Biopharma: Kicking Off 2H 2026 With a Bang With Atacicept's PDUFA on Tuesday, But Multiple Other Near-Term Catalysts Coming Up Across Our Coverage

Research evidence excerpt

Biopharma: Kicking Off 2H 2026 With a Bang With Atacicept's PDUFA on Tuesday, But Multiple Other Near-Term Catalysts Coming Up Across Our Coverage

cicept is currently dosed weekly, although Vera management has

suggested we may get an update from them later this year or next year on a potential

path to market for a once-monthly dosing option for atacicept as well. We believe these

commercial questions may limit the immediate upside potential in VERA shares on a

possible atacicept approval, with the stock likely going back up to the high $40's on approval,

by our estimates, but down to the $10-15 range on a rejection or the possibility of a lengthy

delay. Savara (SVRA) has already experienced a 3-month extension to the review for

Molbreevi for autoimmune pulmonary alveolar proteinosis (aPAP), with the PDUFA now

set for November 22. We expect most are also expecting approval for Molbreevi this time

around, with questions here also more focused on the commercial side given unknowns

on the size of the aPAP market. We believe the 3-month extension to the FDA review may

ironically benefit the company in some ways by providing them with additional time to identify

patients with aPAP ahead of launch, although the company has already achieved its goal

of having line of sight to ~1,000 patients by year-end 2025 out of a total US market that

they currently estimate to be ~5,500 patients. With most investors likely assuming approval,

we believe SVRA shares could appreciate to the ~$8-9 range on approval, but likely down

to the ~$2 range should Molbreevi not get approved and/or if the product faces another

meaningful delay.

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