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

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

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  · 
Regulatory Science

Claria Medical wins FDA De Novo clearance for hysterectomy device

The Claria System is the first integrated tissue containment and removal device cleared by the FDA, cutting median uterine extraction time to four minutes.
The Claria System is the first integrated tissue containment and removal device cleared by the FDA, cutting median uterine extraction time to four minutes.
The Biotech Times Editorial Team  · 
Biologics

Immutep efti shows 30.9-month mOS in 1L NSCLC despite trial setback

Mature INSIGHT-003 data show efti plus pembrolizumab and chemotherapy achieved 30.9-month mOS in low PD-L1 first-line NSCLC patients.
Mature INSIGHT-003 data show efti plus pembrolizumab and chemotherapy achieved 30.9-month mOS in low PD-L1 first-line NSCLC patients.
The Biotech Times Editorial Team  · 
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