𧬠Your daily dose of FDA news! Tracking the next big drug approvals π Simplifying clinical data & regulatory headlines π Patient education Biotech insight
Joined April 2026
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Photos and videos
May 20
π¨π§¬ 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 π§΅π
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May 20
π² My approval odds: 87%
Breakthrough Therapy Priority Review clean safety 72% TG drop = very strong case.
π Bull: 2.1M patients, no targeted therapy exists
π» Bear: Docs habit β fibrates "good enough"
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May 20
Will FDA approve olezarsen? π’ Yes / π΄ No β drop your take π
RT Tweet 1 if this helped π
#FDA #PDUFA #Biotech #IONS #Hypertriglyceridemia #CardioTwitter #BiotechTwitter
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May 17
π¨π§¬ THREAD: $VRDN's veligrotug faces FDA decision on Jun 30.
The first drug that could treat CHRONIC thyroid eye diseaseβwhen bulging eyes don't heal on their own.
Here's why this matters π§΅π
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May 17
π² 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 realβbut manageable. FDA wants to fill this unmet need. Bull case wins here.
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May 17
Will FDA approve? π’ Yes / π΄ No β drop your take π
RT tweet 1 if this helped π
#FDA #PDUFA #Biotech #VRDN #ThyroidEyeDisease #BiotechTwitter
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May 17
But here are the red flags:
β οΈ Trial enrolled obese patients only β label may be restricted
β οΈ GLP-1 class effect? Semaglutide (SELECT) showed CV benefits too β differentiation unclear
β οΈ FDA may demand additional post-marketing data before full approval
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May 17
π’ Eli Lilly and Company
π $LLY β NYSE | π° ~$700B market cap
π Zepbound HFpEF label expands into cardiology β new $10B annual opportunity per analyst estimates
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May 12
π¨π§¬ THREAD: $CYTK's aficamten faces FDA decision on Jun 16.
A 2nd cardiac myosin inhibitor enters the ring β can it out-compete Camzyos in obstructive HCM?
Here's everything you need to know before the decision π§΅π
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May 12
π² My approval odds: 75%
Bull: Clean efficacy differentiated safety profile β $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.
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May 12
Will FDA approve aficamten? π’ Yes / π΄ No β drop your take π
RT tweet 1 if this helped π
#FDA #PDUFA #Biotech #CYTK #HCM #CardioTwitter #BiotechTwitter
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