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Alnylam's (ALNY) Vutrisiran NDA Faces Delay in FDA Decision
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Alnylam Pharmaceuticals(ALNY - Free Report) announced that the FDA has delayed its decision on its new drug application (“NDA”) for its investigational RNAi therapeutic, vutrisiran, developed for the treatment of transthyretin-mediated (ATTR) amyloidosis.
A decision from the regulatory body is now expected on Jul 14, 2022, instead of Apr 14, as expected previously.
The FDA recently inspected the original third-party secondary packaging and labeling facility that Alnylam had planned to use for the vutrisiran launch. Though the observations of the inspection were not related to the vutrisiran NDA, the inspection requires classification for the FDA to take action on the vutrisiran NDA.
To avoid further delay in getting the FDA decision, Alnylam has identified another packaging and labeling facility for vutrisiran and submitted an amendment to the NDA. The FDA needs time to review new information incorporated into the NDA related to this new secondary packaging and labeling facility, which has been cited as a reason for the delay. The FDA has not asked the company to conduct a new study.
Shares of Alnylam have declined 4.6% so far this year compared with the industry's decline of 11.6%.
Image Source: Zacks Investment Research
The FDA had accepted the vutrisiran NDA in June last year. Regulatory applications seeking approval of vutrisiran for a similar indication are also under review in Europe, Japan and Brazil.
Vutrisiran has been granted Orphan Drug designation in both the United States and Europe for the treatment of ATTR amyloidosis and in Japan for transthyretin type familial amyloidosis with polyneuropathy.
Solid Biosciences’ stock has declined 76.3% in the past year. The consensus estimate for Solid Biosciences’ bottom line has narrowed from a loss of 77 cents to 72 cents per share, while that for 2023 has narrowed from 69 cents per share to 59 cents per share over the past 60 days.
Solid Biosciences beat estimates in the last four quarters, with the average surprise being 17.1%.
BELLUS Health’s stock has surged 83.4% in the past year.
The Zacks Consensus Estimate for BELLUS Health’s 2022 bottom line has narrowed from a loss of 99 cents to 77 cents per share, while that for 2023 has narrowed from $1.34 per share to $1.11 per share over the past 60 days.
Aligos Therapeutics’ stock has declined 90.8% in the past year. The Zacks Consensus Estimate for Aligos Therapeutics’ 2022 bottom line has narrowed from a loss of $3.23 to $2.43 per share, while that for 2023 has narrowed from $3.08 per share to $1.67 per share over the past 60 days.
Aligos Therapeutics beat estimates in three of the last four quarters, with the average surprise being 4.76%.
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Alnylam's (ALNY) Vutrisiran NDA Faces Delay in FDA Decision
Alnylam Pharmaceuticals (ALNY - Free Report) announced that the FDA has delayed its decision on its new drug application (“NDA”) for its investigational RNAi therapeutic, vutrisiran, developed for the treatment of transthyretin-mediated (ATTR) amyloidosis.
A decision from the regulatory body is now expected on Jul 14, 2022, instead of Apr 14, as expected previously.
The FDA recently inspected the original third-party secondary packaging and labeling facility that Alnylam had planned to use for the vutrisiran launch. Though the observations of the inspection were not related to the vutrisiran NDA, the inspection requires classification for the FDA to take action on the vutrisiran NDA.
To avoid further delay in getting the FDA decision, Alnylam has identified another packaging and labeling facility for vutrisiran and submitted an amendment to the NDA. The FDA needs time to review new information incorporated into the NDA related to this new secondary packaging and labeling facility, which has been cited as a reason for the delay. The FDA has not asked the company to conduct a new study.
Shares of Alnylam have declined 4.6% so far this year compared with the industry's decline of 11.6%.
Image Source: Zacks Investment Research
The FDA had accepted the vutrisiran NDA in June last year. Regulatory applications seeking approval of vutrisiran for a similar indication are also under review in Europe, Japan and Brazil.
Vutrisiran has been granted Orphan Drug designation in both the United States and Europe for the treatment of ATTR amyloidosis and in Japan for transthyretin type familial amyloidosis with polyneuropathy.
Zacks Rank & Stocks to Consider
Alnylam currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the drug/biotech sector include Solid Biosciences (SLDB - Free Report) , BELLUS Health and Aligos Therapeutics (ALGS - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Solid Biosciences’ stock has declined 76.3% in the past year. The consensus estimate for Solid Biosciences’ bottom line has narrowed from a loss of 77 cents to 72 cents per share, while that for 2023 has narrowed from 69 cents per share to 59 cents per share over the past 60 days.
Solid Biosciences beat estimates in the last four quarters, with the average surprise being 17.1%.
BELLUS Health’s stock has surged 83.4% in the past year.
The Zacks Consensus Estimate for BELLUS Health’s 2022 bottom line has narrowed from a loss of 99 cents to 77 cents per share, while that for 2023 has narrowed from $1.34 per share to $1.11 per share over the past 60 days.
Aligos Therapeutics’ stock has declined 90.8% in the past year. The Zacks Consensus Estimate for Aligos Therapeutics’ 2022 bottom line has narrowed from a loss of $3.23 to $2.43 per share, while that for 2023 has narrowed from $3.08 per share to $1.67 per share over the past 60 days.
Aligos Therapeutics beat estimates in three of the last four quarters, with the average surprise being 4.76%.