mRNA-1083

The EMA's drug advisory panel issued its latest basket of recommendations and rejections on Friday, throwing its support behind six drugs, whilst declining to back two treatments. The most notable nod went to Moderna for mCombriax (mRNA-1083), a combination mRNA vaccine designed to protect adults 50 years and older against both seasonal flu and COVID-19. The shot's support from European regulators comes shortly after the FDA initially declined to review a US application for the standalone flu portion of the jab — mRNA-1010 — before reversing course and promising a decision by August 5. With the positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) in-hand, Moderna is now awaiting a final marketing authorisation decision on mCombriax from the European Commission. Good news for Crinetics, NovartisJust five months after Crinetics Pharmaceuticals won US clearance for its once-daily oral acromegaly treatment, it now has CHMP backing for Palsonify (paltusotine) in the EU.The nonpeptide somatostatin receptor type 2 (SST2) agonist is supported by data from two Phase III pivotal trials, PATHFNDR-1 and PATHFNDR-2, which respectively enrolled previously treated and treatment-naïve adults with acromegaly, a rare hormonal disorder caused by the the production of excess growth hormone. In both studies, a significantly higher proportion of participants receiving Palsonify maintained IGF-1 levels ≤1 times the upper limit of normal compared with those on placebo, alongside significant reductions in acromegaly-associated symptoms.A FirstWord analysis pegged Crinetics as a likely takeout target this year, given its positive US launch of Palsonify (see – Vital Signs: The seller's marketplace heading into JPM).On a similar timeline as Crinetics, Novartis also bagged CHMP backing after a September FDA approval; the Swiss pharma got a positive recommendation for Rhapsido (remibrutinib) to treat chronic spontaneous urticaria (CSU).In the late-stage REMIX-1 and REMIX-2 studies, Rhapsido outperformed placebo on standard measures of itch, hive counts and overall disease activity at 12 weeks, with significantly more treated patients than placebo recipients reporting control of symptoms as early as the second week.In the US, the BTK inhibitor is indicated for adults who remain symptomatic despite taking antihistamines. As a twice-daily pill, it offers patients with CSU an oral alternative to existing injectable therapies.Nods for Ipsen, X4Also earning a thumbs up from CHMP was Ipsen and its paediatric brain cancer treatment, Ojemda (tovorafenib). The conditional marketing recommendation covers its use as monotherapy in patients aged 6 months and older with low-grade glioma harbouring a BRAF fusion or rearrangement or BRAF V600 mutation and who have progressed after one or more prior systemic therapies. Ipsen licensed the pan-RAF kinase inhibitor from Day One Biopharmaceuticals in 2024, after it received FDA approval in a similar setting. Rounding out the positive opinions was X4 Pharmaceuticals' Xolremdi (mavorixafor), which got a nod from CHMP "under exceptional circumstances" to treat patients aged 12 and up with WHIM syndrome, an ultra-rare immunodeficiency and chronic neutropenic disorder caused by CXCR4 pathway dysfunction; The disease is named for its four classic manifestations: warts, hypogammaglobulinaemia, infections and myelokathexis.Despite winning FDA approval in 2024 for the CXCR4 antagonist, X4 has struggled to remain afloat. The company in 2025 underwent two separate rounds of layoffs to stretch its cash runway to a topline readout of the Phase III 4WARD study evaluating Xolremdi in chronic neutropenia, expected next half. Negative opinions for Acadia, VandaOne of Friday's two rejections was not a surprise. Acadia Pharmaceuticals disclosed earlier this month that it expected to receive a negative opinion for trofinetide in Rett syndrome, a rare neurodevelopmental condition. Acadia has said it will seek a re-examination of its application for the IGF-1 analogue, which is already approved in the US and Canada under the brand name Daybue.The other thumbs-down, however, went to an atypical antipsychotic that has been cleared in the US to treat schizophrenia since 2009. More recently, Vanda Pharmaceutical's Fanapt (iloperidone) got a nod from the FDA in 2024 for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. In its rejection of iloperidone in both disease settings, CHMP wrote that the drug was associated with pronounced QT prolongation, "which is not outweighed by the benefits of treatment." Vanda may ask for re-examination of the opinion within 15 days.

mCOMBRIAX is the world's first flu plus COVID combination vaccine to receive a positive CHMP opinion recommending marketing authorization and represents Moderna's fourth vaccine to receive a positive CHMP opinion mCOMBRIAX will be made available in the European Union, subject to final European Commission authorization and national regulatory and access procedures CAMBRIDGE, MASSACHUSETTS / ACCESS Newswire / February 27, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization in the European Union for mCOMBRIAX ® (mRNA-1083), Moderna's combination vaccine indicated for active immunization for the prevention of influenza and COVID-19 caused by SARS-CoV-2 in individuals 50 years of age and older. "The CHMP's positive opinion represents an important milestone for respiratory virus vaccination and for Moderna, with the introduction of the world's first flu plus COVID combination vaccine. If approved, this would be Moderna's fourth marketed product in Europe," said Stéphane Bancel, Chief Executive Officer of Moderna. "Combination vaccines have the potential to simplify vaccination and support improved health outcomes. We appreciate the EMA's rigorous scientific review." mCOMBRIAX builds on the advances of mNEXSPIKE ® , Moderna's COVID-19 vaccine, and mRNA-1010, Moderna's investigational seasonal influenza vaccine, which has been accepted for review in the United States, the European Union, Canada and Australia. The CHMP opinion is supported by results from the pivotal Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT06097273 ), a randomized, observer-blind, active-controlled study evaluating the safety, reactogenicity and immunogenicity of mRNA-1083 in two independent age cohorts of approximately 4,000 adults each. One cohort included adults 65 years of age and older and compared mRNA-1083 to co-administered Fluzone HD ® (licensed in the European Union as Efluelda ® ), a high-dose influenza vaccine, and Spikevax ® , Moderna's licensed COVID-19 vaccine. The second cohort included adults 50 to 64 years of age and compared mRNA-1083 to co-administered Fluarix ® , a standard-dose influenza vaccine, and Spikevax. All primary endpoints demonstrating the non-inferiority of immune responses were met. Following a single dose, mRNA-1083 elicited statistically significantly higher immune responses against three influenza virus strains (A/H1N1, A/H3N2 and B/Victoria) and against SARS-CoV-2 in both age cohorts. The B/Yamagata strain, which is no longer recommended for inclusion in seasonal influenza vaccines, was the only strain for which a statistically significantly higher immune response was not observed for adults 65 years of age and older compared to the co-administered licensed comparator vaccines. [1] mRNA-1083 demonstrated an acceptable safety and tolerability profile. The majority of solicited adverse reactions were grade 1 or 2 in severity and consistent with the licensed vaccines used in the trial. Following the CHMP's positive opinion, the European Commission will consider the recommendation and is expected to adopt a final decision on marketing authorization. Once the European Commission approves a product, the marketing authorization is valid in all EU Member States as well as in the European Economic Area (EEA) countries of Iceland, Liechtenstein and Norway. Upon European Commission approval, Moderna will work with national regulatory and health authorities to support local access and implementation. About Moderna Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more. With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit  modernatx.com  and connect with us on X, Facebook, Instagram, YouTube and LinkedIn. mCOMBRIAX ® , mNEXSPIKE ® and Spikevax ® are registered trademarks of Moderna. Fluzone HD ® and Efluelda ® are registered trademarks of Sanofi Pasteur. Fluarix ® is a registered trademark of the GlaxoSmithKline group of companies. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the availability of mCOMBRIAX in Europe; the potential of combination vaccines to simplify vaccination and support improved health outcomes; potential approvals of mRNA-1010 in markets worldwide; the immunogenicity and safety pro mCOMBRIAX; the European Commission's anticipated marketing authorization of mCOMBRIAX; and local access and implementation upon approval. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at . Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release. Moderna Contacts Media: Chris Ridley Vice President, Global Head of Communications +1 617-800-3651 Chris.Ridley@modernatx.com Investors: Lavina Talukdar Senior Vice President & Head of Investor Relations +1 617-209-5834 Lavina.Talukdar@modernatx.com [1] Immunogenicity and Safety of Influenza and COVID-19 Multicomponent Vaccine in Adults ≥50 Years: A Randomized Clinical Trial. JAMA: The Journal of the American Medical Association, published online 7 May 2025, SOURCE: Moderna, Inc. View the original press release on ACCESS Newswire