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Generate Biomedicines raises $400M: AI design funds pivotal asthma trials
Generate Biomedicines priced a landmark IPO, raising roughly $400 million to advance its AI‑designed pipeline and fund pivotal phase 3 trials for its anti‑TSLP antibody GB‑0895 in severe asthma....
Systimmune’s iza‑bren passes China phase III endpoints — survival gains reported
Systimmune reported that izalontamab brengitecan (iza‑bren) met both progression‑free survival and overall survival endpoints in a phase III trial in Chinese patients with advanced triple‑negative...
Caris Detect interim readout: ctDNA‑guided MCED shows stage‑dependent sensitivity
Caris Life Sciences unveiled interim validation results from its Achieve 1 study supporting the planned commercial launch of Caris Detect, a multicancer early detection (MCED) blood assay. In...
Atrium rises from Avidity sale – $270M spinout to pursue cardiac RNA programs
Atrium Therapeutics launched as a spinout preserving Avidity Biosciences’ cardiac RNA programs after Novartis closed its $12 billion acquisition of Avidity. Led by former Avidity executives,...
Earendil inks up to $885M pact with WuXi XDC — ADC linker access secured
Earendil Labs struck an exclusive deal to access WuXi XDC’s WuXiTecan‑2 payload‑linker technology for next‑generation antibody‑drug conjugates, a transaction valued at up to $885 million in...
Asahi Kasei buys Aicuris for $920M — expands antiviral portfolio
Asahi Kasei agreed to acquire German antiviral specialist Aicuris for about $920 million, gaining marketed cytomegalovirus product Prevymis and late‑stage assets including pritelivir for herpes...
Regulator rhetoric rattles market — UniQure slides after FDA comments
UniQure’s market value plunged after FDA Commissioner Marty Makary defended recent rare‑disease therapy rejections on a public broadcast, prompting investor concerns that the agency’s stance could...
FDA proposes ‘plausible mechanism’ route — new framework for ultra‑rare therapies
The U.S. Food and Drug Administration proposed a draft ‘plausible mechanism’ framework to accelerate development of individualized and ultra‑rare therapies when randomized controlled trials are...
Earendil–WuXi XDC pact: $885M play for next‑gen ADC linkers
Earendil Labs signed an exclusive pact with WuXi XDC to license the WuXiTecan‑2 payload‑linker platform and tap WuXi XDC’s CRDMO capabilities to advance antibody‑drug conjugates (ADCs). The deal...
Atrium launches as Novartis closes $12B Avidity buyout
Novartis completed its $12 billion acquisition of Avidity Biosciences and simultaneously spun out Atrium Therapeutics to carry forward Avidity’s early cardiac RNA programs. Atrium launched with...
Generate prices $400M IPO: AI drug discovery lists on Nasdaq
Generate:Biomedicines priced a $400 million Nasdaq IPO, selling 25 million shares at $16 apiece and positioning proceeds to fund two phase 3 asthma trials for its anti‑TSLP antibody GB‑0895 and to...
Caris Detect interim: MCED assay posts high specificity, stage‑linked sensitivity
Caris Life Sciences released interim Achieve‑1 validation data for Caris Detect, its multicancer early detection (MCED) blood test, reporting approximately 95% specificity in 1,505 undiagnosed...
Rezatapopt NEJM: p53 reactivation shows activity in TP53 Y220C tumors
PMV Pharmaceuticals published Phase I results of rezatapopt in the New England Journal of Medicine, reporting objective responses in heavily pretreated patients whose tumors harbored the TP53...
Ginkgo divests biosecurity arm as Q4 revenue drops 24%
Ginkgo Bioworks agreed to sell its biosecurity business to a consortium of investors in exchange for a minority equity stake in the standalone firm, and reported Q4 2025 revenue of $33.0 million—a...
DOJ asks SCOTUS to revive generic pathway: solicitor general backs Hikma
The U.S. Solicitor General filed a brief urging the Supreme Court to reverse an appeals‑court decision that had revived Amarin’s lawsuit against generic maker Hikma over skinny‑labeling for...
Sequencing showdown: Roche’s $150 genome vs Ultima’s UG200 throughput leap
Roche disclosed pricing and performance details for its Axelios 1 sequencing‑by‑expansion system, claiming a $150 list cost to sequence a 30× human genome and positioning the platform for launch...
Ultra‑sensitive CAR‑T (HIT cells): preclinical eradication of multiple solid tumors
Columbia University researchers led by Michel Sadelain reported an engineered HLA‑independent T cell (HIT) receptor with ultra‑sensitivity that detects low levels of CD70 and eradicated kidney,...
ctDNA momentum: Natera eyes Medicare wins as tumor‑informed tests scale
Natera projected that expanded reimbursement for its minimal residual disease (MRD) assays will drive 2026 growth, confirming submissions to CMS MolDx for Latitude in colorectal cancer and...
Mutant p53 reactivation shows clinical responses – NEJM phase I
PMV Pharmaceuticals reported Phase I data showing the p53 reactivator rezatapopt produced objective responses in heavily pretreated patients whose tumors harbor the TP53 Y220C mutation. The New...
Ultra‑sensitive CAR‑T and checkpoint edits push into solid tumors
Two separate preclinical advances aim to overcome solid tumor barriers for cellular immunotherapy. Columbia University researchers reported ultra‑sensitive HLA‑independent T (HIT) receptors that...