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Viatris Inc

For the period ended Feb 23, 2026. Filed Feb 26, 2026.

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About this filing

A notice of a major event between regular reports, such as results, a deal or a change of executives. It is often the first formal record of the news.

Feb 23, 2026 · Filed Feb 26, 2026

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VTRS$19.91+5.0%Stored close · as of Nov 6, 2026
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EX-99.1 · Additional Updates

Additional Updates

In mid-February 2026, a fire occurred in a service area at the Company's oral solid dose manufacturing facility in Nashik, India. Manufacturing at the facility has been temporarily suspended and the Company currently expects to resume operations beginning in April 2026.The Company has considered the potential impact of this incident and the facility shutdown in formulating its 2026 financial guidance.

In February 2026, the Company announced that the U.S. Food and Drug Administration (FDA) accepted for review the supplemental New Drug Application (sNDA) for MR-141 (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia. The FDA has assigned a PDUFA goal date of October 17, 2026. Presbyopia is the age-related progressive loss of the ability to focus on close objects that results in blurred near vision and eye strain. The condition affects approximately 90% of adults in the U.S. over 45.

In January 2026, the Company announced the launch of Inpefa ® (sotagliflozin) in the United Arab Emirates, the first country within Viatris’ current operations to commercialize the treatment. Future launches are planned in multiple countries over the next several years, supporting Viatris' strategy to expand access to the treatment in key markets outside of the U.S. and Europe.

In December 2025, the Company announced that the FDA approved the Company's octreotide acetate for injectable suspension, a generic version of Sandostatin® LAR Depot. The therapy is indicated for treatment in patients who have responded to and tolerated Sandostatin Injection subcutaneous injection for acromegaly, severe diarrhea/flushing episodes associated with metastatic carcinoid tumors, and profuse watery diarrhea associated with Vasoactive Intestinal Peptide secreting tumors.

In December 2025, the Company announced that the FDA accepted for review the New Drug Application (NDA) for the Company's investigational low-dose estrogen weekly patch (150 mcg norelgestromin and 17.5 mcg ethinyl estradiol) for contraception. The NDA was accepted under the FDA's 505(b)(2) regulatory pathway, and the FDA has assigned a PDUFA goal date of July 30, 2026.

In December 2025, the Company announced that the FDA cleared the Company's Investigational New Drug (IND) application for MR-146, an Enriched Tear FilmTM (ETF) Adeno-Associated Virus (AAV) gene therapy candidate targeted to treat people with neurotrophic keratopathy (NK).

In December 2025, the Company announced that its Japanese New Drug Application (J-NDA) for pitolisant in obstructive sleep apnea syndrome (OSAS) was under review by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) and that the Company was on track to submit a J-NDA for narcolepsy by the end of 2025. Both applications are now under review by the agency.

In December 2025, the Company announced that it entered into definitive agreements with Biocon Limited ("Biocon") for the sale of Viatris' equity stake in Biocon Biologics Limited ("Biocon Biologics"). Under those agreements, Biocon acquired all of Viatris' convertible preferred equity in Biocon Biologics for total consideration of $815 million, consisting of $400 million in cash and $415 million in newly issued equity shares of Biocon. The transaction closed in the first quarter of 2026.

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