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Zelluna hires Medpace to run Phase I of off‑the‑shelf TCR‑NK solid tumor program
Zelluna selected CRO Medpace to manage its first‑in‑human Phase I trial of ZI‑MA4‑1 (ZIMA‑101), an off‑the‑shelf TCR‑NK cell therapy targeting MAGE‑A4 in advanced solid tumors. The scope covers...
Gilead buys Genhouse MAT2A asset: $80M upfront, billion‑dollar milestones for synthetic‑lethal cancer drug
Gilead paid $80 million upfront to acquire global rights to Genhouse Bio’s MAT2A‑targeting synthetic‑lethal oncology candidate GH31, with up to $1.45 billion in milestones and tiered double‑digit...
Fujifilm opens UK mega‑CDMO: single‑use capacity and innovation hub go live
Fujifilm Biotechnologies inaugurated its expanded Teesside site—the UK’s largest single‑use CDMO—bringing new 2,000 L and 5,000 L single‑use bioreactor capacity and a combined 19,000 L total to...
Public cash backs early biotech: Germany funds DNAzyme platform, Sweden’s CubaseBio raises €5.9M
European public and venture funding flowed to two early biotech platforms this week. German research teams won €3.2 million from the federal Go‑Bio Next program to develop a DNAzyme cancer therapy...
FDA says no to Disc’s bitopertin: voucher program faces its first major test
The FDA has declined to approve Disc Medicine’s bitopertin for erythropoietic protoporphyria (EPP), issuing a complete response that questioned whether the drug’s surrogate biomarker reliably...
Compass posts second pivotal win – psilocybin approval push intensifies
Compass Pathways reported a second successful Phase 3 study for its COMP360 psilocybin formulation in treatment‑resistant depression, prompting management to pursue regulatory filings. The company...
Axpaxli edges out low‑dose Eylea – wet‑AMD durability data draw close scrutiny
Ocular Therapeutix reported Phase 3 results showing its Axpaxli formulation maintained vision longer than a low‑dose regimen of Regeneron’s Eylea, meeting the trial’s primary durability and...
FDA clears Lex’s Velo POC PCR and grants CLIA waiver – multiplex respiratory test cleared
Lex Diagnostics received 510(k) clearance and a CLIA waiver for its Velo point‑of‑care molecular system and an influenza A/B plus COVID‑19 assay. The cartridge‑based system delivers multiplex...
Watchmaker licenses Caribou’s CRISPR‑Cas9 to solve NGS bottlenecks
Watchmaker Genomics secured a non‑exclusive license to foundational CRISPR‑Cas9 intellectual property from Caribou Biosciences to use the nuclease as a programmable binding tool for...
Sweden’s CubaseBio launches with €5.9M to map 3D transcriptomes
CubaseBio, a Stockholm startup, closed €5.9 million to commercialize a 3D spatial transcriptomics platform for organoids and intact tissues. Funding includes a €2M non‑dilutive EIC Transition...
Fujifilm opens UK mega‑CDMO: 19,000 L single‑use capacity comes online
Fujifilm Biotechnologies inaugurated its expanded Teesside site in the U.K., unveiling what it calls the largest single‑use CDMO facility in the country. The £400 million investment adds 2,000 L...
Gilead pays upfront for China’s Genhouse MAT2A asset – $1.5B deal on the table
Gilead Sciences struck a licensing deal with Genhouse Bio for GH31, a MAT2A‑targeting synthetic‑lethal oncology candidate, paying $80 million up front and agreeing up to $1.45 billion in...
FDA clears IND for CSPC’s SYH‑2082: new GLP‑1/GIP candidate enters US trials
CSPC Pharmaceutical Group received FDA clearance for an investigational new drug application for SYH‑2082, a long‑acting GLP‑1/GIP dual‑biased agonist intended for weight management in people with...
NeoGenomics posts 11% Q4 growth; NGS sales accelerate and salesforce to expand
NeoGenomics reported fourth‑quarter revenue of $190.2 million, up 11% year‑over‑year and topping consensus, driven by a shift to higher‑value testing and strong clinical revenue growth. The...
Compass posts second Phase‑3 win — Approval push begins
Compass Pathways reported positive results from two Phase 3 trials of its psilocybin therapy COMP360, and the company is preparing regulatory discussions aimed at seeking approval. The firm...
Ocular’s Axpaxli edges Eylea — Durability data sparks debate
Ocular Therapeutix disclosed Phase 3 results showing its investigational drug Axpaxli maintained vision with fewer injections versus a low-dose Eylea comparator, meeting the trial’s primary...
FDA rejects Disc’s bitopertin — Agency wants clinical endpoints
The FDA issued a complete response letter rejecting approval of Disc Medicine’s bitopertin for erythropoietic protoporphyria (EPP), citing uncertainty that the surrogate biomarker (percent change...
Gilead pays $80m upfront for China’s synthetic‑lethality asset — $1.45bn upside
Gilead signed a global deal for Genhouse Bio’s MAT2A‑targeting synthetic‑lethality asset GH31, paying $80 million upfront and structuring up to $1.45 billion in milestones plus tiered double‑digit...
Fujifilm opens UK mega‑CDMO — 19,000 L capacity online H1 2026
Fujifilm Biotechnologies inaugurated its expanded Teesside campus, unveiling the UK’s largest single‑use CDMO facility and a Bioprocess Innovation Centre. The £400 million investment adds 2,000 L...
Prima Mente deploys AI epigenome test for early Alzheimer’s — 89–97% detection reported
AI biology company Prima Mente unveiled Pleiades, an AI model that analyses DNA methylation patterns in cell‑free DNA to detect early‑stage Alzheimer’s and Parkinson’s from blood. The company...