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FDA Clears Ascendis’ Weekly Dwarfism Shot – Market Battle Begins
The FDA granted accelerated approval to Ascendis Pharma’s TransCon CNP (now Yuviwel) for children two years and older with achondroplasia, using annualized growth velocity as the surrogate basis...
Cardiac Signal Halts Aardvark’s Phase 3 Hunger Trial – Data Review Underway
Aardvark Therapeutics voluntarily paused dosing and enrollment in its Phase 3 HERO trial of ARD‑101 for hyperphagia in Prader‑Willi syndrome after routine safety monitoring in a healthy volunteer...
Candid to Go Public via Rallybio Reverse Merger – $505M War Chest
Candid Therapeutics agreed to a reverse merger with Rallybio that will leave the combined company publicly traded and well‑capitalized after a $505 million private financing. The deal transfers...
Merck Expands Biomarker Hunt With Tempus AI – Precision Oncology Focus
Merck has expanded a multi‑year collaboration with Tempus AI to accelerate discovery of precision‑medicine biomarkers across oncology and potentially other therapeutic areas. Under the agreement,...
Asia Deals: GSK Buys siRNA Programs; Astellas Taps Vir for a T‑Cell Engager
GlaxoSmithKline struck a global exclusive licensing deal with China’s Frontier Biotechnologies for two siRNA therapeutic candidates—one IND‑ready and one preclinical—paying $40 million upfront and...
Earendil Locks Payload-Linker Tech With WuXi XDC in Up‑to‑$885M Pact
Earendil Labs signed a licensing and development agreement with WuXi XDC to access payload‑linker technology and end‑to‑end CRDMO services for antibody‑drug conjugates, in a deal valued at up to...
Hepion Pivots to Liquid Biopsy – Licenses ctRNA Assay for Early HCC Detection
Hepion Pharmaceuticals licensed rights from Cirna Diagnostics to develop a circulating tumor RNA (ctRNA) assay aimed at detecting early, high‑risk hepatocellular carcinoma (HCC). The deal includes...
Theravance Winds Down R&D After Phase 3 Failure – Major Jobs Impact
Theravance Biopharma announced it will wind down its R&D organization and cut roughly 50% of its workforce after a Phase 3 failure for ampreloxetine, its experimental candidate. The company said...
FDA Demands Sham-Controlled Study: uniQure’s AMT-130 Approval Path Blocked
The FDA has told uniQure that existing single-arm data for its Huntington’s gene therapy AMT‑130 are insufficient and has strongly recommended a randomized, double‑blind, sham surgery–controlled...
Phase III Halted: Aardvark Pauses PWS HERO Trial After Cardiac Signals
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...
FDA Grants Accelerated Approval: Ascendis’ Yuviwel Cleared for Achondroplasia
The FDA granted accelerated approval to Ascendis Pharma’s TransCon CNP (now Yuviwel, navepegritide) for children aged two and older with achondroplasia, ending BioMarin’s practical monopoly on the...
FDA Lifts Hold: Intellia Restarts Phase 3 CRISPR Trial With Safety Limits
The FDA has fully lifted a clinical hold on Intellia’s Magnitude Phase 3 trial of CRISPR gene editing candidate nexiguran ziclumeran (nex‑z) for ATTR‑CM, allowing enrollment to resume under...
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...