The world is anxiously waiting for more-effective weapons against the coronavirus, so it was little wonder that the stock of Molecular Partners (NASDAQ:MOLN) shot more than 30% higher on Monday. The German biotech, along with its partner Novartis (NYSE:NVS), had some potentially excellent news to report about their pipeline drug targeting the still-raging disease.
Molecular Partners and Novartis announced that the initial part of a phase 2 clinical trial evaluating intravenous dosing of that drug, ensovibep, met its primary endpoint of viral load reduction. This included all tested variants of the coronavirus, particularly the still-rampaging omicron.
Just as encouragingly, ensovibep also showed a clinically meaningful benefit over a placebo in two secondary endpoints: hospitalization and/or emergency room visits or death, and period of time to sustained recovery.
As a result of this performance, Novartis will exercise an option it held to in-license the drug from its partner biotech. With this, it said, it “will seek expedited access globally.” The first step in that process is a planned application for Emergency Use Authorization (EUA) from the Food and Drug Administration.
“As COVID-19 continues to burden healthcare systems across the globe, a range of treatments will be needed, and Novartis is proud to continue our collaboration with Molecular Partners on this unique treatment for COVID-19 and contribute ensovibep to this suite of options,” Novartis CEO Vas Narasimhan was quoted as saying in the announcement.
This is very exciting news for Molecular Partners, which originally signed the deal with Novartis in October 2020. Novartis has the scope and resources to get ensovibep marketed quickly and broadly if it receives an EUA in the U.S. Such authorization would also likely be followed rapidly by authorizations or approvals in other major jurisdictions around the world.
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