Clinical Trials

Cell & Gene Therapy
Biologics

Currus Biologics wins FDA IND clearance for CUR-001 CAR-T trial

The Australian biotech will begin a first-in-human Phase 1 basket study in mesothelin-positive solid tumours, with first patient dosing expected in early
The Australian biotech will begin a first-in-human Phase 1 basket study in mesothelin-positive solid tumours, with first patient dosing expected in early
Pharmaceuticals
Biologics

HUTCHMED files US NDA for savolitinib plus osimertinib in NSCLC

AstraZeneca has submitted a US NDA for savolitinib plus osimertinib in MET-driven EGFR-mutated NSCLC, backed by Phase III PFS and OS data.
AstraZeneca has submitted a US NDA for savolitinib plus osimertinib in MET-driven EGFR-mutated NSCLC, backed by Phase III PFS and OS data.
Pharmaceuticals
Genomics
Regulatory Science

Oryzon secures EMA approval to start HOPE-2 vafidemstat trial in PMS

Oryzon Genomics has received EMA authorisation to begin a Phase IIa study of vafidemstat in Phelan-McDermid Syndrome, a rare autism-linked genetic disorder with
Oryzon Genomics has received EMA authorisation to begin a Phase IIa study of vafidemstat in Phelan-McDermid Syndrome, a rare autism-linked genetic disorder with
Pharmaceuticals
Biologics

SCYNEXIS wins $214m BARDA contract to develop SCY-247 antifungal

The NASDAQ-listed biotech secured up to $214m in non-dilutive federal funding to advance its second-generation fungerp candidate through NDA submission.
The NASDAQ-listed biotech secured up to $214m in non-dilutive federal funding to advance its second-generation fungerp candidate through NDA submission.
Pharmaceuticals
Biotech

Addex Therapeutics posts H1 2026 loss as cash falls to CHF 0.8m

Addex reported a net loss of CHF 3.5m for the first half of 2026, with cash at CHF 0.8m after an ATM raise
Addex reported a net loss of CHF 3.5m for the first half of 2026, with cash at CHF 0.8m after an ATM raise
Biologics
Pharmaceuticals

Annexon to present ARCHER II baseline data at Retina Society meeting

Annexon will give two oral presentations on vonaprument at the Retina Society annual meeting, with Phase 3 month-15 results expected in Q4 2026.
Annexon will give two oral presentations on vonaprument at the Retina Society annual meeting, with Phase 3 month-15 results expected in Q4 2026.
Cell & Gene Therapy
Biologics
Bioprocessing

Avaí Bio and Austrianova present Klothonova encapsulated-cell data

The preclinical joint venture presented its α-Klotho cell-encapsulation programme at a Miami longevity conference, outlining progress on a GMP cell bank.
The preclinical joint venture presented its α-Klotho cell-encapsulation programme at a Miami longevity conference, outlining progress on a GMP cell bank.
Pharmaceuticals
Medical Devices
Regulatory Science

Crossject strengthens balance sheet as BARDA deal extended to $48m

The Dijon-based emergency-medicine biotech returned to positive equity after a €15m capital raise, with its BARDA contract now extended through 2030.
The Dijon-based emergency-medicine biotech returned to positive equity after a €15m capital raise, with its BARDA contract now extended through 2030.
Pharmaceuticals
Biologics
Diagnostics

ITM reports re-treatment and dosimetry data for ITM-11 at ASTRO

Real-world SwissNET registry data showed patients re-treated with 177Lu-edotreotide achieved nearly triple the median overall survival of those switched to
Real-world SwissNET registry data showed patients re-treated with 177Lu-edotreotide achieved nearly triple the median overall survival of those switched to
Medical Devices

Kessler Foundation and UPnRIDE partner on upright mobility study

Kessler Foundation and UPnRIDE are studying real-world use of the FDA-cleared standing mobility platform among rehabilitation patients.
Kessler Foundation and UPnRIDE are studying real-world use of the FDA-cleared standing mobility platform among rehabilitation patients.
Cell & Gene Therapy
Biologics
Regulatory Science

Ocugen's OCU400 gains provisional approval in The Bahamas for RP

Ocugen's modifier gene therapy OCU400 has received provisional LARTA approval in The Bahamas, enabling expanded access for retinitis pigmentosa patients within 90 days.
Ocugen's modifier gene therapy OCU400 has received provisional LARTA approval in The Bahamas, enabling expanded access for retinitis pigmentosa patients within 90 days.
Biologics
Pharmaceuticals

Absci plans Phase 2 STORYLINE trial of ABS-201 for endometriosis

Absci will launch a global, placebo-controlled Phase 2 study of its AI-designed anti-PRLR antibody ABS-201 in endometriosis patients from mid-2027.
Absci will launch a global, placebo-controlled Phase 2 study of its AI-designed anti-PRLR antibody ABS-201 in endometriosis patients from mid-2027.
Pharmaceuticals
Biologics
Cell & Gene Therapy

C4 Therapeutics cemsidomide shows T-cell data at IMS 2026

Biomarker data from two trials support cemsidomide's T-cell activating mechanism, as the 75 µg dose combination with elranatamab clears safety review.
Biomarker data from two trials support cemsidomide's T-cell activating mechanism, as the 75 µg dose combination with elranatamab clears safety review.
Cell & Gene Therapy
Biologics

Celularity closes $10m first tranche of $28m recapitalisation

Celularity has completed an initial $10m raise from convertible notes, targeting positive monthly operating cash flow by end of Q1 2027.
Celularity has completed an initial $10m raise from convertible notes, targeting positive monthly operating cash flow by end of Q1 2027.
Cell & Gene Therapy
Biologics

CIRM awards $9m to Enloe Health for Northern California CGT centre

The California Institute for Regenerative Medicine is funding a new Community Care Centre of Excellence in Chico, extending CAR-T access to underserved Northern
The California Institute for Regenerative Medicine is funding a new Community Care Centre of Excellence in Chico, extending CAR-T access to underserved Northern
Biologics
Pharmaceuticals

Medicenna to present bizaxofusp rGBM survival data at SNO 2026

Medicenna's IL-4-targeted glioblastoma candidate will receive an oral slot at the Society for Neuro-Oncology meeting in November.
Medicenna's IL-4-targeted glioblastoma candidate will receive an oral slot at the Society for Neuro-Oncology meeting in November.
Pharmaceuticals
Diagnostics

Milestone Pharma enrols first Canadian patient in AFib-RVR trial

Milestone Pharmaceuticals has activated the Montreal Heart Institute as its first Canadian site for the ReVeRA-301 Phase 3 study of etripamil nasal spray in
Milestone Pharmaceuticals has activated the Montreal Heart Institute as its first Canadian site for the ReVeRA-301 Phase 3 study of etripamil nasal spray in
Pharmaceuticals
Regulatory Science

Newron's ENIGMA-TRS 2 US enrolment hold stays as ex-US sites expand

The FDA has confirmed its US clinical hold on evenamide's ENIGMA-TRS 2 trial; Newron is expanding enrolment across Europe, Asia and Latin America.
The FDA has confirmed its US clinical hold on evenamide's ENIGMA-TRS 2 trial; Newron is expanding enrolment across Europe, Asia and Latin America.
Pharmaceuticals
Biologics

PridCor Therapeutics advances Phase 2 SHIELD Long COVID study

The Alabama biotech has made its first payment to Mount Sinai under a clinical agreement, with enrollment in the 150-patient SHIELD trial expected shortly.
The Alabama biotech has made its first payment to Mount Sinai under a clinical agreement, with enrollment in the 150-patient SHIELD trial expected shortly.
Pharmaceuticals

Vistagen sees fasedienol signal in severe social anxiety

Exploratory subgroup analyses from two trials showed fasedienol reduced anxiety symptoms in participants with very severe social anxiety disorder.
Exploratory subgroup analyses from two trials showed fasedienol reduced anxiety symptoms in participants with very severe social anxiety disorder.
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