Get the Daily Brief
Latest Biotech News
Immunology trials – Blocking IL-13 atopic dermatitis advances to phase 3 via Blackstone non-dilutive funding
Apogee Therapeutics landed a major non-dilutive capital package from Blackstone Life Sciences to push zumilokibart (anti-IL-13) into phase 3 for atopic dermatitis. The deal provides up to $1.3...
Gene editing – YolTech raises $70M to advance CRISPR therapies
China’s gene editing startup YolTech raised $70 million as it accelerates development of CRISPR-based therapies and prepares for a potential Hong Kong IPO. The funding marks the company’s largest...
Obesity – CVS expands access to Lilly’s oral Foundayo and Zepbound amid GLP-1 formulary battle
CVS Caremark expanded formulary access for Eli Lilly’s oral obesity drug Foundayo and adjusted coverage for Lilly’s injectable Zepbound, narrowing Novo Nordisk’s earlier formulary advantage in the...
Oncology diagnostics – FDA Breakthrough Device Designation for Gene Solutions multiomics blood test
The U.S. FDA granted Breakthrough Device Designation to Gene Solutions’ SPOT-MAS 10, a blood-based, multiomics lab-developed test intended for early detection of ten cancer types. The company said...
Diagnostics regulation – New York approves Delfi FirstLook Lung LDT for blood-based screening
Delfi Diagnostics received approval from the New York State Department of Health to offer its FirstLook Lung laboratory-developed test (LDT) across the state. The cfDNA-based liquid biopsy assay...
Health policy & regulation – White House draft rules give political appointees final say on federal research grants
The White House released draft regulations that, if implemented, would give political appointees final authority over federal research grants and other funding decisions across government science...
Cell therapy ecosystem – Verge rebrands after AI drug trial failure, pivots to target/biomarker dataset business
Verge Genomics rebranded as Verge Labs after an early clinical trial of AI-designed VRG50635 for ALS failed to show benefit. The company said it laid off about 90% of its workforce before shifting...
Medtech deals – Olympus buys BioProtect for $270M to expand prostate cancer implant technology
Olympus agreed to acquire BioProtect for $270 million to bolster its urology and oncology implant portfolio. BioProtect’s Balloon Spacer implant is designed to create space between the prostate...
Oral PCSK9 cholesterol lowering via engineered-enzyme manufacturing
Merck reported a new engineered-enzyme manufacturing approach for enlicitide decanoate, positioning the drug as a potential first oral PCSK9 inhibitor. The work, published in Science, targets the...
Hepatitis B functional cure—phase 3 bepirovirsen results
GSK said its antisense oligonucleotide bepirovirsen (also described as bepiroversen/variants in reporting) achieved functional cure in chronic hepatitis B patients in two Phase 3 trials after...
AbbVie’s Decnupaz ADC wins FDA approval in BPDCN
AbbVie received FDA approval for Decnupaz (pivekimab sunirine) for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN), following its acquisition of ImmunoGen’s ADC program in 2023....
Atopic dermatitis pipeline financing—Apogee + Blackstone to fund Phase 3
Apogee Therapeutics secured up to $1.3 billion in non-dilutive capital from Blackstone Life Sciences to advance zumilokibart (zumi) into Phase 3 for atopic dermatitis, with potential expansion...
GLP-1 coverage reshuffle—CVS Caremark expands Lilly’s obesity formulary
CVS Caremark expanded coverage for Eli Lilly’s oral obesity therapy Foundayo and changed preference dynamics for injected GLP-1 products, adding Foundayo to formularies June 1 and re-adding...
FDA review timeline—AstraZeneca’s camizestrant decision delayed after adcomm
The FDA delayed its decision on AstraZeneca’s camizestrant, an oral SERD for breast cancer, after an advisory committee voted against approval for the proposed setting. The additional time is...
AI-powered multiomics cancer test—FDA Breakthrough Device Designation
Gene Solutions received FDA Breakthrough Device Designation for SPOT-MAS 10, a blood-based multiomics early detection test that screens asymptomatic adults for ten cancer types. The designation...
Diagnostics and clinical delivery—Delfi gains NY approval for lung cancer LDT
Delfi Diagnostics said New York State Department of Health approved its FirstLook Lung laboratory-developed test, enabling the company to offer its cfDNA-based liquid biopsy assay to patients...
Biopharma funding—Countable closes $26M for single-molecule PCR and MRD
Countable Labs closed a $26 million financing round to scale commercial expansion of its single-molecule PCR technology and advance measurable residual disease (MRD) applications for cell and gene...
Biotech IPO momentum—Kardigan files to fund late-stage cardiovascular assets
Kardigan filed for a U.S. IPO as the company aims to raise capital for three late-stage cardiovascular therapies targeting conditions with limited approved options. The company’s pipeline includes...
Hepatitis B functional cure readouts
GSK reported two Phase 3 trials of the antisense oligonucleotide bepirovirsen showing functional cure after discontinuing background nucleos(t)ide therapy. In NEJM-published results, 20% (B-Well...
FDA approval for ultra-rare BPDCN ADC
AbbVie won U.S. approval for Decnupaz (pivekimab sunirine), its CD123-targeting antibody-drug conjugate for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The approval follows...