REGN News & Events

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.

Stocks finished mixed to start the week as investors continue to watch climbing oil prices while awaiting more developments out of the Middle East. Investors are increasingly worried that inflation is becoming entrenched due to energy prices, persistent fiscal deficits and resilient economic demand. Markets are now pricing in a meaningful possibility that the Federal Reserve could raise rates again later this year instead of cutting them.Of note, President Trump stated in athat he was asked by the leaders of several Middle Eastern nations to hold off a planned military attack on Iran, which was scheduled for tomorrow, but added that he has instructed the U.S. military leadership "to be prepared to go forward with a full, large scale assault of Iran, on a moment's notice, in the event that an acceptable Deal is not reached."Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:Dominionand NextEra Energyin an all-stock transactionPublicisLiveRampfor $2.2BFordand EDF Group announced the signing of aTrump plans to announce a "dramatic expansion" of discounted prescription medication offerings available on TrumpRx,A U.S. jury on Monday ruled against Elon Musk in his lawsuit against OpenAI, finding the AI company not liable to the Teslafounder for having allegedly strayed from its original mission to benefit humanity,2. WALL STREET CALLS:F5to Outperform from In Line at Evercore ISIZscalerto Buy at B. RileyCoreWeaveand Nebiuswith lowered Neutral ratings as a new analyst took over coverage at DA DavidsonApplied Materialsto Equal Weight at Morgan StanleySalesforcewith an Underperform at BofA amid structural reset3. AROUND THE WEB:NvidiaCEO Jensen Huang told Bloomberg that it is up to China to decide on AI chips and that he looks forward to China being a more open marketTakedahas been ordered to pay hundreds of millions for violating antitrust law by delaying the generic version of its branded Amitiza drug, Bloomberg saysApple'srevamped Siri may launch in beta, and will have an option to auto-delete chats, Bloomberg reportsPresident Trump said he "should have asked for more" of a stake in Intelon behalf of the U.S. government, Fortune saysVinFast'splanned sale of two Vietnamese factories will allow the company to shed $6.9B in debt and obligations to help assist its path to profitability, Bloomberg says4. MOVERS:Hive Digitalwas higher afteris planning to build a new AI infrastructure facility in the Greater Toronto Area with approximately 320 megawatts of utility capacityCourseraincreased after announcing aServiceNowgained after BofAcoverage of the stock with a Buy ratingDesign Therapeuticswas lower afterRegeneronfell after its Phase 3 trial of fianlimab5. EARNINGS/GUIDANCE:Bradyand raised its guidance for FY26iQiyi, with EPS and revenue lower year-over-yearGossamer Bio, with CEO Faheem Hasnain commenting, "We are executing across multiple fronts at Gossamer"RedCloudreportedand reaffirmed guidance for FY26Baidu, with EPS and revenue lower year-over-yearINDEXES:The Dow rose 159.95, or 0.32%, to 49,686.12, the Nasdaq lost 134.41, or 0.51%, to 26,090.73, and the S&P 500 declined 5.45, or 0.074%, to 7,403.05.