Somnus Therapeutics is developing a timed-release formulation of zaleplon, a GABA agonist that is currently approved for short-term difficulty in falling asleep. According to company, its version of the drug is expected to offer patients an initial two hours of drug-free delta sleep, followed by the controlled release of a short-acting active ingredient, which may allow people to awaken more refreshed and alert.
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CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.
A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand
The company believes its drug could eventually displace Novartis’s Scemblix in first-line chronic myeloid leukemia treatment, but for now is preparing for a second-/third-line pivotal study.
Successive annual reductions in European drug prices following the pandemic are affecting the global sales of generic pharmaceutical companies. Additionally, the imposition of US import tariffs may result in generic drug supply becoming unprofitable.
Innovent presented data on multiple pipeline assets at ASCO, including promising OS results for its first-in-class anti-PD-1/IL-2α-bias bispecific. The Chinese firm is also continuing to build out its metabolic disease portfolio and consider its partnering strategies, its CEO tells Scrip.
