Tag Archive for: rare diseases

Calliditas announces an additional seven year orphan drug exclusivity period for TARPEYO®

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the FDA has granted an orphan drug exclusivity period of seven years for TARPEYO®, expiring in December 2030 based on when the company obtained full approval with a new indication for this drug product. Following full approval in December 2023, TARPEYO® (budesonide) is indicated […]

Vivet Therapeutics receives EUR 4.9 million to advance development of a gene therapy

Vivet Therapeutics receives EUR 4.9 million to advance development of a gene therapy for the treatment of cerebrotendinous xanthomatosis  Funding from French Government as part of the France Health Innovation Plan 2030 operated by Bpifrance  Paris, France, February 1, 2024 – Vivet Therapeutics (“Vivet”), a clinical stage biotech company developing novel and long-lasting gene therapies for […]

Calliditas Therapeutics announces full results from the NefIgArd Phase 3 trial published in The Lancet

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced publication in The Lancet of the full data from the Phase 3 NefIgArd Study with Nefecon® (TARPEYO® (budesonide) delayed release capsules/Kinpeygo®) in adults with Primary IgA nephropathy (IgAN). The Phase 3 trial met the primary endpoint, estimated glomerular filtration rate (eGFR), with Nefecon demonstrating significant kidney protective effect over […]

Novo Holdings participates in portfolio company Amolyt Pharma’s $138 million financing

Amolyt is developing therapeutic peptides for rare endocrine and related diseases, including AZP-3601 (eneboparatide) for hypoparathyroidism Proceeds will fund the Phase 3 programme for hypoparathyroidism, as well as its growing endocrine pipeline Copenhagen, Denmark – Novo Holdings A/S, a leading international life sciences investor, has announced it has invested in a €130 million (approx. $138 million) […]