Disease

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
Diagnostics
Biologics

Trinity Biotech faces Nasdaq delisting risk amid diagnostics overhaul

Dublin-based Trinity Biotech has requested a Nasdaq hearing after failing to meet the exchange's minimum market value threshold by its August deadline.
Dublin-based Trinity Biotech has requested a Nasdaq hearing after failing to meet the exchange's minimum market value threshold by its August deadline.
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
Regulatory Science

Teva bids $57.5m for BioXcel dexmedetomidine film in bankruptcy sale

Teva has entered a stalking-horse bid for BXCL501, a sublingual agitation treatment under FDA review with a PDUFA date of 14 November 2026.
Teva has entered a stalking-horse bid for BXCL501, a sublingual agitation treatment under FDA review with a PDUFA date of 14 November 2026.
Biologics

BioXcel Therapeutics files Chapter 11, eyes Teva asset sale

BioXcel Therapeutics has entered Chapter 11 bankruptcy, naming Teva as stalking-horse bidder for IGALMI and a pending agitation sNDA.
BioXcel Therapeutics has entered Chapter 11 bankruptcy, naming Teva as stalking-horse bidder for IGALMI and a pending agitation sNDA.
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.
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

Philips and Imricor launch combined cardiac iMR lab solution

The partners have commercialised a 1.5T MRI-based interventional lab for cardiac ablation, removing reliance on X-ray fluoroscopy in CE-marked markets.
The partners have commercialised a 1.5T MRI-based interventional lab for cardiac ablation, removing reliance on X-ray fluoroscopy in CE-marked markets.
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
Biologics

MBX Biosciences doses first patient in Phase 3 canvuparatide trial

The NASDAQ-listed biotech has initiated its pivotal oPTimize study of once-weekly canvuparatide in roughly 160 adults with chronic hypoparathyroidism.
The NASDAQ-listed biotech has initiated its pivotal oPTimize study of once-weekly canvuparatide in roughly 160 adults with chronic hypoparathyroidism.
Regulatory Science

Nicox NCX 470 glaucoma NDA accepted with April 2027 PDUFA date

The FDA has set a 30 April 2027 review deadline for NCX 470, a nitric oxide-donating bimatoprost eye drop targeting open-angle glaucoma.
The FDA has set a 30 April 2027 review deadline for NCX 470, a nitric oxide-donating bimatoprost eye drop targeting open-angle glaucoma.
Biologics
Regulatory Science

Pfizer and BioNTech win FDA approval for XFG-adapted COMIRNATY

The companies' 2026-2027 mRNA COVID-19 vaccine, targeting the XFG variant, has been approved for high-risk adults and children aged five and over.
The companies' 2026-2027 mRNA COVID-19 vaccine, targeting the XFG variant, has been approved for high-risk adults and children aged five and over.
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