FDA Greenlights Viatris' Generic Version of Sandostatin LAR Depot; Weekly Contraceptive Patch Under Review Next July
FDA Approvals: Viatris Inc. received FDA approval for octreotide acetate injectable suspension, a generic version of Sandostatin LAR Depot, aimed at managing symptoms of rare conditions like acromegaly.
New Drug Application: The FDA has accepted Viatris' New Drug Application for a low-dose estrogen weekly contraceptive patch, targeting women with a BMI below 30 kg/m², with a decision expected by July 30, 2026.
Gene Therapy Development: The FDA cleared the investigational new drug application for MR-146, a gene therapy for neurotrophic keratopathy, with plans to initiate a Phase 1/2 clinical trial in 2026.
Japanese Market Expansion: The Japan PMDA accepted Viatris' new drug application for pitolisant in obstructive sleep apnea syndrome, supported by positive Phase 3 data, with plans for a narcolepsy application by year-end.
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- Rating Upgrade: UBS upgraded Viatris from Neutral to Buy and raised its price target from $8 to $11 per share, reflecting confidence in the company's growth prospects and likely attracting more investor interest.
- Pipeline Growth: Analyst Ashwani Verma noted that the new product cycle and potential cost savings assumptions for Viatris will further drive performance, which is expected to enhance market demand for its stock.
- Valuation Attractiveness: According to Bloomberg, Viatris trades at 5x consensus EPS estimates for 2027, which Verma identified as
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- Earnings Release Schedule: Viatris plans to report its Q4 and full year 2025 financial results on February 26, 2026, with executives hosting a webcast at 8:30 a.m. ET to discuss performance details with investors and the public.
- Investor Event Announcement: The company will hold an Investor Event in New York City on March 19, 2026, with more details to be provided during the February investor call, aiming to enhance engagement with analysts and institutional investors.
- Webcast Access: Investors can participate in the earnings call via the company’s website or by calling designated numbers, with a replay available online, ensuring that those unable to attend live can still access the information.
- Global Healthcare Mission: Viatris is committed to providing high-quality healthcare to approximately 1 billion patients worldwide through its extensive portfolio and global supply chain, highlighting the company's unique position and mission in the global health sector.
- Earnings Release Schedule: Viatris plans to report its Q4 and full year 2025 financial results on February 26, 2026, with executives hosting a webcast at 8:30 a.m. ET to enhance transparency and communication with investors and the public.
- Investor Event Announcement: The company will hold an Investor Event in New York City on March 19, 2026, providing further details during the February investor call, aimed at strengthening interactions with analysts and institutional investors to enhance investor relations management.
- Webcast Access: Investors can participate in the earnings call and investor event via the company’s website or designated phone lines, ensuring broad participation and providing replay services to further expand information dissemination.
- Global Healthcare Mission: Viatris is committed to providing high-quality healthcare services to approximately 1 billion patients worldwide through its diverse portfolio of medicines, reflecting the company's unique positioning and strategic significance in addressing health needs at various life stages.








