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

SOTIO's SOT106 ADC wins FDA Fast Track for soft tissue sarcoma

SOTIO Biotech's LRRC15-targeting antibody-drug conjugate gained Fast Track Designation, with a first-in-human study expected before year end.
SOTIO Biotech's LRRC15-targeting antibody-drug conjugate gained Fast Track Designation, with a first-in-human study expected before year end.
The Biotech Times Editorial Team  · 
Regulatory Science
Biologics

INmune Bio files EMA packages for Ebstrocel in rare skin disease

INmune Bio has submitted an orphan drug designation application and pre-MAA scientific advice package to the EMA for its cell therapy Ebstrocel in RDEB.
INmune Bio has submitted an orphan drug designation application and pre-MAA scientific advice package to the EMA for its cell therapy Ebstrocel in RDEB.
The Biotech Times Editorial Team  · 
Digital Health
Biologics

Johns Hopkins wins NIH R01 to study GLP-1 long-term value

A five-year NIDDK-funded study will use Truveta's 140-million-patient dataset to assess GLP-1 cost-effectiveness and inform coverage decisions.
A five-year NIDDK-funded study will use Truveta's 140-million-patient dataset to assess GLP-1 cost-effectiveness and inform coverage decisions.
The Biotech Times Editorial Team  · 
Biologics

Mesoblast posts US$120m revenue as RYONCIL ramps

Mesoblast reported sevenfold revenue growth in FY2026, driven by RYONCIL's US commercial launch, while its Phase 3 back pain trial completed patient treatment.
Mesoblast reported sevenfold revenue growth in FY2026, driven by RYONCIL's US commercial launch, while its Phase 3 back pain trial completed patient treatment.
The Biotech Times Editorial Team  · 
Biologics

MicrobiotiX clears sentinel cohort in first phage trial for pneumonia

MicrobiotiX's MP101 bacteriophage candidate passed its 72-hour safety review in South Korea's first MFDS-approved phage therapy trial.
MicrobiotiX's MP101 bacteriophage candidate passed its 72-hour safety review in South Korea's first MFDS-approved phage therapy trial.
The Biotech Times Editorial Team  · 
Regulatory Science
Biologics

Mereo BioPharma licenses alvelestat to Sentynl in $475m-plus US deal

Mereo will receive up to $475m and tiered royalties if Sentynl exercises its US commercialisation option for the oral AATD-LD candidate.
Mereo will receive up to $475m and tiered royalties if Sentynl exercises its US commercialisation option for the oral AATD-LD candidate.
The Biotech Times Editorial Team  · 
Biologics

Spyre Therapeutics' SPY072 misses RA monotherapy bar in SKYWAY Phase 2

SPY072 showed statistically significant benefits in rheumatoid arthritis but fell short of Spyre's internal threshold to advance it as a standalone therapy.
SPY072 showed statistically significant benefits in rheumatoid arthritis but fell short of Spyre's internal threshold to advance it as a standalone therapy.
The Biotech Times Editorial Team  · 
Biologics

Monte Rosa doses first patient in Phase 2 MRT-2359 prostate cancer study

Monte Rosa Therapeutics has initiated MODeFIRe-1, a Phase 2 trial of its GSPT1 degrader MRT-2359 plus apalutamide in AR mutation-positive mCRPC patients.
Monte Rosa Therapeutics has initiated MODeFIRe-1, a Phase 2 trial of its GSPT1 degrader MRT-2359 plus apalutamide in AR mutation-positive mCRPC patients.
The Biotech Times Editorial Team  · 
Biologics

Beyond Air sells NeuroNOS stake to UNIVO for equity and milestones

Beyond Air is offloading its 58% stake in Israeli neuro-oncology spinout NeuroNOS to TASE-listed UNIVO in exchange for a 19.99% shareholding and
Beyond Air is offloading its 58% stake in Israeli neuro-oncology spinout NeuroNOS to TASE-listed UNIVO in exchange for a 19.99% shareholding and
The Biotech Times Editorial Team  · 
Biologics

Ascendis shares two-year YUVIWEL data at ISDS 2026

Ascendis Pharma will present Week 104 ApproaCH Trial data on navepegritide in achondroplasia, with FDA approval secured and an EMA decision due Q4 2026.
Ascendis Pharma will present Week 104 ApproaCH Trial data on navepegritide in achondroplasia, with FDA approval secured and an EMA decision due Q4 2026.
The Biotech Times Editorial Team  · 
Biologics

Apollo Therapeutics: Phase 1 pan-rhinovirus vaccine data positive

APL-10456 induced broad cross-reactive T cell responses against all three rhinovirus species in a 144-participant Phase 1 trial, with no serious adverse
APL-10456 induced broad cross-reactive T cell responses against all three rhinovirus species in a 144-participant Phase 1 trial, with no serious adverse
The Biotech Times Editorial Team  · 
Biologics

Alvotech and Lotus sign $150m biosimilar deal for two biologics

Alvotech and Lotus Pharmaceutical will co-commercialise durvalumab and emicizumab biosimilars across the US and eight Asian markets.
Alvotech and Lotus Pharmaceutical will co-commercialise durvalumab and emicizumab biosimilars across the US and eight Asian markets.
The Biotech Times Editorial Team  · 
Biologics

Leads Biolabs' opamtistomig posts 65% ORR in Phase 2 NSCLC study

Updated data from over seven months of follow-up, including PFS rates, will be presented at WCLC on 14 September 2026.
Updated data from over seven months of follow-up, including PFS rates, will be presented at WCLC on 14 September 2026.
The Biotech Times Editorial Team  · 
Biologics

ADARx wins FDA Fast Track for onvuzosiran in hereditary angioedema

ADARx Pharmaceuticals has secured Fast Track designation for its siRNA candidate onvuzosiran, now in Phase 3 trials for HAE prophylaxis.
ADARx Pharmaceuticals has secured Fast Track designation for its siRNA candidate onvuzosiran, now in Phase 3 trials for HAE prophylaxis.
The Biotech Times Editorial Team  · 
Biologics

Alvotech and Lotus Pharmaceutical sign biosimilar deal worth up to $150m

Alvotech has licensed two biosimilar candidates to Lotus Pharmaceutical across the US and eight Asian markets, with milestone payments potentially reaching $150 million.
Alvotech has licensed two biosimilar candidates to Lotus Pharmaceutical across the US and eight Asian markets, with milestone payments potentially reaching $150 million.
The Biotech Times Editorial Team  · 
Biologics

Biomea Fusion completes enrolment in COVALENT-211 icovamenib trial

Biomea Fusion has fully enrolled its Phase II trial of oral menin inhibitor icovamenib in insulin-deficient type 2 diabetes, with topline data expected in
Biomea Fusion has fully enrolled its Phase II trial of oral menin inhibitor icovamenib in insulin-deficient type 2 diabetes, with topline data expected in
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Humacyte to file supplemental BLA for ATEV in dialysis access

Humacyte plans a November 2026 supplemental BLA filing to add haemodialysis access as a second approved indication for its bioengineered vessel.
Humacyte plans a November 2026 supplemental BLA filing to add haemodialysis access as a second approved indication for its bioengineered vessel.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Capricor's DMD cell therapy BLA gets three-month FDA extension

The FDA has pushed Deramiocel's PDUFA date to 22 November 2026 after Capricor submitted 24-month HOPE-3 open-label extension data.
The FDA has pushed Deramiocel's PDUFA date to 22 November 2026 after Capricor submitted 24-month HOPE-3 open-label extension data.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

FDA awards Orphan Drug status to Lakefront's gamgertamig in pemphigus

Lakefront Biotherapeutics gains a third FDA designation for gamgertamig, its BCMAxCD3 bispecific T cell engager, as pemphigus joins its autoimmune pipeline.
Lakefront Biotherapeutics gains a third FDA designation for gamgertamig, its BCMAxCD3 bispecific T cell engager, as pemphigus joins its autoimmune pipeline.
The Biotech Times Editorial Team  · 
Biologics

ACTG launches alendronate trial to test HIV reservoir clearance

The global HIV trials network is testing a common osteoporosis drug as a latency-reversing agent in a 30-person randomised, placebo-controlled study.
The global HIV trials network is testing a common osteoporosis drug as a latency-reversing agent in a 30-person randomised, placebo-controlled study.
The Biotech Times Editorial Team  · 
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