Presage teams with Merck on its Phase 0 testing; KemPharm ADHD drug wins approval in children aged 6 and up
Seattle-based Presage Biosciences, which approaches drug development through its microdosing platform, has some new partnerships and cash to come with them.
Presage closed a $13 million financing round Tuesday, aiming to expand its network of clinical trial sites and advance development of its microdosing injection devices. They also closed partnership deals with Merck and Maverick Therapeutics.
The financing included $7 million from new investors, including the LabCorp Venture Fund, Bristol Myers Squibb, and InHarv Partners. An additional $6 million convertible note from Takeda Ventures will convert to equity.
Presage’s big idea centers around what they call Phase 0 testing, which uses microdoses of multiple drugs and combos on patients to gauge their pharmacodynamic effects. Their tech allows researchers to pepper a tumor with multiple therapies while in use by patients, providing a better snapshot of relative activity.
Tuesday’s new research collaborations with Merck and Maverick will utilize Presage’s platform to evaluate new oncology programs in these Phase 0 trials, bringing their total number of partners to five.
KemPharm ADHD drug wins approval in children 6 and up
KemPharm scored a new approval on Wednesday, and it’s sending their stock soaring.
The Celebration, FL-based biotech notched the FDA OK for Azstarys, a once-daily treatment for ADHD in children aged six and older. Azstarys, formerly dubbed KP415, consists of serdexmethylphenidate, KemPharm’s prodrug of the drug Focalin, co-formulated with an immediate-release version of the product.
Shares of KemPharm $KMPH skyrocketed as much as 90% in early Wednesday trading, settling in at around a 70% increase later in the morning. Azstarys will be commercially available as soon as the second half of this year, and that process will be led by a subsidiary of Gurnet Point Capital.
The approval will also trigger a milestone payment from Gurnet Point Capital to KemPharm, which may total up to $468 million.
ADHD has been a lucrative market for drugmakers, accounting for nearly $18 billion of revenue in 2019, KemPharm said.
The pediatric field has proven tough for competitors, though, with the FDA spurning Supernus’ pitch last November. Regulators cited concerns about an in-house lab used to analyze their experimental drug.