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  • Biotech & Pharma Updates | September 4 - 7, 2025

Biotech & Pharma Updates | September 4 - 7, 2025

BioNTech notches Ph3 ADC win in metastatic breast cancer, Delaware-based Braveheart Bio in-licenses Hengrui's late stage selective myosin blocker HRS-1893 for $65M upfront, Summit & Akeso's PD-1xVGEF approval hopes keep ticking due to newly calculated patient survival data, Mineralys Tx closes upsized $287.5M public offering, Japan finesses generic tariff exemption with the US - skirting 15% baseline tariff, WHO put GLP-1's on "Essential Medicine" list but points out high prices, RFK Jr. to (allegedly) link tylenol usage during pregnancy to autism

All the top Biotech & Pharma news in one daily newsletter.

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✅ The Good News ✅ 

THE GOOD
Business Development & Partnerships

Gilead, US State Department partner to distribute HIV prophylactic Yeztugo to low-income countries at no profit
Global partnership, infectious disease, drug accessibility, manufacturing agreement, royalty-free licensing, HIV prevention - Read more

Hengrui licenses heart disease drug HRS-1893 to Braveheart Bio for $65M upfront, potential $1B+ in milestones
Licensing deal, cardiovascular disease, small molecule, milestone payments - Read more

THE GOOD
Clinical Trials

BioNTech's HER2-targeted ADC trastuzumab pamirtecan meets Ph3 endpoint in metastatic breast cancer trial
Antibody-drug conjugate, cancer, ADC, breast cancer, HER2-positive, topoisomerase-1 inhibitor - Read more

AstraZeneca's Tagrisso-chemotherapy combo shows Ph3 survival benefit in EGFR-mutated non-small cell lung cancer
Small molecule, cancer, EGFR inhibitor, non-small cell lung cancer, combination therapy, targeted therapy - Read more

23andMe Research Institute opens Ph2 Lung Cancer Genetics Study data to researchers, aims to improve treatment options
Genetic testing, cancer, genomics, lung cancer, non-smokers, research collaboration - Read more

Simcere's QUVIVIQ (daridorexant) achieves Ph3 success for insomnia, demonstrating improved sleep quality without residual effects
Small molecule, neurological, insomnia, sleep disorder, dual orexin receptor antagonist - Read more

Regenxbio’s clemidsogene lanparvovec shows sustained biomarker reduction in Ph1/2/3 MPS II trial as FDA extends review deadline
Gene therapy, rare disease, AAV vector, MPS II, Hunter syndrome, lysosomal storage disorder - Read more

Merck & Co., Daiichi's ifinatamab deruxtecan (B7-H3 ADC) achieves 48% response in Ph2 extensive-stage small-cell lung cancer trial
Antibody-drug conjugate, cancer, ADC, small-cell lung cancer, B7-H3 target - Read more

Junshi's IL-17A antibody JS005 succeeds in Ph3 trial for moderate-to-severe plaque psoriasis, regulatory filing planned
Antibody, autoimmune, monoclonal antibody, psoriasis, IL-17 inhibitor, plaque psoriasis - Read more

Summit's ivonescimab (PD-1xVEGF) shows 33% PFS benefit in Western patients with lung cancer in Ph3 trial
Antibody, cancer, bispecific antibody, non-small cell lung cancer, PD-1xVEGF, global clinical trial - Read more

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 More Good News 

THE GOOD
Fundraises

Mineralys Therapeutics raises $287.5M in public offering for hypertension drug development
Hypertension, clinical-stage, cardiovascular, chronic kidney disease - Read more

Octave Bioscience raises $35.6M Series C, advancing MS diagnostics and Parkinson's pipeline
Neurological, multiple sclerosis, Parkinson's disease, biomarker discovery, precision care, diagnostic platform - Read more

RBL LLC raises strategic investment from Carnrite Ventures for biotech venture creation studio expansion
Venture creation studio, biotech incubator, technology translation, services, platform technology - Read more

Congruence Therapeutics raises $32M funding for protein misfolding disease therapeutics development
Protein misfolding, computational drug discovery, rare disease, small molecule, platform-enabled, AI-driven - Read more

THE GOOD
Politics & Policy

Japan secures exemption from US tariffs on generic pharmaceuticals in Trump's new trade deal
Generic drugs, drug supply chain, regulatory, trade policy, financial impact - Read more

THE GOOD
Regulatory

WHO adds GLP-1 drugs to essential medicines list, highlighting high costs limiting access
GLP-1 receptor agonist, metabolic disease, regulatory, pricing, access, essential medicines - Read more

❌ The Bad News

THE BAD
Lawsuits

GSK expands patent lawsuit against Moderna to include next-generation COVID-19 shot, seeking royalties
mRNA vaccine, infectious disease, patent litigation, financial, competitive - Read more

 👹 The Ugly News 👹

THE UGLY
Politics & Policy

CDC Director Monarez claims firing followed refusal to rubber-stamp vaccine policies under RFK Jr.
Vaccine policy, regulatory, public health, operational, political controversy - Read more

RFK Jr. to blame Tylenol use during pregnancy for autism; Kenvue shares drop 10%
Acetaminophen, neurodevelopmental disorder, regulatory, public health, consumer healthcare - Read more

THE UGLY
Regulatory

European regulators warn of surge in counterfeit Novo Nordisk and Eli Lilly weight loss drugs
GLP-1 agonist, obesity, counterfeiting, regulatory, consumer safety - Read more

You’re all caught up on the latest Pharma & Biotech News!

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