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  • Biotech & Pharma Updates | September 14 - 15, 2025

Biotech & Pharma Updates | September 14 - 15, 2025

🧬 Novartis + Monte Rosa's protein degrader deal ($120M upfront + $5.7B biobucks), Lila Sciences secures $235M Series A to automate the drug discovery process, BMS sell majority stake in historic US-China pharma joint venture, Novo Nordisk's GLP-1 Rybelsus nabs EU label extension into cardiovascular benefits, CBER Director back-tracks on earlier ad-comm "scrapping" comments, Revvity shutters Mass. facility (74 jobs cut), ATyr shares plummet after ATYR1923's pulmonary sarcoidosis Ph3 flop

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

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✅ The Good News ✅ 

THE GOOD
Approvals & Labels

FDA approves Corstasis Therapeutics' Enbumyst nasal spray for edema in congestive heart failure, chronic kidney disease
Small molecule, cardiovascular, diuretic, heart failure, drug delivery, chronic kidney disease - Read more

EMA approves Novo Nordisk's Rybelsus label update claiming cardiovascular benefits for type 2 diabetes patients
Small molecule, metabolic, cardiovascular, GLP-1 receptor agonist, type 2 diabetes, oral administration - Read more

FDA approves Biocartis, Bristol Myers Squibb's companion diagnostic for MSI-H colorectal cancer patients eligible for Opdivo/Yervoy immunotherapy
Immunotherapy, cancer, companion diagnostic, colorectal cancer, MSI-H biomarker, precision medicine - Read more

FDA approves expanded VYJUVEK label for Krystal Biotech's topical therapy for dystrophic epidermolysis bullosa from birth
Gene therapy, dermatological, topical gene therapy, dystrophic epidermolysis bullosa, rare disease, self-administration - Read more

THE GOOD
Business Development & Partnerships

Novartis, Monte Rosa partner on protein degradation for immune conditions in $120M upfront, $5.7B potential deal
Licensing deal, protein degradation, immune disease, small molecule, R&D, milestone payments - Read more

Mycenax, SPERA PHARMA form strategic alliance for integrated ADC manufacturing services, combining biologics and CMC expertise
Strategic alliance, manufacturing agreement, antibody-drug conjugate, drug development, global - Read more

Ocugen, Kwangdong license RP gene therapy OCU400 for Korean market; $7.5M upfront, 25% royalties, up to $180M sales milestones
Licensing deal, gene therapy, rare disease, ophthalmology, milestone payments - Read more

Bristol Myers Squibb sells 60% stake in Sino-American Shanghai Squibb Pharmaceutical joint venture to focus on core innovative drugs in China
Acquisition, manufacturing agreement, pharmaceutical production, China, divestiture, legacy products - Read more

Matica Bio, US biotech company partner for commercial-scale viral vector manufacturing for cell and gene therapy
Manufacturing agreement, viral vector, gene therapy, cell therapy, manufacturing, commercialization - Read more

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 More Good News 

THE GOOD
Clinical Trials

Entera Bio's oral GLP-2 analog shows promising PK data for short bowel syndrome in preclinical studies
Protein therapy, metabolic, peptide therapy, short bowel syndrome, gastrointestinal, oral delivery - Read more

Kodiak Sciences' KSI-101 bispecific IL-6/VEGF antibody shows promising Ph1b results for macular edema secondary to inflammation
Antibody, ophthalmologic, bispecific antibody, macular edema, inflammation, IL-6/VEGF dual inhibitor - Read more

Nacuity's NPI-001 antioxidant shows 50% slower photoreceptor loss in Ph1/2 trial for retinitis pigmentosa with Usher syndrome
Small molecule, ophthalmological, antioxidant therapy, retinitis pigmentosa, Usher syndrome, photoreceptor protection - Read more

THE GOOD
Fundraises

Lila Sciences raises $235M Series A, expanding AI-powered autonomous research labs
AI/ML platform, drug discovery, autonomous research, platform technology, lab automation, AI-driven - Read more

Gyala Therapeutics raises €3M ($3.52M) funding, developing immunotherapies for hematological cancers
Cancer, immunotherapy, cell therapy, hematological malignancies, preclinical - Read more

Cocrystal Pharma raises $4.7M registered direct offering, with potential for $8.3M more through warrants
Small molecule, infectious disease, preclinical, drug discovery - Read more

AuraVax receives Gates Foundation grant for NanoSTING-001 respiratory infection therapeutic testing
Infectious disease, platform technology, host-directed therapeutic, respiratory infections, nanomedicine, preclinical - Read more

Drug Hunter raises seed funding led by Teamworthy, expanding drug discovery knowledge platform for R&D teams
Platform technology, data analytics, software platform, drug discovery, AI-driven - Read more

Avidity Biosciences closes $690M in public offering for RNA therapeutics development and commercialization
RNA therapeutics, platform technology, Antibody Oligonucleotide Conjugates, clinical-stage - Read more

Sarat Ventures Y Innovations Biotech Fund launches $50M fund for early-stage biotech in Saudi Arabia/MENA region
Venture capital, early-stage, biotech, MENA region - Read more

THE GOOD
Product Launches

Swedish AI firm Mavatar launches Discovery platform, transforming complex biological data analysis for researchers
AI platform, drug discovery, strategic, operational - Read more

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❌ The Bad News

THE BAD
Clinical Trials

ATyr's efzofitimod fails Ph3 trial in pulmonary sarcoidosis, missing steroid-reduction endpoint
Protein therapy, respiratory disease, anti-inflammatory, pulmonary sarcoidosis, clinical trial failure - Read more

Genmab halts Ph1/2 trial of GEN1107 antibody-drug conjugate for solid tumors, citing unfavorable risk-benefit profile
Antibody, cancer, antibody-drug conjugate, solid tumors, clinical trial termination - Read more [Paywall]

THE BAD
Investments

Sanofi freezes UK R&D investments amid drug pricing dispute, joining Merck & Co., Eli Lilly, and AstraZeneca
R&D investment, strategic, financial, regulatory, market access - Read more

THE BAD
Layoffs

Revvity closing Boston facility, eliminating 74 jobs at South End site by 2026
Biomanufacturing, operational, cost reduction, workforce reduction - Read more

THE BAD
Regulatory

CDER Director George Tidmarsh backpedals on statement suggesting elimination of drug advisory committee meetings
Regulatory, policy, strategic, operational - Read more

HHS adds five new members to CDC vaccine advisory panel ahead of COVID-19 and hepatitis B discussions
Vaccines, infectious disease, regulatory, strategic, operational - Read more

FDA Commissioner Makary intensifies crackdown on misleading drug ads, citing distortion of doctor-patient relationships
Pharmaceutical advertising, regulatory, operational, public health, healthcare marketing - Read more

👹 The Ugly News 👹

THE UGLY
No Ugly News Today!

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