MacuCLEAR's lead molecule for AMD, based on a marketed anti-hypertensive, stimulates choroidal blood flow so that cellular wastes in the eye can be cleared and never cause the breakdown of critical tissues that diminish vision. The company has received IND clearance to shepherd its treatment down the 505(b)(2) approval pathway with fast track status.
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CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.
A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand
Coartem Baby to be rolled out in eight African countries in the autumn.
Apogee Therapeutics reports data from Phase II APEX trial of its long-acting antibody against atopic dermatitis, showing similar efficacy to Regeneron/Sanofi’s Dupixent and Eli Lilly’s Ebglyss.
Public Company Edition: A breakthrough designation, data and deals prompted big follow-on public offerings in late June and early July, including $402.5m for Cidara, $250.8m for Kymera and $230m for Dyne. Also, Revolution Medicines accessed up to $2bn from Royalty Pharma.
