Innovation

Regulatory Science

Candel prostate therapy shows 30% DFS gain in Lancet Oncology

Candel Therapeutics' aglatimagene cut disease recurrence by 30% versus placebo in a 745-patient Phase 3 trial, with a BLA filing planned for Q4 2026.
Candel Therapeutics' aglatimagene cut disease recurrence by 30% versus placebo in a 745-patient Phase 3 trial, with a BLA filing planned for Q4 2026.
Diagnostics
Genomics

Cardiff Oncology: onvansertib hits 72% ORR in RAS-mutated mCRC

Phase 2 CRDF-004 data presented at ASCO 2026 support a registrational Phase 3 trial after FDA End-of-Phase 2 alignment.
Phase 2 CRDF-004 data presented at ASCO 2026 support a registrational Phase 3 trial after FDA End-of-Phase 2 alignment.
Diagnostics
Regulatory Science

Disc Medicine RALLY-MF data show broad anemia responses in MF

Updated Phase 2 data for DISC-0974 show durable anemia responses across all patient subgroups, with an FDA end-of-phase meeting expected by year
Updated Phase 2 data for DISC-0974 show durable anemia responses across all patient subgroups, with an FDA end-of-phase meeting expected by year
Biotech

JJP Biologics: nebaprubart shows early efficacy in rare LAD trial

Interim Phase 1b data show rapid blister reduction and dapsone tapering in Linear IgA Disease, supporting a rheumatoid arthritis trial in Q3 2026.
Interim Phase 1b data show rapid blister reduction and dapsone tapering in Linear IgA Disease, supporting a rheumatoid arthritis trial in Q3 2026.
Regulatory Science

J&J nipocalimab meets Phasea 2 primary endpoint in lupus study

Phase 2 JASMINE data show nipocalimab reduced SLE disease activity through 52 weeks, with stronger responses in autoantibody-positive patients.
Phase 2 JASMINE data show nipocalimab reduced SLE disease activity through 52 weeks, with stronger responses in autoantibody-positive patients.
Genomics

Ziftomenib triplet shows 87% ORR in venetoclax-naive R/R AML

Blood publication of KOMET-007 data shows deep, durable responses for ziftomenib plus venetoclax/azacitidine in NPM1-mutated relapsed/refractory AML.
Blood publication of KOMET-007 data shows deep, durable responses for ziftomenib plus venetoclax/azacitidine in NPM1-mutated relapsed/refractory AML.
Cell & Gene Therapy
Biotech

Legend Biotech reports 100% ORR in Phase 1 in vivo CAR-T NHL trial

LB2501, a single-infusion in vivo CAR-T candidate, achieved 100% objective response in six relapsed/refractory NHL patients with no dose-limiting toxicities.
LB2501, a single-infusion in vivo CAR-T candidate, achieved 100% objective response in six relapsed/refractory NHL patients with no dose-limiting toxicities.
Digital Health

Amazon One Medical GLP-1 programme launch reshapes weight-loss market

Amazon's integrated GLP-1 programme combines One Medical clinical care, Amazon Pharmacy, and same-day delivery, but cash-pay and new patients face notable
Amazon's integrated GLP-1 programme combines One Medical clinical care, Amazon Pharmacy, and same-day delivery, but cash-pay and new patients face notable
Bioprocessing
Synthetic Biology
Biotech

AMG Critical Materials beats Q1 2026 guidance on vanadium strength

AMG Critical Materials posted $44m adjusted EBITDA in Q1 2026, ahead of guidance, driven by vanadium gains and the AURA acquisition.
AMG Critical Materials posted $44m adjusted EBITDA in Q1 2026, ahead of guidance, driven by vanadium gains and the AURA acquisition.
Medical Devices

Anika Therapeutics posts 13% revenue rise as margins recover sharply

The Bedford-based orthopaedic biotech grew Q1 2026 revenue to $29.6m and lifted gross margin eight points to 64%, driven by its Integrity regenerative
The Bedford-based orthopaedic biotech grew Q1 2026 revenue to $29.6m and lifted gross margin eight points to 64%, driven by its Integrity regenerative
Biotech

Avalo Therapeutics hits Phase 2 primary endpoint in HS trial

Abdakibart met HiSCR75 at both doses in the 253-patient LOTUS trial, with Avalo now planning a registrational Phase 3 programme in hidradenitis suppurativa.
Abdakibart met HiSCR75 at both doses in the 253-patient LOTUS trial, with Avalo now planning a registrational Phase 3 programme in hidradenitis suppurativa.
Regulatory Science
Biotech

Avalyn Pharma to present AP01 usability and IPF patient data at ATS 2026

Avalyn will show poster data on inhaled pirfenidone nebuliser usability and patient-centred supportive care in pulmonary fibrosis at ATS in Orlando.
Avalyn will show poster data on inhaled pirfenidone nebuliser usability and patient-centred supportive care in pulmonary fibrosis at ATS in Orlando.
Pharmaceuticals

BriaCell wins FDA clearance for Bria-BRES+ breast cancer IND

BriaCell Therapeutics can now initiate a Phase 1/2a study of its next-generation personalised cell immunotherapy in metastatic breast cancer.
BriaCell Therapeutics can now initiate a Phase 1/2a study of its next-generation personalised cell immunotherapy in metastatic breast cancer.
Regulatory Science

CDT Equity advances AZD5904 to PCT stage and seeks pharma partner

CDT Equity has filed for PCT patent protection on its myeloperoxidase inhibitor AZD5904 and is now actively seeking an out-licensing partner for late-stage
CDT Equity has filed for PCT patent protection on its myeloperoxidase inhibitor AZD5904 and is now actively seeking an out-licensing partner for late-stage
Regulatory Science

Dupixent shows esophageal function gains in Phase 4 EoE trial

Regeneron and Sanofi's REMODEL trial found dupilumab improved esophageal distensibility and reduced structural damage in adults with EoE at 24 weeks.
Regeneron and Sanofi's REMODEL trial found dupilumab improved esophageal distensibility and reduced structural damage in adults with EoE at 24 weeks.
Cell & Gene Therapy

Ernexa's ERNA-101 clears tumours completely in ovarian cancer models

Ernexa Therapeutics reported 100% survival and complete tumour clearance for ERNA-101 combined with PD-1 blockade in preclinical ovarian cancer models.
Ernexa Therapeutics reported 100% survival and complete tumour clearance for ERNA-101 combined with PD-1 blockade in preclinical ovarian cancer models.
Diagnostics

Femasys logs first commercial use of FemaSeed Complete in OB/GYN offices

Femasys says its integrated intratubal insemination system has achieved its first revenue-generating use, positioning OB/GYNs as first-line fertility providers.
Femasys says its integrated intratubal insemination system has achieved its first revenue-generating use, positioning OB/GYNs as first-line fertility providers.
Bioprocessing
Diagnostics

ChemoMetec Q3 revenue rises 15% as XcytoMatic platform gains traction

The Danish cell-counting specialist reported DKK 142.3m in Q3 revenue, with XcytoMatic instrument sales quadrupling year-on-year, excluding a one-off accounting
The Danish cell-counting specialist reported DKK 142.3m in Q3 revenue, with XcytoMatic instrument sales quadrupling year-on-year, excluding a one-off accounting
Diagnostics

Jelly Lean gummy supplement rides viral "Pink Gelatin Trick" wave

A ClickBank-distributed ACV and BHB gummy has surged in searches after a viral pre-meal satiety trend, but counterfeit listings cloud the market.
A ClickBank-distributed ACV and BHB gummy has surged in searches after a viral pre-meal satiety trend, but counterfeit listings cloud the market.
Medical Devices

LeMaitre Vascular posts 11% Q1 sales growth on Artegraft expansion

The Burlington-based vascular device maker reported Q1 2026 sales of $66.6m, with EPS up 42% year-on-year and full-year guidance raised.
The Burlington-based vascular device maker reported Q1 2026 sales of $66.6m, with EPS up 42% year-on-year and full-year guidance raised.
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