Schweiz
Idorsia: post hoc aprocitentan data in obese and cardio-kidney-metabolic patients
Two oral presentations at the AHA Hypertension Scientific Sessions on 10 October re-analysed the Phase 3 PRECISION trial of aprocitentan (Tryvio in the US, Jeraygo in Europe) in resistant hypertension. In 506 patients with obesity, office systolic blood pressure fell by 15.4 mmHg (12.5 mg) and 16.0 mmHg (25 mg) at week 4, and the effect held to week 36. Across cardio-kidney-metabolic stages, the albumin-to-creatinine ratio in urine fell by almost 50% in patients with albuminuria, with stable kidney function. Both analyses are post hoc, and the presenters are Idorsia consultants.
Context Aprocitentan is Idorsia’s second marketed drug. Most revenue comes from the insomnia drug Quviviq: CHF 91M of CHF 110M net revenue in H1 2026. Idorsia has moved the rights to aprocitentan, cenerimod and selatogrel into a subsidiary to allow repayment of notes issued in its August 2025 repurchase offer. The release gives no new sales figures or regulatory steps.
Frankreich
Medincell: FDA approves Weltruza, its once-monthly olanzapine injection partnered with Teva
The FDA has approved Weltruza (olanzapine extended-release injectable suspension) for adults with schizophrenia. It is the first once-monthly olanzapine given under the skin. It needs no loading dose or oral top-up at the start, and no monitoring after the injection. In the SOLARIS trial, no case of post-injection delirium/sedation syndrome was seen across 3,971 injections, although the label carries a warning on the syndrome. Teva, which markets the drug, plans a US launch in the coming weeks. Medincell receives $4M on approval and is eligible for up to $105M more in sales milestones, plus mid- to high-single-digit royalties on net sales. Trading in Medincell shares was suspended on Friday morning until the announcement.
Context Weltruza is the second approved product based on Medincell’s BEPO long-acting technology, after Teva’s risperidone injection Uzedy. Uzedy’s US net sales reached $77M in Q2 2026, up 43%, and Teva expects $270–290M for 2026. Royalties on Uzedy brought Medincell €9.3M in the year to March 2026, against €45M of operating costs. Medincell held €84.8M in cash at 31 March 2026 and added €28M of bank loans in July. The EMA has been reviewing olanzapine LAI since May 2026.
Read-across Adds competition for Lundbeck (LUN) and Otsuka’s long-acting aripiprazole injections (Abilify Maintena, Abilify Asimtufii) in US schizophrenia. It is also a direct alternative to the existing intramuscular long-acting olanzapine, which requires administration in a certified facility and 3 hours of monitoring after each dose.
Source: Medincell release · Psychiatric Times on SOLARIS and monitoring · Uzedy Q2 2026 sales · Medincell FY 2025-26 results · Cash and July debt refinancing · Abilify Asimtufii
Sweden
Ascelia Pharma: FDA still wants more evidence for Orviglance, but opens a route via existing images
After the Type A meeting on 9 September, the FDA maintains that approval of Orviglance needs additional clinical evidence from a new study. It said this evidence could possibly come from a prospective analysis of images from the Phase 3 SPARKLE study, using a different primary endpoint. The agency recognised the unmet need, saw no major safety concerns and agreed a path to resolve the quality issues, which concern specifications and analytical methods rather than manufacturing. Ascelia does not plan another clinical study and will look for the most efficient US route based on SPARKLE, while advancing in Europe and continuing partnering talks.
Context Orviglance is an oral manganese-based contrast agent for liver MRI in patients with severe kidney impairment, for whom gadolinium agents carry a boxed warning. It is Ascelia’s lead product. The FDA issued a complete response letter on 3 July, saying that SPARKLE missed its co-primary endpoints and that a later re-read of the images was not adequately justified. Ascelia had SEK 38M in cash at 30 June, with runway into Q2 2027 after cost cuts, and has said that more financing may be needed depending on the FDA’s requirements. The release gives no timelines or costs.
Source: Ascelia Pharma release · July CRL · Published CRL contents · Q2 2026 report