🧬 Your daily dose of FDA news! Tracking the next big drug approvals 🚀 Simplifying clinical data & regulatory headlines 💊 Patient education + Biotech insight
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🚨🧬 THREAD: $IONS's olezarsen faces FDA decision on Jun 30.
72% TG reduction. 85% less pancreatitis. 2.1M patients with no good options.
Can this gene-silencing shot change lipid medicine forever?
Here's why it matters 🧵👇
🎲 My approval odds: 87%
Breakthrough Therapy + Priority Review + clean safety + 72% TG drop = very strong case.
🐂 Bull: 2.1M patients, no targeted therapy exists
🐻 Bear: Docs habit — fibrates "good enough"
Will FDA approve olezarsen? 🟢 Yes / 🔴 No — drop your take 👇
RT Tweet 1 if this helped 🙏
#FDA #PDUFA #Biotech #IONS #Hypertriglyceridemia #CardioTwitter #BiotechTwitter
🚨🧬 THREAD: $VRDN's veligrotug faces FDA decision on Jun 30.
The first drug that could treat CHRONIC thyroid eye disease—when bulging eyes don't heal on their own.
Here's why this matters 🧵👇
🎲 My approval odds: 80%
Two Ph3 trials. Both hit EVERY endpoint. Breakthrough Therapy. First-ever chronic TED data in a Ph3.
The hearing signal is real—but manageable. FDA wants to fill this unmet need. Bull case wins here.
Will FDA approve? 🟢 Yes / 🔴 No — drop your take 👇
RT tweet 1 if this helped 🙏
#FDA #PDUFA #Biotech #VRDN #ThyroidEyeDisease #BiotechTwitter
But here are the red flags:
⚠️ Trial enrolled obese patients only — label may be restricted
⚠️ GLP-1 class effect? Semaglutide (SELECT) showed CV benefits too — differentiation unclear
⚠️ FDA may demand additional post-marketing data before full approval
🏢 Eli Lilly and Company
📍 $LLY – NYSE | 💰 ~$700B market cap
📈 Zepbound + HFpEF label expands into cardiology → new $10B+ annual opportunity per analyst estimates
🚨🧬 THREAD: $CYTK's aficamten faces FDA decision on Jun 16.
A 2nd cardiac myosin inhibitor enters the ring — can it out-compete Camzyos in obstructive HCM?
Here's everything you need to know before the decision 🧵👇
🎲 My approval odds: 75%
Bull: Clean efficacy + differentiated safety profile → $1B+ peak sales potential, room alongside Camzyos
Bear: REMS + entrenched competition limits commercial uptake even post-approval
FDA has strong reason to say yes. The market question is harder.
Will FDA approve aficamten? 🟢 Yes / 🔴 No — drop your take 👇
RT tweet 1 if this helped 🙏
#FDA #PDUFA #Biotech #CYTK #HCM #CardioTwitter #BiotechTwitter