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Amneal Stock Up on FDA Nod for Romidepsin Injection Solution
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Key Takeaways
AMRX won FDA approval for romidepsin injection to treat cutaneous T-cell lymphoma in adults.
Romidepsin injection received CGT status, giving AMRX 180 days of generic market exclusivity.
The ready-to-use formulation is likely to expand Amneal's differentiated injectables portfolio.
Amneal Pharmaceuticals (AMRX - Free Report) announced that the FDA has approved romidepsin injection solution (27.5 mg/5.5 mL), supplied in single-dose, ready-to-use vials for treating cutaneous T-cell lymphoma in adult patients who have received at least one prior systemic therapy.
Romidepsin injection is eligible for Competitive Generic Therapy (CGT) designation, which provides Amneal with 180 days of market exclusivity. As a result, the company can sell this generic drug without competition from other generic versions in this period.
Shares of Amneal were up 5% yesterday following the announcement of the news.
Per management, the ready-to-use romidepsin formulation is more convenient and easier to use than the existing powder form, which must be mixed before administration.
Notably, Romidepsin injection solution is based on a romidepsin formulation that was previously marketed by Teva but was withdrawn from the market several years ago.
The latest FDA approval is likely to expand Amneal’s differentiated and growing injectables portfolio. It also brings an important cancer treatment back to the market.
AMRX’s Price Performance
Year to date, shares of Amneal have rallied 7.3% against the industry’s decline of 9.8%.
Image Source: Zacks Investment Research
AMRX’s Diversified Business Portfolio
Amneal has a diversified business model spanning generics, specialty drugs and government distribution. The company operates through three segments — Affordable Medicines, Specialty and AvKARE.
Amneal’s total revenues rose 4% year over year to $723 million in the first quarter of 2026.
Affordable Medicines develops and markets retail generics, injectables and biosimilars across multiple dosage forms. Specialty focuses on branded drugs for neurological and endocrine disorders, while AvKARE distributes pharmaceuticals and other products to the U.S. government, retail and institutional markets.
Affordable Medicines’ first-quarter revenues were $423 million, up 2% year over year. The Specialty segment’s first-quarter revenues of $133 million grew 23% year over year.
However, AvKARE's net revenues of $166 million declined 4% year over year in the first quarter.
The company expects total revenues to be in the range of $3.05 billion-$3.15 billion in 2026.
Amneal appears well-positioned for continued growth in 2026, supported by its broad portfolio, robust pipeline and expanding injectables and biosimilars businesses.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share (EPS) have increased from $3.33 to $4.05. Over the same period, EPS estimates for 2027 have risen from $3.66 to $4.27. INDV shares have risen 4.4% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 60 days, estimates for Liquidia’s 2026 EPS have increased to $2.97 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.81 from $2.91. LQDA shares have surged 81.3% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 60 days, estimates for Immunocore’s 2026 have improved from a loss of 88 cents per share to earnings of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR shares have lost 17.2% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 46.66%.
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Amneal Stock Up on FDA Nod for Romidepsin Injection Solution
Key Takeaways
Amneal Pharmaceuticals (AMRX - Free Report) announced that the FDA has approved romidepsin injection solution (27.5 mg/5.5 mL), supplied in single-dose, ready-to-use vials for treating cutaneous T-cell lymphoma in adult patients who have received at least one prior systemic therapy.
Romidepsin injection is eligible for Competitive Generic Therapy (CGT) designation, which provides Amneal with 180 days of market exclusivity. As a result, the company can sell this generic drug without competition from other generic versions in this period.
Shares of Amneal were up 5% yesterday following the announcement of the news.
Per management, the ready-to-use romidepsin formulation is more convenient and easier to use than the existing powder form, which must be mixed before administration.
Notably, Romidepsin injection solution is based on a romidepsin formulation that was previously marketed by Teva but was withdrawn from the market several years ago.
The latest FDA approval is likely to expand Amneal’s differentiated and growing injectables portfolio. It also brings an important cancer treatment back to the market.
AMRX’s Price Performance
Year to date, shares of Amneal have rallied 7.3% against the industry’s decline of 9.8%.
Image Source: Zacks Investment Research
AMRX’s Diversified Business Portfolio
Amneal has a diversified business model spanning generics, specialty drugs and government distribution. The company operates through three segments — Affordable Medicines, Specialty and AvKARE.
Amneal’s total revenues rose 4% year over year to $723 million in the first quarter of 2026.
Affordable Medicines develops and markets retail generics, injectables and biosimilars across multiple dosage forms. Specialty focuses on branded drugs for neurological and endocrine disorders, while AvKARE distributes pharmaceuticals and other products to the U.S. government, retail and institutional markets.
Affordable Medicines’ first-quarter revenues were $423 million, up 2% year over year. The Specialty segment’s first-quarter revenues of $133 million grew 23% year over year.
However, AvKARE's net revenues of $166 million declined 4% year over year in the first quarter.
The company expects total revenues to be in the range of $3.05 billion-$3.15 billion in 2026.
Amneal appears well-positioned for continued growth in 2026, supported by its broad portfolio, robust pipeline and expanding injectables and biosimilars businesses.
AMNEAL PHARMACEUTICALS, INC. Price
AMNEAL PHARMACEUTICALS, INC. price | AMNEAL PHARMACEUTICALS, INC. Quote
AMRX’s Zacks Rank & Other Stocks to Consider
Amneal currently has a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the drug/biotech sector are Indivior Pharmaceuticals (INDV - Free Report) , Liquidia Corporation (LQDA - Free Report) and Immunocore (IMCR - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share (EPS) have increased from $3.33 to $4.05. Over the same period, EPS estimates for 2027 have risen from $3.66 to $4.27. INDV shares have risen 4.4% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 60 days, estimates for Liquidia’s 2026 EPS have increased to $2.97 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.81 from $2.91. LQDA shares have surged 81.3% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 60 days, estimates for Immunocore’s 2026 have improved from a loss of 88 cents per share to earnings of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR shares have lost 17.2% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 46.66%.