REGN News & Events

RBC Capital analyst Trung Huynh tells investors in a research note that CMS on Friday proposed making the Medicare Drug Price Negotiation Program permanent beginning in 2029 and tightening rules around fixed-combination lifecycle strategies, creating headline risk for Johnson & Johnson (JNJ), Bristol Myers Squibb (BMY), Merck (MRK), and Regeneron (REGN), although legal challenges, statutory exemptions, and portfolio diversification are expected to limit the practical impact.

CytomX Therapeutics (CTMX) announced an expansion of its collaboration and licensing agreement with Regeneron Pharmaceuticals (REGN) to create conditionally-activated bispecific cancer therapies utilizing CytomX's Probody therapeutic platform and Regeneron's Veloci-Bi bispecific antibody development platform. The Regeneron and CytomX collaboration, initially entered into in 2022, is focused on applying CytomX's biologic masking strategies in combination with Regeneron's bispecific antibodies to develop investigational bispecifics that remain inactive until activated by proteases in the tumor microenvironment. Under the expanded agreement, Regeneron and CytomX will continue to collaborate on discovery activities to identify and validate conditionally active bispecific antibodies. Regeneron will be responsible for funding preclinical and clinical development and commercialization activities. CytomX will receive a target nomination payment of $37M for two additional targets that have been selected, and Regeneron has the option to select up to six additional future targets. Total potential target nomination payments, preclinical, clinical, regulatory and commercial milestones covered under the scope of the expanded collaboration could reach up to approximately $4B. CytomX is also eligible to receive tiered global net sales royalties on products covered under the collaboration.

Regeneron announced that maftivimab, the most potent neutralizing antibody included in Inmazeb, has been recommended by the World Health Organization's, or WHO, Therapeutics Advisory Group to be prioritized for evaluation in clinical trials of investigational treatments for Bundibugyo ebolavirus. Maftivimab has demonstrated broad activity in vitro against multiple Ebola species, including Bundibugyo. The trial pertains to the WHO's recent declaration that the current outbreak of Ebola disease caused by Bundibugyo virus in the Democratic Republic of the Congo and Uganda constitutes a public health emergency of international concern. WHO is now working closely with the governments of DRC and Uganda to facilitate the implementation of research evaluations of the prioritized products. "We are closely coordinating our efforts with the U.S. Department of Health and Human Services (HHS) and look forward to working with the World Health Organization and others as clinical evaluation moves ahead," said Leonard S. Schleifer, board co-chair, president and CEO of Regeneron. "Regeneron has a track record of rapidly delivering important medical solutions during times of global health crisis, such as the COVID-19 pandemic and multiple Ebola outbreaks, and we know that independently run and locally executed clinical trials are critical to developing effective new medicines in such situations." Inmazeb is already approved by the FDA for the treatment of infection caused by Orthoebolavirus zairense, also known as Zaire ebolavirus, in adult and pediatric patients, including neonates born to infected mothers. Regeneron is working as quickly as possible to prepare existing supply of maftivimab for use in potential upcoming clinical trials. Supply of Inmazeb is already on the ground in the DRC, should WHO wish to utilize it for immediate treatment or as an additional component of the study.

Regeneron Pharmaceuticals announced the European Medicines Agency, EMA, has accepted for review under Accelerated Assessment, AA, the Marketing Authorization Application, MAA, for Otarmeni, an in vivo adeno-associated virus vector-based gene therapy for the treatment of biallelic OTOF variant-associated hearing loss. Otarmeni, formerly known as DB-OTO, previously received Orphan Designation from the EMA. If approved, Otarmeni will be the first gene therapy for OTOF-related hearing loss in the European Union, EU. The MAA is supported by data from the pivotal CHORD clinical trial, in which 24 participants received a single dose of Otarmeni via intracochlear infusion, either unilaterally or bilaterally. An earlier cut of results from the CHORD trial also supported the U.S. Food and Drug Administration's recent accelerated approval of Otarmeni in April 2026. Regulatory submissions are planned in additional markets, including Japan.