Clinical Trials

Biologics

FDA approves Pluvicto for hormone-sensitive prostate cancer

Novartis wins approval to use its radioligand therapy earlier in metastatic prostate cancer, nearly doubling the eligible patient population.
Novartis wins approval to use its radioligand therapy earlier in metastatic prostate cancer, nearly doubling the eligible patient population.
Biologics

Leads Biolabs completes enrolment in Phase II BTC study of opamtistomig

The Nanjing biotech has enrolled 70 patients in a Phase II trial of its PD-L1/4-1BB bispecific, with full data expected at ESMO
The Nanjing biotech has enrolled 70 patients in a Phase II trial of its PD-L1/4-1BB bispecific, with full data expected at ESMO

Moleculin AML trial holds 37% blinded CRc in venetoclax-failed patients

Interim blinded data from MIRACLE Part A show Annamycin's remission rate is unchanged even as nearly half of evaluable patients had failed prior venetoclax
Interim blinded data from MIRACLE Part A show Annamycin's remission rate is unchanged even as nearly half of evaluable patients had failed prior venetoclax
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.
Biologics

Annexon secures $200m credit facility from Oxford Finance

The Brisbane-based neuroinflammation biotech drew $50m at closing, with up to $150m more tied to milestones for vonaprument and tanruprubart.
The Brisbane-based neuroinflammation biotech drew $50m at closing, with up to $150m more tied to milestones for vonaprument and tanruprubart.
Biologics
Regulatory Science

Capricor adcom setback leaves deramiocel fate with FDA

An FDA advisory panel voted 9-3 against effectiveness of deramiocel for DMD cardiomyopathy, but the PDUFA date of 22 August 2026 remains in place.
An FDA advisory panel voted 9-3 against effectiveness of deramiocel for DMD cardiomyopathy, but the PDUFA date of 22 August 2026 remains in place.

Cingulate publishes Phase 3 data for CTx-1301 ADHD candidate

All three dose levels of Cingulate's once-daily dexmethylphenidate tablet beat placebo on the ADHD-RS-5 scale, with the highest dose yielding an
All three dose levels of Cingulate's once-daily dexmethylphenidate tablet beat placebo on the ADHD-RS-5 scale, with the highest dose yielding an
Biologics

Diakonos Oncology doses first patients in DOC1021 melanoma trial

The Houston biotech has initiated its Phase 1/2 DOC-RM study in refractory melanoma, with early safety results expected by end of 2026.
The Houston biotech has initiated its Phase 1/2 DOC-RM study in refractory melanoma, with early safety results expected by end of 2026.
Biologics

Disc Medicine eyes two pivotal programmes by 2027 after busy Q2

The Watertown biotech reported $718m in cash runway to 2029 and flagged a Q4 Phase 3 readout for bitopertin in EPP as its nearest catalysts.
The Watertown biotech reported $718m in cash runway to 2029 and flagged a Q4 Phase 3 readout for bitopertin in EPP as its nearest catalysts.
Biologics

Keros Therapeutics earns $20m milestone as elritercept Phase 3 enrols

Keros will receive a $20m payment from Takeda after the ELRiSE MDS Phase 3 trial dosed its first patient, with 25% to be distributed to
Keros will receive a $20m payment from Takeda after the ELRiSE MDS Phase 3 trial dosed its first patient, with 25% to be distributed to
Biologics

Madrigal Pharmaceuticals posts $364m Q2 Rezdiffra sales, up 71%

Madrigal's MASH therapy Rezdiffra surpassed 50,000 active patients and nearly $1.3bn in trailing annual sales as the company advanced an oral GLP
Madrigal's MASH therapy Rezdiffra surpassed 50,000 active patients and nearly $1.3bn in trailing annual sales as the company advanced an oral GLP
Biologics

Celcuity gedatolisib gains NCCN Category 1 status in breast cancer

REVTORPYK earned a preferred second-line NCCN listing just 16 days after FDA approval, backed by Phase 3 data showing a 7.3-month PFS
REVTORPYK earned a preferred second-line NCCN listing just 16 days after FDA approval, backed by Phase 3 data showing a 7.3-month PFS

TScan Therapeutics doses first patient in Phase 3 ALLOHA-2 trial

TScan's TCR-T therapy TSC-101 has entered pivotal Phase 3 testing in AML and MDS patients following allogeneic stem cell transplant.
TScan's TCR-T therapy TSC-101 has entered pivotal Phase 3 testing in AML and MDS patients following allogeneic stem cell transplant.
Biologics

Allogene wins FDA RMAT and Fast Track tags for cema-cel in LBCL

Allogene's allogeneic CAR T candidate cema-cel gained dual FDA designations backed by ALPHA3 interim data showing 58% MRD clearance in first-line large
Allogene's allogeneic CAR T candidate cema-cel gained dual FDA designations backed by ALPHA3 interim data showing 58% MRD clearance in first-line large
Biologics

Claris Bio raises $118m Series B to fund pivotal LSCD eye-drop study

The New Jersey biotech secured the round from eight investors to advance CSB-001, a recombinant protein eye drop, into two pivotal trials in 2027.
The New Jersey biotech secured the round from eight investors to advance CSB-001, a recombinant protein eye drop, into two pivotal trials in 2027.
Biologics

Dyne Therapeutics gains FDA Priority Review for DMD drug z-rostudirsen

Dyne's BLA for z-rostudirsen in exon 51 Duchenne muscular dystrophy has a PDUFA date of 21 January 2027, as the company readies for
Dyne's BLA for z-rostudirsen in exon 51 Duchenne muscular dystrophy has a PDUFA date of 21 January 2027, as the company readies for
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