A year and half from its inception, Adcytherix SAS has raised a €105 million (US$122 million) series A, enabling it to take the lead antibody-drug conjugate (ADC) program into clinical development next year.

Aicuris Anti-Infective Cures AG is preparing to file for U.S. FDA approval after reporting positive phase III results for lead antiviral pritelivir in the healing of refractory herpes simplex virus lesions in immunocompromised patients.

Antibody-drug conjugate specialist Tubulis GmbH has raised a hefty €308 million (US$356 million) series C to expand clinical development of TUB-040, positioning its lead program for use in additional indications and as an earlier line of therapy.

Paroxysmal nocturnal hemoglobinuria (PNH) – the rare blood disorder characterized by premature destruction of red blood cells – found itself in the spotlight, as did shares of Omeros Corp. (NASDAQ:OMER), which closed Oct. 15 at $10.42, up $6.32, or 154%, on word of an asset purchase and license agreement with Novo Nordisk A/S for zaltenibart (formerly OMS-906).

Private equity firm Keensight Capital acquired a majority stake in Bedfont Scientific Ltd. in a move that will allow the company to expand the use of its devices for breath analysis and monitoring worldwide. Although the value of the deal was undisclosed, Keensight typically invests in profitable companies generating revenues in the range of €10 million to €400 million.

Oura Health Oy raised more than $900 million in a series E funding round to fuel global expansion of its popular smart ring and development of new health technologies. The new infusion brings the company’s total funds raised to date to $1.5 billion and implies a corporate valuation of about $11 billion, Oura said.

Who knew? In addition to adopting a new name, Kneu Health Ltd. recently raised $5.6 million in a seed funding round for its smart-phone-based platform which helps to monitor neurological disorders to enable timely intervention. The funds secured will be used to expand commercial operations in the U.S., scale deployments for Parkinson's disease and advance the monitoring capabilities of the platform for dementia.

One in six common bacterial infections diagnosed worldwide in 2023 were resistant to treatment with antibiotics, according to the latest surveillance data gathered by the World Health Organization (WHO). Drug-resistant gram-negative bacteria that cause bloodstream infections that can lead to sepsis, organ failure and death are an increasing threat globally.

Vektor Medical Inc. recently secured CE mark for Vmap, its AI-powered electrocardiogram mapping system, marking a “major milestone” for the company, said CEO Rob Krummen. The regulatory approval from the EU authorities confirms that Vmap meets the stringent safety and performance requirements of the EU Medical Device Regulation, opening the door for clinical use in Europe, he told BioWorld.

The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) reported that it will seek to deepen its collaboration with other regulators, a list that includes but is not limited to the FDA. MHRA said that the U.K.-U.S. reliance program would apply to not only class II devices under the 510(k) and de novo programs, but to class III PMA devices as well, promising a somewhat more streamlined path to a market ripe with opportunity for the devices and diagnostics industries.