Chimerix Submits Dordaviprone New Drug Application for Accelerated Approval to U.S. FDA for Patients with Recurrent H3 K27M-Mutant Diffuse Glioma

Rhea-AI Summary

Chimerix (NASDAQ: CMRX) has submitted a New Drug Application (NDA) to the FDA seeking accelerated approval for dordaviprone, targeting patients with recurrent H3 K27M-mutant diffuse glioma. The company has requested Priority Review, which could lead to a potential PDUFA date in Q3 2025. Dordaviprone has received Rare Pediatric Disease Designation and the company has applied for a Rare Pediatric Disease PRV.

To support the potential launch, Chimerix has secured access to up to $30 million through a Silicon Valley Bank credit facility. The agreement allows for an initial draw of up to $20 million through February 2026, with an additional $10 million available through February 2027, subject to approval. The company has enhanced its commercial capabilities across multiple functions to prepare for potential market launch.

Positive

• NDA submission completed for dordaviprone with potential accelerated approval pathway
• Secured access to $30 million credit facility to support launch
• Priority Review request could lead to faster approval timeline (Q3 2025)
• Rare Pediatric Disease Designation obtained with potential for PRV

Negative

• No immediate revenue as approval pending
• Additional capital needs through credit facility suggest cash constraints
• Approval timeline extends to Q3 2025 even with Priority Review

Insights

Medical Research Analyst

The NDA submission for dordaviprone represents a important milestone in addressing the significant unmet need in H3 K27M-mutant diffuse glioma treatment. This rare and aggressive form of brain cancer predominantly affects children and young adults, with current treatment options being extremely The request for Priority Review could expedite the approval process substantially, potentially bringing this therapy to market by Q3 2025.

The accelerated approval pathway being pursued indicates that dordaviprone has shown promising clinical data in terms of surrogate endpoints that are reasonably likely to predict clinical benefit. This regulatory strategy is particularly relevant for rare diseases where conducting large-scale clinical trials can be challenging due to patient populations.

The Rare Pediatric Disease Designation and potential Priority Review Voucher (PRV) add significant value - PRVs are transferable and have historically sold for $100-200 million, representing a potential future monetization opportunity beyond the drug's direct commercial potential.

Financial Analyst

The secured credit facility of up to $30 million from Silicon Valley Bank strategically positions Chimerix for a potential commercial launch. The flexible draw-down structure through 2026, with additional options through 2027, provides important financial runway without immediate dilution to shareholders. This financing approach is particularly shrewd given current market conditions and biotech funding environment.

The company's proactive investment in commercial infrastructure suggests confidence in approval prospects and demonstrates strategic foresight in preparation for market entry. The rare disease market typically commands premium pricing and with competition in this indication, dordaviprone could represent a significant revenue opportunity.

The potential award of a Priority Review Voucher represents a valuable asset that could be monetized to further strengthen the balance sheet. Combined with the credit facility, this provides multiple options for funding the commercial launch without immediate need for equity financing, which is particularly advantageous in preserving shareholder value.

Secures Access of Up To $30 Million to Support Potential Launch Through Silicon Valley Bank Credit Facility

DURHAM, N.C., Dec. 30, 2024 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ: CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, 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.

“This NDA submission marks a pivotal moment for Chimerix in our mission to bring this potentially life-altering drug to patients diagnosed with recurrent H3 K27M-mutant diffuse glioma,” said Mike Andriole, Chief Executive Officer of Chimerix. “With this submission, we now turn our attention to preparing for potential commercial launch in the U.S. next year. To maximize availability and access of dordaviprone at launch, we have enhanced our commercial capabilities across multiple functions including market access, distribution, reimbursement, patient services, marketing and commercial operations, all supported by a robust manufacturing and quality management system.”

“We also entered into a credit facility of up to $30 million with Silicon Valley Bank providing access to additional capital during this upcoming investment cycle and helping ensure dordaviprone availability to as many patients as possible, as quickly as possible, if approved. We are grateful to our partners at Silicon Valley Bank for their long-term support of Chimerix. This credit facility provides valuable financial optionality leading up to, and through, a potential U.S. launch of dordaviprone,” said Michelle LaSpaluto, Chief Financial Officer of Chimerix.

Chimerix has requested Priority Review for the NDA. If granted, the resulting six-month FDA review period is expected to result in a potential Prescription Drug User Fee Act (PDUFA) action date in the third quarter of 2025. Dordaviprone has received Rare Pediatric Disease Designation for H3 K27M-mutant glioma and has applied for a Rare Pediatric Disease PRV as part of this NDA submission.

In addition, the Company announced it entered into an amended and restated loan and security agreement for up to $30 million with Silicon Valley Bank (SVB), a division of First-Citizens Bank. Under the terms of the agreement, Chimerix may draw down up to $20.0 million through the period ending February 28, 2026. An additional $10 million may also be made available upon the Company’s request through February 28, 2027, subject to SVB’s approval. No draws have been made on this facility to date.

About Chimerix
Chimerix is a biopharmaceutical company with a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The Company’s most advanced clinical-stage development program, dordaviprone, is in development for H3 K27M-mutant glioma. The Company is conducting Phase 1 dose escalation studies of ONC206 to evaluate safety and PK data.

About Dordaviprone
Dordaviprone (ONC201) is a novel first-in-class small molecule imipridone that selectively targets the mitochondrial protease ClpP and dopamine receptor D2 (DRD2).

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include those relating to, among other things: the availability and use of any future borrowings under the credit facility; the possible regulatory path forward for dordaviprone, including the timing and consequences of accelerated approval, Priority Review, rare pediatric disease Priority Review vouchers and approval for marketing authorization; FDA’s acceptance for filings; the timeline of related discussions with the FDA; the initial potential PDUFA timing; the timing of the U.S. commercial launch; the ability of dordaviprone to attain significant market acceptance among disease experts, patient advocates and their patients; and the expected impact of dordaviprone on patients. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are: risks related to the availability and use of any future borrowings under the credit facility; risks related to the ability to obtain and maintain accelerated approval, Priority Review, rare pediatric disease Priority Review vouchers, and approval for marketing authorization; uncertainty on the response of regulators to including additional supportive data to be submitted in the NDA filing, including RANO 2.0 assessments, and uncertainty with respect to the initial potential PDUFA timing; risks related to the timing, completion and outcome of the Phase 3 ACTION study of dordaviprone; risks associated with market acceptance; risks associated with repeating positive results obtained in prior preclinical or clinical studies in future studies; risks related to the clinical development of our clinical candidates; and additional risks set forth in the Company’s filings with the Securities and Exchange Commission. These forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.

CONTACT:
Will O’Connor
Stern Investor Relations
212-362-1200

Dana Davis
Steelwire Public Relations
dana@steelwire.co

FAQ

When is the expected PDUFA date for Chimerix's (CMRX) dordaviprone NDA?

If Priority Review is granted, the PDUFA date is expected in the third quarter of 2025.

What is the size of the credit facility secured by Chimerix (CMRX) for dordaviprone launch?

Chimerix secured a credit facility of up to $30 million from Silicon Valley Bank, with $20 million available through February 2026 and an additional $10 million through February 2027.

What disease does Chimerix's (CMRX) dordaviprone target?

Dordaviprone targets recurrent H3 K27M-mutant diffuse glioma.

What special designations has Chimerix (CMRX) received for dordaviprone?

Dordaviprone has received Rare Pediatric Disease Designation for H3 K27M-mutant glioma and the company has applied for a Rare Pediatric Disease PRV.

When can Chimerix (CMRX) access the full $30 million credit facility?

$20 million is accessible through February 2026, with an additional $10 million available through February 2027, subject to SVB's approval.