Shares of Alnylam Pharmaceuticals Inc. ALNY have increased 14.8% year to date compared with the industry’s growth of 8.2%. This growth can be attributed to the following developments.
In March 2020, the European Commission approved Givlaari for the treatment of AHP in patients aged 12 years or older. The drug will be available as a subcutaneous injection. In November 2019, the FDA approved Givlaari (givosiran injection) for subcutaneous use for the treatment of adults with acute hepatic porphyria (AHP).
In April 2020, Alnylam announced that it completed the rolling submission of the new drug application (NDA) seeking approval for lumasiran as a treatment for primary hyperoxaluria type 1 in the United States. The company also filed a marketing authorization application (MAA) seeking approval for the candidate in the same indication in Europe. In May, the FDA granted priority review to theNDA. A decision from the FDA is expected by Dec 3, 2020.Regulatory applications for lumasiran included positive data from the pivotal ILLUMINATE-A study. Data from the study showed that PH1 patients treated with the candidate met the primary efficacy endpoint of percent change from baseline relative to placebo. The study also achieved statistically significant results for all six tested secondary endpoints, including the proportion of patients achieving a near-normalization or normalization of urinary oxalate.There is a huge unmet need in PH1 and the potential approval of the drug will be a big boost.
In April 2020, the FDA granted a Fast Track designation to vutrisiran for the treatment of polyneuropathy of hATTR amyloidosis in adults. The Fast Track status will help Alnylam submit a rolling NDA for vutrisiran.
In April 2020, Alnylam and The Blackstone Group entered into a broad strategic collaboration.The collaborationwill support Alnylam’s advancement of innovative RNAi medicines with up to a $2-billion investment from Blackstone. Alnylam believes that the deal with Blackstone will make it self-sustainable. The Blackstone investment isalso likely to accelerate the commercial potential of Alnylam’s rapidly advancing product portfolio and support the development and delivery of promising medicines.
Alnylam and partner Vir Biotechnology announced the identification of a development candidate, VIR-2703 (ALN-COV), targeting SARS-CoV-2 for the treatment of COVID-19 in May 2020. The companies plan to meet with the FDA to discuss a potential accelerated path for filing an investigational new drug application to initiate a clinical study to evaluate the candidate at or around 2020-end.
Alnylam Pharmaceuticals, Inc. Price
Alnylam Pharmaceuticals, Inc. price | Alnylam Pharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
Alnylam is a Zacks Rank #3 (Hold) stock, presently.
Some better-ranked stocks in the biotech sector are AkceaThrapeuticss Inc. AKCA, Axcella Health Inc. AXLA and Aytu BioScience Inc. AYTU, all carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Akcea’s loss per share estimates have narrowed from $2.07 to $1.37 for 2020 and from $2.46 to $1.85 for 2021 in the past 60 days.
Axcella’s loss per share estimates have narrowed from $1.14 to 79 cents for 2020 and from $3.30 to $3.03 for 2021 in the past 60 days.
Aytu’s loss per share estimates have narrowed from $1.26 to 12 cents for 2020 in the past 60 days.
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