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FDA flags ImmunityBio — Agency says ads, podcast misled on cancer claims
The U.S. Food and Drug Administration issued formal warnings to ImmunityBio and publicly criticized statements by Patrick Soon‑Shiong after television ads and a podcast implied the company’s...
China seed rounds and US Series B: New money flows into T‑cell engager startups
Two early‑stage firms raised sizable rounds to advance T‑cell engager pipelines. Excalipoint Therapeutics launched with a $68.7 million oversubscribed seed financing to build T‑cell engagers for...
Novartis to pay $2 billion for Synnovation PI3Kα program – Strategic bolt‑on
Novartis agreed to acquire Synnovation’s Pikavation subsidiary for $2 billion up front to secure SNV4818, a pan‑mutant‑selective PI3Kα inhibitor in phase II/II testing for HR+/HER2‑ metastatic...
Apogee’s long‑acting IL‑13 antibody shows durable control — Less‑frequent dosing touted
Apogee Therapeutics reported phase II maintenance data for zumilokibart (APG‑777) showing durable EASI‑75 responses with dosing every three to six months, results the company presented and STAT...
Pfizer and Valneva: Lyme vaccine cuts cases but misses statistical bar — Regulators next
Pfizer and Valneva reported phase III results showing >70% efficacy for their Lyme disease vaccine candidate but said the trial failed to meet a pre‑specified statistical criterion because...
Engineered LNPs detour the liver and home to lymph nodes — New delivery route for mRNA vaccines
Researchers at the University of Pennsylvania reported a redesign of ionizable lipids that produces “aroLNPs,” lipid nanoparticles that substantially reduce liver delivery and preferentially...
UK probes AI for trials as startups scale agentic platforms for clinical data
The House of Lords Science and Technology Committee opened an inquiry into how artificial intelligence can accelerate personalized medicine and clinical trials, probing barriers between early...
WHO urges rapid roll‑out of near‑point‑of‑care TB tests — New guidance endorsed
On World Tuberculosis Day the World Health Organization issued new guidance endorsing near‑point‑of‑care molecular NAAT tests and use of tongue swabs when sputum is not attainable, urging rapid...
Gilead front-loads $1.675B for Ouro... reshapes Galapagos role
Gilead Sciences agreed to acquire Ouro Medicines in a deal that pays roughly $1.675 billion upfront and up to $500 million in milestones, adding OM336 (gamgertamig), a BCMAxCD3 T‑cell engager, to...
Novartis buys Synnovation’s PI3Kα program — $2B upfront
Novartis agreed to acquire Pikavation Therapeutics, Synnovation’s subsidiary, for up to $3 billion including $2 billion upfront to secure SNV4818, a pan‑mutant selective PI3Kα inhibitor in early...
Pfizer, Valneva miss statistical bar on Lyme shot — plan to file anyway
Pfizer and Valneva reported Phase 3 data showing their Lyme disease vaccine reduced cases by roughly 70–73% but failed to meet the trial’s pre‑specified statistical threshold because fewer than...
Apogee posts long‑acting eczema wins — dosing every 3–6 months shows durability
Apogee Therapeutics released Phase 2 maintenance data for zumilokibart (APG‑777) showing durable skin and itch responses with dosing intervals of three and six months. Company‑reported endpoints...
Sanofi pays $180M up front for Kali’s trispecific — big autoimmune bet
Sanofi licensed KT‑501, a trispecific T‑cell engager from Kali Therapeutics, in a deal that includes roughly $180 million in upfront and near‑term payments and more than $1 billion in milestones...
RyboDyn raises $10M to mine the dark proteome for cancer targets
RyboDyn closed a $10 million seed round to accelerate RyboCypher, its platform for discovering oncology targets in the 'dark proteome'—proteins encoded by non‑canonical RNAs and cryptic peptides....
Crossbow closes $77M Series B to advance T‑Bolt T‑cell engagers
Crossbow Therapeutics raised $77 million in Series B financing to advance CBX‑250, a first‑in‑class T‑cell engager targeting relapsed or refractory myeloid malignancies, and to nominate a second...
FDA clears IND for ENDO‑205 — first‑in‑class nonhormonal endometriosis peptide
Endocyclic Therapeutics secured IND clearance from the FDA for ENDO‑205, a targeted, nonhormonal peptide therapeutic for endometriosis. The company positions ENDO‑205 as a first‑in‑class approach...
AroLNPs redirect mRNA vaccines to lymph nodes — liver detargeting breakthrough
Researchers at the University of Pennsylvania reported a redesign of ionizable lipids that produced aromatic, bioreducible LNPs (aroLNPs) which reduce liver accumulation and enhance delivery to...
WHO urges rollout of near point‑of‑care TB molecular tests — new guidance
On World Tuberculosis Day the WHO issued guidance endorsing near point‑of‑care (nPOC) nucleic acid amplification tests (NAATs) as initial diagnostics for pulmonary TB in adults and adolescents,...
Gilead’s $1.68B bet: Ouro buyout reshapes Galapagos role
Gilead agreed to acquire Ouro Medicines in a front‑loaded deal that pays roughly $1.675–1.68 billion upfront for OM336, a BCMAxCD3 T‑cell engager being developed for autoimmune disorders. Company...
Novartis spends big on PI3Kα: Pikavation deal expands breast‑cancer pipeline
Novartis moved to acquire Pikavation Therapeutics (a Synnovation subsidiary) in a deal valuing the transaction at up to $3 billion, including a $2 billion upfront component for a mutant‑selective...