Disease

Biologics

Spero Therapeutics licenses anti-CD40L antibody SP001 from Innovent

Spero gains ex-China rights to a Phase 2-ready monoclonal antibody targeting autoimmune diseases, in a deal worth up to $1.1 billion.
Spero gains ex-China rights to a Phase 2-ready monoclonal antibody targeting autoimmune diseases, in a deal worth up to $1.1 billion.
The Biotech Times Editorial Team  · 
Biologics

Spero Therapeutics raises $105m royalty financing to fund SP001 Phase 2

The Cambridge biotech is monetising Utebzi royalties via a KKR-backed deal to fund its anti-CD40L immunology candidate SP001.
The Cambridge biotech is monetising Utebzi royalties via a KKR-backed deal to fund its anti-CD40L immunology candidate SP001.
The Biotech Times Editorial Team  · 
Diagnostics

Aligos Therapeutics completes enrolment in Phase 2 HBV study

Aligos has fully enrolled 245 participants in B-SUPREME, its Phase 2 trial of pevifoscorvir sodium in chronic hepatitis B, with topline data expected in
Aligos has fully enrolled 245 participants in B-SUPREME, its Phase 2 trial of pevifoscorvir sodium in chronic hepatitis B, with topline data expected in
The Biotech Times Editorial Team  · 
Biologics

Aligos receives $25m upfront as China HBV licence deal activates

Aligos Therapeutics has received the first cash payment from its Greater China licence of HBV candidate pevifoscorvir sodium, which also secured China's Breakthrough
Aligos Therapeutics has received the first cash payment from its Greater China licence of HBV candidate pevifoscorvir sodium, which also secured China's Breakthrough
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Bavarian Nordic files chikungunya vaccine for approval in Brazil

Partner Eurofarma has submitted CHIKV VLP to Anvisa, targeting a country that reported more than half of global chikungunya cases in 2025.
Partner Eurofarma has submitted CHIKV VLP to Anvisa, targeting a country that reported more than half of global chikungunya cases in 2025.
The Biotech Times Editorial Team  · 
Biologics

Cadrenal Phase 2 data show 25% thrombotic event cut in HIT

CAD-1005 cut new thrombotic events by more than 25% versus placebo in the first randomised, blinded trial in heparin-induced thrombocytopenia.
CAD-1005 cut new thrombotic events by more than 25% versus placebo in the first randomised, blinded trial in heparin-induced thrombocytopenia.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Elevar Therapeutics receives FDA CRL for rivoceranib-camrelizumab in HCC

The FDA cited manufacturing deficiencies at a listed site, not clinical data concerns, in declining to approve the first-line hepatocellular carcinoma combination.
The FDA cited manufacturing deficiencies at a listed site, not clinical data concerns, in declining to approve the first-line hepatocellular carcinoma combination.
The Biotech Times Editorial Team  · 
Biologics

FDA clears lecanemab subcutaneous autoinjector for Alzheimer's

Eisai and Biogen's LEQEMBI IQLIK autoinjector gains FDA approval as an initiation dose, offering patients a home-use alternative to intravenous infusion.
Eisai and Biogen's LEQEMBI IQLIK autoinjector gains FDA approval as an initiation dose, offering patients a home-use alternative to intravenous infusion.
The Biotech Times Editorial Team  · 
Biologics

Mesoblast hits 300-patient target in Phase 3 back pain trial

Mesoblast said its pivotal rexlemestrocel-L trial is now fully enrolled, with top-line results expected in mid-2027 and a BLA filing to follow.
Mesoblast said its pivotal rexlemestrocel-L trial is now fully enrolled, with top-line results expected in mid-2027 and a BLA filing to follow.
The Biotech Times Editorial Team  · 
Biologics

Sana Biotech's HIP-modified islets show durable function at 14 months

NEJM follow-up data show HIP-modified islet cells surviving and producing insulin at 14 months in a type 1 diabetes patient without immunosuppression.
NEJM follow-up data show HIP-modified islet cells surviving and producing insulin at 14 months in a type 1 diabetes patient without immunosuppression.
The Biotech Times Editorial Team  · 
Biologics

Ipsen Dysport hits Phase III endpoints in episodic and chronic migraine

Ipsen's abobotulinumtoxinA met primary endpoints in both BEOND trials, becoming the first botulinum toxin with Phase III efficacy across episodic and chronic migraine.
Ipsen's abobotulinumtoxinA met primary endpoints in both BEOND trials, becoming the first botulinum toxin with Phase III efficacy across episodic and chronic migraine.
The Biotech Times Editorial Team  · 
Diagnostics
Biologics

Roche wins CE Mark for automated blood test for latent TB

The Elecsys IGRA TB test processes samples in 19 minutes, cutting standard IGRA turnaround in half and integrating with Roche's existing cobas immunoassay platforms.
The Elecsys IGRA TB test processes samples in 19 minutes, cutting standard IGRA turnaround in half and integrating with Roche's existing cobas immunoassay platforms.
The Biotech Times Editorial Team  · 
Diagnostics

Tarsus Pharmaceuticals acquires iRenix Medical for up to $565m

Tarsus is acquiring iRenix and its IRX-101 ocular antiseptic, backed by Phase 2b/3 data showing significant pain and corneal toxicity reductions.
Tarsus is acquiring iRenix and its IRX-101 ocular antiseptic, backed by Phase 2b/3 data showing significant pain and corneal toxicity reductions.
The Biotech Times Editorial Team  · 
Diagnostics

Endogenex completes 350-patient enrolment in ReCET diabetes device trial

Endogenex has fully enrolled its sham-controlled ReCET study of a duodenal pulsed electric field device for type 2 diabetes across 40 sites.
Endogenex has fully enrolled its sham-controlled ReCET study of a duodenal pulsed electric field device for type 2 diabetes across 40 sites.
The Biotech Times Editorial Team  · 
Biologics

Anaveon promotes Laetitia Pouzol to Chief Scientific Officer

The Basel biotech has elevated its Head of Immunology to CSO, as ANV200 advances through IND-enabling studies toward clinical testing.
The Basel biotech has elevated its Head of Immunology to CSO, as ANV200 advances through IND-enabling studies toward clinical testing.
The Biotech Times Editorial Team  · 
Diagnostics
Genomics

DiamiR and AlzLabs join forces on Alzheimer's biomarker study

DiamiR Biosciences and AlzLabs will combine protein and microRNA blood biomarkers to improve early detection of Alzheimer's disease.
DiamiR Biosciences and AlzLabs will combine protein and microRNA blood biomarkers to improve early detection of Alzheimer's disease.
The Biotech Times Editorial Team  · 
Biologics

FibroBiologics wins patent allowance for 3D spheroid wound therapy

The Houston biotech secured USPTO allowance for fibroblast spheroid wound healing claims that directly cover its Phase 1/2 CYWC628 diabetic foot ulcer programme.
The Houston biotech secured USPTO allowance for fibroblast spheroid wound healing claims that directly cover its Phase 1/2 CYWC628 diabetic foot ulcer programme.
The Biotech Times Editorial Team  · 
Regulatory Science

Incannex secures US patent for IHL-42X sleep apnoea therapy to 2040

Incannex Healthcare has won a USPTO patent covering its oral OSA combination therapy IHL-42X, with baseline protection running to July 2040.
Incannex Healthcare has won a USPTO patent covering its oral OSA combination therapy IHL-42X, with baseline protection running to July 2040.
The Biotech Times Editorial Team  · 
Biologics

NewAmsterdam Pharma to present obicetrapib Alzheimer's data at AAIC 2026

NewAmsterdam Pharma will share four BROADWAY-derived analyses at AAIC 2026, including biomarker data suggesting obicetrapib may slow Alzheimer's pathology.
NewAmsterdam Pharma will share four BROADWAY-derived analyses at AAIC 2026, including biomarker data suggesting obicetrapib may slow Alzheimer's pathology.
The Biotech Times Editorial Team  · 
Bioinformatics

NorthStrive and Yuva Biosciences validate four ANT1-inducing compounds

Four AI-selected small molecules increased ANT1 expression in human skeletal muscle cells, advancing NorthStrive's muscle-preservation programme toward confirmatory
Four AI-selected small molecules increased ANT1 expression in human skeletal muscle cells, advancing NorthStrive's muscle-preservation programme toward confirmatory
The Biotech Times Editorial Team  · 
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