Chimerix Delivers More Than 130% Gain In Less Than 3 Months

Chimerix

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(RTTNews) - Shares of Chimerix (CMRX) touched a new high of $5.15 yesterday, with the company moving one step closer to its goal of accelerating access to the first medicine specific to patients diagnosed with recurrent H3 K27M-mutant diffuse glioma.

H3 K27M-mutant diffuse glioma is a highly aggressive and rare form of brain cancer, classified as WHO Grade 4. It primarily affects children and young adults, with over 2,000 new cases diagnosed annually in the United States. Surgical resection is challenging due to the tumor's location, and current treatment options are limited to radiotherapy, though the tumor almost always recurs. Despite the severity of this condition, there are no approved therapies specifically targeting H3 K27M mutations. The median overall survival for patients is approximately one year from diagnosis, with survival dropping to just 5.1 months from recurrence.

The company's New Drug Application seeking accelerated approval for its lead drug candidate Dordaviprone as a treatment for patients with recurrent H3 K27M-mutant diffuse glioma, has been granted Priority Review, with a decision date set for August 18, 2025. The FDA does not currently plan to hold an advisory committee meeting to discuss the application.

A phase III trial of Dordaviprone, dubbed ACTION, is enrolling H3 K27M-mutant diffuse glioma patients at over 150 sites in 17 countries. In this trial, patients are randomized 1:1:1 to receive Dordaviprone at one of two dosing frequencies or placebo, i.e.,625mg of Dordaviprone once per week (the Phase 2 dosing regimen), 625mg on two consecutive days per week or placebo. Patients are enrolled in this study shortly after they have completed front-line radiation therapy which is the standard of care for glioma.

Chimerix expects interim data from the ACTION study in the third quarter of 2025.

The second drug candidate in clinical development is ONC206, currently being evaluated in two phase I dose escalation trials in patients with advanced central nervous system (CNS) tumors. The study is being conducted in partnership with the National Institutes of Health (NIH) and with the Pacific Pediatric Neuro-Oncology Consortium (PNOC).

Cash Position

Chimerix ended September 30, 2024, with $152.4 million of capital available to fund operations and no outstanding debt.

The company's common stock began trading on the NASDAQ Global Market under the symbol "CMRX" on April 11, 2013, priced at $14 per share.

We featured Chimerix on our site on Dec.10, 2024, when it was trading at $2.18.

In the last 1 year, CMRX has traded in a range of $0.75 to $5.15. The stock closed yesterday's trading at $4.83, up 10.27%.