Shots:
Q32 Bio has sold ADX-097, a P-II complement inhibitor, to Akebia Therapeutics
As per the deal, Akebia will acquire ADX-097 from Q32 Bio for ~$592M, incl. $12M in upfront & near-term milestones ($7M at signing, $3M after 6mos., $2M payable upon the earlier of a milestone or end-2026), plus development, regulatory & commercial milestones &…
Shots:
Health Canada has approved Eydenzelt, a biosimilar version of Eylea (aflibercept 2mg), in both vial & PFS presentation for all the indications of the reference product
Approval was based on extensive analytical, nonclinical, & clinical data, incl. a global 52wk. P-III trial of Eydenzelt vs Eylea in 348 pts with diabetic macular edema, which met…
Shots:
Sanofi has reported the P-II (ElevAATe) trial data assessing efdoralprin alfa (Q3W or Q4W) vs SoC plasma-derived augmentation therapy (QW) in 97 adults with AATD emphysema for ~32wks.
Trial met its 1EP with a greater mean increase in functional AAT (fAAT) levels at Wk. 32 & achieved key 2EPs of higher fAAT levels &…
Shots:
The US FDA has approved Eydenzelt, a biosimilar version of Eylea (aflibercept), to treat neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema (DME), & diabetic retinopathy
Approval was supported by extensive analytical, non-clinical, & clinical data, incl. a P-III trial in DME pts (n=348) comparing Eydenzelt vs Eylea over…

