Phase III
Despite tolerability concerns, nomlabofusp’s overall efficacy represents a “large win” for Larimar, according to analysts at William Blair, who lauded the therapy’s functional benefits.
Imlifidase, an IgG-destroying enzyme, could receive FDA approval in the second half of 2026 and hit peak sales of $306 million, according to William Blair.
While Harmony management has not disclosed future plans for ZYN002, Jefferies analysts expect the asset to be shelved.
Acadia Pharmaceuticals was testing the drug, an intranasal formulation of the oxytocin analogue carbetocin, for its potential to ease hyperphagia in the rare neurological condition.
Jefferies analysts expect a regulatory filing for rocatinlimab later this year, with a product launch in 2026.
Ivonescimab elicited better overall survival in Asian patients with non-small cell lung cancer than in those from North America and European countries, in Western countries narrowly missing the statistical significance threshold the FDA is seeking.
Data from the late-stage MAPLE-HCM study position Cytokinetics’ cardiac myosin inhibitor aficamten as a potential first-line therapy for patients with obstructive hypertrophic cardiomyopathy.
Regeneron’s cemdisiran, used alone or in combination with its complement inhibitor Veopoz, significantly improved activities of daily living in patients with generalized myasthenia gravis.
While Truist Securities analysts said the results from the ATTAIN-2 trial leave “room for competition,” they also pointed to a manufacturing advantage that could unlock a “double-digit billion dollar opportunity” for Eli Lilly.
Based on new data, argenx expects to file for the expansion of Vyvgart’s label into patients with generalized myasthenia gravis who are negative for antibodies against the AChR marker—an indication William Blair analysts called the broadest option in this disease space.
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