“They'll meet with the EMA, you know, see what can they do to, like, enrich patient population or their subgroups. Right? Maybe they focus on this, like, more severe patient population where, like, there was a benefit in in, you know, six minute walk.”
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Ten X announces meetings with EMA and/or FDA regarding potential path forward for HFpEF program
Tarsus Pharmaceuticals' Alkias phase three Northstar study for gilderretinol will report data in H2 2029.
Brian Skorney predicts Lilly's Lp(a) CVOT data may read out in 2029.
Eric Schmidt predicts the HARMONY three study for evanesquimab will read out positively in 6-9 months.
Daphne Zohar predicts Heidi Overton's FDA commissioner confirmation hearings will occur after the Senate summer recess.
Paul Matisse reports Biohaven's KV7 epilepsy drug is on partial clinical hold with phase 3 data coming soon.
Belight Bio's tennleribans will receive FDA approval decision by February 12, 2027 for Stargardt disease.
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