Pharmaceuticals

Biologics
Pharmaceuticals

SOTIO doses first patient in CDH17-targeting ADC trial for CRC

SOTIO Biotech has initiated its CADENCIA-01 Phase 1/2 trial of SOT109, the only CDH17-targeting ADC with FDA Fast Track Designation, in advanced
SOTIO Biotech has initiated its CADENCIA-01 Phase 1/2 trial of SOT109, the only CDH17-targeting ADC with FDA Fast Track Designation, in advanced
Biologics
Pharmaceuticals

Solstice Oncology launches with $225m Series A for CTLA-4 antibody

The Boston immuno-oncology startup closed a $225m Series A to advance porustobart, a next-generation CTLA-4 antibody, in neoadjuvant colon cancer.
The Boston immuno-oncology startup closed a $225m Series A to advance porustobart, a next-generation CTLA-4 antibody, in neoadjuvant colon cancer.
Pharmaceuticals
Biologics

Sobi wins FDA Fast Track for pacritinib in VEXAS syndrome

The designation accelerates review of the dual IRAK1/JAK2 inhibitor in a rare autoinflammatory disease with no approved treatments; topline Phase 2 data expected in
The designation accelerates review of the dual IRAK1/JAK2 inhibitor in a rare autoinflammatory disease with no approved treatments; topline Phase 2 data expected in
Pharmaceuticals
Regulatory Science

BridgeBio PROPEL 3 data show infigratinib cuts ear infections

Exploratory analyses from the Phase 3 PROPEL 3 trial show oral infigratinib reduced otitis media rates by 38% and stabilised sleep apnea measures versus placebo.
Exploratory analyses from the Phase 3 PROPEL 3 trial show oral infigratinib reduced otitis media rates by 38% and stabilised sleep apnea measures versus placebo.
Cell & Gene Therapy
Genomics
Pharmaceuticals

Opus Genetics reports positive Phase 1/2 OPGx-BEST1 data

All five Cohort 1 participants showed clinically meaningful visual improvement, and the FDA has aligned on a potential pivotal endpoint for the rare retinal disease
All five Cohort 1 participants showed clinically meaningful visual improvement, and the FDA has aligned on a potential pivotal endpoint for the rare retinal disease
Pharmaceuticals
Biologics

Caspian Therapeutics launches with $50m to target diabetes

Kura Oncology's newly spun-out subsidiary will use menin inhibition to try to restore pancreatic beta-cell function in Type 1 and Type 2
Kura Oncology's newly spun-out subsidiary will use menin inhibition to try to restore pancreatic beta-cell function in Type 1 and Type 2
Pharmaceuticals
Diagnostics

ImPact Biotech completes ENLIGHTED Phase 3 for padeliporfin VTP

ImPact Biotech has treated all 91 patients in its Phase 3 LG-UTUC trial and expects to file an NDA with the FDA in 2027.
ImPact Biotech has treated all 91 patients in its Phase 3 LG-UTUC trial and expects to file an NDA with the FDA in 2027.
Pharmaceuticals
Biologics

Ascendis Pharma reports 52-week infant data for TransCon CNP at ESPE

Week 52 sentinel cohort data show navepegritide stabilised foramen magnum stenosis and improved linear growth in infants with achondroplasia.
Week 52 sentinel cohort data show navepegritide stabilised foramen magnum stenosis and improved linear growth in infants with achondroplasia.
Biologics
Pharmaceuticals

Disc Medicine RESTORE-PV data show DISC-3405 cut phlebotomy in PV

Phase 2 results show the anti-TMPRSS6 antibody reduced mean phlebotomy events from 4.0 to 0.6 over 26 weeks, with 61.5% of
Phase 2 results show the anti-TMPRSS6 antibody reduced mean phlebotomy events from 4.0 to 0.6 over 26 weeks, with 61.5% of
Pharmaceuticals
Biologics

Beeline Medicines' afimetoran meets Phase 2 primary endpoint in SLE

The Stamford biotech reported highly significant SRI-4 response rates versus placebo at Week 48, supporting pivotal development in systemic and cutaneous lupus.
The Stamford biotech reported highly significant SRI-4 response rates versus placebo at Week 48, supporting pivotal development in systemic and cutaneous lupus.
Biologics
Pharmaceuticals

Spyre Therapeutics completes IBD proof-of-concept with SPY003 data

SPY003 met its primary endpoint in ulcerative colitis, giving Spyre positive Phase 2 monotherapy readouts for all three of its IBD combination components.
SPY003 met its primary endpoint in ulcerative colitis, giving Spyre positive Phase 2 monotherapy readouts for all three of its IBD combination components.
Pharmaceuticals
Biologics

Roivant's mosliciguat hits Phase 2 primary endpoint in PH-ILD

Phase 2 PHocus trial showed a 56.3% placebo-adjusted PVR reduction; Roivant has now initiated the Phase 3 PHrontier study in the same indication.
Phase 2 PHocus trial showed a 56.3% placebo-adjusted PVR reduction; Roivant has now initiated the Phase 3 PHrontier study in the same indication.
Pharmaceuticals
Regulatory Science
Biologics

Pharvaris HAE prophylaxis trial hits 83% attack rate reduction

Pharvaris's CHAPTER-3 Phase 3 study of once-daily deucrictibant XR met all endpoints, with NDA submissions planned for the first half of 2027.
Pharvaris's CHAPTER-3 Phase 3 study of once-daily deucrictibant XR met all endpoints, with NDA submissions planned for the first half of 2027.
Pharmaceuticals
Biologics
Regulatory Science

Monte Rosa pockets $50m milestone as Novartis starts MRT-6160 Phase 2

Novartis has dosed its first Sjögren's disease patient with MRT-6160, triggering a $50m payment to Monte Rosa under the pair's $2.1bn
Novartis has dosed its first Sjögren's disease patient with MRT-6160, triggering a $50m payment to Monte Rosa under the pair's $2.1bn
Pharmaceuticals
Biologics

Novo Nordisk: semaglutide clears obesity threshold in 40% of children

Phase 3 STEP Young data show 40.4% of children aged 6 to 11 treated with semaglutide dropped below the obesity BMI threshold after 68
Phase 3 STEP Young data show 40.4% of children aged 6 to 11 treated with semaglutide dropped below the obesity BMI threshold after 68
Biologics
Pharmaceuticals

Novartis HARBOR Phase III trial misses primary endpoint in DM1

Del-desiran failed to improve hand myotonia in a 150-patient Phase III study, though secondary endpoints showed signs of clinical activity.
Del-desiran failed to improve hand myotonia in a 150-patient Phase III study, though secondary endpoints showed signs of clinical activity.
Biologics
Pharmaceuticals

NorthStrive files patents for EL-22 and EL-32 in spaceflight muscle loss

NorthStrive Biosciences has filed two US patent applications extending its myostatin-targeting probiotic candidates into microgravity-induced muscle atrophy.
NorthStrive Biosciences has filed two US patent applications extending its myostatin-targeting probiotic candidates into microgravity-induced muscle atrophy.
Pharmaceuticals
Biologics

Ascendis to present infant achondroplasia data at ESPE 2026

Ascendis Pharma will share sentinel cohort data from its reACHin pivotal trial of navepegritide in infants under two at ESPE 2026.
Ascendis Pharma will share sentinel cohort data from its reACHin pivotal trial of navepegritide in infants under two at ESPE 2026.
Pharmaceuticals
Regulatory Science

Aprea Therapeutics expands patent estate for WEE1 and ATR programmes

The Nasdaq-listed oncology company has detailed patents covering APR-1051 and ATRN-119, with WEE1 protection potentially running to 2047.
The Nasdaq-listed oncology company has detailed patents covering APR-1051 and ATRN-119, with WEE1 protection potentially running to 2047.
Pharmaceuticals
Diagnostics

Zentalis Pharmaceuticals launches share offering for azenosertib

Zentalis is raising fresh capital via an underwritten public offering to fund trials and pre-commercial activities for its WEE1 inhibitor azenosertib in ovarian cancer.
Zentalis is raising fresh capital via an underwritten public offering to fund trials and pre-commercial activities for its WEE1 inhibitor azenosertib in ovarian cancer.
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