1️⃣ Viridian made TED a two-shot franchise question
Viridian said REVEAL-2 hit in chronic thyroid eye disease: elegrobart delivered 50% and 54% proptosis responder rates at week 24 on Q4W and Q8W dosing, versus 15% on placebo.
💡 Why it matters
The second phase 3 win supports a Q1 2027 BLA and keeps pressure on Amgen’s Tepezza before Viridian’s IV asset faces a June 30 PDUFA.
☕ Coffee talk
If Amgen’s edge is efficacy and Viridian’s edge is dosing, who owns the chronic TED patient who never wanted an infusion chair?
2️⃣ Vertex and Moderna lost the lung delivery bet
Vertex ended the phase 1/2 VX-522 study after persistent tolerability issues, stopping the inhaled mRNA CFTR program it had built with Moderna for cystic fibrosis patients not helped by current modulators.
💡 Why it matters
The asset was Moderna’s only inhaled therapeutic approach. For Vertex, the issue is narrower but still important: CF patients without functional CFTR remain outside its current franchise.
☕ Coffee talk
How many more pulmonary mRNA programs now have to prove the delivery system before anyone cares about the payload?
3️⃣ Mirum turned PSC itch into a filing path
Mirum’s phase 2b VISTAS study met its primary endpoint in PSC pruritus, with volixibat showing a 2.72-point Adult ItchRO reduction and a 1.64-point placebo-adjusted benefit.
💡 Why it matters
There are no approved PSC therapies, and Mirum already has a summer pre-NDA meeting planned. The safety detail still matters: discontinuations were higher on drug.
☕ Coffee talk
Does FDA treat itch in PSC like a real approval endpoint, or does Mirum still need a harder liver story?