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  • Biotech & Pharma Updates | September 22 - 23, 2025

Biotech & Pharma Updates | September 22 - 23, 2025

🧬 Eli Lilly drops $6.5B on Houston API plant, BMS' multiple myeloma protein degrader iberdomide hits a Ph3 goal, Merck & Co. commits further $349M into Variational AI drug discovery partnership, atai Life Sciences & Beckley Psytech report positive Ph2a data for DMT analog in treatment resistant depression, Sanofi commits further $625M into venture investment arm Sanofi Ventures, Manas AI touts $26M seed extension for "full-stack, AI native drug discovery and development"

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

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✅ The Good News ✅ 

THE GOOD
Approvals & Labels

CHMP recommends AstraZeneca's Tezspire for EU approval in chronic rhinosinusitis with nasal polyps following Ph3 success
Antibody, autoimmune, monoclonal antibody, chronic rhinosinusitis with nasal polyps, TSLP inhibitor, severe asthma - Read more

THE GOOD
Business Development & Partnerships

Merck & Co. partners with Variational AI for $349M deal using Enki technology to design small molecules against challenging targets
Research collaboration, AI/ML, small molecule, drug discovery, milestone payments - Read more

Credence MedSystems, SMC partner on dual chamber fill-finish capabilities for injectable drug-device combination products
Manufacturing agreement, drug-device combination, fill-finish, injectable delivery, pharmaceutical manufacturing - Read more

TegMine, Boehringer Ingelheim partner on 2-Factor Antibody System for cancer therapies; upfront payment plus milestones
Research collaboration, oncology, antibody, milestone payments, royalties - Read more

Prellis, Eli Lilly partner on multi-target human antibody discovery using organoid and AI platforms; financial terms include upfront payment and milestones
Research collaboration, antibody, drug discovery, AI/ML, milestone payments, royalties - Read more

Illumina partners with multiple pharma companies to develop KRAS companion diagnostic tests for precision cancer care
Co-development, diagnostics, oncology, companion diagnostics, genomic profiling - Read more

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 More Good News 

THE GOOD
Clinical Trials

Moderna's Ph3b/4 data shows mNEXSPIKE vaccine induces stronger antibody response against COVID-19 LP.8.1 strain
Vaccine, infectious disease, mRNA vaccine, COVID-19, SARS-CoV-2, LP.8.1 variant - Read more

Bristol Myers Squibb's iberdomide protein-degrading drug hits Ph3 goal against multiple myeloma
Small molecule, cancer, protein degrader, multiple myeloma, combination therapy, blood cancer - Read more

Affibody's izokibep meets Ph3 primary endpoint in hidradenitis suppurativa, with 37% achieving HiSCR75 at week 16
Protein therapy, autoimmune, IL-17A inhibitor, hidradenitis suppurativa, dermatology - Read more

atai, Beckley Psytech report Ph2a success for BPL-003 (intranasal mebufotenin) in treatment-resistant depression
Small molecule, neurological, psychedelic, treatment-resistant depression, intranasal delivery, 5-HT receptor - Read more

Neurocrine's Ph2 trial shows osavampator outperforms placebo in major depressive disorder at lower dose
Small molecule, neurological, major depressive disorder, NMDA receptor modulator, oral antidepressant - Read more [Paywall]

THE GOOD
Fundraises

DaltonTx raises £4M ($5.41M) seed to build AI-enabled drug discovery platforms
AI/ML platform, drug discovery, platform technology, software platform, biologics, small molecule - Read more

Eupraxia Pharmaceuticals raises $70M public offering for Diffusphere drug delivery technology pipeline advancement
Drug delivery, platform technology, clinical-stage, biotechnology - Read more

Santhera secures CHF 20M ($25.2M) growth funding to accelerate global rollout of DMD treatment AGAMREE
Rare disease, Duchenne muscular dystrophy, small molecule, clinical-stage, global commercialization - Read more

Manas AI raises $26M Seed Extension, advancing AI-native drug discovery development
AI/ML platform, drug discovery, platform-enabled, AI-driven - Read more

Neurocentrx raises $5M+ seed extension, developing safer ketamine treatments for mental health conditions
mental health, clinical-stage, small molecule, treatment-resistant depression, bipolar depression, drug reformulation - Read more

SEED Therapeutics raises $30M Series A-3, developing molecular glue degraders for undruggable targets
Molecular glue degraders, small molecule, platform technology, clinical-stage, oncology - Read more

InVivo Partners aims for a €100M ($118M) fund for AI-driven science investments
Venture capital, AI-driven, life sciences, investment fund - Read more

THE GOOD
Investments

Eli Lilly to build $6.5B API manufacturing plant in Houston for oral drugs, including GLP-1 candidate orforglipron
Small molecule, cardiometabolic, manufacturing expansion, major investment, supply chain, strategic - Read more

Catalent opens new global headquarters in Tampa as Novo Holdings acquisition nears one-year anniversary
CDMO services, strategic, operational, headquarters relocation, major transaction - Read more

Sanofi injects $625M into its investment arm to boost biotech innovation across core therapeutic areas
Biotech investment, strategic, financial, major transaction, competitive - Read more

❌ The Bad News

THE BAD
Approvals & Labels

FDA rejects Scholar Rock's apitegromab for spinal muscular atrophy due to manufacturing issues at Catalent facility
Protein therapy, neurological, monoclonal antibody, spinal muscular atrophy, myostatin inhibitor, rare disease - Read more

THE BAD
Layoffs

Rome Therapeutics plans layoffs, strategic review amid market challenges as preclinical biotech struggles
Small molecule, oncology, financial distress, operational restructuring, workforce reduction - Read more

Seres Therapeutics cuts 25% of workforce to fund Phase 2 bloodstream infection therapy amid cash concerns
Microbiome biotherapeutic, infectious disease, operational, cost reduction, financial - Read more

MaxCyte cuts 34% of workforce to save $13.6M annually, accelerating path to profitability
Cell therapy platform, operational, cost reduction, financial, strategic restructuring - Read more

THE BAD
Market Reports

YouGov survey reveals declining pharma trust among Gen Z and millennials amid pricing concerns
Market perception, generational trends, strategic, consumer trust, operational - Read more

THE BAD
Regulatory

FDA issues warning letter to J&J's Janssen Vaccines over stopper issues at Korean plant
Manufacturing quality control, regulatory compliance, operational risk, safety monitoring - Read more

FDA delays feedback on Lexicon's resubmitted diabetes drug Zynquista until Q4 following prior rejection
SGLT inhibitor, diabetes, regulatory delay, FDA rejection - Read more

 👹 The Ugly News 👹

THE UGLY
Regulatory

FDA seeks to repurpose GSK's leucovorin for autism treatment, bypassing typical clinical trials
Leucovorin, autism spectrum disorder, rare disease, repurposing, regulatory, off-label use - Read more

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

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