprone) for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.

Jazz Pharmaceuticals announced the FDA has granted accelerated approval to Modeyso (dordaviprone) for adults and children (1 year and older) with diffuse midline glioma carrying an H3 K27M mutation after prior therapy fails. This is the first FDA-approved therapy for this rare, aggressive brain tumor that affects about 2,000 people annually, many of them children and young adults.

Modeyso is taken once weekly as an oral capsule. The approval is based on an integrated analysis of 50 patients from five studies, showing an overall response rate of 22%, with some patients responding for over 10 months. Seventy-three percent of responders maintained benefit for at least six months.

Continued approval depends on confirming clinical benefit in the Phase 3 ACTION trial. Modeyso is expected to be available commercially in the coming weeks, addressing a critical unmet need in neuro-oncology.

PDUFA Date - February 18,2025

NDA

• Drug: dordaviprone
• Announced Date: February 18, 2025
• Target Action Date: August 18, 2025
• Indication: treatment for recurrent H3 K27M-mutant diffuse glioma

Chimerix announced that PDUFA Target Action Date of August 18, 2025

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.

FDA Accepted - February 18,2025

NDA

• Drug: dordaviprone
• Announced Date: February 18, 2025
• Indication: treatment for recurrent H3 K27M-mutant diffuse glioma

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.

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.

NDA Filing - December 30,2024

NDA

• Drug: dordaviprone
• Announced Date: December 30, 2024
• Indication: treatment for recurrent H3 K27M-mutant diffuse glioma

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.

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.

NDA Filing - December 9,2024

NDA

• Drug: dordaviprone
• Announced Date: December 9, 2024
• Indication: treatment for recurrent H3 K27M-mutant diffuse glioma

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.

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.