Latest European Medicines Agency News

Actinogen Medical has locked in full underwriting for nearly 127 million unlisted options, guaranteeing $4.77 million in fresh funding as it approaches pivotal Alzheimer’s trial results due in November.

Avecho has resumed enrolment for the last stage of its pivotal Phase III trial of a TPM®-enhanced CBD capsule for insomnia, following a unanimous Data Monitoring Board recommendation to continue without expanding the sample size.

Actinogen Medical reported a $15.38 million loss for FY2026 while progressing its lead Alzheimer's drug Xanamem toward pivotal trial results expected this November. The company secured regulatory alignment and strengthened its cash position to fund operations through mid-2027.

Syntara Limited’s FY2026 results show a 7.9% revenue decline and a 13.6% increase in net loss amid significant clinical progress, including FDA backing for its lead drug amsulostat and a successful $8.8 million capital raise.

Biotron Limited posted a $1.52 million net loss for FY2026, driven by integration and R&D costs following its Sedarex acquisition, while progressing regulatory and clinical development for its SedRxTM anaesthetic and antiviral pipeline.

Clinuvel Pharmaceuticals marked its tenth consecutive profit with stable revenues and rising cash reserves, while accelerating U.S. expansion including a Nasdaq uplisting and potential ASX delisting.

Neuren Pharmaceuticals reported an 8% rise in H1 2026 revenues driven by DAYBUE royalties, but profit fell 68% due to ramped-up R&D. The company declared its first ever dividend, signalling confidence amid ongoing clinical and regulatory milestones.

Prescient Therapeutics cut its net loss by 4.4% to $7 million in FY26 while expanding its PTX-100 Phase 2a trial across three continents and securing key regulatory designations in Europe and the US.

Neuren Pharmaceuticals saw a record Q2 with DAYBUE net sales hitting US$125 million, driven by strong uptake of the new STIX formulation. The company upgraded its 2026 royalty guidance following Acadia Pharmaceuticals’ sales boost and awaits key regulatory milestones in Europe and Japan.

Actinogen Medical’s pivotal XanaMIA Alzheimer’s trial stays on track for November topline results, buoyed by strong open-label extension enrolment and aligned EMA-FDA regulatory advice. A new antidepressant study publication and fresh patents add momentum, supported by a $16.7 million cash runway to mid-2027.

PYC Therapeutics has made significant progress across its four RNA therapeutic programs, including dose escalation approvals in its Polycystic Kidney Disease trial and orphan drug designation for its Retinitis Pigmentosa candidate, supported by a robust cash position of $669 million.

Clinuvel Pharmaceuticals targets year-end for topline results from its pivotal vitiligo trial of SCENESSE® combined with narrowband UVB, aiming to expand the drug's use beyond its current rare disease indication.