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Alnylam (ALNY) Gets FDA Approval for Oxlumo Label Expansion

Alnylam Pharmaceuticals, Inc. ALNY recently announced that the FDA has approved its RNAi therapeutic administered via subcutaneous injection, Oxlumo (lumasiran) for a new indication. The injection is now approved for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate (UOx) and plasma oxalate (POx) levels in pediatric and adult patients.

The FDA approved Oxlumo for the treatment of PH1 to lower UOx levels in pediatric and adult patients in November 2020. During the same time, the European Commission granted marketing authorization to Oxlumo for the treatment of PH1 in all age groups.

The latest FDA nod was based on positive safety and efficacy data from the phase III ILLUMINATE-C study, which evaluated Oxlumo in patients with severe renal impairment, including those who are on hemodialysis.

Data from the same showed that treatment with Oxlumo led to substantial reductions in POx levels and showed encouraging safety and tolerability profile in patients with compromised renal function, including those with kidney failure and those on hemodialysis.

Last December, ALNY submitted a supplemental new drug application (sNDA) to the FDA and a Type II filing variation to the European Medicines Agency (EMA) seeking approval for Oxlumo for the reduction of plasma oxalate in the treatment of patients with advanced PH1.

Notably, The EMA’s Committee for Medicinal Products for Human Use has rendered a positive opinion recommending a variation to the marketing authorization of Oxlumo’s label expansion in September 2022.

Shares of Alnylam have rallied 19.3% so far this year against the industry’s decline of 25.3%


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Oxlumo injection recorded global net product revenues of around $29.5 million during the first six months of 2022, reflecting an increase of approximately 15.7% year over year. Label expansion into additional indications should drive sales in future quarters.

Apart from Oxlumo, Alnylam markets Onpattro, which is approved for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. The company’s second product, Givlaari, is approved for the treatment of acute hepatic porphyria both in the United States and Europe.

In June 2022, the FDA approved ALNY’s other RNAi therapeutic, Amvuttra (vutrisiran), for the treatment of adult patients with polyneuropathy of hATTR-mediated amyloidosis. Amvuttra was approved for the same indication in Europe last month.

Zacks Rank & Stocks to Consider

Alnylam currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Achilles Therapeutics plc ACHL, Atara Biotherapeutics, Inc. ATRA and ORIC Pharmaceuticals, Inc. ORIC, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Achilles Therapeutics’ loss per share estimates narrowed 7.4% for 2022 and 9.5% for 2023 in the past 60 days.

Earnings of Achilles Therapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. ACHL delivered an earnings surprise of 12.45%, on average.

Atara Biotherapeutics’ loss per share estimates narrowed 43.2% for 2022 and 21.3% for 2023 in the past 60 days.

Earnings of Atara Biotherapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. ATRA delivered an earnings surprise of 4.83%, on average.

ORIC Pharmaceuticals’ loss per share estimates narrowed 8.6% for 2022 and 22% for 2023 in the past 60 days.

Earnings of ORIC Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ORIC delivered an earnings surprise of 8.85%, on average.


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