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Oxford Nanopore Restructures – Revenue Up 22% Amid Layoffs and Refocus
Oxford Nanopore announced a strategic restructuring that included job reductions and a narrowed product focus while reporting 22% revenue growth for 2025. The company said it will discontinue some...
Candid to Go Public via Reverse Merger – $505M Fuels TCE Push
Privately held Candid Therapeutics agreed to merge with Rallybio in a reverse merger that will list the combined entity on Nasdaq and raised $505 million in private financing to advance a...
Earendil Secures WuXi XDC Payload-Linker Deal in Up-to-$885M ADC Partnership
Earendil Labs signed a global license and development pact with WuXi XDC to access payload‑linker and CMC capabilities for ADC programs, a deal valued at up to approximately $885 million including...
BioAtla Cuts 70% of Workforce, Seeks Strategic Options for Antibody Assets
BioAtla announced a reduction of roughly 70% of its workforce and launched a formal strategic‑review process to explore sale, licensing, or other transactions for its antibody pipeline. The...
Powerful NA‑Targeting Antibody Shows Broad H5N1 Neutralization
Researchers reported an antibody that targets influenza neuraminidase (NA) with broad neutralizing activity across diverse H5N1 strains. The study—described in press materials—characterizes...
Engineered Probiotic Reverses Type 2 Diabetes in Mice: Gut‑Host Axis Reset
A Nature Communications study reported that a genetically engineered, ROS‑tolerant probiotic remodeled the gut microbiota and host metabolism to reverse key features of type 2 diabetes in male...
FDA says sham‑controlled trial needed – uniQure’s Huntington program stalls
U.S. regulators told uniQure that data from its single‑arm AMT‑130 program are insufficient and “strongly recommended” a randomized, double‑blind, sham surgery–controlled study before the company...
FDA lifts CRISPR hold – Intellia cleared to restart Magnitude trials with caveats
The FDA lifted clinical holds on Intellia’s Phase 3 Magnitude and Magnitude‑2 trials of in‑vivo CRISPR candidate nexiguran ziclumeran (nex‑z), allowing enrollment to resume under new safety...
Aardvark halts Phase III HERO after cardiac signals – program paused
Aardvark Therapeutics voluntarily paused dosing and enrollment in its Phase III HERO trial of ARD‑101 for hyperphagia in Prader‑Willi syndrome after routine safety monitoring in a healthy...
Roche wins Phase 3 in MS – liver‑safety signal clouds approval path
Roche reported another positive Phase 3 readout for its oral BTK inhibitor fenebrutinib in multiple sclerosis, clearing primary efficacy endpoints across indications. However, the study also...
FDA grants accelerated approval: Ascendis’ once‑weekly Yuviwel cleared for achondroplasia
The FDA granted accelerated approval to Ascendis Pharma’s once‑weekly TransCon CNP (now Yuviwel; navepegritide) for children aged two and older with achondroplasia, the most common form of...
Candid to go public via reverse merger – $505M backs T‑cell engager push
Candid Therapeutics will merge with Rallybio in a reverse merger to list on Nasdaq and has secured $505 million in private financing to advance its pipeline of bispecific T‑cell engagers (TCEs)....
Earendil taps WuXi XDC for ADC development – pact worth up to $885M
Earendil Labs signed a global license and development agreement with WuXi XDC to use WuXi’s payload‑linker and manufacturing platform for multiple antibody‑drug conjugate (ADC) programs, with...
Merck to end Gardasil runs at Durham plant – >150 jobs to be cut
Merck disclosed plans to stop producing Gardasil and Gardasil 9 at its Durham, North Carolina, facility and will lay off 147 workers tied to that operation, citing a worldwide reduction in demand...
FDA clears Delivery Date AI: De Novo nod for ultrasound‑based prediction software
The FDA granted De Novo clearance to Ultrasound AI’s cloud‑based Delivery Date AI software-as‑a‑medical‑device, allowing obstetric providers to use standard ultrasound images to predict delivery...
Universal newborn cCMV screening boosts early detection – Minnesota study shows gains
A retrospective cohort study from Minnesota found that mandated universal newborn screening for congenital cytomegalovirus (cCMV) substantially increased early detection rates and identified mild...
FDA Demands Sham-Controlled Trial – UniQure’s Huntington Path Stalls
The FDA has recommended a randomized, double-blind, sham surgery–controlled trial for uniQure’s AMT‑130 gene therapy program in Huntington’s disease, the company said after a recent regulator...
Aardvark Halts Phase III HERO Trial – Cardiac Signals Trigger Safety Pause
Aardvark Therapeutics voluntarily paused dosing and enrollment in its Phase III HERO trial of ARD‑101 for hyperphagia in Prader‑Willi syndrome after routine safety monitoring identified reversible...
Candid to Go Public Through Reverse Merger With Rallybio – $505M Backing
Candid Therapeutics agreed to a reverse merger with Rallybio to list on Nasdaq and raised $505 million in private financing to advance its bispecific T‑cell engager (TCE) portfolio. The deal...
FDA Lifts Clinical Hold on Intellia CRISPR Trials – New Safeguards Imposed
The FDA has lifted a clinical hold on Intellia’s Magnitude Phase 3 trial of in‑vivo CRISPR gene editing therapy nexiguran ziclumeran (nex‑z) in transthyretin amyloidosis with cardiomyopathy,...