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FDA Accepts Amneal's (AMRX) Parkinson's Candidate NDA For Review
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Amneal Pharmaceuticals (AMRX - Free Report) announced that the new drug application (“NDA”) for its Parkinson’s disease (PD) candidate, IPX203, has been accepted for review by the FDA.
The company submitted the NDA for IPX203 for treating PD patients by the end of August 2022.
The FDA also assigned a Prescription Drug User Fee Act (PDUFA) date set for Jun 30, 2023, to complete its evaluation of the NDA.
IPX203 is a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules.
Parkinson’s Disease is the fastest-growing central nervous system (CNS) disorder in the world, characterized by a slowdown of movement, resting tremors, impaired balance and stiffness in the body.
The acceptance of the NDA was based on positive results from a double-blind, double-dummy, active-controlled RISE-PD study.
Shares of Amneal Pharmaceuticals rose 3.36% during market hours on Nov 11. The stock has declined 39.3% in the year-to-date period compared with the industry’s fall of 29.4%.
Image Source: Zacks Investment Research
The RISE-PD study evaluated the efficacy and safety of IPX203 CD/LD extended-release capsules against the immediate-release CD/LD capsules in PD patients who have motor fluctuations. The study met its primary and secondary endpoints.
Amneal Pharma is an essentials medicine company with three reportable segments, namely generics, specialty and AvKARE.
The generics segment includes more than 250 product families, covering a broad range of complex products and therapeutic areas, including injectables and biosimilars. The specialty segment deals with products focused on CNS and endocrine disorders.
Earlier this month, the company received an abbreviated new drug application (ANDA) from the FDA for its leuprolite acetate injection for treating advanced prostatic cancer.
Catalyst Pharmaceuticals earnings per share estimates for 2022 have improved by a cent to 71 cents in the past 30 days. The same for 2023 has remained steady at 85 cents in the same time frame.
Earnings of Catalyst missed estimates in two of the trailing four quarters, while beating the same in the reaming two occasions. The average negative earnings surprise for CPRX is 4.10%.
Esperion’s loss per share estimates for 2022 have narrowed from $3.82 to $3.66 in the past 30 days. The loss per share for 2023 has narrowed from $1.89 to $1.67 in the same time frame.
Earnings of Esperion beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion. The average earnings surprise for ESPR is 7.30%.
Ionis Pharmaceuticals’ loss estimates for 2022 have narrowed down from $2.53 to $2.45 in the past 30 days. The loss estimates for 2023 have widened from $1.96 to $2.36 in the same time frame.
IONS surpassed earnings in three of the trailing four quarters, missing the same in one. The average earnings surprise for Ionis is 35.68%.
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FDA Accepts Amneal's (AMRX) Parkinson's Candidate NDA For Review
Amneal Pharmaceuticals (AMRX - Free Report) announced that the new drug application (“NDA”) for its Parkinson’s disease (PD) candidate, IPX203, has been accepted for review by the FDA.
The company submitted the NDA for IPX203 for treating PD patients by the end of August 2022.
The FDA also assigned a Prescription Drug User Fee Act (PDUFA) date set for Jun 30, 2023, to complete its evaluation of the NDA.
IPX203 is a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules.
Parkinson’s Disease is the fastest-growing central nervous system (CNS) disorder in the world, characterized by a slowdown of movement, resting tremors, impaired balance and stiffness in the body.
The acceptance of the NDA was based on positive results from a double-blind, double-dummy, active-controlled RISE-PD study.
Shares of Amneal Pharmaceuticals rose 3.36% during market hours on Nov 11. The stock has declined 39.3% in the year-to-date period compared with the industry’s fall of 29.4%.
Image Source: Zacks Investment Research
The RISE-PD study evaluated the efficacy and safety of IPX203 CD/LD extended-release capsules against the immediate-release CD/LD capsules in PD patients who have motor fluctuations. The study met its primary and secondary endpoints.
Amneal Pharma is an essentials medicine company with three reportable segments, namely generics, specialty and AvKARE.
The generics segment includes more than 250 product families, covering a broad range of complex products and therapeutic areas, including injectables and biosimilars. The specialty segment deals with products focused on CNS and endocrine disorders.
Earlier this month, the company received an abbreviated new drug application (ANDA) from the FDA for its leuprolite acetate injection for treating advanced prostatic cancer.
AMNEAL PHARMACEUTICALS, INC. Price
AMNEAL PHARMACEUTICALS, INC. price | AMNEAL PHARMACEUTICALS, INC. Quote
Zacks Rank and Stocks to Consider
Amneal Pharmaceuticals currently has a Zacks Rank #4 (Sell).
Some better-ranked stocks in the same sector include Catalyst Pharmaceuticals (CPRX - Free Report) , Esperion Therapeutics (ESPR - Free Report) , and Ionis Pharmaceuticals (IONS - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
Catalyst Pharmaceuticals earnings per share estimates for 2022 have improved by a cent to 71 cents in the past 30 days. The same for 2023 has remained steady at 85 cents in the same time frame.
Earnings of Catalyst missed estimates in two of the trailing four quarters, while beating the same in the reaming two occasions. The average negative earnings surprise for CPRX is 4.10%.
Esperion’s loss per share estimates for 2022 have narrowed from $3.82 to $3.66 in the past 30 days. The loss per share for 2023 has narrowed from $1.89 to $1.67 in the same time frame.
Earnings of Esperion beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion. The average earnings surprise for ESPR is 7.30%.
Ionis Pharmaceuticals’ loss estimates for 2022 have narrowed down from $2.53 to $2.45 in the past 30 days. The loss estimates for 2023 have widened from $1.96 to $2.36 in the same time frame.
IONS surpassed earnings in three of the trailing four quarters, missing the same in one. The average earnings surprise for Ionis is 35.68%.