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TICKERS: ALT

Biopharma's New MASH Drug Has Two MOAs
Research Report

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Altimmune Inc.'s (ALT:NASDAQ) pemvidutide achieves metabolic improvement and directs hepatic anti-fibrotic activity with singular dosing, noted an H.C. Wainwright & Co. report.

Altimmune Inc. (ALT:NASDAQ) and its lead drug candidate for MASH (metabolic dysfunction-associated steatohepatitis) should benefit from the announced acquisition of Akero Therapeutics Inc. (AKRO:NASDAQ) by Novo Nordisk (NVO:NYSE), reported H.C. Wainwright & Co. Analyst Patrick Trucchio in an Oct. 10 research note. Through the deal, Novo will gain all rights to Akero's investigative drug for MASH, efruxifermin.

"We view Novo's acquisition of Akero as further validation of the MASH market opportunity and of pemvidutide's strategic fit within a rapidly consolidating therapeutic landscape," Trucchio wrote.

200% Upside Implied

H.C. Wainwright reiterated its $12 per share target price on the California-based biopharmaceutical firm, trading at the time of Trucchio's report at about $4 per share, the analyst noted. From this price, the return to target is 200%

Altimmune remains a Buy.

The company has 88.3 million shares outstanding, a market cap of $353 million and a 52-week range of $2.90–11.16 per share.

Growth in MASH Space

Novo Nordisk announced on Oct. 9 it will acquire Akero for $4.7 billion in cash, plus a contingent value right worth up to $500 million. Through the deal, Novo will gain full rights to efruxifermin. Akero's Phase 3 treatment for MASH, efruxifermin is a fibroblast growth factor 21 analog, meaning it mimics the hormone FGF21 to improve liver function and other metabolic processes.

The acquisition "reinforces accelerating business development momentum in MASH," Trucchio wrote.

Along with Novo, large caps like Roche Holding AG (RHHBY:OTCQX; ROG:SWX) and GSK Plc (GSK:NYSE) have expressed interest in the space over the past six months, Altimmune Chief Executive Officer Vipin Garg told H.C. Wainwright, reported Trucchio. Garg said he considers the Novo-Akero acquisition "a great sign for the MASH space overall."

Dual Mechanisms Needed

Effective MASH treatments must target both metabolic and hepatic components of the disease, and this realization is growing, thus so is the focus on combination approaches, noted Trucchio. The Novo-Akero deal further substantiates these trends.

Novo's plan for efruxifermin is to pair it with a semaglutide in a combination MASH treatment, aiming for dual results, to achieve metabolic improvement and to direct hepatic anti-fibrotic activity.

Altimmune's pemvidutide could achieve the same outcomes and without the need for and complexity of combination dosing, CEO Garg highlighted. He added that the upcoming data readout of the biopharma's Phase 2b IMPACT trial will confirm pemvidutide's dual mechanisms of action. These 48-week study results, due out this quarter, will be on key noninvasive tests (NITs) measuring inflammation and fibrosis.

"With pemvidutide, Altimmune's lead MASH candidate, already combining GLP-1 and glucagon activity in a single molecule, we believe Altimmune remains well-positioned as the field consolidates around multimechanism strategies," the analyst wrote.

Further, Altimmune is advancing pemvidutide in alignment with the U.S. Food and Drug Administration's shift in desired endpoints, from biopsy-based ones to artificial intelligence-assisted histologic reads and NITs. Vibration-controlled transient elastography and iron-corrected T1 are two examples. As such, the drug developer is designing Phase 3 of IMPACT "with built-in flexibility to pivot toward these noninvasive frameworks," wrote Trucchio.


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