Pharmaceuticals

Pharmaceuticals
Diagnostics

Actinogen XanaMIA Alzheimer's trial completes visits; data due November

Actinogen Medical's phase 2b/3 XanaMIA trial has completed all 247 patient visits, with topline results for its oral cortisol inhibitor expected in November.
Actinogen Medical's phase 2b/3 XanaMIA trial has completed all 247 patient visits, with topline results for its oral cortisol inhibitor expected in November.
Pharmaceuticals
Medical Devices
Regulatory Science

Crossject and BARDA align ZEPIZURE paediatric plan with FDA

An additional $4.7m in non-dilutive BARDA funding extends Crossject's ZEPIZURE development contract through June 2030, bringing total support to $48m.
An additional $4.7m in non-dilutive BARDA funding extends Crossject's ZEPIZURE development contract through June 2030, bringing total support to $48m.
Pharmaceuticals

Elevar Therapeutics wins FDA approval for Lyrfigtu in bile duct cancer

Lirafugratinib becomes a second-line option for FGFR2-rearranged cholangiocarcinoma after posting a 46% confirmed response rate in the ReFocus trial.
Lirafugratinib becomes a second-line option for FGFR2-rearranged cholangiocarcinoma after posting a 46% confirmed response rate in the ReFocus trial.
Pharmaceuticals
Biologics

Roche sefaxersen hits Phase III primary endpoint in IgA nephropathy

Interim IMAgINATION trial data show sefaxersen significantly reduced proteinuria versus placebo at 37 weeks in 459 adults with IgAN.
Interim IMAgINATION trial data show sefaxersen significantly reduced proteinuria versus placebo at 37 weeks in 459 adults with IgAN.
Biologics
Pharmaceuticals

SOTIO wins dual FDA designations for ADC SOT106 in sarcoma

SOTIO Biotech has secured Fast Track and Orphan Drug designations from the FDA for SOT106, its LRRC15-targeting ADC, ahead of a planned first-in
SOTIO Biotech has secured Fast Track and Orphan Drug designations from the FDA for SOT106, its LRRC15-targeting ADC, ahead of a planned first-in
Pharmaceuticals
Bioprocessing

Roquette posts 9% revenue growth in H1 2026 on pharma excipient gains

The French plant-based ingredients group lifted H1 turnover to €2.6bn, with pharmaceutical excipients and its Shift & Lead transformation plan driving margin improvement.
The French plant-based ingredients group lifted H1 turnover to €2.6bn, with pharmaceutical excipients and its Shift & Lead transformation plan driving margin improvement.
Pharmaceuticals
Biologics

HUTCHMED takes savolitinib-osimertinib combo to ESMO 2026

Two positive Phase III NSCLC studies, SAFFRON and SANOVO, will feature as oral presentations at ESMO Congress 2026 in Madrid this October.
Two positive Phase III NSCLC studies, SAFFRON and SANOVO, will feature as oral presentations at ESMO Congress 2026 in Madrid this October.
Pharmaceuticals
Biologics

Zealand Pharma starts Phase 3 ZUPREME programme for petrelintide

The Copenhagen biotech and Roche partner have initiated three placebo-controlled trials enrolling around 7,000 participants across obesity sub-populations.
The Copenhagen biotech and Roche partner have initiated three placebo-controlled trials enrolling around 7,000 participants across obesity sub-populations.
Pharmaceuticals
Regulatory Science

Quoin Pharma wins FDA Fast Track for QRX003 in Peeling Skin Syndrome

Quoin Pharmaceuticals secured the first-ever Fast Track Designation for a Peeling Skin Syndrome therapy, with a Phase 2/3 trial set to start by
Quoin Pharmaceuticals secured the first-ever Fast Track Designation for a Peeling Skin Syndrome therapy, with a Phase 2/3 trial set to start by
Biologics
Pharmaceuticals

PDS Biotech's PDS0101 combo shows 39-month survival in HNSCC trial

VERSATILE-002 Phase 2 results, published in JAMA Oncology, showed 39.3 months median overall survival in HPV16-positive head and neck cancer, more than
VERSATILE-002 Phase 2 results, published in JAMA Oncology, showed 39.3 months median overall survival in HPV16-positive head and neck cancer, more than
Pharmaceuticals
Regulatory Science

Ophirex BRAVIO trial misses endpoints but signals krait benefit

Phase 2 data published in PLOS NTD show varespladib cut krait patients' ventilation time by half, despite missing both primary endpoints.
Phase 2 data published in PLOS NTD show varespladib cut krait patients' ventilation time by half, despite missing both primary endpoints.
Pharmaceuticals
Regulatory Science

Filana Therapeutics clears FDA hold on simufilam for TSC epilepsy

The NASDAQ-listed biotech can now progress its Phase 2a proof-of-concept study after the FDA lifted a clinical hold on its simufilam IND.
The NASDAQ-listed biotech can now progress its Phase 2a proof-of-concept study after the FDA lifted a clinical hold on its simufilam IND.
Biologics
Pharmaceuticals

Eledon tegoprubart shows 13 mL/min eGFR edge over tacrolimus

Eledon's Phase 2 BESTOW extension data show tegoprubart maintained significantly better kidney function than tacrolimus at 24 months, with no rejections beyond six
Eledon's Phase 2 BESTOW extension data show tegoprubart maintained significantly better kidney function than tacrolimus at 24 months, with no rejections beyond six
Biologics
Pharmaceuticals

Celldex barzolvolimab Phase 3 trials meet all endpoints in CSU

Both EMBARQ-CSU studies hit primary and key secondary endpoints, with complete response rates above 40% at 12 weeks; a BLA filing is planned for
Both EMBARQ-CSU studies hit primary and key secondary endpoints, with complete response rates above 40% at 12 weeks; a BLA filing is planned for
Cell & Gene Therapy
Biologics
Pharmaceuticals

Vironexis VNX-101 achieves MRD-negative responses in R/R ALL

All three antibody-naïve relapsed/refractory ALL patients in SENTRY-CD19 achieved durable MRD-negative complete responses after a single VNX-101 infusion.
All three antibody-naïve relapsed/refractory ALL patients in SENTRY-CD19 achieved durable MRD-negative complete responses after a single VNX-101 infusion.
Pharmaceuticals
Biologics

Roche enicepatide hits both Phase II endpoints in T2D and obesity

Roche's once-weekly dual GLP-1/GIP agonist enicepatide achieved 2.65% HbA1c reduction and 15.5% weight loss at 48 weeks, with Phase
Roche's once-weekly dual GLP-1/GIP agonist enicepatide achieved 2.65% HbA1c reduction and 15.5% weight loss at 48 weeks, with Phase
Biologics
Pharmaceuticals

AnaptysBio reports Jemperli royalties up 34% as FDA decision looms

AnaptysBio posted $644m in Jemperli global net sales for H1 2026 and expects an FDA ruling on a rectal cancer indication by February 2027.
AnaptysBio posted $644m in Jemperli global net sales for H1 2026 and expects an FDA ruling on a rectal cancer indication by February 2027.
Pharmaceuticals
Diagnostics

Avalyn publishes Phase 1 data showing AP02's lung-targeted delivery

Peer-reviewed Phase 1 results confirm nebulised nintedanib achieved 26-fold higher lung exposure than the oral dose, with no serious adverse events.
Peer-reviewed Phase 1 results confirm nebulised nintedanib achieved 26-fold higher lung exposure than the oral dose, with no serious adverse events.
Pharmaceuticals
Regulatory Science

HMNC Brain Health names Doebler CEO ahead of Phase 3 push

The Munich neuroscience company promotes its Chief Business Officer to lead Ketabon and Nelivabon into late-stage development following a $50m Series B close.
The Munich neuroscience company promotes its Chief Business Officer to lead Ketabon and Nelivabon into late-stage development following a $50m Series B close.
Pharmaceuticals
Biologics

NewAmsterdam and Menarini win EC approval for obicetrapib

The European Commission has approved obicetrapib as both a monotherapy and fixed-dose combination, marking the CETP inhibitor's first regulatory clearance worldwide.
The European Commission has approved obicetrapib as both a monotherapy and fixed-dose combination, marking the CETP inhibitor's first regulatory clearance worldwide.
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