We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Viatris Gets FDA Nod for Generic Sandostatin, Shares Regulatory Updates
Read MoreHide Full Article
Key Takeaways
VTRS reported four regulatory achievements, including FDA approval of a generic Sandostatin LAR injectable.
VTRS' low-dose estrogen weekly patch NDA was accepted, with an FDA action date set for July 30, 2026.
VTRS also cleared an IND for MR-146 gene therapy and gained Japan NDA acceptance for pitolisant in OSAS.
Viatris Inc. (VTRS - Free Report) 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.
Image Source: Zacks Investment Research
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.
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%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Viatris Gets FDA Nod for Generic Sandostatin, Shares Regulatory Updates
Key Takeaways
Viatris Inc. (VTRS - Free Report) 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.
Image Source: Zacks Investment Research
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 - Free Report) , CorMedix (CRMD - Free Report) and Amicus Therapeutics (FOLD - Free Report) , 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%.