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.
News about Chimerix, Inc. (NASDAQ: CMRX) centers on its work as a biopharmaceutical company developing medicines for patients facing deadly diseases, with a particular focus on rare and high-grade brain tumors. Recent press releases emphasize the company’s lead clinical program, dordaviprone (ONC201), in development for H3 K27M-mutant diffuse glioma.
Investors and followers of CMRX news will find updates on key regulatory milestones, including the U.S. Food and Drug Administration’s acceptance of Chimerix’s New Drug Application for dordaviprone in recurrent H3 K27M-mutant diffuse glioma, Priority Review status, and the assigned PDUFA target action date of August 18, 2025. Company news also highlights Rare Pediatric Disease Designation, Fast-Track Designation, and Orphan Drug Designation for dordaviprone in multiple regions.
Chimerix news releases describe ongoing clinical development activities, such as the Phase 3 ACTION trial in newly diagnosed, non-recurrent H3 K27M-mutant diffuse glioma patients following radiation, and Phase 1 dose escalation studies of ONC206 to evaluate safety and pharmacokinetic data. Additional items include corporate events like participation in oncology and precision medicine forums and updates on equity inducement grants under Nasdaq Listing Rule 5635(c)(4).
Another major theme in recent CMRX coverage is the definitive agreement for Jazz Pharmaceuticals to acquire Chimerix for approximately $935 million in cash. News articles outline the transaction terms, expected closing timing subject to customary conditions, and how dordaviprone would fit within Jazz’s rare oncology portfolio. For readers tracking CMRX, this news stream provides a view into Chimerix’s clinical progress, regulatory interactions, and announced strategic transaction with Jazz.
Chimerix (CMRX) announced the launch of the ONC201 Phase 3 ACTION study, focusing on its potential approval for treating glioma. Recent analyses showed that patients with recurrent H3 K27M-mutant glioma have a median overall survival (OS) of 5.1 months without ONC201, compared to 13.7 months in earlier Phase 2 data. External studies presented at SNO indicated significant OS benefits for ONC201-treated patients. Following FDA feedback, Chimerix plans to reduce workforce by 25% to streamline oncology efforts, positioning itself for future success in clinical trials.
Chimerix (NASDAQ:CMRX) recently addressed potential liquidation discussions with Rubric Capital Management. The company emphasized its commitment to its Phase 3 neuro-oncology program, ONC201, which targets a significant patient need. Chimerix highlighted its recent sale of TEMBEXA as a funding source for ongoing oncology developments, asserting that liquidation would hinder progress and deprive shareholders of potential gains. The leadership remains optimistic about creating value through continued advancements in their product pipeline, especially with promising Phase 2 data for ONC201.
Rubric Capital Management, owning about 8.5% of Chimerix (CMRX), has expressed concerns regarding the company's strategy and calls for a winddown process. The investment advisor highlights a significant discount of the share price to its liquidation value and urges management to conserve cash while exploring strategic alternatives for ONC201. They estimate a liquidation value of $2.95 to $4.36 per share, implying a potential return of 52% to 125% based on recent prices. Rubric emphasizes the urgent need for cost reduction and a change in direction to protect shareholder value.
Chimerix (CMRX) announced a strong financial position with approximately $285 million in cash as of September 30, 2022. The company is on track to open enrollment for its Phase 3 ACTION study of ONC201 in November and has scheduled a meeting with the FDA to discuss accelerated approval. Chimerix reported net income of $241.4 million for Q3 2022, with revenues rising to $32.6 million, driven by international sales of TEMBEXA. R&D expenses increased to $15.3 million as the company focuses on oncology treatments.
Chimerix (NASDAQ:CMRX) will host a live conference call on November 3, 2022, at 8:30 a.m. ET to report its financial results for Q3 2022, ending September 30, 2022. The event aims to provide insights into the company’s business overview. Investors can join by dialing (646) 307-1963 for domestic calls or (800) 715-9871 for international calls, with the conference ID 2765632. A live audio webcast will also be available on Chimerix's website, and an archived version will be accessible shortly after the event.
Chimerix, Inc. (CMRX) announced the sale of its antiviral drug TEMBEXA to Emergent BioSolutions, receiving $238 million upfront. This transaction also includes potential milestone payments totaling up to $136.5 million and royalties on future sales. The sale is expected to enhance Chimerix's financial position, supporting the ongoing development of its oncology product ONC201, specifically for treating H3 K27M mutant gliomas. TEMBEXA is FDA-approved for smallpox treatment, although its efficacy in humans remains unproven due to ethical concerns.
Chimerix (NASDAQ:CMRX) announced that CEO Mike Sherman will present a pre-recorded corporate presentation at the H.C. Wainwright 24th Annual Global Investment Conference. The presentation will be accessible on September 12, 2022, at 7:00 a.m. ET. An audio webcast of the presentation will also be available on Chimerix's Investor Relations website for about 90 days. Chimerix is dedicated to developing treatments that enhance the lives of patients with severe diseases, with its leading program, ONC201, focused on H3 K27M-mutant glioma.
Chimerix (NASDAQ:CMRX) has secured a multi-year contract with BARDA for the provision of up to 1.7 million treatment courses of TEMBEXA, with an initial procurement of 319,000 courses valued at $115 million. This 10-year contract could reach a total value of $680 million, including future procurements and post-marketing activities. Emergent BioSolutions, Inc. will make an upfront payment of $238 million and potential milestones of up to $124 million for TEMBEXA. The drug, approved for smallpox treatment, offers a vital therapeutic option in emergencies.
Chimerix (NASDAQ:CMRX) has announced plans to initiate the Phase 3 ACTION study for ONC201 targeting H3 K27M-mutant glioma this year. Following international agreements, approximately $32 million in revenue from TEMBEXA has been recognized. The company obtained U.S. anti-trust clearance for the $225 million sale of TEMBEXA to Emergent BioSolutions. Chimerix reported a net loss of $23.5 million for Q2 2022, up from $17.8 million YoY, with R&D expenses rising to $18 million. The company expects to use recent revenues to fund clinical studies and further pipeline development.
Chimerix (NASDAQ:CMRX), a biopharmaceutical company, announced its participation in the Targeted Oncology panel at the 2022 Wedbush PacGrow Healthcare Conference on August 9, 2022, at 10:20 a.m. During this event, the management will discuss their mission to develop life-extending medicines for patients facing deadly diseases. A live audio webcast of the presentation will be available on the Investor Relations section of Chimerix’s website, where it will remain archived for approximately 90 days.
Chimerix's advanced development program focuses on ONC201 for H3 K27M-mutant glioma.