Pharmaceuticals

Pharmaceuticals
Bioinformatics

X-Chem wins Chordoma Foundation TBXT Challenge with novel binder

X-Chem beat 25 competing teams to become the first to bind Brachyury below 1 micromolar, validating its DEL-based Chemomics platform against a long
X-Chem beat 25 competing teams to become the first to bind Brachyury below 1 micromolar, validating its DEL-based Chemomics platform against a long
Pharmaceuticals
Diagnostics

BioVie's bezisterim hits subgroup endpoints in Phase 2 Long COVID trial

BioVie reported statistically significant improvements in Long COVID patients with high symptom burden, with Phase 3 now planned for bezisterim.
BioVie reported statistically significant improvements in Long COVID patients with high symptom burden, with Phase 3 now planned for bezisterim.
Pharmaceuticals
Diagnostics

BlossomHill's BH-30643 hits 45% response rate in C797S NSCLC

Updated SOLARA Phase 1/2 data show an 88% disease control rate in a resistance population with no approved targeted therapies.
Updated SOLARA Phase 1/2 data show an 88% disease control rate in a resistance population with no approved targeted therapies.
Biologics
Pharmaceuticals

Connect Biopharma's rademikibart cuts asthma treatment failure by 66%

Phase 2 data show rademikibart reduced treatment failure and improved lung function in acute asthma, with COPD readout and FDA engagement planned.
Phase 2 data show rademikibart reduced treatment failure and improved lung function in acute asthma, with COPD readout and FDA engagement planned.
Pharmaceuticals
Diagnostics

Dogwood Therapeutics completes enrolment in Halneuron CINP Phase 2b

The Atlanta-based biotech enrolled 239 patients at the top of its target range, with topline data expected in November 2026.
The Atlanta-based biotech enrolled 239 patients at the top of its target range, with topline data expected in November 2026.
Pharmaceuticals
Regulatory Science

Elevar Therapeutics files EMA application for lirafugratinib in CCA

Elevar has submitted a marketing authorisation application to the EMA for its selective FGFR2 inhibitor, backed by a 46.5% response rate in second-line
Elevar has submitted a marketing authorisation application to the EMA for its selective FGFR2 inhibitor, backed by a 46.5% response rate in second-line
Pharmaceuticals
Biologics

ENA Respiratory begins Part B dosing in INNA-051 Phase IIa study

The Melbourne biotech has started dosing up to 900 participants in Part B of its community study of the virus-agnostic nasal spray INNA-051.
The Melbourne biotech has started dosing up to 900 participants in Part B of its community study of the virus-agnostic nasal spray INNA-051.
Pharmaceuticals

Kestrel Therapeutics wins FDA Fast Track for pan-KRAS inhibitor KST-6051

Kestrel's oral pan-KRAS inhibitor enters Phase 1 with Fast Track status, targeting KRAS-mutant solid tumours across PDAC, CRC and NSCLC.
Kestrel's oral pan-KRAS inhibitor enters Phase 1 with Fast Track status, targeting KRAS-mutant solid tumours across PDAC, CRC and NSCLC.
Pharmaceuticals
Diagnostics
Cell & Gene Therapy

KORTUC hits 184-patient enrolment in registrational breast cancer trial

The Palo Alto radiosensitizer biotech said its UK-led breast cancer study is now moving toward a 2027 efficacy readout, as two further cancer trials
The Palo Alto radiosensitizer biotech said its UK-led breast cancer study is now moving toward a 2027 efficacy readout, as two further cancer trials
Biologics
Pharmaceuticals

One04 Therapeutics launches on Phase 1 data for Factor H candidate

The Freiburg biotech launched publicly on encouraging CPV-104 Phase 1 interim results in C3G, with two new trials targeting kidney disease and dry AMD
The Freiburg biotech launched publicly on encouraging CPV-104 Phase 1 interim results in C3G, with two new trials targeting kidney disease and dry AMD
Pharmaceuticals
Diagnostics

Agomab reports positive Phase 1 data for inhaled IPF drug AGMB-447

Agomab's lung-restricted ALK5 inhibitor showed favourable safety and proof-of-mechanism in IPF patients; a Phase 2 study is set to begin before
Agomab's lung-restricted ALK5 inhibitor showed favourable safety and proof-of-mechanism in IPF patients; a Phase 2 study is set to begin before
Pharmaceuticals
Biologics

Curium wins FDA approval for BEXLUTRY lutetium RLT in GEP-NETs

Curium's BEXLUTRY, a 505(b)(2) lutetium Lu 177 dotatate equivalent, has received FDA approval for somatostatin receptor-positive GEP-NETs in adults.
Curium's BEXLUTRY, a 505(b)(2) lutetium Lu 177 dotatate equivalent, has received FDA approval for somatostatin receptor-positive GEP-NETs in adults.
Diagnostics
Pharmaceuticals
Biologics

Telix's Pixclara wins FDA approval as first glioma FET-PET agent

Telix Pharmaceuticals has secured FDA approval for Pixclara, the first radiopharmaceutical PET imaging drug cleared in the US for glioma diagnosis.
Telix Pharmaceuticals has secured FDA approval for Pixclara, the first radiopharmaceutical PET imaging drug cleared in the US for glioma diagnosis.
Biologics
Pharmaceuticals

Immunocore completes TEBE-AM enrolment as tebentafusp Phase 3 matures

Immunocore has enrolled 540 patients in its registrational TEBE-AM trial, with topline overall survival data expected as early as end of 2026.
Immunocore has enrolled 540 patients in its registrational TEBE-AM trial, with topline overall survival data expected as early as end of 2026.
Biologics
Pharmaceuticals

J&J's amivantamab plus chemo hits 34-month OS in EGFR Ex20ins NSCLC

Final PAPILLON Phase 3 data show a 34.3-month median overall survival with amivantamab plus chemotherapy, the longest reported in this historically difficult-to
Final PAPILLON Phase 3 data show a 34.3-month median overall survival with amivantamab plus chemotherapy, the longest reported in this historically difficult-to
Pharmaceuticals
Regulatory Science

Leios Therapeutics clears FDA end-of-phase 2 meeting for 10XB-101

The La Jolla biotech secured FDA alignment on Phase 3 design for its injectable submental fat treatment, clearing the path to a 505(b)(2
The La Jolla biotech secured FDA alignment on Phase 3 design for its injectable submental fat treatment, clearing the path to a 505(b)(2
Pharmaceuticals
Regulatory Science

Pharmazz wins FDA Orphan Drug Designation for sovateltide in NHIE

Pharmazz's endothelin-B receptor agonist sovateltide gains Orphan Drug Designation for neonatal hypoxic-ischaemic encephalopathy, unlocking US development incentives.
Pharmazz's endothelin-B receptor agonist sovateltide gains Orphan Drug Designation for neonatal hypoxic-ischaemic encephalopathy, unlocking US development incentives.
Biologics
Pharmaceuticals

Revelyx Bio Phase 2 data back recombinant liquid botulinum toxin YY003

YY003 hit its composite primary endpoint in 80.8% of participants at the 40-unit dose, with rapid onset by week one and no neutralising
YY003 hit its composite primary endpoint in 80.8% of participants at the 40-unit dose, with rapid onset by week one and no neutralising
Biologics
Pharmaceuticals

Leads Biolabs opamtistomig hits 87% ORR in squamous NSCLC at WCLC

Phase II data for the PD-L1/4-1BB bispecific showed consistent responses regardless of PD-L1 expression, as an NDA advances under NMPA priority
Phase II data for the PD-L1/4-1BB bispecific showed consistent responses regardless of PD-L1 expression, as an NDA advances under NMPA priority
Pharmaceuticals
Bioprocessing
Biologics

WuXi AppTec outlines long-acting oligonucleotide manufacturing hurdles

WuXi AppTec's TIDES platform sets out the chemistry, purification and stability challenges that arise when engineering oligonucleotides for monthly or longer dosing
WuXi AppTec's TIDES platform sets out the chemistry, purification and stability challenges that arise when engineering oligonucleotides for monthly or longer dosing
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