Shares of Chimerix CMRX have skyrocketed 323.7% in the past three months following the company’s submission of a new drug application (NDA) to the FDA, seeking accelerated approval for its lead candidate, dordaviprone, to treat patients with recurrent H3 K27M-mutant diffuse glioma. CMRX’s dordaviprone is a first-in-class small molecule imipridone with a novel mechanism of action.
Chimerix has also requested the FDA to grant the Priority Review status to the dordaviprone NDA filing for the glioma indication. A filing accepted under the regulatory body’s Priority Review pathway reduces the review period to six months from the standard 10 months. This status is given to treatments that the FDA believes, could significantly improve existing options or provide solutions where no approved therapy exists. Subject to a grant from the FDA, a final decision is expected in the third quarter of 2025.
Please note that CMRX’s dordaviprone already enjoys the Rare Pediatric Disease Designation for H3 K27M-mutant glioma in the United States. Following the NDA submission, the company has also requested the FDA for a Rare Pediatric Disease Priority Review Voucher.
Chimerix, still in the clinical stage, has no marketed drugs. However, potential FDA approval of dordaviprone for K27M-mutant glioma could make it its first approved product, with a U.S. launch planned next year.
In the past six months, CMRX shares have soared 380.7% against the industry’s 9.9% decline.
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More on the NDA Submission for CMRX’s Glioma Drug
Chimerix’s dordaviprone NDA for the glioma indication is supported by the phase II objective response rate of the 50-patient primary efficacy analysis, assessed by a blinded independent central review. Using the latest Response Assessment in Neuro-Oncology 2.0 criteria for gliomas, dordaviprone achieved an objective response rate of 28%, with a median duration of response of 10.4 months and a median time to response of 4.6 months.
Additional clinical data sets and patient narratives that further support the primary efficacy analysis have also been included in the NDA submission. Dordaviprone has demonstrated the ability to reverse the central hallmark of H3 K27M-mutant glioma, H3K27 trimethyl loss, in both clinical and nonclinical studies. A robust safety database, including data from glioma patients and healthy volunteers, underscores the candidate’s favorable benefit/risk profile. Comprehensive clinical pharmacology and CMC studies also strengthen the NDA submission.
H3 K27M-mutant gliomas are highly aggressive, impacting more than 2,000 patients annually in the United States. If approved, dordaviprone would be the first FDA-approved treatment for this deadly disease and among the first molecularly targeted therapies for high-grade gliomas.
Chimerix has also recently amended its loan agreement with Silicon Valley Bank (SVB), securing up to $30 million in funding. Per the agreement, the company can access $20 million until Feb. 28, 2026, with an additional $10 million available upon SVB’s approval through Feb. 28, 2027. No funds have been drawn yet.
The company plans to use this credit facility to aid the launch of dordaviprone in the United States, subject to approval, to help ensure maximum patient accessibility.
CMRX’s Ongoing Pipeline Programs
Chimerix is currently evaluating dordaviprone in a phase III ACTION study, which is currently enrolling H3 K27M-mutant diffuse glioma patients at more than 145 sites in 15 countries. Interim overall survival data is expected in the third quarter of 2025. Positive results could convert a potential accelerated approval of dordaviprone into full approval.
The company also has another clinical candidate, ONC206, which is being evaluated in early-stage, dose-escalating studies for adult and pediatric patients with advanced central nervous system tumors.
Chimerix, Inc. Price and Consensus
Chimerix, Inc. Price and Consensus
Chimerix, Inc. price-consensus-chart | Chimerix, Inc. Quote
CMRX's Zacks Rank & Stocks to Consider
Chimerix currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the sector are Castle Biosciences CSTL, BioMarin Pharmaceutical BMRN and Alnylam Pharmaceuticals ALNY. While CSTL and BMRN currently sporta Zacks Rank #1 (Strong Buy) each, ALNY carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, Castle Biosciences’ earnings estimates for 2024 have increased from 34 cents to 39 cents per share. During the same timeframe, the loss per share for 2025 has improved from $1.84 to $ 1.70. In the past three months, shares of Castle Biosciences have plunged 15.6%.
CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.
In the past 30 days, estimates for BioMarin Pharmaceutical’s 2024 earnings per share have Improved from $3.28 to $3.29. Estimates for 2025 earnings per share have decreased from $4.05 to $4.02 during the same timeframe. In the past three months, BioMarin Pharmaceutical shares have lost 4.2%.
BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 28.7%.
In the past 30 days, estimates for Alnylam Pharmaceuticals’ 2024 loss per share have remained constant at 39 cents. The estimate for 2025 earnings per share is currently pegged at 41 cents. In the past three months, shares of Alnylam Pharmaceuticals have gained 2.3%.
ALNY’s earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 65.67%.
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