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Theravance collapses R&D after pivotal failure — workforce halved
Theravance Biopharma announced a sweeping retrenchment after its Phase 3 trial of ampreloxetine missed the primary endpoint, prompting the company to cease all R&D activity and cut about half its...
FDA tightens rare‑disease bar: Regenxbio, UniQure meet resubmission demands
Two high-profile gene therapy programs ran into fresh regulatory headwinds as the FDA pushed for more rigorous evidence. In a public complete response letter, the agency told Regenxbio that its...
Private capital backs Teva’s IBD push: Blackstone to fund anti‑TL1A program
Blackstone Life Sciences agreed to provide up to $400 million to Teva to accelerate development of duvakitug, an anti‑TL1A antibody partnered with Sanofi that is in Phase 3 for ulcerative colitis...
GSK bulks up oligonucleotide and PAH pipelines with two big buys
GlaxoSmithKline struck two strategic deals this week: a licensing pact with China’s Frontier Biotechnologies for two siRNA immunology candidates and an outright $950 million cash acquisition of...
Ascendis wins FDA nod for once‑weekly dwarfism shot — market shifts
The FDA granted accelerated approval to Ascendis Pharma’s TransCon CNP (now Yuviwel), a once‑weekly injection for children with achondroplasia two years and older, ending BioMarin’s de facto...
AGBT sparks high‑throughput sequencing war — Illumina faces new challengers
Announcements at the Advances in Genome Biology and Technology meeting painted a picture of intensifying competition in high‑throughput sequencing. Multiple vendors unveiled or detailed...
Earendil and WuXi XDC ink up to $885M ADC partnership
Earendil Labs entered a strategic collaboration with WuXi XDC to license payload‑linker and manufacturing technologies for antibody‑drug conjugates, a deal valued up to approximately $885 million...
Asahi Kasei buys Aicuris for €780M — antiviral portfolio expands
Asahi Kasei agreed to acquire Aicuris Anti‑infective Cures AG in an all‑cash transaction valued at €780 million (about $920 million), adding marketed cytomegalovirus products and a herpes therapy...
Candid goes public: reverse merger with Rallybio and $505M raise
Candid Therapeutics will go public via a reverse merger with Rallybio, taking the combined company forward under Candid’s name and ticker CDRX. The transaction accompanies a $505 million private...
FDA presses for sham‑controlled trial — uniQure’s Huntington bid stalls
The FDA has told uniQure that its existing evidence for the AMT‑130 Huntington’s gene therapy is insufficient and has recommended a randomized, sham surgery–controlled study before considering...
Theravance winds down R&D — halves workforce after Phase 3 loss
Theravance Biopharma announced an end to its R&D organization and plans to cut roughly 50% of its workforce after ampreloxetine failed a pivotal Phase 3 trial in multiple system atrophy. The...
Blackstone backs Teva: $400M to accelerate Sanofi‑partnered IBD drug
Private equity arm Blackstone Life Sciences agreed to provide Teva Pharmaceutical with up to $400 million over four years to support development of duvakitug, an anti‑TL1A antibody co‑developed...
GSK doubles down on oligonucleotides: siRNA license and $950M buy
GlaxoSmithKline expanded its oligonucleotide and pulmonary portfolios with two major deals: a global license for two siRNA assets from Frontier Biotechnologies and a $950 million acquisition of...
FDA lifts hold on Intellia CRISPR trials — safety caveats attached
The FDA has lifted a clinical hold on Intellia Therapeutics’ Phase 3 CRISPR gene‑editing trials for transthyretin amyloidosis after reviewing safety data from a prior hepatic adverse event that...
Moderna settles patent dispute: $950M upfront to Arbutus and Roivant
Moderna agreed to pay $950 million upfront to Arbutus Biopharma and Roivant’s Genevant to settle long‑running patent claims tied to its Covid‑19 mRNA vaccine. The settlement closes a multi‑year...
Candid to list via reverse merger — $505M cash to push T‑cell engager pipeline
Candid Therapeutics announced a reverse merger with RallyBio to take the AI‑driven T‑cell engager developer public on Nasdaq, supported by a $505 million private financing. The combined company...
AGBT sparks high‑throughput sequencing race — rivals circle Illumina
Advances unveiled at the Advances in Genome Biology and Technology (AGBT) meeting signaled a renewed scramble for high‑throughput genomics: Element Biosciences, Ultima Genomics, Roche (Axelios 1),...
Prime Medicine pivots to file — prime editing therapy moves toward FDA
Prime Medicine said it will seek FDA approval for a previously shelved rare‑disease therapy after agency interactions signaled a regulatory environment for gene editing that may still be...
Pharma leans on AI: Tempus‑Merck biomarker pact and Evinova trial deals
Pharma companies are expanding AI partnerships to accelerate biomarker discovery and clinical development. Tempus AI and Merck signed a multi‑year deal to mine de‑identified clinical and molecular...
FDA urges sham‑surgery control — uniQure’s Huntington program stalls
The FDA has pushed back on uniQure’s Huntington’s disease program, recommending a randomized, double‑blind, sham‑surgery–controlled trial before it will consider approval. Company disclosures and...