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AbbVie (ABBV) Gets FDA Rejection for Parkinson's Candidate

AbbVie ABBV announced that FDA has issued a complete response letter (CRL) to its new drug application (“NDA”) seeking approval for ABBV-951 for the treatment of motor fluctuations in patients with advanced Parkinson's disease (PD).

ABBV-951 is a solution of carbidopa and levodopa prodrugs, which are the standard of care for PD patients. ABBV-951 has been designed to offer continuous subcutaneous delivery of CD/LD prodrugs through a pump device and offer a better patient experience. In the CRL, the FDA has asked for some extra information about the pump device used to administer the medicine. The FDA has not requested any additional efficacy/safety studies.

AbbVie’s shares were down almost 2% on Wednesday in response. The CRL will potentially delay the approval of ABBV-951. AbbVie’s stock has declined 3% in the past year against an increase of 2.9% for the industry.

 

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The NDA was based on data from a phase III head-to-head study, which showed that treatment with ABBV-951 led to a statistically significant improvement in "On" time without troublesome dyskinesia compared with oral immediate-release CD/LD. Per the press release, "On" time is cited as the period when symptoms are well controlled without dyskinesia or involuntary movements. The goal of PD patients and physicians is to extend the amount of "On" time.

Zacks Rank and Stocks to Consider

AbbVie currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Some better-ranked drugmakers/biotech companies are Novo Nordisk NVO and Ligand Pharmaceuticals LGND, both with a Zacks Rank of 1.

Estimates for Novo Nordisk’s 2023 earnings per share have increased from $4.15 to $4.43. Estimates for 2024 have jumped from $4.38 per share to $5.19 in the past 60 days. The stock has surged 34.1% in the past year.

Novo Nordisk beat earnings expectations in three of the trailing four quarters. The company delivered a four-quarter earnings surprise of 3.00%, on average.

Estimates for Ligand Pharmaceuticals’ 2023 earnings per share have increased from $3.30 to $4.15 over the past 60 days while that for 2024 have jumped from $3.10 per share to $4.28 over the same timeframe. The stock has declined 38.4% in the past year.

Ligand Pharmaceuticals beat earnings expectations in one of the trailing four quarters. The company delivered a four-quarter negative earnings surprise of 10.07%, on average.

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Novo Nordisk A/S (NVO) : Free Stock Analysis Report

Ligand Pharmaceuticals Incorporated (LGND) : Free Stock Analysis Report

AbbVie Inc. (ABBV) : Free Stock Analysis Report

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Zacks Investment Research