Neos Therapeutics got an ominous note from the FDA just weeks ahead of the expected approval date for its long-acting ADHD treatment, clouding the future of the company's lead asset.
Neos Therapeutics, a Dallas-area maker of extended-release formulations for ADHD that disintegrate in the mouth, announced that it aims to raise $60 million on the Nasdaq in an IPO planned for next week. The company expects to sell 4 million shares at $14 to $16 a pop.
Drugmakers often do pediatric studies of their drugs to broaden the markets. But in the case of drugs for attention deficit and hyperactivity disorder (ADHD) that were primarily developed with children in mind, the market is developing the other way, with more adults now taking the drugs than children.
Shire has said it's targeting $10 billion in sales by 2020, with $3 billion of that coming from its current pipeline. Now, it looks like an ADHD product waiting in the wings could be ready in time to help it get there.
Akili Interactive Labs has partnered with the nonprofit Autism Speaks to conduct a clinical trial of its cognitive assessment and personalized treatment video game.
Highland Therapeutics, a Toronto-based company with delayed-release technology for ADHD treatment, brought in $25 million to push its lead candidates through mid- and late-stage trials and prepare for commercialization.
Alcobra is touting the benefits of its in-development ADHD treatment, saying the drug provided a statistically significant benefit over placebo--but only after the company removed data from four "extreme" responders from its analysis.
The recently IPO'd Catalent has signed a deal with biotech Cingulate Therapeutics to help develop a duo of candidates for ADHD, tapping its expertise in crafting controlled-release tablets.
Acne remedies and ADHD drugs are big markets for the teen demographic--but how exactly are young consumers interpreting advertisements for these products? A soon-to-launch FDA study aims to find out exactly that.
To hear Shire tell it, there aren't many adequate and well-controlled drug studies in preschool-aged children with ADHD. But never fear, the company says: It's agreed to a written request by the FDA to investigate its ADHD drug Vyvanse in children aged 4 to 5, with a potential 6-month exclusivity boost for the drug on the line.