FDA unveils a “plausible mechanism” pathway for personalized rare-disease drugs
The FDA introduced a new approval route that allows personalized treatments for rare and fatal genetic diseases to win marketing authorization after showing convincing benefit in very small numbers of patients, sometimes just a few, without traditional randomized trials. The decision, outlined by Commissioner Marty Makary and the agency’s Chief Medical and Scientific Officer in the New England Journal of Medicine, leans on a biologically plausible mechanism of action plus clear clinical improvement, with a requirement for ongoing real-world data collection. 👉 Read more

Why it matters
This pathway is aimed at ultra rare and often pediatric diseases, where large trials are impossible, and it will likely be most relevant for cell and gene therapies and N=1 style programs. Rare-disease experts have welcomed the intent but previously questioned whether a brand-new pathway is necessary, given existing accelerated tools, and some have warned that “plausible mechanism” is a very low evidentiary bar if not tightly controlled.

Metagenomi lays off 25 percent of staff and parts ways with its CEO
Gene-editing biotech Metagenomi is cutting about 25 percent of its workforce, including its CEO, and concentrating resources on its preclinical hemophilia A program MGX-001. The company expects this restructuring to extend its cash runway into the fourth quarter of 2027, targeting first-in-human data for MGX-001 that same year. 👉 Read more

Korro Bio pauses Novo Nordisk collaboration and cuts a third of remaining staff
Korro Bio told investors it will pause its research and license agreement with Novo Nordisk for one year and lay off about one third of its remaining workforce, on top of a prior 20 percent staff cut in the spring. The move is framed as a strategic restructuring that should stretch cash into the second half of 2027, but shares dropped about 80 percent after hours on the news. 👉 Read more

Ovid Therapeutics lines up new CEO and raises substantial private capital
Ovid Therapeutics announced an orderly leadership succession, with President and COO Meg Alexander becoming CEO on January 1, 2026, while long-time chief Jeremy Levin moves to Executive Chair. In parallel, Ovid detailed a multi-tranche private placement of up to about 175 million dollars, with an initial close of roughly 81 million dollars, which together with existing cash is expected to extend runway into the second half of 2028. 👉 Read more

NextCure raises 21.5 million dollars in a private placement to push ADC programs
NextCure announced a 21.5 million dollar private placement of common stock and pre-funded warrants, priced at the market under Nasdaq rules, to fund advancement of its antibody-drug conjugate programs and extend runway. The financing is expected to close around November 13, subject to customary conditions. 👉 Read more

Sanara MedTech leans harder into core surgical products after a mixed quarter
Sanara MedTech reported higher Q3 revenue and used its earnings update to emphasize a sharper focus on core surgical products, with a decision to realign around that business after evaluating non-core operations. Commentary highlighted that the tighter focus is resonating with analysts who see improved growth and margin potential in surgery. 👉 Read more

Perimeter Medical Imaging AI posts strong Q3, builds toward AI device launch
Perimeter Medical Imaging AI reported strong third quarter 2025 financial results, including triple-digit revenue growth and a significantly reduced net loss as it transitions from development to a more commercial posture. The company underscored growing adoption of its S-Series imaging platform and reminded investors that its AI-powered B-Series device remains under FDA review. 👉 Read more

KORU Medical Systems delivers 27 percent Q3 revenue growth and raises guidance
KORU Medical Systems, which focuses on large volume subcutaneous infusion systems, reported 27 percent revenue growth in Q3 2025 and raised full-year revenue guidance to 40.5 to 41 million dollars, implying 20 to 22 percent growth. Management emphasized continued demand for home- and specialty-infusion solutions and reiterated a target of sustaining more than 20 percent top-line growth. 👉 Read more

London’s life-science spin-outs prepare to showcase at London Life Sciences Week
UCL Business (UCLB) and UCL life-sciences spin-outs will be a central feature of London Life Sciences Week, with expectations of about 2.1 billion pounds of life-science venture inflows into London in 2025. The event will highlight UCL’s growing portfolio of therapeutics, medtech and diagnostics companies and underlines London’s rise as a serious competitor to US hubs for early-stage capital. 👉 Read more

EU AI Act and medtech: industry asks for clarity and relief
Regulatory and industry groups remain concerned about how the EU AI Act overlaps with the Medical Devices Regulation (MDR) and IVDR for AI-enabled devices. The Regulatory Affairs Professionals Society highlighted calls for “relief” from some obligations for medtech, while MedTech Europe has urged the European Commission to provide near-term regulatory breathing room, including postponing certain recertification deadlines to avoid new bottlenecks. 👉 Read more

AI in healthcare seen as a regulated safety component, not an add-on
Recent commentary on EU compliance notes that AI in medtech is treated as a safety-critical component over the full lifecycle, rather than an optional feature. That means companies will need robust governance, monitoring and post-market accountability, and they will have to align AI transparency and explainability work with MDR and IVDR expectations.

Regulators are opening a door for ultra rare therapies at the same time that they are raising the bar for AI-enabled devices.

Biotech platforms are under pressure to demonstrate focus and runway, which is leading to layoffs and collaboration pauses on one side and opportunistic financings on the other.

Medtech is quietly having a good quarter, with several names posting strong revenue growth and raising guidance, especially in imaging and infusion.

Capital is concentrating in proven ecosystems like London and in selective stories like ADCs and neurology, even as high-concept platforms take cuts.