Clinical Trials

Diagnostics

Autonomix Medical secures US patent on feedback-guided neuromodulation

Autonomix Medical has been granted a US patent covering real-time feedback-guided precision neuromodulation systems, including neural ablation for cancer pain relief.
Autonomix Medical has been granted a US patent covering real-time feedback-guided precision neuromodulation systems, including neural ablation for cancer pain relief.
Biologics

HUTCHMED SANOVO trial shows PFS gain for savolitinib plus osimertinib

HUTCHMED's Phase III SANOVO trial met its primary endpoint in treatment-naïve MET-overexpressing EGFR-mutated NSCLC, with an encouraging early overall survival signal.
HUTCHMED's Phase III SANOVO trial met its primary endpoint in treatment-naïve MET-overexpressing EGFR-mutated NSCLC, with an encouraging early overall survival signal.
Biologics

Immuron posts record A$7.7m FY26 sales as CDI asset heads to partner

The Melbourne-based polyclonal antibody company reported 6% revenue growth and a A$1.4m profit improvement while advancing IMM-529 towards a Phase 2
The Melbourne-based polyclonal antibody company reported 6% revenue growth and a A$1.4m profit improvement while advancing IMM-529 towards a Phase 2
Biologics

Leios Therapeutics licenses 10XB-101 to CMS for China market

Leios Therapeutics has signed an exclusive licensing deal with CMS subsidiaries covering mainland China, its second major regional deal this year.
Leios Therapeutics has signed an exclusive licensing deal with CMS subsidiaries covering mainland China, its second major regional deal this year.
Biologics

CLINUVEL posts tenth consecutive profit as cash hits A$252m

The Melbourne biopharmaceutical company reported FY2026 net profit of A$33.9m and plans to use its balance sheet strength to accelerate US expansion.
The Melbourne biopharmaceutical company reported FY2026 net profit of A$33.9m and plans to use its balance sheet strength to accelerate US expansion.
Biologics

AskBio presents GenePHIT Phase 2 baseline data at ESC 2026

AskBio's umiposgene parvec heart failure gene therapy trial enrolled over 170 patients across 64 sites; efficacy data are expected in H1 2027.
AskBio's umiposgene parvec heart failure gene therapy trial enrolled over 170 patients across 64 sites; efficacy data are expected in H1 2027.
Biologics

Insulinova partners San Raffaele to test encapsulated beta cells

Insulinova will fund OSR-led research combining stem cell-derived beta cells with Austrianova's Cell-in-a-Box encapsulation platform to pursue immunosuppression-free
Insulinova will fund OSR-led research combining stem cell-derived beta cells with Austrianova's Cell-in-a-Box encapsulation platform to pursue immunosuppression-free
Biologics

Cytokinetics aficamten data show structural heart benefits in HCM

New analyses from ACACIA-HCM and MAPLE-HCM presented at ESC 2026 strengthen aficamten's case across both obstructive and non-obstructive HCM subtypes.
New analyses from ACACIA-HCM and MAPLE-HCM presented at ESC 2026 strengthen aficamten's case across both obstructive and non-obstructive HCM subtypes.
Biologics

Tenax Therapeutics presents Phase 3 LEVEL data at ESC 2026

TNX-103 showed a 26.3-metre walk improvement and 47% NT-proBNP reduction in lower-function PH-HFpEF patients, shaping the LEVEL-2 trial
TNX-103 showed a 26.3-metre walk improvement and 47% NT-proBNP reduction in lower-function PH-HFpEF patients, shaping the LEVEL-2 trial
Biologics

CRISPR Therapeutics' CTX310 shows durable lipid cuts at one year

Phase 1a data published in NEJM show a single CTX310 infusion sustained 79% mean ANGPTL3 reduction and 53% LDL reduction at one year.
Phase 1a data published in NEJM show a single CTX310 infusion sustained 79% mean ANGPTL3 reduction and 53% LDL reduction at one year.
Diagnostics
Regulatory Science
Biologics

hVIVO acquires CRS Berlin to enter dermatology and women's health

hVIVO has bought the Berlin-based Phase I/II unit for a nominal upfront fee plus a revenue-linked earnout capped at roughly €6 million.
hVIVO has bought the Berlin-based Phase I/II unit for a nominal upfront fee plus a revenue-linked earnout capped at roughly €6 million.
Diagnostics
Digital Health

Heartflow FFRCT cuts unnecessary heart catheterisations by 44%

Independent Dutch government-funded FUSION trial found adding Heartflow's AI analysis to standard CT scans halved avoidable invasive coronary procedures at one year.
Independent Dutch government-funded FUSION trial found adding Heartflow's AI analysis to standard CT scans halved avoidable invasive coronary procedures at one year.
Biologics

Amarin REDUCE-IT legacy analysis suggests durable CV benefit after IPE

A post hoc analysis of REDUCE-IT, presented at ESC 2026, suggests icosapent ethyl's cardiovascular benefit may persist years after treatment stops in adherent
A post hoc analysis of REDUCE-IT, presented at ESC 2026, suggests icosapent ethyl's cardiovascular benefit may persist years after treatment stops in adherent
Diagnostics

Quoin Pharmaceuticals raises up to $50m in private placement

The rare-disease specialist said upfront proceeds of $30.8m, plus warrants, will fund its Netherton Syndrome programme into the second half of 2029.
The rare-disease specialist said upfront proceeds of $30.8m, plus warrants, will fund its Netherton Syndrome programme into the second half of 2029.
Regulatory Science

Quoin Pharmaceuticals hits interim Phase 2/3 endpoints for QRX003

Quoin's topical serine protease inhibitor met both primary and key secondary endpoints in six Netherton Syndrome patients after 12 weeks of treatment.
Quoin's topical serine protease inhibitor met both primary and key secondary endpoints in six Netherton Syndrome patients after 12 weeks of treatment.
Biologics

Roche Vabysmo shows sustained two-year data in PCV subtype of nAMD

Two-year SALWEEN results show faricimab cleared polypoidal lesions in most patients and extended dosing intervals to 20 weeks in 61% by year two.
Two-year SALWEEN results show faricimab cleared polypoidal lesions in most patients and extended dosing intervals to 20 weeks in 61% by year two.
Biologics

argenx acquires Forte Biosciences, adding anti-CD122 antibody

argenx has completed its takeover of Forte Biosciences, gaining FB102, an anti-CD122 antibody with clinical data in vitiligo and coeliac disease.
argenx has completed its takeover of Forte Biosciences, gaining FB102, an anti-CD122 antibody with clinical data in vitiligo and coeliac disease.
Digital Health

BrainsWay Deep TMS data show 70% cut in suicidal ideation in MDD

A peer-reviewed secondary analysis found suicidal ideation fell from 22.5% to 6.7% of patients after six weeks of Deep TMS treatment for
A peer-reviewed secondary analysis found suicidal ideation fell from 22.5% to 6.7% of patients after six weeks of Deep TMS treatment for
Diagnostics

Conavi Medical wins FDA 510(k) for hybrid IVUS-OCT imaging system

The Toronto-based medical device firm secured FDA clearance for its Novasight Hybrid platform and targets first U.S. hospital placements in H2 2026.
The Toronto-based medical device firm secured FDA clearance for its Novasight Hybrid platform and targets first U.S. hospital placements in H2 2026.
Biologics

Corvus Pharmaceuticals publishes Phase 1 soquelitinib data in Blood

Final Phase 1/1b data for the ITK inhibitor in T cell lymphoma show durable responses and support an ongoing Phase 3 trial in relapsed
Final Phase 1/1b data for the ITK inhibitor in T cell lymphoma show durable responses and support an ongoing Phase 3 trial in relapsed
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