Shares in biotech firm Pharming were hit hard in Amsterdam on Monday following the US food and drug adminisration’s refusal to accept the company´s drug Rhucin for review.
Pharming shares were trading down 18% at 15 cents, 30 minutes after the stock exchange opened.
The FDA said the application by Pharming and partner firm Santarus was ‘not sufficiently complete to enable a critical medical review’, the Dutch firm said in a statement.
Pharming said both companies intend to meet with the FDA at the ‘earliest opportunity’ to discuss the issues raised in the FDA letter and to reach a more comprehensive understanding of what would be required for the drug to be accepted for review.
Rhucin is produced using milk of genetically modified rabbits and is approved in Europe to treat acute attacks in patients with a hereditary angioedema
Thank you for donating to DutchNews.nl.
We could not provide the Dutch News service, and keep it free of charge, without the generous support of our readers. Your donations allow us to report on issues you tell us matter, and provide you with a summary of the most important Dutch news each day.Make a donation