ROIV - Alnylam sends Arbutus lower after FDA snub for amyloidosis drug

2023-10-09 13:48:11 ET

The FDA's decision to reject a label expansion for Alnylam’s ( NASDAQ: ALNY ) amyloidosis therapy patisiran on Monday pressured shares of Arbutus Biopharma ( NASDAQ: ABUS ), which has out-licensed the product to the RNAi therapeutics company.

However, Alnylam ( ALNY ) has avoided a sharp selloff after a group of independent experts questioned its effectiveness despite recommending it for cardiomyopathy linked to transthyretin-mediated (ATTR) amyloidosis, the targeted indication.

Alnylam ( ALNY ) already markets patisiran as Onpattro for polyneuropathy of hereditary ATTR amyloidosis in adults.

Jefferies analyst Dennis Ding argues that the FDA's decision "obviously is not a positive" for ABUS, which generates 2-3% royalties from Onpattro sales.

However, in comments to Bloomberg , Ding acknowledged that Arbutus' ( ABUS ) bullish narrative on Wall Street does not depend on Onpattro royalties.

Additionally, Ding opined that the company indicates a "massive +100-300% upside potential" if it can win a patent dispute over mRNA-based COVID-19 vaccine technology at an upcoming hearing in February 2024.

Arbutus ( ABUS ) and Genevant Sciences, its joint venture with Roivant Sciences ( ROIV ), are battling Moderna ( MRNA ) over the ownership of several patents related to the production and sale of the biotech's COVID shot.

More on Arbutus, Alnylam, etc.

• Alnylam Continues To Deliver, But An Upcoming FDA Meeting Could Create Some Volatility
• Arbutus Biopharma Corporation 2023 Q2 - Results - Earnings Call Presentation
• Alnylam: Unlimited Promise Or Unlimited Losses?
• Alnylam U.S. label expansion for amyloidosis drug denied
• Ionis, AbbVie, Alnylam draw bullish views at Raymond James

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