Amneal (AMRX) Shares Down on CRL for Parkinson's Disease Drug
Amneal Pharmaceuticals, Inc. AMRX announced on Jul 3 that it received a CRL from the FDA regarding the NDA for IPX203 for the treatment of Parkinson’s disease. Shares are trading down in pre-market trading on Jul 5 in response to the same.
The CRL indicated that the data from pharmacokinetic studies suggest an adequate scientific bridge was established for the safety of one ingredient, levodopa (LD), but it was not adequately established for the other ingredient, carbidopa (CD). Consequently, the regulatory body requested additional information.
The letter did not identify any issues with respect to the efficacy or manufacturing of IPX203. Amneal will work closely with the FDA to address its comments and plans to meet with the agency to align on the best path forward.
IPX203 is a novel oral formulation of CD/LD extended-release capsules designed for the treatment of Parkinson’s disease. Amneal is developing IPX203 to provide a longer duration of therapeutic benefit than existing formulations with fewer doses. The NDA, based on the results from the late-stage RISE-PD clinical trial, was accepted by the FDA in November 2022.
The stock has gained 53.2% in the year-to-date period against the industry’s decline of 3.1%.
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Amneal Pharma is an essentials medicine company with three reportable segments, namely generics, specialty and AvKARE.
The specialty division’s portfolio of products includes Rytary, an extended-release oral capsule formulation of carbidopa-levodopa for the treatment of Parkinson’s disease, post-encephalitic parkinsonism and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.
Concurrently, Amneal announced the launch of its authorized generic for Xyrem (sodium oxybate) oral solution CIII in the United States. In addition, Amneal has received abbreviated new drug application (ANDA) approvals from the FDA for five complex generic products.
Zacks Rank and Stocks to Consider
Amneal Pharmaceuticals currently has a Zacks Rank #3 (Hold). Some top-ranked stocks in the healthcare sector are Ligand Pharmaceuticals LGND and Novartis NVS. While Ligand sports a Zacks Rank #1 (Strong Buy), NVS carries a Zacks Rank #2 (Buy).
You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, earnings estimates for LGND have increased by $1.09 to $5.25. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
Over the past 60 days, earnings estimates for NVS have increased to $6.74 from $6.60. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.
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