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Nektar resurfaces: rezpeg maintenance data fuels stock surge and $460M offering
Nektar Therapeutics announced positive Phase IIb maintenance data for rezpegaldesleukin (rezpeg) in atopic dermatitis showing high EASI‑75 and EASI‑90 response rates in maintenance dosing cohorts,...
Nanoparticle gene editing inserts full gene into airway cells – CF therapy advance
UCLA researchers unveiled a lipid nanoparticle gene‑editing platform capable of inserting a full‑length healthy gene into human airway cells, addressing a key delivery and payload size limitation...
Boehringer halts inhaled CF gene program after Phase I/II readout
Boehringer Ingelheim discontinued development of its inhaled lentiviral gene therapy BI‑3720931 for cystic fibrosis following Phase I/II data that failed to show efficacy. The company reported the...
FDA moves to curb compounded GLP‑1 weight‑loss drugs – Hims & Hers flagged
The FDA announced plans to crack down on active pharmaceutical ingredients used by compounding pharmacies to produce off‑label GLP‑1 weight‑loss formulations, explicitly calling out major...
Danaher to buy Masimo for $9.9B – diagnostics push accelerates
Danaher Corp. agreed to acquire Masimo Corp. for $9.9 billion in cash at $180 per share, representing a roughly 38% premium, to expand Danaher’s diagnostics and monitoring capabilities. The...
Compass psilocybin nears NDA – second Phase III hit
Compass Pathways reported a second positive Phase III trial for its synthetic psilocybin candidate COMP360, and is preparing to push a rolling NDA toward U.S. regulators. The company disclosed two...
Ocular’s Axpaxli beats Eylea in Phase III – superiority met
Ocular Therapeutix said its intravitreal Axpaxli (OTX‑TKI) met the superiority primary endpoint versus a low-dose aflibercept (Eylea) comparator in the Sol‑1 Phase III trial for wet age-related...
Danaher to buy Masimo: $9.9 billion diagnostics push
Danaher agreed to acquire Masimo for $9.9 billion cash, offering $180 per share in a transaction that values Masimo at a roughly 38% premium to its prior close. Danaher said the deal will bolster...
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...