First cruise ship hantavirus genome points to zoonotic spillover
The initial appraisal of the first complete genome sequence of a hantavirus isolated from a patient in Switzerland who was a passenger on the cruise ship MV Hondius is consistent with a spillover from its natural reservoir, rather than the emergence of a markedly altered virus.

First cruise ship hantavirus genome points to zoonotic spillover
The initial appraisal of the first complete genome sequence of a hantavirus isolated from a patient in Switzerland who was a passenger on the cruise ship MV Hondius is consistent with a spillover from its natural reservoir, rather than the emergence of a markedly altered virus.
MBX highlights early data for monthly obesity drug MBX-4291
Shares of MBX Biosciences Inc. hit a 52-week high on preliminary phase I data for its MBX-4291, a GLP-1/GIP co-agonist prodrug for obesity. Though early and still blinded, findings from the trial showed promising efficacy, along with good tolerability and the potential for once-monthly dosing, factors that will likely be critical for MBX to compete in the crowded obesity space.
Curacle, Memento ink $1B deal for ocular TIE2/VEGF bispecific
Curacle Co. Ltd. inked a potential $1.07 billion deal with U.S.-based “newco” Memento Medicines on May 10, granting the latter exclusive global rights to develop and commercialize preclinical TIE2/VEGF-directed bispecific antibody MT-103 for retinal disorders.
Today's news in brief
BioWorld briefs for May 11, 2026.
Bright Uro secures FDA approval for abdominal sensor
Bright Uro Inc. secured U.S. FDA 510(k) clearance for the Glean abdominal sensor, which expands the capabilities of its Glean urodynamics system to enable multichannel urodynamic studies. The new sensor will allow clinicians to perform multichannel urodynamics, capturing both abdominal and detrusor pressures without the need for catheters, supporting treatment decision-making for patients with lower urinary tract dysfunction and other urological conditions.
Alzheimer’s, beyond the brain
Researchers at Daping Hospital in China have reported that liver-targeted delivery of the APOE3-Christchurch (APOE3Ch) variant, a rare protective form of apolipoprotein E, can indirectly reduce brain pathology, highlighting the therapeutic potential of peripheral approaches to Alzheimer’s disease.
FDA pregnancy safety guidance evolves with the science
Seven years, almost to the day, after releasing a draft guidance on post-approval pregnancy safety studies, the U.S. FDA is now finalizing it – albeit with a few changes.

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Analysis and data insight

Follow-ons hit 7-year high, lead med-tech's $10B start to 2026
Financings
Med-tech financing activity in the first four months of 2026 reached $10.05 billion, similar to 2025’s $10.31 billion and 2022’s $10.62 billion. While below the peak years of 2019-2021, when financings were above $15 billion in the time period, total value is still above the levels seen in...
Budo judo moves aplenty for Climb in autoimmune
Clinical
Climb Bio Inc. outlined May 5 an enticing data spill ahead this year with Fc-enhanced monoclonal antibody budoprutug (budo) in autoimmune diseases. Mizuho analyst Joseph Catanzaro appreciated in his report Wellesley Hills, Mass.-based Climb’s “conviction that CD19 represents a best-in-class...
Moderna, Vir among early 2026 top infectious disease gainers
Infection
Infectious disease-focused biopharma stocks, tracked on the BioWorld Infectious Disease Index (BIDI), saw their collective shares roughly follow the path of broader markets like the Nasdaq Biotechnology Index (NBI) and the Dow Jones Industrial Average (DJIA) in early 2026. The BIDI ended April up...
Hantavirus is ‘sentinel’ more than acute pandemic threat
Science
News of eight infections and three deaths so far due to an emerging zoonotic virus has brought back unhappy memories of the early days of SARS-CoV-2. At a press conference on Thursday, officials from the WHO did their best to calm the public’s fears that the MV Hondius, the ship currently heading...

Financings

Mobia debuts on Nasdaq to bring stroke therapy to more patients
Medical technology
Mobia Medical Inc. began trading on Nasdaq under the ticker MOBI on May 8. The company priced its IPO at the midpoint of its proposed $14 to $16 range, selling 10 million shares at $15 each and raising approximately $150 million. The stock closed at $11.75 its first day of trading, down 21.7%.

Medical technology

US FDA tries out 1-day inspections
Regulatory
Even before the U.S. FDA announced its one-day inspection pilot May 6, it already had test-flown 46 of the shorter inspections across several of its centers.

Multiple appearances on Priority Watch List leading to action?
Regulatory
It’s a sure bet when the U.S. Trade Representative releases its annual Special 301 Report that Chile, China, India, Indonesia, Russia and Venezuela will be on the Priority Watch List. The 2026 report was no exception.
MMI’s Symani system treats Alzheimer’s patient in IDE study
Clinical
Medical Microinstruments Inc.’s (MMI) Symani surgical system was used to treat a patient with Alzheimer’s disease as part of a study evaluating robotic-enabled microsurgery for the condition. The procedure investigated whether restoring lymphatic drainage pathways in the deep cervical lymph nodes...

Newco news

Eyes are first prize for newco Link Biologics
Science
The classic origin story for a biotech startup is that of a scientist who nurtures his work out of a university and to commercial success. For Link Biologics Ltd. and its TSG6-based pipeline, the story is the other way around; it began with now-CEO Reuben Dawkins meeting University of Manchester...
Pilatus PLT-012 takes immunometabolic approach to reprogram TME
Cancer
Pilatus Bio Inc. is working to address a major under-addressed target of current checkpoint inhibitors: metabolic stress within solid tumors. “Traditional immunotherapies release immune ‘brakes,’ but they do not address the underlying metabolic stress in tumors,” Pilatus CEO and cofounder Raven Lin...
Anaptysbio’s spinout First Tracks hits the slopes
Immune
Anaptysbio Inc. announced in September of 2025 that it planned to separate its drug development business from the royalties it receives on Jemperli (dostarlimab) from GSK plc and imsidolimab from Vanda Pharmaceuticals Inc. Just seven months later, on April 20, 2026, well ahead of its “year-end...
Tortugas launches with $106M for neurology, neuropsychiatric drugs
Financings
Tortugas Neuroscience Inc. came out of its shell to announce the raising of $106 million between its seed and series A financing rounds. “We like the symbolism of the sea turtle – long-lived, persistent, very determined,” Tortugas CEO Jeff Jonas said of the company’s name.
Remedy pushes ‘cell-free’ secretome therapy for IPF into phase I
Clinical
“Single drugs targeting single biological pathways are insufficient for complex diseases,” Remedy Cell Ltd. CEO Ayelet Dilion Mashiah told BioWorld. Remedy is taking a secretome-based approach to treat lung disorders, having moved its lead asset, RC-0315, into a first-in-human clinical trial for...

U.S.

Phase II Engene trouble: NMIBC detalimogene data throttle stock
Clinical
Hopes piqued last November for detalimogene voraplasmid in bladder cancer took a hit from the latest word from the study, as did shares of Engene Therapeutics Inc. (NASDAQ:ENGN), which closed May 7 at $1.72, down 80.6%, or $7.13.

Europe

Swiss Biotech reports record private investment, employment in 2025
Analysis and data insight
Privately-funded biotechs in Switzerland raised a record CHF1.15 billion (US$1.47 billion) in 2025, an increase of 38% over 2024, and 45% of the total capital raised by the sector. This was a significant advance on previous years, when private companies typically attracted about 30% of overall...

Cytospire raises £61M series A to target EGFR in solid tumors
Financings
Next-generation T-cell engager (TCE) specialist Cytospire Therapeutics Ltd. has raised £61 million (US$82.7 million) in a series A round, equipping it to advance the lead program CYT-X300 to the clinic in the treatment of EGFR-positive solid tumors. The company’s pan gamma delta (γδ) TCEs are...
UCB onboards more autoimmune TCEs with $2.2B Candid buy
Cancer
UCB SA agreed to pay $2 billion up front to acquire bispecific T-cell engager (TCE)-maker Candid Therapeutics Inc. and lead BCMA/CD3 TCE asset cizutamig (CND-106), continuing big pharma’s spree for China-made autoimmune assets in 2026.

Clinical

Abdakibart phase II graded, puts Avalo in HS upper class
Dermatologic
Avalo Therapeutics Inc. may have designed in lead asset abdakibart, a drug for hidradenitis suppurativa (HS) that offers a novel mechanism of action, wide dosing interval, and more-than-satisfying outcomes on the Hidradenitis Suppurativa Clinical...
Celcuity rises on gedatolisib on top-line data in breast cancer
Cancer
As Celcuity Inc. awaits a U.S. FDA approval decision for gedatolisib in HER-positive, HER2-negative, PIK3CA wild-type advanced breast cancer, the company already is setting its sights on a supplemental NDA filing, based on a top-line readout of...
Up to BAT in PSC, Mirum base case proven with phase IIb
Endocrine/metabolic
Entering what Mirum Pharmaceuticals Inc. CEO Chris Peetz called “a new phase of growth and value creation,” the company plans to submit an NDA to the U.S. FDA in the second half of this year, based on phase IIb data from the Vistas trial with oral...
How to Summit up? Dis-Harmoni on ivonescimab NSCLC phase III
Cancer
Wall Street pundits were divided about the likely fate of ivonescimab, Summit Therapeutics Inc.’s bispecific antibody partnered with Akeso Pharmaceuticals Inc., of Hong Kong, and undergoing phase III testing in first-line squamous non-small-cell...
Bio Korea 2026 kicks off with spotlight on oligonucleotides
Analysis and data insight
Three decades of trial-and-error, and the resulting safety data, in the oligonucleotide-based therapeutic space have paved way for the present-day innovations and the promise of “programmable,” precision medicine for patients, speakers at Bio...
AA meeting of minds as PTC, Novartis push votoplam in HD
Neurology/psychiatric
What PTC Therapeutics Inc.’s latest data with votoplam might mean in the Huntington’s disease (HD) landscape became grist for Wall Street after the firm unveiled top-line results from the phase II Pivot-HD study, sharing data from the 24-month...

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