Drug Development
The mixed data from the Phase III COAST 2 trial follows an underwhelming data drop from COAST 1 in September that Leerink Partners said “fell well below expectations.”
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Following the hard-won success of early anti-amyloid drugs, a new generation of Alzheimer’s modalities—from tau-targeting gene silencers to blood-brain barrier delivery platforms—is entering the pipeline to anchor future combination therapies.
Three years after the accelerated approval of its anti-amyloid Alzheimer’s therapy, Biogen—neck and neck in the market with Eli Lilly and its Kisunla offering—is focused on a near-term FDA decision for a subcutaneous induction dose of Leqembi, a presymptomatic readout in 2028 and a clutch of next-generation candidates.
BMO analysts say Eli Lilly is well-positioned to maintain its lead in the ballooning weight loss space, predicting “strengthening leadership in obesity and beyond” as portfolios expand and patient access improves.
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The trial demonstrated a safety profile in the younger age group as seen in patients 12 and older, with no severe side effects and no one dropping out from adverse events.
Eli Lilly has shared positive results of lebrikizumab combination therapy with topical corticosteroids, which is intended to treat atopic dermatitis (AD).
Although the data was preliminary from a Phase Ib trial, investors are already speculating that the drug - when and if it makes it to regulators - could compete with Amgen’s Lumakras (sotorasib).
The FDA’s decision to lift the hold directive on April 11 involving the investigational drug magrolimab follows a comprehensive review of each trial’s safety data.
As Aeglea presents the data this week at the Society for Inherited Metabolic Disorders (SIMD), its stock has responded to both announcements with a strong leap.
EXUMA Biotech is developing a new modality to produce CAR cells in a single day, with potentially lower toxicity and higher efficacy without the need for preparative chemotherapies.
Cytovia could become the first company to use a combination of natural killer (NK) cells derived from induced pluripotent stem cell (iPSC) and NK engager antibodies to treat solid tumors.
Veru posted positive interim Phase III data from its late-stage study assessing oral antiviral sabizabulin in hospitalized COVID-19 patients. Here’s more about it.
Curis, a biotech company that develops treatments for cancer, has announced that the FDA has placed a partial clinical hold on its TakeAim lymphoma study.
The American Association for Cancer Research (AACR) Annual Meeting is running from April 7-13 in New Orleans. Here’s a look at some of the preclinical and early-stage studies recently presented.