MedPath

Chimerix

🇺🇸United States
Ownership
-
Employees
72
Market Cap
$88M
Website
Introduction

Chimerix, Inc. is a biopharmaceutical company, which engages in the research, development, and commercialization of pharmaceutical products. Its portfolio includes Brincidofovir for the treatment of adenovirus, cytomegalovirus, and smallpox. The company was founded in April 2000 and is headquartered in Durham, NC.

Leap Therapeutics Halves Workforce and Refocuses Cancer Drug Development Amid Market Challenges

• Leap Therapeutics has announced a significant restructuring, reducing its workforce by approximately 50% and narrowing the development focus of its lead cancer drug candidate in response to challenging market conditions. • The strategic pivot aims to extend the company's cash runway while concentrating resources on the most promising clinical applications of its lead oncology asset, potentially improving its chances for regulatory success. • This move follows similar restructuring trends across the biotech sector, with companies like Arcturus, NGM Bio, and Erasca all recently announcing staff reductions and pipeline reprioritizations to navigate the difficult funding environment.

Jazz Pharmaceuticals Reports Strong Q1 2025 Performance with $898 Million in Revenue, Advances Pipeline with Zepzelca sNDA Submission

• Jazz Pharmaceuticals reported total revenues of $898 million in Q1 2025, with Xywav and Epidiolex showing strong year-over-year growth of 9% and 10% respectively. • The company submitted a supplemental New Drug Application for Zepzelca in combination with atezolizumab as maintenance therapy for first-line extensive-stage small cell lung cancer, based on promising Phase 3 trial results. • Jazz completed the acquisition of Chimerix, adding dordaviprone to its late-stage pipeline for H3 K27M-mutant diffuse glioma, with an FDA PDUFA target date of August 18, 2025.

Novo Nordisk Launches NovoCare® Pharmacy, Offering Authentic Wegovy® at $499 Monthly

• Novo Nordisk has introduced NovoCare® Pharmacy, providing FDA-approved Wegovy® (semaglutide) at $499 per month for cash-paying patients, with convenient home delivery service. • The new service aims to combat the rising problem of counterfeit semaglutide products by offering reliable access to authentic medication in a once-weekly, single-dose pen format. • This initiative addresses affordability concerns for weight management medication while ensuring patients receive legitimate FDA-approved treatment amid growing demand for GLP-1 receptor agonists.

Pipeline Advances in Head and Neck Cancer Treatment: Over 100 Drugs in Development for 2025

• DelveInsight's latest report reveals a robust pipeline with over 80 companies developing 100+ drug candidates for head and neck cancer, highlighting significant research momentum in this therapeutic area. • Key late-stage candidates include Debiopharm/Merck's xevinapant, GlaxoSmithKline's dostarlimab, and QBiotics' tigilanol tiglate, each employing novel mechanisms to potentially improve outcomes for patients with limited treatment options. • Multiple clinical trials are underway testing innovative approaches including IAP inhibitors, immune checkpoint blockers, and oncolytic therapies, with several Phase III studies expected to deliver results that could reshape treatment paradigms.

Brain Hemorrhage Treatment Market Expected to Grow Significantly by 2032 as AI Solutions Gain FDA Approval

• The brain hemorrhage treatment market is projected to experience substantial growth through 2032, driven by an aging population and increasing prevalence of risk factors such as hypertension and traumatic brain injuries. • Recent FDA approvals for AI-based diagnostic tools, including JLK-LVO and Heuron ICH, mark significant advancements in early detection and treatment of brain hemorrhages. • Several pharmaceutical companies including Baxter, Pfizer, and Novartis are developing promising pipeline therapies such as tissue plasminogen activator, alteplase, and BAF312 to address the significant unmet needs in brain hemorrhage treatment.

Over 120 Pipeline Therapies Target Acute Myeloid Leukemia as Research Intensifies

• DelveInsight's latest report reveals a robust pipeline with 110+ companies developing 120+ therapies for acute myeloid leukemia (AML), showing significant investment in this aggressive blood cancer. • Several promising candidates are advancing through clinical trials, including GlycoMimetics' uproleselan in Phase III, BioSight's aspacytarabine (BST-236) in Phase II, and novel approaches like Senti Biosciences' logic-gated CAR-NK cell therapy. • Recent developments include Moleculin Biotech's Phase III MIRACLE trial for annamycin, Qurient's adrixetinib IND approval, and Rigel Pharmaceuticals' trial of REZLIDHIA in combination therapy for IDH1-mutated AML.

Jazz Pharmaceuticals Acquires Chimerix, Strengthening Late-Stage Pipeline

• Jazz Pharmaceuticals has announced the strategic acquisition of Chimerix, expanding its portfolio with a promising late-stage drug candidate. • The acquisition positions Jazz to strengthen its presence in the pharmaceutical market, with potential near-term approval catalysts on the horizon. • The deal demonstrates Jazz's continued commitment to growth through strategic acquisitions in the specialty pharmaceutical space.

Jazz Pharmaceuticals to Acquire Chimerix for $935M, Gaining Novel Brain Tumor Drug Candidate

• Jazz Pharmaceuticals announces acquisition of Chimerix for $935 million, gaining dordaviprone, a first-in-class treatment for rare H3 K27M-mutant diffuse glioma with FDA Priority Review status. • The FDA has set a PDUFA target action date of August 18, 2025, for dordaviprone, which could become the first approved therapy for this rare brain tumor affecting children and young adults. • The acquisition strengthens Jazz's oncology portfolio and addresses an urgent unmet need, with potential commercial launch in late 2025 and patent protection extending to 2037.

InflaRx's Gohibic Receives EU Approval for COVID-19-Induced ARDS, Bolstering Market Potential

• InflaRx's Gohibic is the first and only treatment approved in the EU for SARS-CoV-2-induced ARDS, marking a significant milestone. • The European Commission's approval was based on positive Phase 3 PANAMO trial results, demonstrating a 23.9% reduction in mortality. • H.C. Wainwright reiterated a Buy rating for InflaRx, setting a price target of $8.00, citing Gohibic's market potential and pipeline. • InflaRx is exploring partnership and distribution options in Europe and is in discussions with the FDA for potential US approval.

Sana Biotechnology's HIP Technology Shows Promise in Type 1 Diabetes Trial, Eliciting Analyst Upgrades

• Sana Biotechnology's HIP-modified islet cells demonstrated immune evasion and C-peptide production in a Type 1 Diabetes patient without immunosuppression. • The positive Phase 1 data supports the potential of Sana's hypoimmune (HIP) cell platform, leading to increased price targets from analysts. • A single patient in the trial showed stable C-peptide levels 4 weeks post-injection, indicating the HIP cells' survival and function without triggering an immune response. • Sana Biotechnology's progress in Type 1 Diabetes treatment has been recognized, potentially setting a more favorable stage for its stock performance.

Capricor Therapeutics Completes FDA Submission for Deramiocel in DMD Cardiomyopathy

• Capricor Therapeutics has completed its Biologics License Application (BLA) submission to the FDA for deramiocel to treat Duchenne muscular dystrophy (DMD) cardiomyopathy. • The BLA is supported by data from Phase 2 HOPE-2 and HOPE-2 Open Label Extension (OLE) trials, showing attenuation of cardiac implications of DMD. • The FDA has been requested to grant priority review, potentially reducing the review period to six months from the standard ten months. • The BLA submission triggers a $10 million milestone payment to Capricor from its distribution partner, Nippon Shinyaku.

FDA Grants Priority Review to Dordaviprone for Recurrent H3 K27M-Mutant Diffuse Glioma

• The FDA has accepted and granted priority review to Chimerix's new drug application for dordaviprone, a treatment for recurrent H3 K27M-mutant diffuse glioma. • Dordaviprone, a first-in-class imipridone, targets mitochondrial protease ClpP and DRD2, offering a novel approach to treating this aggressive brain cancer. • The FDA has set a PDUFA target action date of August 18, 2025, and does not currently plan to hold an advisory committee meeting. • Clinical data from pooled analyses showed a 20% overall response rate and a median duration of response of 11.2 months, supporting the application.
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