Genomics

Rhythm reports positive Phase 2 setmelanotide data in PWS

Six-month interim data from 17 patients showed BMI reductions, fat mass loss and improved hyperphagia scores, reinforcing the case for Phase 3.
Six-month interim data from 17 patients showed BMI reductions, fat mass loss and improved hyperphagia scores, reinforcing the case for Phase 3.
The Biotech Times Editorial Team  · 
Biotech

Shattuck Labs prices $75m public offering to fund DR3 programme

Shattuck Labs priced a $75 million public offering of shares and pre-funded warrants, with proceeds set to advance its DR3 antibody pipeline.
Shattuck Labs priced a $75 million public offering of shares and pre-funded warrants, with proceeds set to advance its DR3 antibody pipeline.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy

SL Bio completes SPAC merger, lists on Nasdaq as SL Science

The Taiwan-based cell therapy company closes its Horizon Space SPAC combination, debuting on Nasdaq under ticker SLBT with a $5.6bn implied valuation.
The Taiwan-based cell therapy company closes its Horizon Space SPAC combination, debuting on Nasdaq under ticker SLBT with a $5.6bn implied valuation.
The Biotech Times Editorial Team  · 

Alpha Tau cleared to complete GBM trial after 100% local disease control

FDA has authorised Alpha Tau to enrol the final seven patients in its REGAIN recurrent glioblastoma trial following encouraging interim data from the first three
FDA has authorised Alpha Tau to enrol the final seven patients in its REGAIN recurrent glioblastoma trial following encouraging interim data from the first three
The Biotech Times Editorial Team  · 
Regulatory Science

Belite Bio completes NDA submission for tinlarebant in Stargardt disease

Belite Bio has filed its full NDA for tinlarebant, a once-daily oral therapy that would be the first approved treatment for STGD1.
Belite Bio has filed its full NDA for tinlarebant, a once-daily oral therapy that would be the first approved treatment for STGD1.
The Biotech Times Editorial Team  · 
Genomics

Cogent Biosciences presents APEX pivotal data for bezuclastinib in AdvSM

Bezuclastinib hit a 65% objective response rate in advanced systemic mastocytosis; Cogent plans to file its NDA in June 2026.
Bezuclastinib hit a 65% objective response rate in advanced systemic mastocytosis; Cogent plans to file its NDA in June 2026.
The Biotech Times Editorial Team  · 
Genomics

Disc Medicine reports durable anemia responses in RALLY-MF Phase 2

DISC-0974 hit major response rates of 50–64% across transfusion subgroups in myelofibrosis, with End of Phase 2 FDA talks targeted for late 2026.
DISC-0974 hit major response rates of 50–64% across transfusion subgroups in myelofibrosis, with End of Phase 2 FDA talks targeted for late 2026.
The Biotech Times Editorial Team  · 

Imviva Biotech CTD402 shows 80–86% response in R/R T-ALL at EHA2026

Allogeneic anti-CD7 CAR-T candidate CTD402 posted strong remission rates in adult and paediatric T-cell leukaemia patients across two EHA2026 poster presentations.
Allogeneic anti-CD7 CAR-T candidate CTD402 posted strong remission rates in adult and paediatric T-cell leukaemia patients across two EHA2026 poster presentations.
The Biotech Times Editorial Team  · 
Genomics

Kyntra Bio roxadustat shows TI benefit in LR-MDS regardless of RS status

Post-hoc MATTERHORN data presented at EHA 2026 show roxadustat achieved transfusion independence in both RS-positive and RS-negative lower-risk MDS patients.
Post-hoc MATTERHORN data presented at EHA 2026 show roxadustat achieved transfusion independence in both RS-positive and RS-negative lower-risk MDS patients.
The Biotech Times Editorial Team  · 

Lyell Immunopharma reports ronde-cel safety data at EHA 2026

Updated Phase 1/2 data in 108 LBCL patients show no Grade 3+ CRS and a 97% manufacturing success rate, supporting outpatient use.
Updated Phase 1/2 data in 108 LBCL patients show no Grade 3+ CRS and a 97% manufacturing success rate, supporting outpatient use.
The Biotech Times Editorial Team  · 
Regulatory Science

Novartis Rhapsido meets Phase 3 endpoints across three CIndU subtypes

RemIND trial data presented at EAACI 2026 show remibrutinib doubled complete response rates versus placebo in symptomatic dermographism, cold urticaria and cholinergic
RemIND trial data presented at EAACI 2026 show remibrutinib doubled complete response rates versus placebo in symptomatic dermographism, cold urticaria and cholinergic
The Biotech Times Editorial Team  · 
Regulatory Science

Sanofi wins FDA approval for Tzield in stage 3 type 1 diabetes

The accelerated approval covers children aged eight to 17 recently diagnosed with stage 3 T1D, making Tzield the first disease-modifying therapy in this setting.
The accelerated approval covers children aged eight to 17 recently diagnosed with stage 3 T1D, making Tzield the first disease-modifying therapy in this setting.
The Biotech Times Editorial Team  · 
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