#Biotech Investor | Recovering Scientist | May have L/S position in names mentioned | Opinions are strictly my own and not intended as investment advice
Joined July 2012
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End of an era!
As a long-time follower of global #biotech/healthcare, I have learned a lot from the many good analysts at @CreditSuisse esp for their ex-US coverage, which was often more critical than typical US sell-side coverage. Best wishes to everyone on their new endeavor!
As expected, FDA AdCom on $BIIB/Eisai lecanemab is setting up to be a "clearing the air" event after the whole Aduhelm saga.
More importantly, FDA reviewer made it very clear the changes observed on the CDR-SB is considered "clinically meaningful".
$BIIB My thought on lecanemab "clinical meaningfulness" debate:
18-mo rx slowed disease progression by 6~8mo.
Is it not meaningful to pts and families to have 6~8 more months of your memory and freedom?
An oncology drug w/ 6~8mo of PFS benefit would be heralded as breakthrough!
Friendly reminder: "Don't talk about something you don't know much about as if you understand it. People in the field can tell."
Making it even harder for $KDNY atrasentan to get FDA approval is a competing drug, sparsentan, has exclusive orphan drug approval. Atrasentan would have to show it is more efficacious and/or safer. Comparing trial data, atrasentan seems to be inferior muddywatersresearch.com/rese…
$SRPT FDA summary slides today emphasizes the key point that "Patients likely have only one chance to receive an AAV vector-based gene therapy for DMD", which could drive the panel discussion today to wait for Ph3 data that will be available later this year.
$SRPT Apparently FDA placed SRP-9001 on clinical hold in Aug 2021 due to an unexpected SAE of asthenia requiring hospitalization and respiratory support, but the company never disclosed it to investors AFAIK.
Did it not count as a material event for most important pipeline drug?
Overall great news for #Alzheimer pts! Another unequivocally positive Ph3 should further validate Aβ MoA, bolster doctor confidence and derisk CMS reimbursement.
$LLY comment to STAT about curve widening over time provides further evidence for the promise of "disease modifying"
This quoted post is unavailable.
Two big FDA Adcom mtg dates just released on FDA agenda
May 12 -- $SRPT DMD gene therapy
public-inspection.federalreg…
June 9 -- $BIIB/Eisai lecanemab
public-inspection.federalreg…
$BIIB/Eisai lecanemab KO $LLY Donanemab in Round 1 of #Alzheimer's new drug fight
FDA Issues Complete Response Letter for Accelerated Approval of Donanemab due to limited number of patients with 12-month drug exposure
$HZNP Cheers for an early Christmas gift!
$145M River Vision acq turned out to be one of the best deals in biotech history:
Pharmacyclics -> Celera for ibrutinib
Vertex -> $538M Aurora for CF franchise
Gilead -> $470M Triangle for HIV franchise
JAZZ -> $122M Orphan Med for Xyrem
$HZNP to acquire River Vision for $145M. Congrats @bmgallagherjr!
globenewswire.com/news-relea…
Nice data in NEJM last wk
xitter.cf/AndyBiotech/status/859…
$BIIB My thought on lecanemab "clinical meaningfulness" debate:
18-mo rx slowed disease progression by 6~8mo.
Is it not meaningful to pts and families to have 6~8 more months of your memory and freedom?
An oncology drug w/ 6~8mo of PFS benefit would be heralded as breakthrough!
$BIIB/Eisai - money slide for Lecanemab at #CTAD22
nejm.org/doi/full/10.1056/NE…
The biggest promise of "disease modifying" (vs. symptomatic) treatments is probably the compounding effect over time.
The widening of curve separation out to 18mo provides an early hint for that promise.
While some debate on clinical meaningfulness, we have to start somewhere for a tough disease like #Alzheimer's and this is a solid first step!
The biggest Q into #CTAD22 is probably whether benefit seen in both ApoE4 carriers and non-carriers given trial enriched w/ 70% carrier.
Great day for #Alzheimer's patients with first unequivocally positive Ph3 for a disease modifying treatment!
Kudos to @EisaiUS for trial execution, believe one big factor for success is how they managed to get dropout rate to only 15% amid COVID19 pandemic (vs >20% historically)
Great day for #Alzheimer's patients with first unequivocally positive Ph3 for a disease modifying treatment!
Kudos to @EisaiUS for trial execution, believe one big factor for success is how they managed to get dropout rate to only 15% amid COVID19 pandemic (vs >20% historically)
