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THE GOOD
Approvals & Labels

AstraZeneca's saphnelo anifrolumab self-injection pen receives CHMP approval recommendation for systemic lupus erythematosus
Antibody, autoimmune, monoclonal antibody, systemic lupus erythematosus, type 1 interferon, subcutaneous administration - Read more

Glaukos receives FDA approval for epioxa corneal cross-linking therapy targeting keratoconus eye disorder
Protein therapy, ophthalmology, topical therapy, keratoconus, corneal cross-linking, rare disease - Read more

Replimune's RP1 herpes virus therapy BLA resubmission accepted by FDA for advanced melanoma treatment
Gene therapy, cancer, oncolytic virus, melanoma, combination therapy, checkpoint inhibitor - Read more

Roche's Gazyva wins FDA approval for lupus nephritis, anti-CD20 antibody's first non-cancer indication
Antibody, autoimmune, monoclonal antibody, lupus nephritis, CD20 target - Read more

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THE GOOD
Clinical Trials

Johnson & Johnson's amivantamab shows 45% response rate in Ph1b/2 trial for recurrent head and neck cancer
Antibody, cancer, monoclonal antibody, head and neck cancer, EGFR target, MET target - Read more

Exelixis zanzalintinib reduces death risk 20% versus stivarga in Ph3 metastatic colorectal cancer trial
Small molecule, cancer, tyrosine kinase inhibitor, colorectal cancer, combination therapy, checkpoint inhibitor - Read more

Kelun-Biotech reports positive Ph3 results for sacituzumab tirumotecan targeting TROP2 in non-small cell lung cancer
Antibody-drug conjugate, cancer, non-small cell lung cancer, TROP2 target, EGFR-mutated - Read more

Daiichi, Merck & Co. advance raludotatug deruxtecan targeting CDH6 to Ph3 for platinum-resistant ovarian cancer after Ph2 success
Antibody-drug conjugate, cancer, ovarian cancer, CDH6 target, combination therapy, interstitial lung disease - Read more

Kelun-Biotech Reports positive Ph3 results for trastuzumab botidotin targeting HER2 in metastatic breast cancer vs T-DM1
Antibody-drug conjugate, cancer, ADC, breast cancer, HER2 target, trastuzumab - Read more

Roche's tecentriq shows 41% death risk reduction in Ph3 muscle-invasive bladder cancer trial
Antibody, cancer, monoclonal antibody, bladder cancer, PD-L1 inhibitor, ctDNA biomarker - Read more

DYNAMIC-III Ph2/Ph3 trial shows ctDNA-guided chemotherapy reduces oxaliplatin exposure in stage III colon cancer
Small molecule, cancer, chemotherapy, colon cancer, biomarker-guided therapy, ctDNA - Read more

IDEAYA's darovasertib shows 83% tumor shrinkage in Ph2 uveal melanoma trial, advancing to Ph3
Small molecule, cancer, protein kinase C inhibitor, uveal melanoma, neoadjuvant therapy - Read more

BioAtla reports promising Ph1 interim data for BA3182 EpCAM/CD3 bispecific in treatment-refractory metastatic adenocarcinoma
Antibody, cancer, bispecific T-cell engager, adenocarcinoma, EpCAM target, conditionally active biologic - Read more

Azitra reports positive preclinical data for ATR-01 targeting filaggrin in ichthyosis vulgaris treatment
Protein therapy, dermatological, engineered bacteria, ichthyosis vulgaris, filaggrin, topical delivery - Read more

Multitude Therapeutics reports 28.6% response rate for AMT-253 MUC18-targeted ADC in Ph1/2 melanoma trial
Antibody-drug conjugate, cancer, ADC, melanoma, MUC18 target, topoisomerase-1 inhibitor - Read more

RAPT Therapeutics, Jeyou report positive Ph2 results for RPT904 in chronic spontaneous urticaria
Antibody, autoimmune, monoclonal antibody, chronic spontaneous urticaria, subcutaneous injection, omalizumab comparator - Read more

Sanofi, Orano Med's AlphaMedix shows 57% response rate in Ph2 gastroenteropancreatic neuroendocrine tumors trial
Radiopharmaceutical, cancer, radioligand therapy, neuroendocrine tumors, gastroenteropancreatic NETs - Read more [Paywall]

Iambic reports Ph1 results: IAM1363 HER2-targeting drug shows 28% response rate in advanced cancer patients
Small molecule, cancer, kinase inhibitor, HER2 target, AI drug design - Read more [Paywall]

THE GOOD
Fundraises

Alto Neuroscience raises $50M PIPE financing to accelerate depression drug development
Neurological, small molecule, clinical-stage, depression - Read more

Tokiwa Bio raises $3.5M funding, RNA vector technology for regenerative medicine
RNA vector technology, regenerative medicine, gene therapy, platform technology - Read more

Riltide Medicines raises seed funding, oral autoimmune drugs and AI molecular design
Autoimmune, AI/ML platform, small molecule, preclinical - Read more

Evommune raises $150M IPO, chronic inflammatory disease treatments
Autoimmune, small molecule, clinical-stage, chronic inflammatory diseases - Read more

Viridian raises $300M royalty financing, accelerating thyroid eye disease drug development
Rare disease, antibody, thyroid eye disease, clinical-stage - Read more

NewLimit raises $45M funding round, epigenetic reprogramming to restore youthful cell function
Epigenetic reprogramming, platform technology, aging/longevity, preclinical - Read more

Faeth Therapeutics raises $25M strategic round, advancing PIKTOR cancer metabolism therapy
Oncology, tumor metabolism, small molecule, clinical-stage - Read more

Valink Therapeutics raises $11.8M Pre-A, developing bispecific antibody-drug conjugates for oncology
Oncology, antibody-drug conjugate, bispecific antibody, preclinical - Read more

Cyclana Bio raises £5M ($6.7M) Pre-Seed, developing tissue-level models for women's health
Women's health, AI/ML platform, biomarker discovery, platform technology, endometriosis, preclinical - Read more

Disc Medicine raises $220M stock offering, commercializing bitopertin for blood disorders
Hematologic diseases, clinical-stage, small molecule, rare disease - Read more

THE GOOD
Investments

Merck & Co. breaks ground on $3B Virginia small-molecule plant, part of $70B US investment plan
Small molecule, strategic, major transaction, operational, manufacturing expansion - Read more

THE GOOD
Mergers & Acquisitions

Eli Lilly buyout rumors send Nektar shares up 12% amid ongoing legal dispute over drug data
Immunotherapy, autoimmune, strategic, major transaction - Read more

THE GOOD
Product Launches

ALK launches EURneffy needle-free nasal adrenaline spray for emergency anaphylaxis treatment in UK
Nasal spray, allergy/anaphylaxis, regulatory, cost reduction - Read more

THE GOOD
Strategic Plans

Summit Therapeutics plans FDA filing for ivonescimab PD-1/VEGF inhibitor in non-small-cell lung cancer despite missing survival endpoint
Antibody, cancer, bispecific antibody, non-small cell lung cancer, PD-1, VEGF - Read more

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THE BAD
Clinical Trials

Roche's vamikibart IL-6 inhibitor shows mixed Ph3 results for uveitic macular edema treatment
Antibody, autoimmune, monoclonal antibody, uveitic macular edema, IL-6 inhibitor, ophthalmology - Read more

Neuphoria's BNC210 fails Ph3 trial for social anxiety disorder, missing primary endpoint despite favorable safety profile
Small molecule, neurological, social anxiety disorder, GABA receptor, phase 3 trial failure - Read more

Amgen, Zai Lab report bemarituzumab survival benefit wanes in Ph3 gastric cancer trial follow-up
Antibody, cancer, monoclonal antibody, gastric cancer, combination therapy, overall survival - Read more [Paywall]

THE BAD
Strategic Plans

BioNTech discontinues BNT111 cancer vaccine development for late-stage melanoma despite positive Ph2 results
Vaccine, cancer, mRNA vaccine, melanoma, checkpoint inhibitor combination, refractory cancer - Read more

THE UGLY
No Ugly News Today!

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