Alnylam Pharmaceuticals, Inc.
ALNY
announced that the FDA has approved its RNAi therapeutic, Amvuttra (vutrisiran), for the treatment of adult patients with polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. hATTR is an inherited, often fatal disease caused by mutations in the TTR gene.
The company plans to launch the drug early next month. Amvuttra is approved as a subcutaneous injection to be administered once every three months (quarterly) for the given indication.
The FDA approval was based on positive nine-month data from the phase III HELIOS-A study that evaluated the safety and efficacy of Amvuttra in patients with hATTR amyloidosis with polyneuropathy. Data from the same showed that treatment with Amvuttra significantly improved the signs and symptoms of polyneuropathy, with more than 50% of patients experiencing halting or reversal of their disease manifestations.
Following the latest FDA nod, Amvuttra became the first and only FDA-approved therapy to demonstrate reversal in neuropathy impairment with subcutaneous administration quarterly.
Shares of Alnylam have plunged 24.7% so far this year compared with the
industry
’s decline of 27.5%.
Image Source: Zacks Investment Research
In April 2022, the FDA
delayed
its decision on Alnylam’s new drug application (“NDA”) for Amvuttra, developed for the treatment of transthyretin-mediated (ATTR) amyloidosis, which encompasses both hATTR and wild-type ATTR (wtATTR) amyloidosis.
As a result of this, a decision from the regulatory body was now expected on Jul 14, 2022 instead of the previously expected date of Apr 14.
The FDA had accepted the NDA in June last year. Regulatory applications seeking approval of vutrisiran for a similar indication are also under review in Europe, Japan and Brazil.
Both the FDA and the EMA have granted Orphan Drug designation to vutrisiran for the treatment of ATTR amyloidosis. Japan has approved the drug for transthyretin type familial amyloidosis with polyneuropathy.
Alnylam’s Onpattro is already approved for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. The injection recorded sales of $137 million in the first quarter of 2022, up around 34% year over year, driven by new patient demand.
Hence, the approval of Amvuttra should help Alnylam diversify its portfolio and drive growth in the days ahead.
Zacks Rank & Stocks to Consider
Alnylam currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector are
Leap Therapeutics, Inc.
LPTX
,
Aeglea BioTherapeutics, Inc.
AGLE
and
Precision BioSciences, Inc.
DTIL
, all carrying a Zacks Rank #2 (Buy) at present. You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
.
The Zacks Consensus Estimate for Leap Therapeutics’ loss per share has narrowed 11.1% for 2022 and 5.9% for 2023 in the past 60 days.
Earnings of Leap Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. LPTX delivered an earnings surprise of 1.92%, on average.
Aeglea BioTherapeutics’ loss per share estimates narrowed 19.4% for 2022 and 37.6% for 2023 in the past 60 days.
Earnings of AegleaBio Therapeutics have surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions. AGLE delivered an earnings surprise of 9.47%, on average.
Precision BioSciences’ loss per share estimates narrowed 21.7% for 2022 and 31.4% for 2023 in the past 60 days.
Earnings of Precision BioSciences have surpassed estimates in each of the trailing four quarters. DTIL delivered an earnings surprise of 76.15%, on average.
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