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Beam launches BEAM‑304 base edit program for PKU – Backed by $500M deal
Beam Therapeutics announced BEAM‑304, a liver‑targeted base‑editing program intended to correct PAH mutations that cause phenylketonuria (PKU). The company plans a mutation‑specific multi‑editor...
Astellas, Vir ink $1.3B pact for masked CD3 engager – Oncology push
Astellas Pharma and Vir Biotechnology signed a global co‑development agreement worth up to $1.3 billion to advance VIR‑5500, Vir’s PRO‑XTEN dual‑masked CD3 T‑cell engager targeting PSMA for...
FDA halts MacroGenics trial after death – Safety probe underway
Regulators ordered a pause on enrollment in MacroGenics’ Phase 2 study of lorigerlimab following a patient death and multiple life‑threatening adverse events, prompting the company to report a...
New polymers target 'undruggable' MYC and KRAS – Proteomimetic degraders
Researchers at Northwestern unveiled HYDRACs, heterobifunctional proteomimetic polymers that recruit cellular degradation machinery to eliminate traditionally undruggable oncogenic drivers MYC and...
CareDx pivots to cell‑therapy surveillance — LCD draft poses headwind
CareDx reported a 25% year‑over‑year revenue increase and said it will prioritize its cell‑therapy surveillance testing pipeline in 2026, citing validation data from the ACROBAT observational...
FDA resurrects Loargys for ARG1‑D – Accelerated approval granted
Immedica Pharma won accelerated FDA approval for Loargys (pegzilarginase) to treat arginase‑1 deficiency (ARG1‑D) in patients aged two and older, reviving a once‑rejected enzyme replacement...
Gilead buys Arcellx for $7.8B – doubles down on CAR‑T
Gilead Sciences agreed to acquire Arcellx in a deal valued at about $7.8 billion to secure full control of anito‑cel, a BCMA‑directed CAR‑T therapy for multiple myeloma. The acquisition converts...
Novo’s next‑gen stumble: CagriSema falls short – price cuts follow
Novo Nordisk reported that its next‑generation obesity candidate CagriSema failed to show noninferiority to Eli Lilly’s Zepbound in a head‑to‑head Phase 3 study, weighing on the company’s market...
FDA pivots: single pivotal trials and bespoke therapies gain runway
The U.S. Food and Drug Administration announced major shifts in evidentiary expectations: endorsing reliance on one well‑controlled pivotal trial in appropriate circumstances and publishing draft...
Beam launches PKU base‑editing program – $500M financing pact in tow
Beam Therapeutics launched BEAM‑304, a liver‑targeted base‑editing program aimed at correcting the most common PAH mutations that cause phenylketonuria (PKU). Beam said preclinical data normalized...
Astellas pays up — $1.3B pact with Vir for masked CD3 T‑cell engager
Astellas Pharma and Vir Biotechnology struck a global co‑development agreement worth up to $1.37 billion plus near‑term payments to advance VIR‑5500, a PRO‑XTEN dual‑masked CD3 T‑cell engager...
CareDx pivots to cell‑therapy surveillance – validation data in hand
CareDx said it will prioritise a cell therapy surveillance testing pipeline in 2026 after reporting solid quarterly revenue growth. The company published validation data from the ACROBAT...
Gossamer’s Phase III miss sends stock tumbling – program under review
Gossamer Bio reported a pivotal Phase III miss for seralutinib in pulmonary arterial hypertension (PAH), with the study failing to meet its primary endpoint amid an outsized placebo response. The...
New polymers degrade ‘undruggable’ MYC and KRAS – HYDRACs show preclinical activity
Researchers at Northwestern reported a new class of protein‑like polymers—HYDRACs—that recruit cellular degradation machinery to selectively eliminate intrinsically disordered, 'undruggable'...
Flagship’s Generate eyes blockbuster IPO — platform play in public markets
Flagship Pioneering’s Generate:Biomedicines is aiming for a major public debut that could value the company in the multibillion‑dollar range, raising capital to fund late‑stage programs and...
Pharma groups ready legal fight over CMS pricing demos — industry aligns
Pharmaceutical trade associations and drugmakers are preparing legal challenges to two proposed Medicare pricing demonstration models that would align U.S. prices with other wealthy nations,...
Gilead snaps up Arcellx for $7.8B – Bets on CAR‑T lead
Gilead Sciences agreed to acquire Arcellx for $7.8 billion in cash, taking full control of anito‑cel, the BCMA‑directed CAR‑T therapy nearing FDA review. The deal consolidates co-development...
Novo’s next‑gen miss and price cuts reshape obesity market
Novo Nordisk’s experimental obesity combo CagriSema failed to meet non‑inferiority versus Eli Lilly’s Zepbound in a head‑to‑head Phase 3 trial, prompting fresh investor concern and strategic...
FDA unveils bespoke therapy pathway: plausible‑mechanism draft
The U.S. Food and Drug Administration published draft guidance laying out a new 'plausible mechanism' pathway to speed individualized and ultra‑rare therapies, including bespoke gene‑editing...
Beam expands base editing to PKU – BEAM‑304 enters IND path
Beam Therapeutics launched BEAM‑304, a liver‑targeted base‑editing program designed to correct pathogenic PAH mutations that cause phenylketonuria (PKU), and secured a $500 million strategic...