Regulatory Science

Tenax Therapeutics awaits Phase 3 LEVEL readout as R&D spend doubles

Topline data from Tenax's pivotal PH-HFpEF trial is due in August 2026, with results set for presentation at ESC Congress in Munich.
Topline data from Tenax's pivotal PH-HFpEF trial is due in August 2026, with results set for presentation at ESC Congress in Munich.
Biologics

Tiziana sees neuroinflammation fall in third MSA patient on foralumab

PET imaging showed up to 34% reduction in brain inflammatory activity in a third MSA patient treated with intranasal foralumab, consistent with earlier results.
PET imaging showed up to 34% reduction in brain inflammatory activity in a third MSA patient treated with intranasal foralumab, consistent with earlier results.
Digital Health
Biotech

MBRIF welcomes 17 companies into Cohort 12 accelerator programme

The UAE Ministry of Finance-backed fund has admitted 17 startups spanning healthtech, AI and sustainability to its twelfth Innovation Accelerator cohort.
The UAE Ministry of Finance-backed fund has admitted 17 startups spanning healthtech, AI and sustainability to its twelfth Innovation Accelerator cohort.
Regulatory Science

Abivax clears FDA pre-NDA meeting for obefazimod in ulcerative colitis

The Paris-listed biotech said the FDA endorsed its NDA submission strategy for obefazimod, keeping a year-end 2026 filing on track.
The Paris-listed biotech said the FDA endorsed its NDA submission strategy for obefazimod, keeping a year-end 2026 filing on track.
Biologics

Annexon secures $200m credit facility from Oxford Finance

The Brisbane-based neuroinflammation biotech drew $50m at closing, with up to $150m more tied to milestones for vonaprument and tanruprubart.
The Brisbane-based neuroinflammation biotech drew $50m at closing, with up to $150m more tied to milestones for vonaprument and tanruprubart.
Biologics
Regulatory Science

Capricor adcom setback leaves deramiocel fate with FDA

An FDA advisory panel voted 9-3 against effectiveness of deramiocel for DMD cardiomyopathy, but the PDUFA date of 22 August 2026 remains in place.
An FDA advisory panel voted 9-3 against effectiveness of deramiocel for DMD cardiomyopathy, but the PDUFA date of 22 August 2026 remains in place.

Cingulate publishes Phase 3 data for CTx-1301 ADHD candidate

All three dose levels of Cingulate's once-daily dexmethylphenidate tablet beat placebo on the ADHD-RS-5 scale, with the highest dose yielding an
All three dose levels of Cingulate's once-daily dexmethylphenidate tablet beat placebo on the ADHD-RS-5 scale, with the highest dose yielding an
Biologics

Diakonos Oncology doses first patients in DOC1021 melanoma trial

The Houston biotech has initiated its Phase 1/2 DOC-RM study in refractory melanoma, with early safety results expected by end of 2026.
The Houston biotech has initiated its Phase 1/2 DOC-RM study in refractory melanoma, with early safety results expected by end of 2026.
Biologics

Disc Medicine eyes two pivotal programmes by 2027 after busy Q2

The Watertown biotech reported $718m in cash runway to 2029 and flagged a Q4 Phase 3 readout for bitopertin in EPP as its nearest catalysts.
The Watertown biotech reported $718m in cash runway to 2029 and flagged a Q4 Phase 3 readout for bitopertin in EPP as its nearest catalysts.
Regulatory Science

Eton Pharmaceuticals files PAS to extend KHINDIVI to under-fives

Eton has submitted a Prior Approval Supplement to the FDA seeking to expand KHINDIVI's hydrocortisone label to children under five with adrenal insufficiency.
Eton has submitted a Prior Approval Supplement to the FDA seeking to expand KHINDIVI's hydrocortisone label to children under five with adrenal insufficiency.
Biologics

Keros Therapeutics earns $20m milestone as elritercept Phase 3 enrols

Keros will receive a $20m payment from Takeda after the ELRiSE MDS Phase 3 trial dosed its first patient, with 25% to be distributed to
Keros will receive a $20m payment from Takeda after the ELRiSE MDS Phase 3 trial dosed its first patient, with 25% to be distributed to
Biologics

Madrigal Pharmaceuticals posts $364m Q2 Rezdiffra sales, up 71%

Madrigal's MASH therapy Rezdiffra surpassed 50,000 active patients and nearly $1.3bn in trailing annual sales as the company advanced an oral GLP
Madrigal's MASH therapy Rezdiffra surpassed 50,000 active patients and nearly $1.3bn in trailing annual sales as the company advanced an oral GLP
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