Biologics

Manufactured-protein therapeutics: monoclonal antibodies (mAbs); bispecifics & fusion proteins; therapeutic proteins & enzymes; vaccines; and blood & plasma products. Distinct from Cell & Gene Therapy (living cells / genetic material) and from chemically-synthesised small molecules (which stay under Pharmaceuticals).

Biologics

Essential Pharma names Becki Morison as CEO from July 2026

The Egham-based rare disease pharma company has appointed the former LEO Pharma and Eli Lilly executive to lead its next phase of commercial growth.
The Egham-based rare disease pharma company has appointed the former LEO Pharma and Eli Lilly executive to lead its next phase of commercial growth.
The Biotech Times Editorial Team  · 
Biologics

Medicenna secures new U.S. patents across IL-2, IL-4 and IL-13 platforms

Medicenna Therapeutics has added two issued U.S. patents and one allowed application, reinforcing IP protection around bizaxofusp and its broader Superkine pipeline.
Medicenna Therapeutics has added two issued U.S. patents and one allowed application, reinforcing IP protection around bizaxofusp and its broader Superkine pipeline.
The Biotech Times Editorial Team  · 
Biologics

MoonLake's sonelokimab hits 67% HiSCR75 at one year in HS

Week 52 VELA data show sonelokimab outperforming competing IL-17 agents in hidradenitis suppurativa, with a BLA filing targeted for late September 2026.
Week 52 VELA data show sonelokimab outperforming competing IL-17 agents in hidradenitis suppurativa, with a BLA filing targeted for late September 2026.
The Biotech Times Editorial Team  · 
Biologics

BioCardia targets Japan PMDA submission for CardiAMP by end of 2026

BioCardia plans to file CardiAMP Cell Therapy for approval in Japan by Q4 2026, targeting an initial patient subgroup of 20,000 ischemic heart failure
BioCardia plans to file CardiAMP Cell Therapy for approval in Japan by Q4 2026, targeting an initial patient subgroup of 20,000 ischemic heart failure
The Biotech Times Editorial Team  · 
Biologics

CTD-ILD pipeline heats up as physicians seek disease modification

A Spherix Global Insights survey of 107 US specialists finds only 15% of CTD-ILD patients achieve drug-free remission, driving pipeline interest.
A Spherix Global Insights survey of 107 US specialists finds only 15% of CTD-ILD patients achieve drug-free remission, driving pipeline interest.
The Biotech Times Editorial Team  · 
Biologics

Kither Biotech completes Phase 1 of inhaled peptide KIT2014 in COPD

The Turin-based biotech reported KIT2014 was safe and well tolerated at all doses, with no detectable systemic exposure, in 56 healthy participants.
The Turin-based biotech reported KIT2014 was safe and well tolerated at all doses, with no detectable systemic exposure, in 56 healthy participants.
The Biotech Times Editorial Team  · 
Biologics

MAIA Biotechnology opens third US site for ateganosine Phase 2 trial

Winship Cancer Institute of Emory University joins THIO-101, evaluating ateganosine as a third-line NSCLC therapy in checkpoint-inhibitor-resistant patients.
Winship Cancer Institute of Emory University joins THIO-101, evaluating ateganosine as a third-line NSCLC therapy in checkpoint-inhibitor-resistant patients.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Sanofi wins Japan approval for Sarclisa subcutaneous formulation

Japan's MHLW has approved isatuximab SC across multiple myeloma indications, with an on-body injector application still under regulatory review.
Japan's MHLW has approved isatuximab SC across multiple myeloma indications, with an on-body injector application still under regulatory review.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Denali Therapeutics sells rare paediatric PRV for $195m

Denali will use the proceeds to accelerate its TransportVehicle pipeline across lysosomal storage disorders and neurodegenerative diseases.
Denali will use the proceeds to accelerate its TransportVehicle pipeline across lysosomal storage disorders and neurodegenerative diseases.
The Biotech Times Editorial Team  · 
Biologics

IMF ASCENT trial shows 82% five-year PFS in smouldering myeloma

Phase 2 ASCENT data presented at EHA 2026 showed 97% overall response and 85% MRD negativity in high-risk smouldering myeloma patients.
Phase 2 ASCENT data presented at EHA 2026 showed 97% overall response and 85% MRD negativity in high-risk smouldering myeloma patients.
The Biotech Times Editorial Team  · 
Biologics

Memento Medicines raises $93m Series A for retinal bispecific

The newly launched Boston biotech licensed MMT-205, a Tie2-agonist and VEGF-inhibitor bispecific antibody, from MabTics and Curacle, with clinical trials targeted for
The newly launched Boston biotech licensed MMT-205, a Tie2-agonist and VEGF-inhibitor bispecific antibody, from MabTics and Curacle, with clinical trials targeted for
The Biotech Times Editorial Team  · 
Biologics

Memo Therapeutics presents full Phase II potravitug data at ATC 2026

Complete SAFE KIDNEY II results show potravitug cut BKPyV viral loads and nephropathy rates in kidney transplant recipients with no treatment-related serious adverse
Complete SAFE KIDNEY II results show potravitug cut BKPyV viral loads and nephropathy rates in kidney transplant recipients with no treatment-related serious adverse
The Biotech Times Editorial Team  · 
Biologics
Genomics

Prime Medicine clears NZ hurdle for first in vivo Prime Editing trial

Medsafe has cleared PM577a for a Phase 1/2 study in Wilson Disease, marking Prime Medicine's first clinical authorisation for an in vivo Prime
Medsafe has cleared PM577a for a Phase 1/2 study in Wilson Disease, marking Prime Medicine's first clinical authorisation for an in vivo Prime
The Biotech Times Editorial Team  · 
Biologics

Biogen to acquire RayThera for up to $1bn to bolster immunology pipeline

Biogen has agreed to buy San Diego-based small-molecule immunology company RayThera, with the lead candidate expected to enter Phase 1 in Q3 2026.
Biogen has agreed to buy San Diego-based small-molecule immunology company RayThera, with the lead candidate expected to enter Phase 1 in Q3 2026.
The Biotech Times Editorial Team  · 
Biologics

Connect Biopharma fills Phase 2 asthma study of rademikibart

The San Diego biotech completed enrolment of 160 participants in its Seabreeze STAT asthma trial, with topline data expected in early September 2026.
The San Diego biotech completed enrolment of 160 participants in its Seabreeze STAT asthma trial, with topline data expected in early September 2026.
The Biotech Times Editorial Team  · 
Biologics

Roche files sBLA for Lunsumio-Polivy combo in relapsed LBCL

The FDA has accepted Roche's supplemental BLA for mosunetuzumab plus polatuzumab vedotin in relapsed or refractory large B-cell lymphoma, with a decision expected
The FDA has accepted Roche's supplemental BLA for mosunetuzumab plus polatuzumab vedotin in relapsed or refractory large B-cell lymphoma, with a decision expected
The Biotech Times Editorial Team  · 
Biologics

Lexeo Therapeutics publishes LX2006 Phase I/II data in JAMA Cardiology

Peer-reviewed findings show LX2006 gene therapy improved cardiac measures in Friedreich ataxia patients, with a pivotal study now initiating.
Peer-reviewed findings show LX2006 gene therapy improved cardiac measures in Friedreich ataxia patients, with a pivotal study now initiating.
The Biotech Times Editorial Team  · 
Biologics

Odyssey Therapeutics IPO raises $315m as OD-001 hits UC proof-of-concept

The Boston biotech floated on Nasdaq in May 2026, reporting Phase 2a remission data for its oral RIPK2 inhibitor in ulcerative colitis alongside a $464m
The Boston biotech floated on Nasdaq in May 2026, reporting Phase 2a remission data for its oral RIPK2 inhibitor in ulcerative colitis alongside a $464m
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Sernova wins FDA Orphan Drug tag for autologous islet transplant

The Canadian biotech's Cell Pouch device could shield total-pancreatectomy patients from type 3c diabetes, with seven years of US exclusivity now on the
The Canadian biotech's Cell Pouch device could shield total-pancreatectomy patients from type 3c diabetes, with seven years of US exclusivity now on the
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

uniQure to file AMT-130 BLA for Huntington's disease in Q3 2026

The FDA has confirmed that three-year Phase I/II data can support an accelerated approval BLA for AMT-130, with uniQure targeting a Q3
The FDA has confirmed that three-year Phase I/II data can support an accelerated approval BLA for AMT-130, with uniQure targeting a Q3
The Biotech Times Editorial Team  · 
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