Viatris Inc. (VTRS), a healthcare company, Thursday announced updates on its four regulatory milestones spanning across all stages of its global pipeline.
-- The FDA has approved the company's octreotide acetate for injectable suspension, a generic version of Sandostatin LAR Depot.
The Octreotide acetate for injectable suspension is a long-acting medication to help manage symptoms of rare conditions, including acromegaly.
This is the fourth approval by the FDA for injectables in 2025, along with iron sucrose, paclitaxel and liposomal amphotericin B.
-- The company's New Drug Application for a low-dose estrogen weekly patch (150 mcg norelgestromin and 17.5 mcg ethinyl estradiol) for contraception has been accepted for review by the FDA. The assigned targeted action date is July 30, 2026.
This treatment is a weekly once transdermal contraceptive patch being developed for women of childbearing potential with a BMI below 30 kg/m² and are appropriate candidates for combined hormonal conception and who prefer noninvasive reversible options.
-- The FDA has cleared the investigational new drug application for MR-146, an Enriched Tear Film (ETF) Adeno-Associated Virus (AAV) gene therapy candidate targeted to treat people with neurotrophic keratopathy (NK). Viatris plans to start a Phase 1 / 2 clinical trial, CORVITA, for MR-146 in patients with NK in the first half of 2026.
NK is a rare but potentially sight-threatening disease of the cornea that impacts about 73000 people in the US. It is a degenerative disease that causes progressive damage to the cornea.
-- The Japan Pharmaceuticals and Medical Devices Agency or PMDA has accepted the company's Japanese new drug application or J-NDA for pitolisant in obstructive sleep apnea syndrome (OSAS). It is on track to submit a J-NDA for narcolepsy by the end of this year.
The J-NDA application is supported by positive Phase 3 data in Japanese patients and evaluates the effect of pitolisant in Japanese patients with OSAS who were experiencing residual Excessive Daytime Sleepiness (EDS) despite treatment with CPAP therapy.
At the end of the 12-week treatment, patients receiving pitolisant scored lower on the Epworth Sleepiness Scale used to measure EDS compared to those in the placebo group with a significant difference statistically (p=0.007).
In pre-market activity, VTRS shares were trading at $11.66, down 0.34% on the Nasdaq.
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