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The Good News

THE GOOD
Approvals & Labels

FDA approves Celcuity's Revtorpyk (gedatolisib) for PI3K pathway hormone receptor-positive, HER2-negative metastatic breast cancer after Ph3 success
Small molecule, cancer, kinase inhibitor, breast cancer, PI3K/AKT pathway, HR-positive HER2-negative - Read more

Sanofi's immunomodulatory therapy wins UAE approval to delay Type 1 diabetes onset in children aged one and older
Antibody, autoimmune, monoclonal antibody, type 1 diabetes, beta cell preservation, pediatric - Read more

THE GOOD
Business Development & Partnerships

Insilico Medicine, Bora Pharmaceuticals partner on AI drug discovery and commercialization, deal worth $2.5B
Co-development, AI/ML, drug discovery, manufacturing, milestone payments - Read more

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More Good News

THE GOOD
Clinical Trials

Huyabio's HBI-8000 (tucidinostat) combo with Bristol Myers Squibb's Opdivo (nivolumab) meets Ph3 primary endpoint in advanced melanoma
Small molecule, cancer, HDAC inhibitor, melanoma, combination therapy, Opdivo - Read more

Kelun-Biotech's (sacituzumab tirumotecan) plus Merck & Co.'s Keytruda meets primary endpoint in Ph3 for PD-L1-negative non-squamous non-small cell lung cancer
Antibody drug conjugate, cancer, non-small cell lung cancer, TROP2, combination therapy, pembrolizumab - Read more

BPGbio reports encouraging Ph2 data for BPM31510 (oxidized CoQ10) targeting mitochondrial metabolism in newly diagnosed glioblastoma multiforme
Small molecule, cancer, glioblastoma, mitochondrial therapy, combination therapy, MGMT unmethylated - Read more

THE GOOD
Fundraises

Attovia Therapeutics files for IPO of undisclosed amount, advancing IL-31 inhibitor challenging Dupixent
Biologics, autoimmune, atopic dermatitis, clinical-stage, bispecific antibody - Read more

Lyora Therapeutics raises $2.5M Pre-Seed funding, developing genetic medicines for inherited retinal diseases
Genetic medicine, inherited retinal disease, CRISPR, gene therapy, rare disease, preclinical - Read more

Cardiff Oncology plans $10M registered direct offering for working capital and general corporate purposes
Oncology, clinical-stage, small molecule, PLK1 inhibition - Read more

Q32 Bio prices $200M public offering to advance bempikibart clinical trials, autoimmune diseases
Clinical-stage, autoimmune, inflammatory disease, alopecia areata, antibody - Read more

Crescent Biopharma prices ~$125M public offering of ordinary shares and pre-funded warrants
Clinical-stage, oncology, cancer - Read more

THE GOOD
Mergers & Acquisitions

GSK completes acquisition of Nuvalent, adding three lung cancer assets with multi-blockbuster potential
Small molecule, oncology, major transaction, strategic - Read more

THE GOOD
Product Launches

Taiho Pharmaceutical launches PI3Kα inhibitor HAIZEXIN in Japan for PIK3CA-mutant ovarian cancer
Small molecule, oncology, regulatory, strategic - Read more

THE GOOD
Regulatory

NICE backs Bayer's finerenone for chronic heart failure patients in England and Wales
Small molecule, cardiovascular, regulatory, revenue impact - Read more

FDA grants priority review to Genentech's Gazyva (obinutuzumab) for primary membranous nephropathy based on Ph3 results
Antibody, autoimmune, monoclonal antibody, primary membranous nephropathy, CD20 target, B cell depletion - Read more

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The Bad News

THE BAD
Lawsuits

Apple Tree Partners loses fund control as Cayman court orders Seth Harrison to relinquish management oversight
Venture capital, biotechnology, financial, operational - Read more

THE BAD
Market Reports

Community Pharmacy England warns 75% of pharmacies losing money as medicine shortages impact patients daily
Pharmacy services, medicine shortages, operational, financial - Read more

THE BAD
Regulatory

FDA resumes releasing drug rejection letters after April pause, addressing redaction concerns
Read more

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

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