German company Tubulis GmbH – which emerged with a $12.3 million series A round and a next-generation antibody-drug conjugate (ADC) platform about six years ago – has commanded up to $5 billion in a buyout offer from Gilead Sciences Inc. To the table Tubulis brings lead asset TUB-040, a NaPi2b-directed topoisomerase-I inhibitor ADC in phase Ib/II development for platinum-resistant ovarian cancer and non-small-cell lung cancer; as well as TUB-030, a 5T4-targeted ADC with potential across various solid tumors. The acquisition agreement – under which Gilead will pay $3.15 billion in up-front cash for all of Tubulis’ equity, plus up to $1.85 billion in contingent milestone payments – evolved out of a two-year collaboration between the companies. The transaction is expected to close in the second quarter, with Tubulis’ Munich site operating as a hub for ADC innovation.
Kennedy sidestepping court order sidelining ACIP?
Don’t like a court order? Sidestep it. That seems to be the idea behind U.S. Health and Human Services Secretary Robert Kennedy’s latest changes to his renewal of the charter for the CDC’s Advisory Committee on Immunization Practices (ACIP). In granting a preliminary injunction last month that shelved all the recommendations made by the panel since June and prohibited the ACIP from meeting, U.S. District Judge Brian Murphy extensively cited the committee’s own charter, noting that most of the members Kennedy appointed don’t have the vaccine expertise required by that governing document. So in response, Kennedy changed the charter to broaden those qualifications.
Amplia halts enrollment in phase II pancreatic cancer trial
Amplia Therapeutics Ltd. has halted recruitment in its phase II Amplicity trial in advanced pancreatic cancer due to three dose-limiting toxicities related to the chemotherapy regimen, modified FOLFIRINOX, which is being administered in combination with lead compound Narmafotinib (AMP-945), a focal adhesion kinase inhibitor. No dose-limiting toxicities have been reported with narmafotinib, and the company is exploring less toxic chemotherapy regimens. Patients already on trial will remain on study and continue treatment.
South Korea streamlines biosimilar review, clinical trials
South Korea is rolling out regulatory changes to speed biosimilar development, including reforms to shorten review timelines, ease phase III trial requirements and simplify oversight of manufacturing changes. The regulatory revisions by the Ministry of Food and Drug Safety come in near lockstep with U.S. FDA to reframe biosimilars as “generic versions of biologic drugs,” forwarded since last year. In the latest update April 6, Korea’s food and drug administrator effected revisions to the country’s Regulations for Review and Approval of Biologics, laying the legal groundwork to expedite review and approval of biosimilars, including cutting timelines from 406 to 295 days.
Sononeu wins $5.2M ARPA-H grant for ultrasound-activated therapeutics
Newco Sononeu Inc. has launched to translate more than a decade of basic research in controlling cells with ultrasound into novel, non-invasive therapies for conditions including peripheral and diabetic neuropathy. The underlying technology of sonogenetics provides the ability to manipulate cellular activity via ultrasound-sensitive ion channels that respond to acoustic pressure. These channels may be endogenous, or could be delivered by targeted vectors to specific cell types. Sononeu has been formed as the commercialization arm of a $41.3 million program funded by the Advanced Research Projects Agency for Health, to coordinate translation of research by six U.S. institutions. As its share of the six-year grant, Sononeu will receive up to $5.2 million.
VC activity drives March med-tech financings to $2.4B
Total med-tech financings reached $8.54 billion in the first quarter of 2026, reflecting a modest pullback from $9.33 billion in the same period of 2025 but remaining well above previous years. In March, $2.44 billion was collected through 35 transactions, with private venture capital rounds accounting for $1.7 billion (about 70%) of the month's total.