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Amneal Stock Rises 29% in a Month on Upbeat Regulatory Updates
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Shares of Amneal Pharmaceuticals (AMRX - Free Report) , a commercial-stage company marketing generics as well as specialty pharmaceutical products for several therapeutic areas, including neurology and endocrinology, have soared 29.3% in the past month after the company announced back-to-back regulatory approvals.
Amneal Gets FDA Nod for Parkinson’s Disease Drug
In August 2024, the FDA approved Amneal’s IPX203, a novel, oral formulation of carbidopa/levodopa (CD/LD) that combines both immediate-release (IR) granules and extended-release pellets for the treatment of Parkinson’s Disease (PD). The drug is expected to be launched in September 2024 in the United States under the brand name, Crexont (carbidopa and levodopa).
The approval was based on positive results from Amneal’s pivotal phase III RISE-PD study, which evaluated Crexont for the PD indication. Data from the study showed that treatment with Crexont led to a statistically significant improvement of 0.5 hours of additional “Good On” time per day with fewer daily doses compared with existing oral IR CD/LD products that are short-acting.
“Good On” time is defined as “On” time without troublesome dyskinesia, as PD progresses. A post-hoc analysis of the primary endpoint on a per-dose basis showed 1.6 hours additional “Good On” time per dose of Crexont compared with IR CD/LD.
Year to date, shares of Amneal have outperformed the industry, surging 42.7% against the industry’s 1% decline.
Image Source: Zacks Investment Research
Amneal Gets FDA Nod for Generic Version of Propofol
In late August, Amneal announced that the FDA approved its abbreviated new drug application for Propofol Injectable Emulsion USPsingle-dose vials. Propofol, a “hard-to-make” intravenous drug widely used for anesthesia and sedation in hospitals, is currently listed as a shortage by the American Society of Health System Pharmacists due to ongoing supply chain issues. To address this, Amneal plans to manufacture the generic version of propofol in-house on a dedicated production line, aiming to ensure a consistent supply. The company expects to launch this initiative in the fourth quarter of 2024.
Per an IQVIA report, propofol generated approximately $314 million in revenues from its U.S. sales for the 12 months ended June 2024.
Amneal Reports Strong Q2 Performance
The company also recorded strong revenues and profit growth in the second quarter of 2024 and raised its financial guidance for the full year on the second-quarter conference call driven by broad-based growth across its business. Net revenues of $702 million recorded in the last reported quarter represented a 17% year-over-year increase. This is likely to have also contributed to the soaring of the stock price in the past month.
Amneal’s oncology biosimilars and new product launches are generating increasing revenues for the Generics segment, while promoted products in Neurology and Endocrinology are boosting the Specialty segment.
Amneal’s Estimates Rising
In the past 60 days, the Zacks Consensus Estimate for Amneal’s 2024 earnings per share has increased from 58 cents to 59 cents. During the same time frame, the estimate for the company’s 2025 earnings per share has also increased from 60 cents to 64 cents.
This indicates that Wall Street analysts expect Amneal’s marketed portfolio of generic and specialty products to continue driving its growth, thereby potentially boosting its stock price further.
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.18 to $3.62. Earnings per share estimates for 2025 have improved from $2.93 to $4.50. Year to date, shares of ILMN have lost 5.6%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.98 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 57.3%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have jumped 26.7%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
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Amneal Stock Rises 29% in a Month on Upbeat Regulatory Updates
Shares of Amneal Pharmaceuticals (AMRX - Free Report) , a commercial-stage company marketing generics as well as specialty pharmaceutical products for several therapeutic areas, including neurology and endocrinology, have soared 29.3% in the past month after the company announced back-to-back regulatory approvals.
Amneal Gets FDA Nod for Parkinson’s Disease Drug
In August 2024, the FDA approved Amneal’s IPX203, a novel, oral formulation of carbidopa/levodopa (CD/LD) that combines both immediate-release (IR) granules and extended-release pellets for the treatment of Parkinson’s Disease (PD). The drug is expected to be launched in September 2024 in the United States under the brand name, Crexont (carbidopa and levodopa).
The approval was based on positive results from Amneal’s pivotal phase III RISE-PD study, which evaluated Crexont for the PD indication. Data from the study showed that treatment with Crexont led to a statistically significant improvement of 0.5 hours of additional “Good On” time per day with fewer daily doses compared with existing oral IR CD/LD products that are short-acting.
“Good On” time is defined as “On” time without troublesome dyskinesia, as PD progresses. A post-hoc analysis of the primary endpoint on a per-dose basis showed 1.6 hours additional “Good On” time per dose of Crexont compared with IR CD/LD.
Year to date, shares of Amneal have outperformed the industry, surging 42.7% against the industry’s 1% decline.
Image Source: Zacks Investment Research
Amneal Gets FDA Nod for Generic Version of Propofol
In late August, Amneal announced that the FDA approved its abbreviated new drug application for Propofol Injectable Emulsion USPsingle-dose vials. Propofol, a “hard-to-make” intravenous drug widely used for anesthesia and sedation in hospitals, is currently listed as a shortage by the American Society of Health System Pharmacists due to ongoing supply chain issues. To address this, Amneal plans to manufacture the generic version of propofol in-house on a dedicated production line, aiming to ensure a consistent supply. The company expects to launch this initiative in the fourth quarter of 2024.
Per an IQVIA report, propofol generated approximately $314 million in revenues from its U.S. sales for the 12 months ended June 2024.
Amneal Reports Strong Q2 Performance
The company also recorded strong revenues and profit growth in the second quarter of 2024 and raised its financial guidance for the full year on the second-quarter conference call driven by broad-based growth across its business. Net revenues of $702 million recorded in the last reported quarter represented a 17% year-over-year increase. This is likely to have also contributed to the soaring of the stock price in the past month.
Amneal’s oncology biosimilars and new product launches are generating increasing revenues for the Generics segment, while promoted products in Neurology and Endocrinology are boosting the Specialty segment.
Amneal’s Estimates Rising
In the past 60 days, the Zacks Consensus Estimate for Amneal’s 2024 earnings per share has increased from 58 cents to 59 cents. During the same time frame, the estimate for the company’s 2025 earnings per share has also increased from 60 cents to 64 cents.
This indicates that Wall Street analysts expect Amneal’s marketed portfolio of generic and specialty products to continue driving its growth, thereby potentially boosting its stock price further.
AMNEAL PHARMACEUTICALS, INC. Price and Consensus
AMNEAL PHARMACEUTICALS, INC. price-consensus-chart | AMNEAL PHARMACEUTICALS, INC. Quote
Zacks Rank & Stocks to Consider
Amneal currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Illumina, Inc. (ILMN - Free Report) , Krystal Biotech, Inc. (KRYS - Free Report) and Fulcrum Therapeutics, Inc. (FULC - Free Report) , each sporting 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 Illumina’s 2024 earnings per share have moved up from $1.18 to $3.62. Earnings per share estimates for 2025 have improved from $2.93 to $4.50. Year to date, shares of ILMN have lost 5.6%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.98 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 57.3%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have jumped 26.7%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.