Shares of Sensei Biotherapeutics Inc. (NASDAQ:SNSE) were trading at $28.29, up $19.16, or almost 210%, after disclosing the buyout of Faeth Therapeutics Inc., a developer of multi-node therapies that target tumor metabolism and signaling. The acquisition brings to Boston-based Sensei the phase II-stage lead asset from Faeth, of Austin, Texas, called Piktor – an all-oral combination of serabelisib and sapanisertib that inhibits nodes of the PI3K/AKT/mTOR pathway through PI3K-alpha and dual mTORC1/2 targeting. At the same time, Sensei signed a definitive agreement for the sale of series B non-voting convertible preferred stock in a private placement, which is expected to result in proceeds of about $200 million.

Moderna’s flu vaccine back in play as FDA shifts course on review

A week after catching Moderna Inc. and its investors off guard with a refuse-to-file letter, the U.S. FDA has reversed course on the company’s BLA submission seeking approval of seasonal influenza vaccine mRNA-1010, now agreeing to review the application, with an assigned PDUFA date of Aug. 5, 2026. The update followed a type A meeting between Moderna and the agency in which the firm said it proposed a revised regulatory approach for mRNA-1010. If all goes as planned, mRNA-1010 would be available for U.S. adults 50 and older, including adults 65 and older, for the 2026-2027 flu season, Moderna said. But, while the company may have dodged a major setback with its flu vaccine, the upcoming patent infringement trial relating to its COVID-19 vaccine took a turn for the worse this week.

AI transforming med tech in 2026; clinical need drives investments

Med-tech companies with an AI component in their solutions will certainly find investors willing to back them. AI after all, is being used to develop more effective, smarter technologies. However, investors will only deploy capital into innovations that address genuine clinical needs. The aging population is driving interest in devices targeting cardiovascular and musculoskeletal disorders, and other solutions geared toward neurological conditions, women’s health and diagnostics are also attracting investor attention.

MHRA proposes path forward for CE-marked devices

With CE-marked products accounting for about 90% of medical devices currently used in Great Britain, the Medicines and Healthcare products Regulatory Agency (MHRA) is considering three proposals for a path forward that would help the U.K. achieve its goal of becoming a leading country for med-tech access by 2030. “The number one request that the med-tech industry made of us was to provide long-term certainty over CE recognition,” MHRA Chief Executive Lawrence Tallon said in announcing the opening of a consultation on the proposals. “It is in the best of interests of British patients to ensure continued access to the latest medical devices approved in Europe. It is also in the best interests of the med-tech sector to reduce friction and costs of doing business.”

First profit in six years positions Leo Pharma for long-awaited IPO

After 118 years as a private company, dermatology specialist Leo Pharma A/S is poised to complete an IPO after reporting a full-year net profit for the first time since 2018. The move from a net loss of DKK1.771 billion (US$270 million) in 2024, to a net profit of DKK2.489 billion (US$390 million) in 2025, was largely driven by an increase of 35% in revenues from North America and by a revenue increase of 48% for the company's three branded biologic products. Ballerup, Denmark-based Leo Pharma first stated its ambition of listing five years ago when the foundation that owns the company sold a 20% stake to the Swedish private equity firm Nordic capital for €450 million.

Unnatural Products signs $1.8B cardio pact with Novartis

In a deal worth up to $1.8 billion for oral macrocyclic peptide developer Unnatural Products Inc. (UNP), Novartis AG has signed a research collaboration and licensing agreement for an undisclosed program. The deal brings UNP’s AI-enhanced macrocycle platform together with Novartis’ global development and commercialization expertise to generate next-generation therapeutics targeting the cardiovascular disease space. Terms call for Novartis to take on all IND-enabling studies and further clinical development, manufacturing and global commercialization of products that emerge. UNP gains $100 million in up-front and pre-IND milestone payments, as well as up to $1.7 billion tied to development, regulatory and commercial milestones, plus net sales royalties ranging from mid-single to low-double digits.

Gilead-Genhouse's $1.5B+ deal boosts synthetic lethality push

Gilead Sciences is stepping deeper into synthetic lethality, licensing a clinic-ready MAT2A (methionine adenosyltransferase 2a) inhibitor from Suzhou, China-based Genhouse Bio Co. Ltd. in a deal worth up to $1.53 billion. Under the deal terms, Genhouse will receive an up-front payment of $80 million and is eligible to receive up to $1.45 billion for development, registration, and commercialization milestone payments, plus sales-based royalties. In exchange, Gilead gains exclusive rights to develop and commercialize GH-31 globally.

SCAN is core circuit affected in Parkinson’s disease

Parkinson’s disease (PD) is a neurodegenerative disorder that affects movement, and tremor is one of its signatures. But it is a much more wide-ranging disorder, and patients experience problems with cognitive and emotional processes as well. It is precisely the wide range of symptoms experienced by patients that has led researchers to consider a dysfunction extending beyond the motor circuit of the basal ganglia and their thalamocortical connections traditionally implicated in the disease. At the core of the process lies the progressive loss of dopaminergic neurons in the substantia nigra, along with additional changes across other neuronal populations. However, SCAN, the somato-cognitive action network identified in 2023, could reshape the definition of PD. Treating this circuit can improve outcomes. “SCAN can not only be used as the target for treatment, it may also provide a biomarker to monitor disease progression or evaluate treatment efficacy,” Hesheng Liu, co-senior author of the study and professor at Changping Laboratory, Beijing, told BioWorld.

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