Disease

Diagnostics

Molecure KITE trial clears interim review with no protocol changes

An IDMC review of 30 patients found sufficient probability of hitting the primary endpoint, letting the Phase II sarcoidosis study proceed unchanged.
An IDMC review of 30 patients found sufficient probability of hitting the primary endpoint, letting the Phase II sarcoidosis study proceed unchanged.
Biologics

Rein Therapeutics publishes LTI-03 IPF data in Nature Communications

Peer-reviewed first-in-human data show inhaled LTI-03 reduced five fibrosis and inflammation markers in IPF patients after just 14 days.
Peer-reviewed first-in-human data show inhaled LTI-03 reduced five fibrosis and inflammation markers in IPF patients after just 14 days.
Diagnostics

Sight Sciences wins FDA 510(k) clearance for OMNI Ultra glaucoma system

The Menlo Park eyecare company cleared its next-generation implant-free MIGS device and is targeting a US commercial launch in Q4 2026.
The Menlo Park eyecare company cleared its next-generation implant-free MIGS device and is targeting a US commercial launch in Q4 2026.
Biologics

Akebia starts Phase 2 basket trial of complement inhibitor ebribafusp

Akebia Therapeutics has dosed first patients in a 30-person Phase 2 study of ebribafusp across three rare complement-mediated kidney diseases, with data expected
Akebia Therapeutics has dosed first patients in a 30-person Phase 2 study of ebribafusp across three rare complement-mediated kidney diseases, with data expected
Biologics
Regulatory Science

Sanofi's MenQuadfi wins EU approval for infants from six weeks

The European Commission has expanded MenQuadfi's indication to cover infants from six weeks, extending protection against four meningococcal serogroups.
The European Commission has expanded MenQuadfi's indication to cover infants from six weeks, extending protection against four meningococcal serogroups.
Biotech

Clearmind reports clean CMND-100 safety data across dose escalation

Clearmind Medicine completed all four ascending-dose cohorts of its Phase I/II AUD trial with no serious adverse events recorded.
Clearmind Medicine completed all four ascending-dose cohorts of its Phase I/II AUD trial with no serious adverse events recorded.
Biologics

DBV Technologies raises $50m via ATM programme with RA Capital

The French peanut-allergy biotech sold 3.66 million new ADSs at $13.67 each to RA Capital, diluting existing shareholders by approximately 5.82%.
The French peanut-allergy biotech sold 3.66 million new ADSs at $13.67 each to RA Capital, diluting existing shareholders by approximately 5.82%.
Biologics
Bioprocessing

Lonza and Engitix strike ADC licence deal targeting ECM biology

Engitix gains access to Lonza's GlycoConnect, HydraSpace and SYNtecan E technologies to build ECM-targeted antibody-drug conjugates for fibrosis and oncology.
Engitix gains access to Lonza's GlycoConnect, HydraSpace and SYNtecan E technologies to build ECM-targeted antibody-drug conjugates for fibrosis and oncology.
Genomics

Medicus Pharma wins UAE IND nod for genomics-guided endometriosis trial

Medicus Pharma has received UAE DOH authorisation to begin PRECISION-E2, a Phase 2a genomics-integrated study of Teverelix in 84 women with endometriosis.
Medicus Pharma has received UAE DOH authorisation to begin PRECISION-E2, a Phase 2a genomics-integrated study of Teverelix in 84 women with endometriosis.
Diagnostics

MMI wins FDA clearance to expand REMIND Alzheimer's robot surgery study

MMI's IDE supplement approval lets the REMIND study enrol up to 15 patients, testing robotic microsurgery to restore lymphatic drainage in Alzheimer's disease.
MMI's IDE supplement approval lets the REMIND study enrol up to 15 patients, testing robotic microsurgery to restore lymphatic drainage in Alzheimer's disease.
Diagnostics

InnSight Technology wins $515k from Mellon Foundation for OcuCheck

Pittsburgh diagnostics firm InnSight secured a $515,000 social impact investment to advance its tear-fluid diabetes screening device toward commercialisation.
Pittsburgh diagnostics firm InnSight secured a $515,000 social impact investment to advance its tear-fluid diabetes screening device toward commercialisation.
Regulatory Science

Rose Hill and Control Z sign LOI for psilocybin PTSD therapy

The two Boston-area companies will jointly develop a regulated, medically supervised psilocybin-assisted therapy programme for PTSD in Massachusetts.
The two Boston-area companies will jointly develop a regulated, medically supervised psilocybin-assisted therapy programme for PTSD in Massachusetts.
Regulatory Science
Biologics

60 Degrees Pharma hits enrolment trigger in babesiosis tafenoquine trial

The Washington biotech has enrolled the minimum 24 patients needed for an interim analysis, with results due by 6 October 2026.
The Washington biotech has enrolled the minimum 24 patients needed for an interim analysis, with results due by 6 October 2026.
Biologics
Regulatory Science

AB2 Bio gets $30m as Nippon Shinyaku takes U.S. Tadekinig rights

Nippon Shinyaku has exercised its U.S. commercialisation option for Tadekinig alfa, triggering a $30m payment and up to $600m in milestones.
Nippon Shinyaku has exercised its U.S. commercialisation option for Tadekinig alfa, triggering a $30m payment and up to $600m in milestones.
Biologics

Atavistik Bio joins Cure HHT network as Harmony-HHT trial opens

Atavistik Bio has partnered with Cure HHT and activated its first clinical site at Massachusetts General Hospital for its Phase 1/2 ATV-1601 trial.
Atavistik Bio has partnered with Cure HHT and activated its first clinical site at Massachusetts General Hospital for its Phase 1/2 ATV-1601 trial.
Biologics

Novo Nordisk ZEUS trial fails to cut cardiovascular events

Ziltivekimab hit its biological targets in 6,300-patient Phase 3 ZEUS but did not reduce MACE versus placebo, triggering a Q3 impairment charge.
Ziltivekimab hit its biological targets in 6,300-patient Phase 3 ZEUS but did not reduce MACE versus placebo, triggering a Q3 impairment charge.
Biologics

Royalty Pharma pays up to $425m for cliramitug royalty stake

Royalty Pharma acquires a 3-4% royalty on AstraZeneca's Phase 3 ATTR-CM antibody cliramitug, paying Neurimmune $125m upfront with more tied to milestones.
Royalty Pharma acquires a 3-4% royalty on AstraZeneca's Phase 3 ATTR-CM antibody cliramitug, paying Neurimmune $125m upfront with more tied to milestones.
Regulatory Science

Tenax Therapeutics awaits Phase 3 LEVEL readout as R&D spend doubles

Topline data from Tenax's pivotal PH-HFpEF trial is due in August 2026, with results set for presentation at ESC Congress in Munich.
Topline data from Tenax's pivotal PH-HFpEF trial is due in August 2026, with results set for presentation at ESC Congress in Munich.
Biologics

Tiziana sees neuroinflammation fall in third MSA patient on foralumab

PET imaging showed up to 34% reduction in brain inflammatory activity in a third MSA patient treated with intranasal foralumab, consistent with earlier results.
PET imaging showed up to 34% reduction in brain inflammatory activity in a third MSA patient treated with intranasal foralumab, consistent with earlier results.
Regulatory Science

Abivax clears FDA pre-NDA meeting for obefazimod in ulcerative colitis

The Paris-listed biotech said the FDA endorsed its NDA submission strategy for obefazimod, keeping a year-end 2026 filing on track.
The Paris-listed biotech said the FDA endorsed its NDA submission strategy for obefazimod, keeping a year-end 2026 filing on track.
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