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Nektar rezpeg maintenance data fuels comeback — Phase IIb success
Nektar Therapeutics reported positive blinded maintenance data from its 52‑week Phase IIb REZOLVE‑AD trial of rezpegaldesleukin (rezpeg) in moderate‑to‑severe atopic dermatitis, driving a sharp...
FDA rejects Disc’s bitopertin — voucher program’s first negative outcome
The FDA issued a Complete Response Letter (CRL rejecting Disc Medicine’s bitopertin for erythropoietic protoporphyria (EPP), marking a notable negative outcome for a drug chosen for an accelerated...
FDA clears Velo point‑of‑care PCR system — 6–10 minute respiratory test
Lex Diagnostics received 510(k) clearance and a CLIA waiver from the FDA for its Velo point‑of‑care molecular system and a multiplex assay detecting influenza A, influenza B, and SARS‑CoV‑2. The...
Medpace to run Zelluna’s first‑in‑human solid tumor cell therapy trial
Zelluna selected Medpace to manage its Phase I study of ZI‑MA4‑1, an allogeneic TCR‑NK cell therapy targeting MAGE‑A4 in advanced solid tumors. The CRO contract covers study operations, regulatory...
NIAID told to de‑emphasize ‘pandemic preparedness’ — agency reshapes priorities
Staff at the National Institute of Allergy and Infectious Diseases were directed to remove references to 'biodefense' and 'pandemic preparedness' from web pages as part of a broader NIAID...
ArgenTag links with PacBio — long‑read single‑cell transcriptomics pact
ArgenTag announced a co‑marketing partnership with Pacific Biosciences (PacBio) confirming compatibility between ArgenTag’s Single‑Cell RNA Library Kit and PacBio’s Kinnex RNA kits to enable...
German grant backs DNAzyme cancer platform — 'DNAmazing' gets €3.2M
A German research consortium led by Heinrich Heine University and partners secured €3.2 million from the Federal Ministry of Research to develop a DNAzyme‑based cancer therapy platform called...
Compass psilocybin scores again: second Phase III paves path to NDA
Compass Pathways reported a second positive Phase III trial for its synthetic psilocybin candidate COMP‑360, reinforcing the company’s plan to seek regulatory approval. The company said the two...
Ocular’s Axpaxli tops low‑dose Eylea in Phase III — market questions linger
Ocular Therapeutix said its Axpaxli (OTX‑TKI) met the superiority primary endpoint in the Sol‑1 Phase III trial for wet age‑related macular degeneration (AMD), outperforming a low‑dose aflibercept...
Danaher to buy Masimo for $9.9B: diagnostics push accelerates
Danaher Corp. agreed to acquire Masimo Corp. for $9.9 billion, buying all outstanding shares at $180 each in cash. Danaher said the acquisition strengthens its diagnostics franchise and expands...
Nektar’s rezpeg posts strong maintenance data — shares and financing surge
Nektar Therapeutics disclosed positive maintenance results from the 52‑week Phase IIb REZOLVE‑AD trial of rezpegaldesleukin (rezpeg) in moderate‑to‑severe atopic dermatitis. The trial showed high...
FDA rejects Disc’s bitopertin… accelerated‑voucher test yields CRL
The FDA issued a complete response letter for Disc Medicine’s bitopertin in erythropoietic protoporphyria (EPP), rejecting the submission despite the drug receiving a Commissioner’s National...
NIH reshapes NIAID: 'pandemic preparedness' language removed
Internal directives at the National Institute of Allergy and Infectious Diseases (NIAID) instructed staff to remove references to 'biodefense' and 'pandemic preparedness' from public webpages,...
Gilead pays $80M upfront for Genhouse’s GH31 — $1.45B upside
Gilead Sciences struck a licensing deal with China’s Genhouse Bio to secure global rights to GH31, a MAT2A‑targeted therapy for MTAP‑deleted solid tumors, paying $80 million upfront with up to...
ArgenTag joins PacBio program: long‑read single‑cell transcriptomics goes portable
ArgenTag announced a co‑marketing partnership with PacBio, confirming compatibility of ArgenTag’s single‑cell RNA library kit with PacBio’s Kinnex RNA kits to enable long‑read, full‑length isoform...
ML‑predicted insulin resistance linked to 12 cancers: population‑scale study
Researchers led by the University of Tokyo applied a machine‑learning model (AI‑IR) to predict insulin resistance from routine clinical data across 500,000 UK Biobank participants and found...
St. Jude unveils M‑PACT: AI liquid biopsy classifies pediatric brain tumors
St. Jude Children’s Research Hospital and international collaborators introduced M‑PACT (Methylation‑based Predictive Algorithm for CNS Tumors), an AI platform that uses cerebrospinal fluid...
Compass psilocybin... Second Phase‑3 Hit Paves NDA Push
Compass Pathways reported a second positive pivotal trial for its synthetic psilocybin candidate COMP‑360, clearing a major regulatory milestone and triggering a fast‑track approval push. The...
Ocular’s Axpaxli Tops Low‑Dose Eylea – Market Reaction Tepid
Ocular Therapeutix announced that Axpaxli (OTX‑TKI) achieved statistical superiority to a low‑dose regimen of Regeneron/Bayer’s Eylea in the Sol‑1 Phase‑3 superiority trial for wet age‑related...
Danaher to buy Masimo: $9.9 billion deal announced
Danaher Corporation agreed to acquire Masimo for $9.9 billion in cash, offering $180 per share and a roughly 38% premium to Masimo’s last close, the companies disclosed. The transaction will fold...