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The Good News

THE GOOD
Approvals & Labels

Shionogi's Xocova (ensitrelvir) wins FDA approval for post-exposure prophylaxis of COVID-19 following Ph3 success
Small molecule, infectious disease, antiviral, COVID-19, protease inhibitor, post-exposure prophylaxis - Read more

THE GOOD
Business Development & Partnerships

ASCO, Ryght AI partner to accelerate breast cancer trial site selection using AI platform
Research collaboration, oncology, AI/ML, clinical trial optimization, small molecule - Read more

Agios Pharmaceuticals acquires Oscotec's cevidoplenib for ITP, $25M upfront, $140M milestones
Licensing deal, rare disease, autoimmune, small molecule, milestone payments, royalties - Read more

Travere Therapeutics, Everest Medicines partner on BTK inhibitor for rare kidney diseases, $112.5M upfront, $1.1B deal
Licensing deal, rare disease, small molecule, autoimmune, milestone payments, royalties - Read more

CEPI invests up to $50M in Moderna's mRNA Ebola vaccine targeting Bundibugyo ebolavirus outbreak
Research collaboration, infectious disease, vaccine, mRNA, milestone payments - Read more

Aragen manufactures Renaissance Pharma's FDA Fast Track anti-GD2 mAb Daretabart at $40M Bengaluru facility
Manufacturing agreement, antibody, oncology, rare disease, CDMO - Read more

Deep Science Ventures, Medicines Discovery Catapult partner to accelerate brain-entry technologies for CNS diseases
Research collaboration, neurological, drug discovery, rare disease, venture creation - Read more

Perceptive Discovery, Certis Oncology collaborate to advance radiopharmaceutical development using PDX models and integrated preclinical workflows
Research collaboration, oncology, radiopharmaceuticals, drug discovery, AI/ML - Read more

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More Good News

THE GOOD
Clinical Trials

Bristol Myers Squibb's (izalontamab brengitecan) Ph3 trial shows 40% reduced death risk in triple-negative breast cancer
Antibody-drug conjugate, cancer, bispecific antibody, breast cancer, triple-negative breast cancer, TROP2 - Read more

Celcuity's (gedatolisib) halves progression, death risk vs. Novartis' Piqray in Ph3 PIK3CA-mutant hormone receptor-positive, HER2-negative metastatic breast cancer
Small molecule, cancer, PI3K/AKT/mTOR inhibitor, breast cancer, PIK3CA mutation, combination therapy - Read more

Takeda and Innovent Biologics' (IBI363) PD-1/IL-2 bispecific shows Ph1 survival benefits in immunotherapy-resistant non-small cell lung cancer
Bispecific antibody, cancer, non-small cell lung cancer, PD-1/IL-2, immunotherapy, tumor microenvironment - Read more

Cardiff Oncology Ph2 (onvansertib) PLK1 inhibitor shows durable responses in RAS-mutated metastatic colorectal cancer, Ph3 initiated
Small molecule, cancer, PLK1 inhibitor, colorectal cancer, RAS mutation, combination therapy - Read more

Gilead's Livdelzi (seladelpar) meets primary endpoint in Ph3 trial for primary biliary cholangitis, supporting broader patient use
Small molecule, liver disease, primary biliary cholangitis, seladelpar, alkaline phosphatase, PPARδ agonist - Read more

Moderna, Merck & Co.'s (intismeran autogene) plus Keytruda shows 49% recurrence risk reduction in Ph2b high-risk melanoma
Vaccine, cancer, mRNA vaccine, melanoma, PD-1 inhibitor, combination therapy - Read more

Gilead's Trodelvy (sacituzumab govitecan)-Keytruda (pembrolizumab) combo shows Ph3 PFS2 benefit in first-line triple-negative breast cancer
Antibody-drug conjugate, cancer, monoclonal antibody, triple-negative breast cancer, TROP2, combination therapy - Read more

AstraZeneca's (camizestrant) Ph3 data presented at ASCO supporting FDA approval for estrogen receptor-positive, HER2-negative advanced breast cancer
Small molecule, cancer, oral SERD, breast cancer, ESR1 mutation, CDK4/6 inhibitor - Read more

Shanghai Juncell Therapeutics' GC101 (Nolgileucel) shows 4.3-month progression-free survival in advanced melanoma in Ph2
Cell therapy, cancer, TIL therapy, melanoma, PD-1, progression-free survival - Read more

Abivax reports "best-in-disease" Ph3 results for (obefazimod) in ulcerative colitis despite safety concerns
Small molecule, autoimmune, ulcerative colitis, inflammatory bowel disease, obefazimod - Read more

THE GOOD
Fundraises

Contraline raises $92.5M Series B to advance NES/T Gel male contraceptive into late-stage development
Men's health, contraception, small molecule, hormone therapy, clinical-stage - Read more

iRegene Therapeutics raises $31M Series C1, advancing Parkinson's and MSA cell therapy programs
Cell therapy, neurological, Parkinson's disease, iPSC platform, clinical-stage - Read more

Periotherapia raises JPY 575M ($3.6M) Series D2 first close, advancing antibody therapeutics clinical trials
Oncology, antibody, breast cancer, clinical-stage, tumor microenvironment - Read more

Waypoint Bio raises $20M Series A to advance CAR T therapies for solid tumors
Cell therapy, oncology, AI/ML platform, solid tumors, spatial biology - Read more

THE GOOD
Mergers & Acquisitions

Rallybio merges with Avenzo Therapeutics in reverse merger, backed by $215M private placement
Antibody-drug conjugate, oncology, major transaction, strategic - Read more

THE GOOD
Strategic Plans

Merck & Co. explores COVID antiviral Lagevrio and Ebola vaccine technology amid worsening DRC outbreak
Small molecule, infectious disease, strategic, operational - Read more

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The Bad News

THE BAD
Approvals & Labels

FDA rejects Cingulate's CTx-1301 (dexmethylphenidate hydrochloride) for attention-deficit/hyperactivity disorder over manufacturing concerns
Small molecule, neurological, ADHD, dexmethylphenidate, drug delivery, controlled release - Read more

THE BAD
Clinical Trials

Praxis pauses Ph3 enrollment of (vormatrigine) for focal onset seizures after Ph2/3 primary endpoint failure
Small molecule, neurological, NaV blocker, epilepsy, focal onset seizures, sodium channel inhibitor - Read more

Roche's Ph3 persevERA trial of giredestrant misses progression-free survival endpoint in estrogen receptor-positive, HER2-negative metastatic breast cancer
Small molecule, cancer, oral SERD, breast cancer, CDK4/6 inhibitor, estrogen receptor - Read more

THE BAD
Layoffs

Merck & Co. cuts 88 New Jersey jobs in latest phase of $3B cost-saving restructuring plan
Cost reduction, operational, financial, strategic - Read more

THE BAD
Politics & Policy

Trump signs executive order directing CDC to overhaul childhood vaccine schedule, reducing recommendations
Vaccine, infectious disease, regulatory, public health policy - Read more

THE BAD
Strategic Plans

Fulcrum Therapeutics discontinues sickle cell asset pociredir over cancer concerns, initiates strategic business review
Small molecule, sickle cell disease, oncology, strategic, cost reduction - Read more

👹 The Ugly News 👹

THE UGLY
No Ugly News Today!

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