Welcome to our dedicated page for Chimerix news (Ticker: CMRX), a resource for investors and traders seeking the latest updates and insights on Chimerix stock.
Chimerix, Inc. (NASDAQ: CMRX) is a United States-based biopharmaceutical company dedicated to developing innovative medicines that address critical unmet medical needs in patients suffering from life-threatening diseases. With a robust clinical pipeline, Chimerix combines cutting-edge science and proprietary technologies to create novel therapeutics aimed at improving patient outcomes and quality of life.
Core Business Areas
Chimerix operates at the intersection of oncology and antiviral therapeutics. The company's primary focus lies in the research, development, and commercialization of treatments for rare and deadly diseases. Its portfolio includes advanced-stage compounds designed to address significant gaps in the current treatment landscape. By targeting diseases with high unmet medical needs, Chimerix aims to deliver transformative therapies that extend survival and enhance the quality of life for patients globally.
Clinical Pipeline and Innovation
At the heart of Chimerix's innovation is its proprietary lipid technology and novel small molecule platforms. The company is advancing two key clinical-stage programs:
- Dordaviprone (ONC201): A first-in-class imipridone, dordaviprone selectively targets the mitochondrial protease ClpP and dopamine receptor D2 (DRD2). It is currently in a pivotal Phase 3 ACTION trial for H3 K27M-mutant diffuse glioma, a rare and aggressive brain cancer with limited treatment options. Dordaviprone's unique mechanism of action includes reversing hallmark epigenetic modifications associated with this disease.
- ONC206: A second-generation imipridone, ONC206 is a ClpP agonist and DRD2 antagonist with enhanced potency. It is being evaluated in Phase 1 trials for central nervous system (CNS) tumors and solid tumors outside the CNS. Early data suggest a favorable safety profile and potential for significant therapeutic impact.
Chimerix also has a history of antiviral drug development, including compounds targeting double-stranded DNA viruses such as cytomegalovirus (CMV) and smallpox.
Business Model and Revenue Streams
Chimerix generates revenue through a combination of licensing agreements, milestone payments, and royalties. For instance, the company has monetized its antiviral asset TEMBEXA through a partnership with Emergent BioSolutions, which includes royalty payments on sales. This diversified revenue model supports the company's ongoing investment in research and development.
Market Position and Competitive Landscape
Operating within the highly competitive biopharmaceutical industry, Chimerix distinguishes itself through its focus on ultra-rare diseases and first-in-class therapies. Its emphasis on innovative science and regulatory collaboration positions it as a key player in niche markets. Competitors include other oncology-focused biotech firms and companies specializing in antiviral therapeutics. Chimerix's ability to advance its pipeline through clinical trials and secure regulatory approvals will be critical to maintaining its competitive edge.
Challenges and Opportunities
Chimerix faces several challenges, including the inherent risks of clinical development, regulatory approval processes, and the commercialization of therapies for ultra-rare diseases. However, its strategic focus on high-value markets with limited competition offers significant growth opportunities. The company's collaborations with global regulators and its pursuit of accelerated approval pathways further underscore its commitment to addressing urgent medical needs.
Commitment to Patients
Chimerix's mission extends beyond drug development to improving the lives of patients and their families. By targeting diseases with few or no treatment options, the company aims to make a meaningful impact on global health. Its patient-centric approach is evident in its focus on rare pediatric diseases and its efforts to expedite access to life-saving therapies.
Chimerix (NASDAQ:CMRX) has announced the granting of inducement awards to three new employees on February 12, 2025. The awards consist of non-statutory stock options to purchase up to 270,000 shares of Chimerix's common stock, approved by the Compensation Committee of Chimerix's Board of Directors.
The stock options have an exercise price equal to Chimerix's closing trading price on the grant date and a 10-year term. They will vest over four years, with 25% vesting after one year and the remaining 75% vesting monthly over the following three years. While subject to the terms of Chimerix's 2024 Equity Incentive Plan, these grants were made outside of it.
Chimerix is a biopharmaceutical company focused on developing medicines for deadly diseases. Their lead program, dordaviprone (ONC201), is being developed for H3 K27M-mutant glioma, while Phase 1 dose escalation studies of ONC206 are ongoing.
Chimerix (NASDAQ: CMRX) announced FDA acceptance of its New Drug Application (NDA) for dordaviprone, targeting recurrent H3 K27M-mutant diffuse glioma treatment. The application received Priority Review status with a PDUFA target action date of August 18, 2025.
The FDA has not planned an advisory committee meeting for the application review. Dordaviprone has received Rare Pediatric Disease Designation, Fast-Track Designation in the US, and Orphan Drug Designation in the US, Europe, and Australia. The company has applied for a Rare Pediatric Disease Priority Review Voucher in the NDA submission.
If approved, dordaviprone would be the first specific treatment for patients with recurrent H3 K27M-mutant diffuse glioma, a form of high-grade glioma with treatment options beyond palliative care.
Chimerix (NASDAQ: CMRX), a biopharmaceutical company focused on developing life-saving medicines, has announced its participation in the upcoming JonesTrading Virtual Precision Medicine Symposium. Mike Andriole, CEO, and Tom Riga, Chief Operating and Commercial Officer, will engage in a fireside chat on Monday, February 3, 2025, at 11:00 a.m. ET.
The presentation will be accessible via audio webcast through the Investor Relations section of Chimerix's website at ir.chimerix.com. The recording will remain available for approximately 90 days following the event.
Chimerix (NASDAQ:CMRX) has announced the granting of inducement awards to six new employees on January 17, 2025. The awards consist of non-statutory stock options to purchase up to 355,000 shares of Chimerix's common stock. The stock options have a 10-year term and will vest over four years, with 25% vesting after one year and the remaining 75% vesting monthly over the following three years.
The exercise price is set at Chimerix's closing trading price on the grant date. While subject to the terms of Chimerix's 2024 Equity Incentive Plan, these grants were made outside of it. The company, a biopharmaceutical firm, is currently developing dordaviprone (ONC201) for H3 K27M-mutant glioma and conducting Phase 1 dose escalation studies of ONC206.
Chimerix (NASDAQ: CMRX) announced that Chief Scientific Officer Dr. Joshua E. Allen will speak at the Biden Cancer Moonshot Mission Report 2024 forum. The presentation will focus on the program's impact on advancing therapies for brain and rare pediatric cancers, particularly H3 K27M-mutant diffuse glioma.
CEO Mike Andriole highlighted the Cancer Moonshot's achievements in improving health equity in clinical trials and expanding pediatric cancer patient navigation services. Dr. Allen emphasized the program's role as a critical platform for advancing innovation in pediatric and rare cancers.
The company recently submitted a New Drug Application (NDA) for dordaviprone to the FDA, seeking accelerated approval for recurrent H3 K27M-mutant diffuse glioma. With a requested Priority Review, a PDUFA action date could be set for Q3 2025. Dordaviprone has received Rare Pediatric Disease Designation and has applied for a Rare Pediatric Disease Priority Review Voucher.
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.
Chimerix (CMRX) announces plans to submit a New Drug Application (NDA) for dordaviprone to the FDA before year-end, seeking accelerated approval for treating recurrent H3 K27M-mutant diffuse glioma. The company anticipates potential approval by Q3 2025, pending Priority Review.
The submission follows productive FDA interactions and includes key data showing a 28% objective response rate, 10.4-month median duration of response, and 4.6-month median time to response under RANO 2.0 criteria. Dordaviprone could become the first FDA-approved therapy for this rare disease affecting over 2,000 U.S. patients annually.
The drug has received Rare Pediatric Disease Designation and is eligible for a Priority Review Voucher. Chimerix is preparing for potential U.S. launch as early as Q3 2025.
Chimerix (NASDAQ:CMRX) has announced that its Compensation Committee granted inducement awards to three new employees on December 2, 2024. The awards consist of non-statutory stock options to purchase up to 385,000 shares of common stock. The options have a 10-year term with an exercise price equal to Chimerix's closing trading price on the grant date.
The vesting schedule spans four years, with 25% vesting after the first year and the remaining 75% vesting monthly over the following three years. While subject to the terms of Chimerix's 2024 Equity Incentive Plan, these grants were made outside of it. The company, focused on developing medicines for deadly diseases, is currently advancing dordaviprone (ONC201) for H3 K27M-mutant glioma and conducting Phase 1 studies of ONC206.
Chimerix (NASDAQ: CMRX) announced updated Phase 2 response assessment results for dordaviprone in treating recurrent H3 K27M-mutant diffuse midline glioma. Using the new RANO 2.0 criteria, the treatment showed a 28.0% overall response rate, with a median time to response of 4.6 months and a median duration of response of 10.4 months. The company plans to include these updated results in their upcoming New Drug Application to Australian regulators. The findings will be presented at the 2024 Society for Neuro-Oncology Annual Meeting in Houston, along with additional pipeline presentations.
Chimerix (NASDAQ: CMRX) reported Q3 2024 financial results with a net loss of $22.9 million ($0.26 per share), compared to $24.0 million ($0.27 per share) in Q3 2023. Research and development expenses increased to $19.6 million from $17.4 million year-over-year, while general and administrative expenses decreased to $5.2 million from $9.3 million.
The company's Phase 3 ACTION study for dordaviprone remains on track with first interim Overall Survival data expected in Q3 2025. The Independent Data Monitoring Committee recommended continuing the study as planned. Chimerix ended Q3 with $152.4 million in available capital and plans to submit a New Drug Application for Provisional Approval in Australia in the coming months.
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