Disease

Pharmaceuticals
Biologics
Regulatory Science

Monte Rosa pockets $50m milestone as Novartis starts MRT-6160 Phase 2

Novartis has dosed its first Sjögren's disease patient with MRT-6160, triggering a $50m payment to Monte Rosa under the pair's $2.1bn
Novartis has dosed its first Sjögren's disease patient with MRT-6160, triggering a $50m payment to Monte Rosa under the pair's $2.1bn
Pharmaceuticals
Regulatory Science
Biologics

Pharvaris HAE prophylaxis trial hits 83% attack rate reduction

Pharvaris's CHAPTER-3 Phase 3 study of once-daily deucrictibant XR met all endpoints, with NDA submissions planned for the first half of 2027.
Pharvaris's CHAPTER-3 Phase 3 study of once-daily deucrictibant XR met all endpoints, with NDA submissions planned for the first half of 2027.
Pharmaceuticals
Biologics

Roivant's mosliciguat hits Phase 2 primary endpoint in PH-ILD

Phase 2 PHocus trial showed a 56.3% placebo-adjusted PVR reduction; Roivant has now initiated the Phase 3 PHrontier study in the same indication.
Phase 2 PHocus trial showed a 56.3% placebo-adjusted PVR reduction; Roivant has now initiated the Phase 3 PHrontier study in the same indication.
Biologics
Pharmaceuticals

Spyre Therapeutics completes IBD proof-of-concept with SPY003 data

SPY003 met its primary endpoint in ulcerative colitis, giving Spyre positive Phase 2 monotherapy readouts for all three of its IBD combination components.
SPY003 met its primary endpoint in ulcerative colitis, giving Spyre positive Phase 2 monotherapy readouts for all three of its IBD combination components.
Biologics
Pharmaceuticals

Vor Bio completes UPSTREAM MG enrolment and launches oMG trial

Vor Bio has fully enrolled its global Phase 3 gMG study and will initiate a sister trial in ocular myasthenia gravis, with topline data expected
Vor Bio has fully enrolled its global Phase 3 gMG study and will initiate a sister trial in ocular myasthenia gravis, with topline data expected
Pharmaceuticals
Biologics

Ascendis to present infant achondroplasia data at ESPE 2026

Ascendis Pharma will share sentinel cohort data from its reACHin pivotal trial of navepegritide in infants under two at ESPE 2026.
Ascendis Pharma will share sentinel cohort data from its reACHin pivotal trial of navepegritide in infants under two at ESPE 2026.
Medical Devices
Diagnostics

BTT Medical opens first-in-human trial of fever-induction device

BTT Medical Institute has launched a safety trial of its brain-guided hyperthermia system, citing a single ALS case report as the basis for development.
BTT Medical Institute has launched a safety trial of its brain-guided hyperthermia system, citing a single ALS case report as the basis for development.
Biologics
Pharmaceuticals

Novartis HARBOR Phase III trial misses primary endpoint in DM1

Del-desiran failed to improve hand myotonia in a 150-patient Phase III study, though secondary endpoints showed signs of clinical activity.
Del-desiran failed to improve hand myotonia in a 150-patient Phase III study, though secondary endpoints showed signs of clinical activity.
Pharmaceuticals
Biologics

Novo Nordisk: semaglutide clears obesity threshold in 40% of children

Phase 3 STEP Young data show 40.4% of children aged 6 to 11 treated with semaglutide dropped below the obesity BMI threshold after 68
Phase 3 STEP Young data show 40.4% of children aged 6 to 11 treated with semaglutide dropped below the obesity BMI threshold after 68
Medical Devices

Nyxoah enrols first patient in BREATHE post-approval OSA study

The Belgian medtech has begun a 229-patient, five-year US real-world study of its Genio bilateral hypoglossal nerve stimulator, approved by the FDA
The Belgian medtech has begun a 229-patient, five-year US real-world study of its Genio bilateral hypoglossal nerve stimulator, approved by the FDA
Biologics
Regulatory Science

Vaxart secures European patent for oral norovirus vaccine platform

The EPO has granted Vaxart protection for its room-temperature, needle-free norovirus pill vaccine across 13 European markets until at least 2036.
The EPO has granted Vaxart protection for its room-temperature, needle-free norovirus pill vaccine across 13 European markets until at least 2036.
Medical Devices
Diagnostics

Nexalin reports ADAS-Cog subscale gains ahead of Alzheimer's pilot

A post-hoc item-level analysis found domain-specific cognitive gains three months after treatment in half of evaluable active-arm participants.
A post-hoc item-level analysis found domain-specific cognitive gains three months after treatment in half of evaluable active-arm participants.
Pharmaceuticals
Biologics

Pulmovant to present Phase 2 PHocus topline data at ERS 2026

Pulmovant will share Phase 2 results for inhaled sGC activator mosliciguat in PH-ILD at ERS Congress on 8 September 2026.
Pulmovant will share Phase 2 results for inhaled sGC activator mosliciguat in PH-ILD at ERS Congress on 8 September 2026.
Pharmaceuticals
Biologics

Roivant to unveil mosliciguat Phase 2 PH-ILD data at ERS 2026

Topline results from the PHocus study will be presented at the European Respiratory Society Congress on 8 September, followed by an investor call.
Topline results from the PHocus study will be presented at the European Respiratory Society Congress on 8 September, followed by an investor call.
Biologics
Pharmaceuticals

HCW Biologics wins patent allowance for HCW9302 in alopecia areata

The Florida biotech has secured a USPTO notice of allowance covering HCW9302 as an alopecia areata treatment, as Phase 1 data show early signs of
The Florida biotech has secured a USPTO notice of allowance covering HCW9302 as an alopecia areata treatment, as Phase 1 data show early signs of
Pharmaceuticals
Biologics

Nxera Pharma to receive $8.6m milestone from Lilly-owned Centessa

A late-stage development advance in Centessa's OX2R agonist pipeline triggers an $8.6 million payment to Nxera, which retains future milestone and royalty
A late-stage development advance in Centessa's OX2R agonist pipeline triggers an $8.6 million payment to Nxera, which retains future milestone and royalty
Medical Devices
Diagnostics

Philips launches FDA-cleared eV14-2v single-transducer for OB/GYN

Philips has introduced a transvaginal transducer claiming a 41.7% penetration gain and 22% weight reduction over its predecessor, with dual regulatory clearance.
Philips has introduced a transvaginal transducer claiming a 41.7% penetration gain and 22% weight reduction over its predecessor, with dual regulatory clearance.
Cell & Gene Therapy
Biologics
Pharmaceuticals

Intellia Therapeutics secures $400m debt facility with OrbiMed

The CRISPR biotech drew an initial $75m at closing, with further tranches tied to milestones for its HAE gene-editing candidate lonvo-z.
The CRISPR biotech drew an initial $75m at closing, with further tranches tied to milestones for its HAE gene-editing candidate lonvo-z.
Diagnostics
Genomics

Kala Bio signs exclusive US deal for Virotek eye genetics tests

Kala Bio will be the sole US distributor of Virotek's ophthalmology genomic testing programme under a one-year deal effective 4 September 2026.
Kala Bio will be the sole US distributor of Virotek's ophthalmology genomic testing programme under a one-year deal effective 4 September 2026.
Pharmaceuticals
Biologics

Novartis pelacarsen Phase III trial fails to cut CV events

The Lp(a)HORIZON outcomes trial in 8,323 patients met its Lp(a)-lowering goal but did not reduce the composite cardiovascular endpoint versus
The Lp(a)HORIZON outcomes trial in 8,323 patients met its Lp(a)-lowering goal but did not reduce the composite cardiovascular endpoint versus
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