Browsing Tag
Hemgenix
5 posts
uniQure (QURE, NASDAQ) targets Q3 BLA after FDA’s Huntington’s reversal
The FDA spent months blocking uniQure's Huntington's gene therapy. Now it wants the filing in Q3. QURE doubled, but approval is still unwon.
June 18, 2026
CSL (ASX: CSL) crashes 17.7% to A$98.59 after FY26 guidance cut and $5bn impairments
CSL cut FY26 NPATA to US$3.1 billion and flagged US$5 billion in impairments. The third downgrade in ten months is repricing the entire ASX healthcare sector.
May 11, 2026
Five-year durability data show Hemgenix is transforming haemophilia B care with a single dose
Five‑year results show Hemgenix delivers long‑lasting bleed protection and stable clotting factor levels for haemophilia B patients. Read more on the breakthrough here.
December 8, 2025
CSL Behring bags Hemgenix EC approval for treatment of Hemophilia B
German-based biotechnology company CSL Behring has received conditional marketing authorization (CMA) from the European Commission (EC) for its…
February 22, 2023
CSL Behring gets Hemgenix FDA approval for hemophilia B
CSL Behring, a US-based biotechnology company, has received approval for its Hemgenix (etranacogene dezaparvovec-drlb) from the US Food…
November 27, 2022