Weekly roundup: FDA filings, funding rounds and key appointments

Hansa Biopharma’s Biologics License Application (BLA) for imlifidase accepted by the FDA

Hansa Biopharma announced that its Biologics License Application (BLA) for imlifidase has been accepted by the U.S. Food and Drug Administration (FDA). The BLA submission for imlifidase is supported by the previously communicated highly statistically significant outcome of the pivotal U.S. Phase 3 ConfIdeS trial, which successfully met its primary endpoint.

Lario Therapeutics awarded $2.4m by The Michael J. Fox Foundation and Wellcome to expand neuronal calcium channel platform across CNS disorders

Lario Therapeutics, a biopharmaceutical company developing first-in-class precision medicines for epileptic and neurological disorders, announced it has received a total of $2.4 million in non-dilutive grant funding from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and Wellcome to support the continued expansion of its neuronal calcium channel drug discovery platform.

Biocomposites to launch SYNICEM^TM bone cement in UK to ease supply crisis

Biocomposites, an international medical devices company that engineers, manufactures and markets world leading products for use in infection management in bone and soft tissue, announced it is making its SYNICEM^TM bone cement products available in the UK with immediate effect. This UK launch has been brought forward to help ease the supply crisis that is currently unfolding.

Nucleome Therapeutics appoints experienced biotech executive Dr. Michelle Morrow as Chief Scientific Officer

Nucleome Therapeutics, a company tackling the molecular causes of inflammatory diseases through a breakthrough approach to 3D human genetics, announced the appointment of Dr. Michelle Morrow as Chief Scientific Officer (CSO), effective as of 23 February 2026.

Pharmacelera raises €6M to expand in U.S. and build out its high speed, high accuracy, deep tech drug discovery platform

Pharmacelera, a deep tech company applying Quantum Mechanics and Artificial Intelligence to revolutionise drug discovery, has closed a €6 million investment round to accelerate its expansion in the United States and grow the capabilities of its proprietary platform.

Oncoinvent to present positive 24-month follow-up data from Phase 1 ovarian cancer study of Radspherin® at ESGO 2026

Oncoinvent announced that it will present final 24‑month results from its Phase 1 study of Radspherin® after cytoreductive surgery in patients with platinum‑sensitive epithelial ovarian cancer and peritoneal recurrence at the European Society of Gynaecological Oncology (ESGO) 2026 Congress. Oncoinvent’s poster presentation will take place in Copenhagen, Denmark, on 27 February 2026 from 17:20-18:20 CET.

Oncoinvent announces webcast presentation of second half 2025 results on Thursday 26 February 2026

Oncoinvent, a biotech company developing a receptor-independent alpha radiopharmaceutical to eradicate cancer cells in the abdominal cavity after surgery with a single, targeted dose, is holding a live webcast for investors, analysts, and stakeholders at 9:30 AM CET on Thursday, 26 February 2026.

Webcast link: https://qcnl.tv/p/l-V8RQZomSSettvFIGnxjg

FundaMental Pharma to showcase groundbreaking approach to treatment-resistant depression at Bio-Neuroscience Conference

FundaMental Pharma, a preclinical-stage biopharmaceutical company focused on developing innovative, dual-acting N-methyl-D-aspartate receptor (NMDAR) modulators aimed at delivering rapid and sustained relief for patients with treatment-resistant depression (TRD), announced its recognition as one of twelve leading companies selected to present at the prestigious Bio-Neuroscience Conference. The presentation by Dr. Dirk Beher, Chief Executive Officer of FundaMental Pharma, will take place on 25 February 2026 at 16:45 CET in Amsterdam, The Netherlands.

Philanthropic partnership including the Novo Nordisk Foundation backs country-led research to guide the use of AI in health

The Novo Nordisk Foundation, the Gates Foundation and Wellcome announced a joint investment of US$60 million to support locally led evaluations of AI health tools in low- and middle-income countries. The Evidence for AI in Health initiative will help governments and health systems determine which tools work, where they add value, and how they can be used responsibly.

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