UK endocrine diseases specialist Diurnal (AIM: DNL) today said it has raised £20 million ($28 million) through a placing to fund the company’s pivotal Phase III trial for Efmody (hydrocortisone modified-release hard capsules), a drug formerly known as Chronocort, as a treatment for congenital adrenal hyperplasia in the US through to registration.
Diurnal, whose shares dipped 2.4% to 69.30 pence as trading neared close today, believes that the most expeditious route to commercialization of Efmody in the USA is to carry out the pivotal US Phase III study itself. In addition, it believes this will increase the future value of the program, as well as broadening the pool of potential commercialization partners.
The company has had positive meetings with the US Food and Drug Administration and expects to receive formal agreement of the Special Protocol Assessment (SPA) for the US Phase III study during second-half 2021.
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