Viatris Gets FDA Nod for Generic Sandostatin, Shares Regulatory Updates

Viatris Inc. VTRS recently announced four regulatory achievements across multiple stages of its pipeline.

These achievements outline the company’s R&D progress in 2025. VTRS will continuously work with health bodies across the world to advance its pipeline further.

FDA Approves VTRS’ Generic Sandostatin LAR Depot

The FDA approved Viatris’ octreotide acetate for injectable suspension, a generic equivalent of Sandostatin LAR Depot. The product is indicated for patients who have responded to and tolerated subcutaneous Sandostatin Injection for the treatment of acromegaly, severe diarrhea and flushing associated with metastatic carcinoid tumors, and profuse watery diarrhea related to vasoactive intestinal peptide-secreting tumors.

This marks VTRS’ first approved injectable using microsphere technology. The FDA approval is also VTRS’ fourth injectable approval in 2025, following iron sucrose, paclitaxel and liposomal amphotericin B.

The approval strengthens VTRS’ generics portfolio with technically complex, high-value products.

VTRS’ NDA For Low-Dose Estrogen Weekly Patch Accepted

The FDA has accepted for review VTRS’ new drug application (NDA) for an investigational low-dose estrogen weekly contraceptive patch.

This experimental treatment is a once-weekly transdermal contraceptive patch being developed for women of childbearing potential with a BMI below 30 kg/m² who are appropriate candidates for combined hormonal contraception and who prefer a non-invasive, reversible option with a lower estrogen dose.

The patch delivers approximately 150 mcg of norelgestromin and 17.5 mcg of ethinyl estradiol per day and is applied once weekly for three weeks, followed by a one-week patch-free period.

The NDA was submitted under the FDA’s 505(b)(2) pathway and is supported by the late-stage Luminous Study, which demonstrated a favorable efficacy and safety profile and strong patch adhesion performance. The FDA has set a target action date of July 30, 2026.

A potential approval will address an important unmet medical need for women seeking alternatives to regular estrogen dose and long-acting contraception treatments. This new transdermal drug delivery represents a lifecycle advancement of the contraceptive patch Xulane (norelgestromin and ethinyl estradiol transdermal system) 150/35 mcg per day.

VTRS’ IND for Gene Therapy Cleared

The FDA also cleared an investigational new drug (IND) application for MR-146. This candidate is an Enriched Tear Film (ETF) adeno-associated virus (AAV) gene therapy candidate for the treatment of neurotrophic keratopathy (NK).

A phase I/II clinical trial, CORVITA, in patients with NK is planned in the first half of 2026.

NK, a rare but potentially sight-threatening corneal disease, affects almost 73,000 people in the United States.

VTRS Updates on Pitolisant

Viatris also announced that Japan’s Pharmaceuticals and Medical Devices Agency accepted its Japanese NDA (J-NDA) for pitolisant in obstructive sleep apnea syndrome (OSAS).

Pitolisant is a selective histamine H3 receptor antagonist/inverse agonist that modulates the brain's sleep-wake pathways.

Viatris remains on track to submit a separate J-NDA for pitolisant in narcolepsy by year-end.

Pitolisant was added to VTRS’ portfolio through the acquisition of Aculys Pharma, Inc., a clinical biopharmaceutical company in Japan.

Our Take on VTRS’ Recent Performance

Viatris has put up a strong show over the past six months. Shares have surged 34.6% compared with the industry’s growth of 6.1% in the said period.

The company’s portfolio expansion in Emerging Markets, along with robust growth in Greater China, is positively impacting sales.

Approval of new drugs and generics will further boost portfolio.

VTRS’ Zacks Rank and Stocks to Consider

Viatris currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the pharma/biotech sector are ANI Pharmaceuticals ANIP, CorMedix CRMD and Amicus Therapeutics FOLD, each carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have risen from $7.29 to $7.56. EPS estimates for 2026 have increased from $7.81 to $8.08 during the same period. Year to date, shares of ANIP have surged 49.8%.

ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.24%.

In the past 60 days, estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87. EPS estimates for 2026 have moved up from $2.49 to $2.88 during the same period. CRMD stock has risen 47.1% year to date. CorMedix’s earnings beat estimates in each of the trailing four quarters, with an average surprise of 27.04%.

In the past 60 days, estimates for Amicus Therapeutics’ 2025 EPS have increased to 36 cents from 31 cents. During the same time, EPS estimates for 2026 have decreased to 67 cents from 70 cents. Year to date, shares of FOLD have gained 15.6%.

 

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