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  • Biotech & Pharma Updates | December 11 - 14, 2025

Biotech & Pharma Updates | December 11 - 14, 2025

🧬 William Blair predicts biotech sector will outperform 2021-24 bear markets in 2026 outlook, CIRM approves $160M funding for regenerative medicine research and clinical trials, Zealand Pharma seeks brain-targeting obesity treatment partners - explores shuttle technology collaborations, Tenaya Therapeutics raises $60M public offering to develop heart disease therapies, Sobi acquires Arthrosi Therapeutics for $950M upfront - adding gout treatment pozdeutinurad to pipeline, Anixa Biosciences' alpha-lactalbumin vaccine shows positive Ph1 results for triple-negative breast cancer prevention, Innovent Biologics' mazdutide (GLP-1/glucagon dual agonist) shows significant weight loss in Ph1b obesity trial in Chinese adolescents, FDA expands Johnson & Johnson's Akeega (abiraterone/niraparib) approval for BRCA2-mutated metastatic castration-sensitive prostate cancer

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

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✅ The Good News ✅ 

THE GOOD
Approvals & Labels

FDA approves Innoviva's Nuzolvence (zoliflodacin) for uncomplicated urogenital gonorrhea following Ph3 trial success
Small molecule, infectious disease, antibiotic, gonorrhea, antimicrobial resistance - Read more

ImmunityBio's Anktiva (nogapendekin alfa inbakicept) receives EU conditional approval recommendation for non-muscle invasive bladder cancer
Protein therapy, cancer, interleukin-15 receptor agonist, bladder cancer, combination therapy, immunotherapy - Read more

FDA expands Johnson & Johnson's Akeega (abiraterone/niraparib) approval for BRCA2-mutated metastatic castration-sensitive prostate cancer
Small molecule, cancer, combination therapy, prostate cancer, BRCA2 mutations - Read more

Milestone Pharmaceuticals receives FDA approval for CARDAMYST (etripamil) nasal spray targeting paroxysmal supraventricular tachycardia
Small molecule, cardiovascular, calcium channel blocker, paroxysmal supraventricular tachycardia, nasal spray, self-administered - Read more

THE GOOD
Business Development & Partnerships

Zealand Pharma seeks brain-targeting obesity treatment partners, explores shuttle technology collaborations
Research collaboration, neurological, small molecule, drug discovery, blood-brain barrier - Read more

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 More Good News 

THE GOOD
Clinical Trials

Celcuity presents updated Ph3 results for gedatolisib targeting PI3K/AKT/mTOR pathway in advanced breast cancer
Small molecule, cancer, PI3K inhibitor, breast cancer, hormone receptor positive - Read more

Relay Therapeutics reports positive subset analysis for zovegalisib (RLY-2608) plus fulvestrant in breast cancer patients
Small molecule, cancer, PI3K inhibitor, breast cancer, combination therapy - Read more

Anixa Biosciences' alpha-lactalbumin vaccine shows positive Ph1 results for triple-negative breast cancer prevention
Vaccine, cancer, breast cancer vaccine, triple-negative breast cancer, alpha-lactalbumin target - Read more

Innovent Biologics' mazdutide (GLP-1/glucagon dual agonist) shows significant weight loss in Ph1b obesity trial in Chinese adolescents
Protein therapy, metabolic, GLP-1 receptor agonist, obesity, adolescent population - Read more

THE GOOD
Fundraises

CIRM approves $160M funding for regenerative medicine research and clinical trials
Regenerative medicine, gene therapy, cell therapy, rare disease, clinical-stage, preclinical - Read more

Tenaya Therapeutics raises $60M public offering, developing heart disease therapies
Cardiovascular, clinical-stage, heart disease, biotechnology - Read more

Zegenex raises $215K social-impact investment for chronic wound healing therapies
Small molecule, wound healing, diabetic foot ulcers, preclinical - Read more

Contineum Therapeutics raises $90M public offering, neuroscience inflammation immunology therapies
Clinical-stage, neurological, autoimmune, inflammation - Read more

THE GOOD
Market Reports

William Blair predicts biotech sector will outperform 2021-24 bear markets in 2026 outlook
Market outlook, strategic, financial, competitive - Read more

THE GOOD
Mergers & Acquisitions

Sobi acquires Arthrosi Therapeutics for $950M upfront, adding gout treatment pozdeutinurad to pipeline
Small molecule, metabolic disease, strategic, major transaction - Read more

Cycle Pharmaceuticals acquires struggling Applied Therapeutics for 8.8 cents per share after FDA rejection
Small molecule, rare disease, strategic, major transaction - Read more

THE GOOD
Regulatory

CDC reports COVID-19 vaccines reduced emergency visits 76% in young children amid FDA death probe
mRNA vaccine, infectious disease, regulatory, operational - Read more

Tenaya Therapeutics receives FDA clearance to resume TN-201 gene therapy trial after clinical hold lifted
Gene therapy, cardiovascular, regulatory, operational - Read more

THE GOOD
Strategic Plans

Eli Lilly shifts Inluriyo-Verzenio combo regulatory strategy to ESR1-mutated advanced breast cancer following Ph3 results
Small molecule, cancer, SERD, breast cancer, CDK4/6 inhibitor, ESR1 mutation - Read more

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❌ The Bad News

THE BAD
Clinical Trials

Arcus Biosciences terminates domvanalimab TIGIT-targeting therapy following Ph3 trial failure in gastric and esophageal cancers
Antibody, cancer, monoclonal antibody, gastric cancer, TIGIT target, combination therapy - Read more

THE BAD
Mergers & Acquisitions

Cosette Pharmaceuticals terminates Mayne Pharma acquisition after Australian Treasurer blocks transaction, both parties dispute breach claims
Generic pharmaceuticals, strategic, major transaction, regulatory - Read more

👹 The Ugly News 👹

THE UGLY
Regulatory

FDA plans black box warning for COVID-19 vaccines following investigation into potential child deaths
mRNA vaccine, infectious disease, regulatory, operational - Read more

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

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