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Clinical trial readouts — cardiopulmonary
Roivant Sciences reported that its inhaled mosliciguat met primary and key secondary endpoints in a 16-week Phase 2 study for pulmonary hypertension, including a 56% placebo-adjusted reduction in...
CAR-T — multiple myeloma efficacy signal
Bristol Myers Squibb said its pivotal GPRC5D-directed CAR-T trial in multiple myeloma hit its primary endpoint, advancing a key program aimed at challenging the post-BCMA landscape. The company...
Phase 3 failure — cardiovascular Lp(a) therapies
Novartis’ antisense therapy pelacarsen failed to demonstrate cardiovascular benefit in its Phase 3 Lp(a)HORIZON outcomes study, according to the company’s announcement. While earlier trials showed...
Immunotherapy — OX40 agonist responses in head and neck cancer
Inhibrx said its OX40 agonist produced clinical responses in patients with head and neck cancer, with the most striking activity appearing in a subset of HPV-positive tumors. The company...
Rare disease cell therapy — pediatric CAR-T funding and trial push
BrainChild Bio raised $116 million in a venture financing to advance CAR-T programs targeting childhood brain cancers, with the bulk of proceeds supporting a pivotal registrational push. The...
Obesity therapeutics — adipose-targeted RNAi heads to the clinic
Moonwalk Biosciences raised $70 million in a Series B to advance its adipose-targeted RNAi obesity program, pushing MW101 toward first-in-human studies. The company said MW101 produced weight loss...
Corporate strategy — biosimilars manufacturing investment
Sandoz outlined a major expansion plan for its newly formed biosimilars unit, including a $300 million investment in a new manufacturing site in Slovenia. The company also said it intends to grow...
Biologics innovation — regulatory-ready growth factor pathway bet
Pharvaris said its deucrictibant achieved a Phase 3 win in a second study, reinforcing the case for its hereditary angioedema therapy as the Swiss biotech awaits an FDA decision. The latest...
Funding — rare genetic obesity platform moves toward clinic
Superluminal Medicines raised an oversubscribed $60 million Series B to advance an AI-powered GPCR platform and initiate its first clinical trial by year-end. The company’s lead candidate is a...
AI-designed mRNA therapy posts Phase 3 win in melanoma
Moderna and Merck (MSD) delivered positive Phase 3 results for INTerpath-001, showing that its AI-designed, patient-specific mRNA-lipid nanoparticle therapy intismeran (mRNA-4157/V940) added to...
Novo Nordisk halts inflammation-linked cardiovascular trials after futility signals
Novo Nordisk stopped two late-stage cardiovascular trials of ziltivekimab, citing a data monitoring committee finding that the studies were unlikely to succeed. The company halted the HERMES and...
FDA accelerates approval of AstraZeneca oral SERD despite advisory committee opposition
The FDA granted AstraZeneca an accelerated approval for camizestrant, an oral selective estrogen receptor degrader (SERD), for patients with emergent ESR1-mutated HR+, HER2– advanced breast...
Beam Therapeutics updates 1-year durability data for AATD base editing
Beam Therapeutics said additional data from its Phase 1/2 trial in alpha-1 antitrypsin deficiency (AATD) support continued performance of its base-editing gene therapy candidate after one year....
Roivant’s mosliciguat hits mid-stage endpoints in lung disease programs
Roivant reported that its inhaled drug candidate mosliciguat met mid-stage study goals, supporting its development plan for pulmonary hypertension and strengthening cash prospects for the company....
GSK pays $110M for Hutchmed ATTC asset – Phase 1-ready cancer conjugate
GSK agreed to pay $110 million to secure rights to Hutchmed’s antibody-targeted therapy conjugate (ATTC) platform asset, characterized as a first-in-class approach combining targeted delivery with...
Funding: Superluminal raises oversubscribed Series B to advance AI GPCR obesity therapy
Superluminal Medicines raised $60 million in an oversubscribed Series B to push its AI-powered GPCR platform and advance its lead program into first-in-human testing by the end of 2026. The...
Regulatory: Acepodia gets FDA IND for GPC3-targeted ACE-723 in HCC
Acepodia said it received FDA IND clearance for ACE-723, a GPC3-targeted dual-payload antibody-drug conjugate aimed at hepatocellular carcinoma. The company plans to begin a Phase 1 trial in...
Rezubio advances RZ-520 after IND clearances in respiratory diseases
Rezubio Pharmaceuticals advanced RZ-520 into Phase I for chronic respiratory diseases after receiving IND clearances from both the FDA and China’s NMPA. The company said dosing is underway in a...
Novartis setback deepens after Avidity-acquired drug misses Phase 3
Novartis reported another late-stage failure as its Harbor Phase 3 trial of del-desiran missed a crucial primary endpoint. The setback follows a high-profile heart disease trial disappointment...
Personalized cancer mRNA therapy clears Phase 3 hurdle in melanoma
Merck and Moderna reported positive Phase III INTerpath-001 results for intismeran (mRNA-4157/V940) combined with pembrolizumab in stage IIB–IV cutaneous melanoma, according to reporting tied to...