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
Pharmaceuticals

Egle Therapeutics: EGL-003 Phase 1 shows clean safety, Treg lift

Egle's IL-2 agonist EGL-003 was well tolerated across four dose cohorts and produced selective Treg expansion, supporting a Q4 2026 atopic dermatitis
Egle's IL-2 agonist EGL-003 was well tolerated across four dose cohorts and produced selective Treg expansion, supporting a Q4 2026 atopic dermatitis
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Highlight Therapeutics: BO-112 meets Phase 2b BCC endpoint

Highlight Therapeutics' intralesional BO-112 met its primary visual and pathological response endpoint in 61% of basal cell carcinoma patients.
Highlight Therapeutics' intralesional BO-112 met its primary visual and pathological response endpoint in 61% of basal cell carcinoma patients.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Novo Nordisk CagriSema data shows brain, organ and bone effects

New EASD 2026 data show CagriSema modifies brain food-cue responses and reduces ectopic fat, with bone health maintained during weight loss.
New EASD 2026 data show CagriSema modifies brain food-cue responses and reduces ectopic fat, with bone health maintained during weight loss.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Knight Therapeutics signs Latin America deal for Kyowa Kirin's Poteligeo

Knight Therapeutics will seek regulatory approval and commercialise mogamulizumab across Brazil, Mexico, Colombia and Argentina under an exclusive distribution pact.
Knight Therapeutics will seek regulatory approval and commercialise mogamulizumab across Brazil, Mexico, Colombia and Argentina under an exclusive distribution pact.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Novo Nordisk licenses Hengrui's oral GLP-1/GIP agonist for $2.6bn

Novo Nordisk will pay $300m upfront for global rights to HRS-1596, a once-weekly oral dual GLP-1/GIP agonist nearing Phase 1 trials.
Novo Nordisk will pay $300m upfront for global rights to HRS-1596, a once-weekly oral dual GLP-1/GIP agonist nearing Phase 1 trials.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

PolarityBio Phase 3 DFU data wins First-to-Podium slot at SAWC 2026

PolarityBio's pivotal COVER DFUS II trial results will be presented on 16 October, ahead of the FDA's March 2027 PDUFA date for SkinTE.
PolarityBio's pivotal COVER DFUS II trial results will be presented on 16 October, ahead of the FDA's March 2027 PDUFA date for SkinTE.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Roche fenebrutinib NDA accepted by FDA for RMS and PPMS

Roche's oral BTK inhibitor fenebrutinib has received priority review acceptance for both relapsing and primary progressive MS, a first for the class.
Roche's oral BTK inhibitor fenebrutinib has received priority review acceptance for both relapsing and primary progressive MS, a first for the class.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Tectonic Therapeutic reports clean Phase 1a data for HHT drug

TX2100 cleared all six dose cohorts without serious adverse events; FDA Fast Track status and a Phase 1b trial in HHT patients are set for
TX2100 cleared all six dose cohorts without serious adverse events; FDA Fast Track status and a Phase 1b trial in HHT patients are set for
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Zealand Pharma petrelintide hits 10.7% weight loss in Phase 2

ZUPREME-1 Phase 2 results, published in The Lancet, show petrelintide cut body weight by up to 10.7% with placebo-comparable GI tolerability.
ZUPREME-1 Phase 2 results, published in The Lancet, show petrelintide cut body weight by up to 10.7% with placebo-comparable GI tolerability.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics

4DMT enrols first patients in 4SIGHT Phase 3 DME gene therapy trial

4D Molecular Therapeutics has opened its 514-patient Phase 3 4SIGHT trial of 4D-150 in diabetic macular edema, backed by two-year SPECTRA data.
4D Molecular Therapeutics has opened its 514-patient Phase 3 4SIGHT trial of 4D-150 in diabetic macular edema, backed by two-year SPECTRA data.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

ALX Oncology's evorpacept hits 63.6% ORR in HER2+ gastric subgroup

Phase 2 ASPEN-06 data published in Nature Medicine show evorpacept doubling response rates in CD47-high, HER2-retained gastric cancer patients.
Phase 2 ASPEN-06 data published in Nature Medicine show evorpacept doubling response rates in CD47-high, HER2-retained gastric cancer patients.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics

Currus Biologics wins FDA IND clearance for CUR-001 CAR-T trial

The Australian biotech will begin a first-in-human Phase 1 basket study in mesothelin-positive solid tumours, with first patient dosing expected in early
The Australian biotech will begin a first-in-human Phase 1 basket study in mesothelin-positive solid tumours, with first patient dosing expected in early
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

HUTCHMED files US NDA for savolitinib plus osimertinib in NSCLC

AstraZeneca has submitted a US NDA for savolitinib plus osimertinib in MET-driven EGFR-mutated NSCLC, backed by Phase III PFS and OS data.
AstraZeneca has submitted a US NDA for savolitinib plus osimertinib in MET-driven EGFR-mutated NSCLC, backed by Phase III PFS and OS data.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

SCYNEXIS wins $214m BARDA contract to develop SCY-247 antifungal

The NASDAQ-listed biotech secured up to $214m in non-dilutive federal funding to advance its second-generation fungerp candidate through NDA submission.
The NASDAQ-listed biotech secured up to $214m in non-dilutive federal funding to advance its second-generation fungerp candidate through NDA submission.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Teva wins FDA approval for DEGEVMA denosumab biosimilar to Xgeva

Teva's DEGEVMA completes a full denosumab biosimilar portfolio covering both Xgeva and Prolia indications in the US market.
Teva's DEGEVMA completes a full denosumab biosimilar portfolio covering both Xgeva and Prolia indications in the US market.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Annexon to present ARCHER II baseline data at Retina Society meeting

Annexon will give two oral presentations on vonaprument at the Retina Society annual meeting, with Phase 3 month-15 results expected in Q4 2026.
Annexon will give two oral presentations on vonaprument at the Retina Society annual meeting, with Phase 3 month-15 results expected in Q4 2026.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Bioprocessing

Avaí Bio and Austrianova present Klothonova encapsulated-cell data

The preclinical joint venture presented its α-Klotho cell-encapsulation programme at a Miami longevity conference, outlining progress on a GMP cell bank.
The preclinical joint venture presented its α-Klotho cell-encapsulation programme at a Miami longevity conference, outlining progress on a GMP cell bank.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Boehringer Ingelheim funds WHO Foundation obesity drive with $5m

The German pharma group will contribute $5 million over three years to strengthen obesity and metabolic health systems in resource-limited settings.
The German pharma group will contribute $5 million over three years to strengthen obesity and metabolic health systems in resource-limited settings.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics
Diagnostics

ITM reports re-treatment and dosimetry data for ITM-11 at ASTRO

Real-world SwissNET registry data showed patients re-treated with 177Lu-edotreotide achieved nearly triple the median overall survival of those switched to
Real-world SwissNET registry data showed patients re-treated with 177Lu-edotreotide achieved nearly triple the median overall survival of those switched to
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Regulatory Science

Ocugen's OCU400 gains provisional approval in The Bahamas for RP

Ocugen's modifier gene therapy OCU400 has received provisional LARTA approval in The Bahamas, enabling expanded access for retinitis pigmentosa patients within 90 days.
Ocugen's modifier gene therapy OCU400 has received provisional LARTA approval in The Bahamas, enabling expanded access for retinitis pigmentosa patients within 90 days.
The Biotech Times Editorial Team  · 
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