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Sensei winds down lead program — halts trial, readies layoffs
Sensei Biotherapeutics said it will stop development of its only clinical‑stage asset, solnerstotug, wind down the ongoing Phase 1/2 study and implement workforce reductions to preserve cash. The...
Takeda abandons alpha‑synuclein program after phase‑2 miss
Takeda said it will discontinue development of TAK‑341 (MEDI1341), an alpha‑synuclein antibody it was co‑developing with AstraZeneca, after a global Phase 2 study in multiple system atrophy (MSA)...
FDA halts Intellia gene-editing trials: clinical hold after liver injury
The U.S. Food and Drug Administration placed a clinical hold on Intellia Therapeutics’ two late‑stage trials of its experimental gene‑editing therapy following a serious liver injury in a treated...
Thermo Fisher to buy Clario — $8.9–$9.4B takeover targets trial data stack
Thermo Fisher Scientific agreed to acquire Clario, a clinical‑trial data‑solutions provider, in a cash deal valued at roughly $8.9–$9.4 billion, according to multiple reports. The move gives...
Roche pays into China bispecific — $1B+ pact for respiratory candidate
Roche struck a licensing agreement with Jiangsu‑based Qyuns Therapeutics securing global rights to QX‑031N, a clinical‑stage bispecific antibody aimed at respiratory disease, in a deal that could...
FDA pivots on biosimilars: draft guidance to cut clinical requirements
The U.S. Food and Drug Administration proposed new draft guidance to streamline biosimilar development, indicating the agency will no longer routinely require comparative clinical efficacy trials...
BridgeBio posts Phase III win — encaleret meets endpoints in genetic hypoparathyroidism
BridgeBio reported positive top‑line results from a global Phase III trial of encaleret for autosomal dominant hypocalcemia type 1 (ADH1), with 76% of treated patients reaching predefined serum...
Recursion hands Roche a microglia map — $30M milestone for AI phenomics
Recursion delivered a genome‑scale microglia phenomap to Roche/Genentech as part of their multi‑year AI discovery collaboration, triggering a $30 million milestone payment. The dataset—millions of...
Tubulis upsizes Series C to $401M — doubling down on ADC platforms
Munich‑based Tubulis expanded its Series C financing to $401 million to accelerate development of its next‑generation antibody‑drug conjugate (ADC) platform. The company said the fresh capital...
Lilly doubles down: buys Adverum for ocular gene therapy and builds AI supercomputer with Nvidia
Eli Lilly agreed to acquire Adverum in a deal focused on ixoberogene soroparvovec (ixo‑vec), a Phase III one‑time gene therapy for wet age‑related macular degeneration, and separately announced a...
GLP‑1 commercialization shift: Lilly builds oral factory while DTC drives Zepbound scripts
Eli Lilly budgeted $1.2 billion for a Puerto Rico plant dedicated to producing an oral GLP‑1 candidate, part of capacity expansion to meet soaring demand for incretin‑class drugs. Separately,...
10x Genomics launches next‑gen Chromium Flex — 384‑plex single‑cell at scale
10x Genomics unveiled the next‑generation Chromium Flex assay, enabling automation‑compatible plate‑based multiplexing for up to 384 samples and claimed throughput of up to 100 million cells per...
FDA moves to fast‑track biosimilars — clinical bar lowered
The U.S. Food and Drug Administration issued new draft guidance to speed approval of biosimilars by reducing or removing requirements for comparative Phase III efficacy studies. Agency leaders...
FDA places clinical hold on Intellia trials — gene‑editing safety alarms
The FDA placed a clinical hold on Intellia Therapeutics’ two late‑stage trials of its CRISPR gene‑editing candidate following a serious liver injury reported in a participant, prompting a trading...
Thermo Fisher to buy Clario — $8.9B cash for trial data muscle
Thermo Fisher Scientific agreed to acquire Clario, a clinical trial data solutions firm, in a deal valued at up to $9.4 billion. The transaction — disclosed with an $8.9 billion upfront cash...
Roche licenses Qyuns bispecific — $1.07B respiratory bet
Roche secured global rights to Qyuns Therapeutics’ long‑acting bispecific antibody QX‑031N in a deal that starts with a $75 million upfront payment and could top $1.07 billion in development and...
BridgeBio posts Phase III wins — rare disease filings ahead
BridgeBio Pharma reported positive late‑stage data for encaleret in an autosomal dominant form of hypoparathyroidism and signaled plans to pursue regulatory filings, marking back‑to‑back Phase III...
Lilly doubles down on scale and AI — $1.2B plant and supercomputer
Eli Lilly disclosed a two‑pronged expansion strategy: a $1.2 billion plant in Puerto Rico to produce oral GLP‑1 candidate orforglipron and an alliance with Nvidia to build a massive AI...
Lilly buys Adverum — single‑dose ocular gene therapy in hand
Eli Lilly agreed to acquire Adverum to advance ixoberogene soroparvovec (ixo‑vec), a one‑time AAV‑based gene therapy in Phase III for wet age‑related macular degeneration (wAMD). Lilly said it...
Kyverna CAR‑T posts robust gMG signals — phase III next
Kyverna Therapeutics released interim Phase II results showing strong efficacy for KYV‑101, an autologous CD19 CAR‑T with CD28 costimulation, in generalized myasthenia gravis (gMG). The company...