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  • Biotech & Pharma Updates | September 29 - 30, 2025

Biotech & Pharma Updates | September 29 - 30, 2025

🧬 Pfizer first to embrace MFN drug pricing + DTC via upcoming "TrumpRx" website, Merck & Co. published positive Winrevair Ph3 data in pulmonary arterial hypertension, Barinthus Therapeutics + Clywedog Therapeutics reverse merger, Rovi to acquire Phoenix-based BMS facility, AstraZeneca to "harmonize its share listing structure" via direct NYSE listing, EMA publishes draft guidance on including patient perspective in drug approval process

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

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✅ The Good News ✅ 

THE GOOD
Business Development & Partnerships

Rovi, Bristol Myers Squibb strike Phoenix facility acquisition plus $250M five-year manufacturing partnership
Manufacturing agreement, acquisition, antibody-drug conjugates, monoclonal antibodies, milestone payments - Read more

Boryung acquires Sanofi's Taxotere chemotherapy rights across 19 markets for up to $205M
Licensing deal, oncology, small molecule, manufacturing, global, milestone payments - Read more

Nxera Pharma lands $10M milestone payment from AbbVie as part of neurological disease collaboration
Research collaboration, neurological, drug discovery, milestone payments, small molecule - Read more

THE GOOD
Clinical Trials

Merck & Co.’s Winrevair shows 76% reduction in clinical worsening in Ph3 trial for newly diagnosed pulmonary arterial hypertension
Protein therapy, cardiovascular, activin signaling inhibitor, pulmonary arterial hypertension, sotatercept - Read more

Opus Genetics reports pediatric gene therapy data for Leber Congenital Amaurosis Type 5, plans FDA discussions
Gene therapy, neurological, AAV vector, Leber congenital amaurosis, pediatric population, rare disease - Read more

AC Immune's ACI-35.030 Tau-targeting therapy shows strong immune response in Ph1b/2a early Alzheimer's disease trial
Neurological, active immunotherapy, Alzheimer disease, tau protein, phosphorylated tau - Read more

Kardigan reports positive Ph2a results for danicamtiv cardiac myosin activator in genetic dilated cardiomyopathy
Small molecule, cardiovascular, cardiac myosin activator, dilated cardiomyopathy, sarcomeric mutations - Read more

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 More Good News 

THE GOOD
Fundraises

ARS Pharmaceuticals secures $250M loan facility, accelerating neffy epinephrine commercialization
Allergy/anaphylaxis, epinephrine delivery, needle-free technology, commercial-stage - Read more

THE GOOD
Mergers & Acquisitions

Barinthus Bio merges with Clywedog Therapeutics in reverse deal advancing diabetes, autoimmune assets
Immunotherapy, diabetes, reverse mergers - Read more

THE GOOD
Politics & Policy

Pfizer signs first US drug pricing deal matching lower international prices under “Most Favoured Nation” scheme under Trump administration + direct to consumer on forthcoming “TrumpRx” website
Multiple therapeutic areas, drug pricing, strategic, cost reduction, major transaction - Read more

THE GOOD
Regulatory

EMA publishes draft paper encouraging patient experience data inclusion in drug regulatory decisions
Patient experience data, draft guidance, drug approval process - Read more

THE GOOD
Strategic Plans

AnaptysBio plans spinoff splitting clinical pipeline from Jemperli royalty businesses into separate companies
Monoclonal antibody, oncology, strategic, major transaction, financial - Read more

AstraZeneca plans direct NYSE listing to replace Nasdaq ADRs, harmonizing share structure globally
Stock listing, publicly traded - Read more

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❌ The Bad News

THE BAD
Business Development & Partnerships

Novo Nordisk terminates $598M Heartseed cell therapy partnership amid strategic restructuring
Cell therapy, research collaboration, heart failure - Read more

THE BAD
Clinical Trials

Moonlake's sonelokimab shows mixed Ph3 results in hidradenitis suppurativa, missing endpoints despite statistical significance
Monoclonal antibody, hidradenitis suppurativa, IL-17 inhibitor, inflammatory skin disease - Read more

Orion's ODM-105 tasipimidine fails Ph2 primary endpoint for insomnia treatment, company discontinues development program
Small molecule, neurological, insomnia, sleep disorders - Read more

THE BAD
Earnings & Finance

Morgan Stanley downgrades Novo Nordisk stock citing GLP-1 demand concerns and Alzheimer's treatment doubts
GLP-1 agonist, metabolic disease, financial, competitive, strategic - Read more

THE BAD
Lawsuits

Indivior discontinues Opvee marketing following New York settlement over unauthorized promotional activities to officials
Opioid reversal drug, opioid addiction, opioid overdose, access - Read more

THE BAD
Layoffs

Sutro Biopharma cuts third of remaining workforce in second round of layoffs this year
Drug pricing, strategic, financial, regulatory, competitive - Read more

👹 The Ugly News 👹

THE UGLY
Regulatory

FDA's Tidmarsh, in an unprecedented move, publicly criticizes Aurinia's Lupkynis approval in now-deleted LinkedIn post, sending stock tumbling
Immunosuppressant, autoimmune, regulatory commentary - Read more

FDA to be impacted by (now in effect) USA government shutdown, with 86% staff retained but new drug applications halted
Government shutdown, public agency - Read more

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

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