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 (NASDAQ:CMRX) announced positive topline results from ONC201 for treating recurrent H3 K27M-mutant glioma, showing a 20% overall response rate. Additionally, the FDA published a benefit-risk assessment of TEMBEXA for smallpox. In the third quarter of 2021, Chimerix reported a net loss of $18.6 million and revenues of $0.1 million, a decline from $1.6 million the previous year. R&D expenses rose to $13.8 million, driven by an expanded pipeline following the Oncoceutics acquisition. The company has $125 million in capital to fund operations.
Chimerix (NASDAQ:CMRX) announced positive topline data for ONC201, reporting a 20.0% objective response rate for recurrent H3 K27M-mutant glioma patients. The median duration of response was 11.2 months, and the median time to response was 8.3 months. These results, highlighted by leading oncologists, showcase the treatment's potential for patients lacking effective options. Chimerix plans to present further findings at the Society for Neuro-Oncology Annual Meeting on November 20, 2021. ONC201 has received Fast Track and Rare Pediatric Disease Designations from the FDA.
DURHAM, N.C., Nov. 01, 2021 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX) announced that CEO Mike Sherman will present at the Credit Suisse 30th Annual Healthcare Conference on November 8, 2021, at 9:40 a.m. ET. An audio webcast will be accessible on the Investor Relations section of Chimerix's website, where it will be archived for about 90 days. Chimerix is focused on developing innovative medicines for serious diseases. The company recently received FDA approval for TEMBEXA, targeting smallpox, and is advancing clinical programs for ONC201 and dociparstat sodium.
Chimerix (CMRX) will host a live conference call on November 4, 2021, at 8:30 a.m. ET to discuss its third-quarter financial results for the period ending September 30, 2021, alongside an operational update. The call can be accessed via phone or through a live audio webcast available on the company's website. Notably, in June 2021, Chimerix received FDA approval for TEMBEXA, a treatment for smallpox. The company is also advancing ONC201, aimed at recurrent H3 K27M-mutant glioma, with efficacy results expected soon, and DSTAT, targeting acute myeloid leukemia.
Chimerix, a biopharmaceutical company, announced that CEO Mike Sherman and CFO Mike Andriole will participate in a pre-recorded fireside chat at the H.C. Wainwright 23rd Annual Global Investment Conference. The chat will be available on September 13, 2021, at 7:00 a.m. ET. Interested parties can access the audio webcast on Chimerix's Investor Relations website, where it will be archived for 90 days.
Chimerix is focused on developing innovative treatments for cancer and other serious diseases, with recent FDA approval for TEMBEXA for smallpox therapy.
Chimerix (NASDAQ:CMRX) announced FDA approval for TEMBEXA® (brincidofovir) as a smallpox treatment, marking its first FDA-approved drug. The approval extends to all age groups, including neonates, with a focus on oral formulations for easier administration. In Q2 2021, the company reported a net loss of $17.8 million and revenues of $0.4 million, down from $1.4 million in 2020. R&D expenses also rose to $13.8 million. Looking ahead, Chimerix plans to finalize TEMBEXA manufacturing and conduct important efficacy analyses for other therapies by the end of 2021.
DURHAM, N.C., Aug. 3, 2021 – Chimerix (NASDAQ:CMRX) announced that CEO Mike Sherman will join a panel at the 2021 Wedbush PacGrow Healthcare Conference on August 10, 2021, at 10:55 a.m. ET. An audio webcast of the discussion will be available on Chimerix's Investor Relations website for 90 days.
The biopharmaceutical company focuses on cancer treatments and has recently gained FDA approval for TEMBEXA, a smallpox countermeasure. Chimerix is also advancing programs for ONC201 and DSTAT in serious diseases like acute myeloid leukemia.
Chimerix (NASDAQ:CMRX) has scheduled a conference call for August 5, 2021, at 8:30 a.m. ET to discuss its Q2 2021 financial results and operational updates. The company recently received FDA approval for TEMBEXA® to treat smallpox and is advancing its clinical programs, including ONC201 for recurrent H3 K27M-mutant glioma and dociparstat sodium (DSTAT) for acute myeloid leukemia. The press release highlights the ongoing clinical trials and the importance of upcoming reviews for ONC201.
Chimerix announced that the FDA has approved TEMBEXA (brincidofovir) for treating smallpox in patients of all age groups, including infants. This marks a significant milestone as it is the first smallpox antiviral approved since the disease's eradication. The approval is based on animal model studies demonstrating a survival benefit. Chimerix aims to collaborate with BARDA for a procurement contract to enhance pandemic preparedness. However, TEMBEXA carries a BOXED WARNING regarding increased mortality risk with prolonged use.
Chimerix (NASDAQ:CMRX) will present a corporate overview at the Jefferies Virtual Healthcare Conference on June 1, 2021, at 10:00 a.m. ET. Mike Sherman, the CEO, will lead the presentation. A live audio webcast will be accessible in the Investor Relations section of Chimerix's website, where it will remain archived for about 90 days. Chimerix is focused on developing treatments for cancer and serious diseases, with key programs including brincidofovir, ONC201, and dociparstat sodium, targeting conditions such as smallpox and acute myeloid leukemia.