Andy Biotech @AndyBiotech
#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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Amazing to see translational science is moving at a much faster pace in #biotech these days from bench to bedside! #CRISPR 11yrs 2012 Doudna/Charpentier paper 2020 Nobel 2023 First FDA approval $CRSP #RNAi 20yrs 1998 Fire/Mello paper 2006 Nobel 2018 First FDA approval $ALNY
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!
$SRPT ELEVIDYS priced at $3.2M This is probably the biggest problem w/ accelerated approvals for the healthcare system. How does it make sense that a drug under AA w/ unproven benefits priced 50% higher than $NVS Zolgensma at $2.1M w/ full approval and established efficacy?
"The exception is more interesting than the rule." #Biotech reverse merger occasionally turn into >$1B buyout Aduro➡️ $KDNY ➡️$3.2B $NVS shell➡️Medivation➡️$14B $PFE Trimeris➡️Synageva➡️$8.4B ALXN CancerVax➡️Micromet➡️$1.2B $AMGN Biodel➡️Albireo➡️$1B Ipsen shell➡️Cougar➡️$1B JNJ
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".
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". https://t.co/RLp7CwuFvs
Friendly reminder: "Don't talk about something you don't know much about as if you understand it. People in the field can tell."
Friendly reminder: "Don't talk about something you don't know much about as if you understand it. People in the field can tell."
$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"
A new addition to #Biotech best turnaround M&A $ISEE $1➡️40X $ALPMY BO in 4y $FPRX $2➡️20X $AMGN BO in 1y $IMMU $2➡️40X $GILD BO in 4y $ARQL $1➡️20X $MRK BO in 2y $ARRY $2➡️20X $PFE BO in 3y $ECYT $1➡️20X $NVS BO in 1y $MDVN $2➡️40X $PFE BO in 6y $PCYC <$1➡️200X $ABBV BO in 6y
Two big FDA Adcom mtg dates just released on FDA agenda May 12 -- $SRPT DMD gene therapy public-inspection.federalregister.gov/2023-07518.pdf June 9 -- $BIIB/Eisai lecanemab public-inspection.federalregister.gov/2023-07526.pdf
$SNY continues its quest as biotech shorties' worst enemy $3.3B $PRVB at 273% premium ahead of first earning after launch $2.5B $THOR at 172% premium before PoC -> IL2 discontinued + $1.7B impairment $3.7B $PRNB -> clinical hold due to DILI $3.2B $TBIO -> COVID19 discontinued
#Biotech another addition to the list of billion$ M&A for drug dumped by pharma $SNY $3.3B $PRVB (LLY/MGNX) $MRK $9.5B Cubist (LLY) $GSK $5B Tesaro(MRK) $GSK $1.9B $SRRA (GILD) $PFE $1.9B Vicuron(LLY) $GALE.SW $1.5B Relypsa(AMGN) $LLY $1.1B Dermira (Roche) $CELG >$1B Impact(SNY)
$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 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
$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/10.10… 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.
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)
#ESMO22 $AMGN Lumakras very underwhelming Codebreak-200 data on top of an already slow launch How to justify $18K/mo price w/ ~1mo mPFS benefit and detrimental overall survival? Double whammy day w/ $BMY Sotyktu clean label re. Otezla. Silver lining: more need for SMID bio M&A?
Brad Loncar @bradloncar
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Adam Feuerstein ✡�.. @adamfeuerstein
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BIO (倍男・バイ�.. @bio_trufflepig
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医次元緩和 @on_esop1
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Jacob Plieth @JacobPlieth
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Drugs @drug_smolecules
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230 Followers 173 Following
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495 Followers 381 Following Health business writer covering China, mRNA vaccines, new drugs, biotech from Beijing
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What is at stake is the perception of Biogen as a company capable of learning from its mistakes and of its new leadership having an internal mandate to turn things around for the better. Onwards!
@AndyBiotech Interestingly, looks like Bell's also showed up in the rabies mRNA vaccine too: jwatch.org/na44718/2017/0… (Welcome back, Andy. We've missed you)
Premature issuance of an EUA could jeopardize the conduct of randomized trials (why get a placebo?) and would backfire if the vaccine is not efficacious or has safety problems. Critically, we need the process to be transparent and trustworthy. 7/END
@jhuber @AndyBiotech So tough to get an asymptomatic claim.... first 7 days since...? We need to aggregate samples that cover the full time course of infection.
@AndyBiotech But not (yet) indicated for screening or surveillance. So far: only symptomatic, doctor-ordered, and CLIA (+waived). Hopefully indication will be expanded soon to asymptomatic/pre-symptomatic and at-home for much broader use, and safe return to school/work. Or not, per CDC.
Nordic Nanovector Appoints Dr Christine Wilkinson Blanc as Chief Medical Officer prn.to/3fGBS03
@AndyBiotech This is the only pathway I can see too, with some sort of aggregation across trials in UK, Brazil, and South Africa. Possible, but still relies on speed, good placement of the trial, and the product working well. Which is why my feeling is still "remains unlikely"
@AndyBiotech This is actually terrible data. But predictable considering how poorly planned this vaccine was. #1 Ad5 vector was a bad choice since there is significant pre-existing immunity #2 nucleocapsid antibodies are associated with vaccine-induced enhancement in prior SARS models.
@MikeNGladstone @AndyBiotech Speaking of IL-1 family members that are upstream and products of the inflammasome, might I introduce you to what's on the bottom of this table of factors associated with ICU admission and death (from @VirusesImmunity's latest paper)... 😜
How would you rate my corgi @AndyBiotech ?
@SaraNayeem @MNakada @bernatolle @aoifemlbrennan @JebKeiper @DrSarcoma @PDRennert @BLLPHD @NucleaseLab @HelsArtandSci @amyritterbusch @BourkePR @BursatilBiotech @DrWoodcockFDA @JTrentMDPhD @ProfDMThomas @geoff_oxnard @SamTruex @drsam @LifeSciVC @bmgallagherjr @karimdabbagh @rosan_daniel @AJKay17 @OtherReneRusso @mkoeris @ShaiBiran @EddieMartucci @RutgerWalls @VanessaE_King @KapellerRosana @IyaKhalil @TEHughes2009 @Car0lyn_Ng @JacobChackoMD @JuliePapanek @cbrenn22 💯 Let’s do this and make it echo far and wide: I pledge to oppose racism, intolerance & hate, through active allyship, continuous unlearning, learning, listening. Join us by nominating 5 others to do same. @ScottGottliebMD @califf001 @AndyBiotech @dougulman @Bobmorevc
@AndyBiotech @ZekeEmanuel @DrPaulOffit I made the same point in a column last month. statnews.com/2020/05/19/mod…
@AndyBiotech I updated this a while back for #COVID19 x.com/randysweismd/s…
The classic xkcd comic is also relevant for #COVID19
@AndyBiotech @florian_krammer Induction of an IgA response has been a blue sky goal for many respiratory viruses. Problem is: hard to do and harder to prove in a large scale trial (due to sampling and sample processing issues).
Our @ncats_nih_gov review on #Remdesivir JUST published in @ACSCentSci - how it was discovered, how it works, and trials for treating #COVID19 @JacobRoth13 @krbrim_hfx pubs.acs.org/doi/10.1021/ac…
Past week over 500 asymptomatic pre-surgical patients tested : with only 1 positive for COVID. Community prevalence extremely low
@connie9030 @AndyBiotech This is just an honest analysis of the preliminary results. Also, In order to reach these benefits, it seems you’d need to find cases earlier. Nobody has a “stay at home forever” fetish. People are just trying to give facts and get this under control so families are safe.
@jeromeleonard5 @STL_Biotech @CloisterRes Good call x.com/andybiotech/st…
#COVID19 #Remdesivir NIAID trial data per @megtirrell 1) Mortality: 8% on RDV vs 11% on placebo 2) Time to recovery: 11 days on RDV vs. 15 days on placebo
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