Clinical Trial SuccessPVLA announced it has completed enrollment of its Ph3 SELVA trial of QTORIN rapamycin for mLM, enrolling more patients than the target, indicating strong execution.
Market PotentialThe orphan drug designation along with the absence of any approved product allows for justifying premium pricing.
Regulatory SupportThe trial was awarded an orphan product development grant of up to $2.6 million by the FDA, highlighting external validation and support.