Regulatory Science

Aclaris Therapeutics wins Fast Track tag for modzatinib in lichen planus

The FDA granted Fast Track Designation to modzatinib for moderate to severe lichen planus, a condition with no currently approved therapies.
The FDA granted Fast Track Designation to modzatinib for moderate to severe lichen planus, a condition with no currently approved therapies.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Artiva Biotherapeutics initiates Phase 3 RA trial after RMAT designation

Artiva's AlloNK NK cell therapy secured FDA RMAT designation for refractory RA as it launches a 150-patient Phase 3 trial backed by $349m
Artiva's AlloNK NK cell therapy secured FDA RMAT designation for refractory RA as it launches a 150-patient Phase 3 trial backed by $349m
The Biotech Times Editorial Team  · 
Biologics

IN8bio GBM data shows mOS above 19.5 months in repeat-dose patients

IN8bio reported updated Phase 1 glioblastoma data and advanced its CD19-targeting gamma-delta T cell engager toward IND-enabling studies.
IN8bio reported updated Phase 1 glioblastoma data and advanced its CD19-targeting gamma-delta T cell engager toward IND-enabling studies.
The Biotech Times Editorial Team  · 
Biologics

Ascendis reports durable growth data from COACH and ApproaCH trials

Ascendis Pharma's combination therapy hit the 97th percentile for growth velocity at Week 78, while YUVIWEL surpassed 170 patient enrolments in the U.S.
Ascendis Pharma's combination therapy hit the 97th percentile for growth velocity at Week 78, while YUVIWEL surpassed 170 patient enrolments in the U.S.
The Biotech Times Editorial Team  · 
Biologics

Cellectis lasme-cel wins FDA RMAT tag ahead of Phase 2 interim read

Cellectis secured RMAT designation for its allogeneic CAR-T candidate lasme-cel and holds $169m in cash into Q4 2027.
Cellectis secured RMAT designation for its allogeneic CAR-T candidate lasme-cel and holds $169m in cash into Q4 2027.
The Biotech Times Editorial Team  · 
Regulatory Science

Priovant enrolls first patients in Phase 3 brepocitinib CS trial

Priovant's BEACON+ study targets a rare inflammatory skin disease with no approved therapies, with topline data expected in 2028.
Priovant's BEACON+ study targets a rare inflammatory skin disease with no approved therapies, with topline data expected in 2028.
The Biotech Times Editorial Team  · 
Digital Health

iRhythm to acquire VitalConnect for $287.5m in cash and stock

The Nasdaq-listed cardiac monitoring company will pay $237.5m in cash and $50m in stock for the wearable biosensor firm.
The Nasdaq-listed cardiac monitoring company will pay $237.5m in cash and $50m in stock for the wearable biosensor firm.
The Biotech Times Editorial Team  · 
Diagnostics

Tarsus Pharmaceuticals raises XDEMVY guidance after 69% sales surge

The Irvine-based eye care company reported record Q2 sales of $173.9m for XDEMVY and announced a deal to acquire Alkeus Pharmaceuticals for its
The Irvine-based eye care company reported record Q2 sales of $173.9m for XDEMVY and announced a deal to acquire Alkeus Pharmaceuticals for its
The Biotech Times Editorial Team  · 

AlFaris International Appoints Nicholas Bingham as Strategic Advisor

AlFaris International Group has appointed Taranis Capital Founder and CEO Nicholas S. Bingham as Strategic Advisor to support its growth strategy.

AlFaris International Group has announced the appointment of Nicholas S. Bingham, Founder and Chief Executive Officer of Taranis Capital, as a Strategic Advisor to the Group. 

AlFaris International Appoints Nicholas Bingham as Strategic Advisor  · 
Diagnostics
Digital Health

Sigrid Therapeutics lists SiPore® portfolio on Fullscript platform

Stockholm-based Sigrid Therapeutics has made its gut-local metabolic health products available to over 125,000 US practitioners via Fullscript.
Stockholm-based Sigrid Therapeutics has made its gut-local metabolic health products available to over 125,000 US practitioners via Fullscript.
The Biotech Times Editorial Team  · 
Diagnostics
Digital Health
Biotech

Sigrid Therapeutics lists SiPore® range on Fullscript platform

The Stockholm-based company's gut-local metabolic health products are now accessible to more than 125,000 US practitioners via Fullscript.
The Stockholm-based company's gut-local metabolic health products are now accessible to more than 125,000 US practitioners via Fullscript.
The Biotech Times Editorial Team  · 
Diagnostics

Biodesix posts 34% revenue growth in Q2 2026 on lung test volumes

The Colorado-based lung diagnostics company reported $26.9m in Q2 revenue and maintained full-year guidance of $108–114m.
The Colorado-based lung diagnostics company reported $26.9m in Q2 revenue and maintained full-year guidance of $108–114m.
The Biotech Times Editorial Team  · 
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