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- Biotech & Pharma Updates | November 24 - 25, 2024
Biotech & Pharma Updates | November 24 - 25, 2024
Cassava's much-controversial Alzheimer's hopeful flunks in Ph3, Alnylam whips out the priority review voucher for cardiomyopathy asset, Adcendo's ADC hopes get $135M injection, AstraZeneca touts Truqap prostrate cancer subtype Ph3 win + 27 more stories

To very little surprise, Cassava Sciences’ controversy-ridden Alzheimer’s hopeful flunks in Ph3 trial, stock collapses | Gif: WelcometoWrexhamFX on Giphy
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⬇️ The Good News ⬇️
THE GOOD
Approvals & Labels
Alnylam uses priority review voucher on vutrisiran (mutant and wild-type transthyretin targeting) as ATTR-CM competition heats up with BridgeBio’s recent approval
RNAi, transthyretin amyloid cardiomyopathy, priority review voucher - Read more
THE GOOD
Business Development
Gilead buys clinical stage HIV vaccine from partner Aelix Therapeutics
Vaccine, human immunodeficiency virus - Read more
Empyrean Therapeutics buys pre-IND asset EMS-312 (TLR-2 antagonist) from Eos Therapeutics
Small molecule, cancer - Read more
THE GOOD
Clinical Trial
Merck & Co.’s Winrevair Ph3 trial meets primary endpoint in PAH functional class III or IV patients at high risk of mortality
Fusion protein, pulmonary arterial hypertension - Read more
AstraZeneca’s Truqap (AKT inhibitor) delivers the Ph3 goods in prostate cancer subtype
Small molecule, prostate cancer - Read more
Cognition Therapeutics’ CT1812 (sigma-2 receptor complex antagonist) Ph2 biomarker analysis shows that molecule “may be preserving cognitive function and slowing disease progression“
Small molecule, Alzheimer’s disease - Read more
Blue Lake Biotechnology, CyanVac tout Ph2a data for CVXGA intranasal COVID-19 vaccine
Vaccine, COVID-19, intranasal delivery - Read more
Incyte’s promising Ph3 Monjuvi (anti-CD19) in follicular lymphoma
Monoclonal antibody, follicular lymphoma, cancer - Read more
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⬇️ More Good News ⬇️
THE GOOD
Company Launches
Advantage Therapeutics spins-off Klothea Bio to take on age-related disease R&D pipeline
mRNA, age-related disease, metabolic disease syndrome, cancer - Read more
THE GOOD
Fundraises
Adcendo $135M Series B, moving ADC candidates into the clinic
Antibody-drug conjugate, sarcoma, cancer - Read more
Kanglin Biotechnology $20M Series A, LVV-based gene therapy for beta thalassemia and sickle cell
Gene therapy, beta thalassemia, sickle cell disease, lentiviral vector - Read more
Replimune $140M upsized public offering
Oncolytic immunotherapy, cancer, herpes simplex virus (HSV) - Read more
BioSurfaces $2.0M grant from Bill and Melinda Gates Foundation
Cell therapy, drug delivery, implant - Read more
THE GOOD
IPOs
HanxBio plans Hong Kong exchange IPO to fund bispecific HX009 (PD-1/CD47 targeting) clinical ambitions
Bispecific antibody, biliary tract cancer - Read more
THE GOOD
Mergers & Acquisitions
Boston Scientific to acquire Intera Oncolocy
Small molecule, cancer, medical device, chemotherapy - Read more
Adragos Pharma acquires Baccinex
CDMO, fill-finish, injectables, lyophilization - Read more
Novo Holdings makes a “fishy” acquisition of aquaculture biotech Benchmark Genetics
Aquaculture, fish genetics - Read more
THE GOOD
Partnerships
GC Biopharma, Kanaph Therapeutics bispecific ADC development partnership
Bispecific antibody-drug conjugate, cancer, solid tumor - Read more
Evergreen Therapeutics, JUXIAN Pharmaceutical AI-enabled drug development partnership
Drug development, AI - Read more
THE GOOD
Patient Access
New transparency on 340B drug pricing shows benefits to clinics and safety net hospitals in Minnesota while pharma trade group PhRMA cries foul
340B drug pricing program, discount drug pricing - Read more
THE GOOD
Politics & Policy
President-elect Trump’s FDA commissioner pick is (mostly) well-received
Regulatory policy, political appointee - Read more [Paywall]
Some President-elect Trump picks might not be as radical as once thought, as former Warp Speed leader was approached for NIH position
National Institute of Health, political appointee - Read more [Paywall]
THE GOOD
Research
NIH publishes research on “TrialGPT” to help connect patients to clinical trials
Clinical trial recruitment, AI - Read more
Scribe Therapeutics touts pre-clinical data for CRISPR epigenetic silencing tech
CRISPR gene editing, cardiovascular disease - Read more
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⬇️ The Bad News ⬇️
THE BAD
Clinical Trials
To very little surprise, Cassava Sciences’ controversy-ridden simufilam (filamin A targeting) flunks in Ph3 trial, stock collapses
Small molecule, Alzheimer’s disease - Read more
Orbus Therapeutics eflornithine (ornithine decarboxylase blocking) misses primary efficacy endpoint in Ph3
Small molecule, astrocytoma, cancer - Read more
Biohaven’s taldefgrobep alfa (myostatin targeting) misses Ph3 endpoint in SMA, though may be a potential obesity treatment
Fusion protein, spinal muscular atrophy, obesity - Read more
THE BAD
Layoffs
Bristol Myers Squibb lays down additional job cuts at New Jersey R&D site
Research & development, early discovery - Read more
⬇️ The Ugly News ⬇️
THE UGLY
Public Health
“I Ran Operation Warp Speed. I’m Concerned About Bird Flu.”
Infectious disease, H5N1 (bird flu), pandemic - Read more
Another reason that pasteurization is awesome - it helps you avoid the side helping of bird flu virus bits in your raw milk
Raw milk, H5N1 (bird flu) - Read more [Paywall]
THE UGLY
Withdrawals & Recalls
Lupin recalls 600k+ bottles of blood pressure med that (somehow) used an unapproved vendor’s API
Small molecule, hypertension - Read more
You’re all caught up on the latest Pharma & Biotech News!

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