The company’s net revenues increased in the first half of 2020 compared with the fisrt half of 2019 Net as a result of the continued, global expansion of Onpattro, in addition to sales generated from the second marketed product, Givlaari, following commercial launch in the United States in November and December 2019, respectively, and initial European launch of Givlaari in the second quarter of 2020.
The company expects that research and development expenses combined with selling, general and administrative expenses will increase for 2020, as compared to the same period in 2019, as it continues to develop its pipeline, advance its product candidates, including partnered programs, into later-stage development, prepare regulatory submissions and build-out of its global commercial infrastructure and field team to support Onpattro, Givlaari and potentially additional product launches.
In March 2020, the European Commission approved Givlaari for the treatment of AHP in patients aged 12 years or older. The drug was 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 (PH1) 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. 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 February 2020, Alnylam completed enrollment in the HELIOS-A phase III study on vutrisiran for the treatment of hATTR amyloidosis with polyneuropathy. Top-line data from the study is expected in early 2021.
In April 2020, Alnylam and The Blackstone Group entered into a broad strategic collaboration.The collaborationwill support the company’sadvancement 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 (IND) to initiate a clinical study to evaluate the candidate at or around 2020-end.During the second quarter of 2020, the company selected VIR-2703 for SARS-CoV-2 — the virus that causes COVID-19 — with a plan to accelerate the filing of an IND around 2020-end.
Zacks Rank and Stocks to Consider
Currently, Alnylam is a Zacks Rank #3 (Hold) stock.
Some better-ranked stocks in the healthcare sector include Emergent Biosolutions Inc. EBS, Horizon Therapeutics Public Limited Company HZNP and Alimera Sciences Inc. ALIM. While Emergent and Horizon Therapeutics sport a Zacks Rank #1 (Strong Buy), Alimera carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Emergent’s earnings estimates have increased from $3.45 to $5.60 for 2020 and from $3.73 to $6.67 for 2021 over the past 60 days.
Horizon Therapeutics’ earnings estimates have increased from $1.78 to $2.86 for 2020 and from $2.74 to $4.29 for 2021 over the past 60 days.
Alimera’s loss per share estimates have narrowed from $2.33 to $1.31 for 2020 and from 63 cents to 52 cents for 2021 over the past 60 days.
Alnylam Pharmaceuticals, Inc. Price
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