Get the Daily Brief
Latest Biotech News
Myeloma CAR T differentiation
Bristol Myers Squibb reported Phase 2 QUINTESSENTIAL results for its BCMA-directed CAR T arlocabtagene autoleucel, signaling improved overall and complete response rates in relapsed or refractory...
AstraZeneca breast cancer SERD cleared after advisory setback
The FDA granted accelerated approval to AstraZeneca’s next-generation oral SERD camizestrant (Etcamah) for a defined group of HR+/HER2– advanced breast cancer patients with ESR1 mutations, despite...
Moonwalk raises for adipose-targeted RNAi obesity therapy
Moonwalk Biosciences raised $70 million in Series B funding to advance its adipose-targeted siRNA obesity program MW101 into IND-enabling work and first-in-human trials planned for late 2027. The...
Solstice raises for next-gen CTLA-4 immunotherapy
Solstice Oncology secured $225 million in a Series A to develop a next-generation immunotherapy targeting CTLA-4, advancing a medicine sourced from Harbour BioMed. The startup said its approach...
GPRC5D-directed CAR T momentum for broader myeloma competition
Bristol Myers Squibb reported that its pivotal multiple myeloma CAR T trial using a GPRC5D-directed construct hit its primary endpoint, extending the company’s push to challenge Johnson & Johnson...
Roivant pulmonary hypertension Phase 2 wins
Roivant Sciences reported that mosliciguat achieved its primary and key secondary endpoints in a 16-week Phase 2 study in pulmonary hypertension, supporting a potential expansion of treatment...
KRAS antibody-conjugate dealmaking
GSK expanded its antibody-drug conjugate efforts by taking ex-China rights to Hutchmed’s preclinical KRAS/EGFR antibody conjugate HMPL-A830 in a deal valued up to $1.295 billion plus...
NLRP3 inflammation platform heads toward Phase 3 and rebrand
NodThera, a decade-old biotech focused on the NLRP3 inflammasome pathway, announced plans for pivotal Phase 3 trial development beginning in 2027 along with a corporate rebrand. The company said...
US FDA IDE for glaucoma implant feasibility
Ciliatech SAS received a U.S. FDA investigational device exemption (IDE) to begin a feasibility study of its Intercil Uveal Spacer implant for glaucoma. The IDE allows the company to test the...
Phase 3 setbacks and clinical pipeline disruptions at Novartis
Novartis took another major hit to its late-stage pipeline as delpacibart etedesiran failed to meet the primary endpoint in the pivotal Phase 3 HARBOR trial in myotonic dystrophy type 1 (DM1). In...
FDA accelerated approval for AstraZeneca’s camizestrant after negative adcomm vote
The FDA granted accelerated approval to AstraZeneca’s oral SERD camizestrant, branded Etcamah, for patients with HR+/HER2– advanced breast cancer with ESR1 mutations detected during aromatase...
GSK expands Hutchmed rights for KRAS-antibody conjugate in large ex-China deal
GSK agreed to acquire ex-China rights to Hutchmed’s HMPL-A830, a KRAS inhibitor antibody conjugate, in a deal valued at up to $1.295 billion plus royalties. The agreement reflects GSK’s push into...
CRO consolidation: Fortrea buys Worldwide’s early phase unit for $45M
Fortrea agreed to buy Worldwide Clinical Trials’ early-phase services business in a $45 million deal, adding three Texas facilities and a 200-bed clinical pharmacology unit to its network. The...
Ciliatech secures FDA IDE for glaucoma implant feasibility study
Ciliatech SAS received a U.S. FDA investigational device exemption (IDE) to run a feasibility study of Intercil Uveal Spacer, its implant aimed at treating glaucoma. The step allows the company to...
Moonwalk raises $70M Series B for adipose-targeted RNAi obesity program
Moonwalk Biosciences raised $70 million in a Series B round to advance its adipose-targeted RNAi candidate MW101 toward first-in-human clinical trials. The company plans to use the funding to...
Inhibrx claims first clinical win for OX40 agonist in head and neck cancer subset
Inhibrx announced first win data for its OX40 agonist immunotherapy in head and neck cancer, reporting responses that were most striking in a subset of patients with HPV-positive tumors. The...
BrainChild Bio raises $116M for pediatric CAR-T pivotal trial in DIPG
BrainChild Bio secured $116 million in Series A financing to support its pivotal pediatric CAR-T program for diffuse intrinsic pontine glioma (DIPG). The lead candidate BCB-276 targets B7-H3 and...
Fortifying antitumor immunity: LAG-3 blockade paired with microwave ablation
Researchers reported that microwave ablation can trigger more than direct tumor cell destruction, with a new preclinical study suggesting benefit from pairing the treatment with anti–LAG-3 immune...
RNAV8 Bio chosen for ARPA-H pilot to build programmable RNA medicines
ARPA-H selected RNAV8 Bio for PROPEL, a one-year pilot program aimed at advancing programmable RNA medicines through a funding award of up to $4.4 million. The initiative will be led by the...
Novartis clinical setbacks in cardiology and neuromuscular disease
Novartis reported two major late-stage setbacks in rapid succession, including the Phase III failure of delpacibart etedesiran (del-desiran) in myotonic dystrophy type 1 and the Phase III failure...