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BioWorld - Sunday, May 10, 2026
Breaking News: Read BioWorld's AACR 2026 coverageBreaking News: Best of BioWorld: Q1
  • Illustration of antibodies attacking nerve cells

    Budo judo moves aplenty for Climb in autoimmune

    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 pan-B-cell depletion target across antibody-mediated autoimmune diseases – a relative white space for conventional mAbs.”
  • Odyssey’s IPO, placement brings $304M to lead drugs in IBD, lupus

  • Mobia debuts on Nasdaq to bring stroke therapy to more patients

  • Scarlet raises $4M to take manufactured red blood cells into clinic

  • Today's news in brief

  • Budo judo moves aplenty for Climb in autoimmune

    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 pan-B-cell depletion target across antibody-mediated autoimmune diseases – a relative white space for conventional mAbs.”
  • Odyssey’s IPO, placement brings $304M to lead drugs in IBD, lupus

    Raising $279 million in an IPO and another $25 million in a concurrent private placement, Odyssey Therapeutics Inc. is advancing its lead phase II asset, OD-001, in ulcerative colitis, with plans to bring its SLC15A4 program into the clinic for lupus.
  • Mobia debuts on Nasdaq to bring stroke therapy to more patients

    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%.
  • Scarlet raises $4M to take manufactured red blood cells into clinic

    Scarlet Therapeutics Ltd. has demonstrated its manufactured red blood cells (RBCs) act in the same way as their natural counterparts in vivo, opening the way for the cells to be used as drug delivery vehicles and raising the possibility they could replace conventional blood transfusions. To build on this, Scarlet has closed a $4 million seed round to work on the first clinical application, in which RBCs loaded with therapeutic proteins will be used to treat rare metabolic diseases.
  • Today's news in brief

    BioWorld briefs for May 8, 2026.
  • APAC monitors hantavirus as Singapore isolates 2 from cruise ship

    Singapore’s Communicable Diseases Agency on May 7 said that it isolated two residents for hantavirus testing after the individuals disembarked from an Atlantic cruise ship on May 2 and May 6, respectively. The measure comes in response to the cluster of cases from the cruise ship, MV Hondius, that has resulted in three deaths so far.
  • In vivo mRNA gene therapy platform reprograms cytotoxic T cells

    A new mRNA and lipid nanoparticle (mRNA-LNP) platform could selectively reprogram in vivo cytotoxic effector T cells (Teff), the cells responsible for eliminating infected or tumor cells. To achieve this, scientists at the University of Pennsylvania conjugated LNPs with fractalkine, a molecule that binds to the CX3CR1 receptor, which is a marker of Teff cells. Using this strategy, the researchers delivered an mRNA encoding new proteins such as IL‑2 or human CD62 L‑selectin, opening the door to temporarily reprogramming these cells within the body, both in the blood and in lymphoid tissue, where they reside and become activated.
  • Follow-ons hit 7-year high, lead med-tech's $10B start to 2026

    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 2023-2024. April saw $1.51 billion raised, compared to $2.44 billion in March, $4.55 billion in February and $1.52 billion in January.

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Analysis and data insight

  • Close up of bow of cruise ship

    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...
  • Viruses

    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...
  • Financial markets rebound illustration

    Kailera's record IPO headlines strong April for biopharma financings

    Financings
    Biopharma financing activity is continuing its rebound in early 2026 compared to the past several years. Total funding reached $38.66 billion in the first four months of 2026, more than doubling 2025’s $15.85 billion in the same period and also exceeding 2022 and 2023. While still below the peak...
  • Swiss currency

    Swiss Biotech reports record private investment, employment in 2025

    Financings
    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...
More in Analysis and data insight

Today's news in brief

  • Appointments and advancements for May 8, 2026

  • Financings for May 8, 2026

  • In the clinic for May 8, 2026

  • Other news to note for May 8, 2026

  • Regulatory actions for May 8, 2026

Deals and M&A

  • Roche to acquire Pathai for up to $1.05B

  • Italy’s Angelini pays $4.1B cash for rare disease specialist Catalyst

  • GSK licenses siRNA asset in $1B deal for Siranbio

  • Resmed boosts sleep health portfolio with Noctrix buy

  • Bayer buying Perfuse for $300M up front in potential $2.45B deal

  • Madrigal expands MASH pipeline in potential $1B Arrowhead deal

  • Beone eyes Huahui Health’s trispecific HH-160 with $2B option deal

  • Dermatology specialist Leo Pharma makes a $50M move into gene therapy

  • Caredx to acquire Naveris for up to $260 million

  • China’s new IIT rules could reshape early stage drug development

Financings

  • ​Star Sports Medicine HKEX IPO ceremony

    China med-tech raises: Star Sports’ $105M IPO; Cofoe nabs $133M

    Medical technology
    Star Sports Medicine Co. Ltd. debuted on the Hong Kong Stock Exchange with an HK$829.55 million (US$105.86 million) IPO May 5, with shares closing about 118% higher on the first day.
  • Cytospire raises £61M series A to target EGFR in solid tumors

    Science
  • Hypervision secures £17M for surgical hyperspectral imaging platform

    Medical technology
  • Hemab prices $301M in latest upsized biopharma IPO

    Hematologic
  • Seaport joins Nasdaq as parent Puretech delists, sticks with LSE

    IPO
More in Financings

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...
  • Sonire starts US study of cancer HIFU after $18M series A

    Clinical
  • EMA launches pilot for breakthrough medical devices in the EU

    Regulatory
  • Nervonik raises $52.5M to advance PNS system

    Financings
  • Thermo Fisher sells microbiology business for $1B

    Deals and M&A
More in Medical technology

Newco news

  • Rays of light beaming from eye

    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...
  • Illustration of monoclonal antibody treatment for cancer

    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...
  • Drug R&D concept image.

    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...
  • Jeff Jonas, CEO and Al Robichaud, president, head of R&D, Tortugas Neuroscience

    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.
  • Ayele Dilion Mashiah, CEO, Remedy

    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...
More in Newco news

Regulatory

  • Atara rises on new FDA pathway for Ebvallo resubmission

  • FDA slowdown on Tzield sBLA underlines CNPV questions

  • White House looks to expand MFN pricing for $530B-plus in savings

  • USTR calls out trade partners for Rx, med-tech pricing policies

  • First PROTAC: Arvinas’ Veppanu wins FDA nod in breast cancer

  • Axsome’s Auvelity cleared for large Alzheimer’s agitation market

  • Biopharma exec settles with SEC over misappropriation claims

  • HHS appeals federal injunction ruling on vaccine changes

  • Unique trial strategy muddies the ODAC waters for camizestrant

  • Purdue sentenced in federal court, ordered to pay $5B

U.S.

  • Bladder

    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.
  • Entrada sinks on mixed DMD data with ENTR-601-44

    Clinical
  • Cytokinetics metrics satisfy in nHCM phase III

    Clinical
  • Viridian’s Reveal-2 beats expectations with elegrobart in TED

    Clinical
  • Bio Korea 2026: US policy risks shift to execution framework

    Analysis and data insight
More in U.S.

Europe

  • T cells

    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.
  • Enterobiotix raises $25.7M for phase IIb of microbiome pill in IBS

    Clinical
    Microbiome specialist Enterobiotix Ltd. has raised £19 million (US$25.7 million) to fund phase IIb development of its lead program EBX-102-02 in the treatment of irritable bowel syndrome with constipation (IBS-C).
  • Chiesi snags on-demand HAE drug in $1.9B Kalvista buy

    Deals and M&A
    In its largest acquisition to date, Chiesi Group is buying Kalvista Pharmaceuticals Inc. for $27 per share, a roughly 40% premium to the previous day’s closing price, putting the total deal value at about $1.9 billion. In return, the Italian pharma firm adds to its rare disease franchise Kalvista’s...
  • Biggest overhaul of UK clinical trials rules in 20 years comes into force

    Clinical
  • UK biotech funding in Q1 2026 hints a recovery is in the offing

    Deals and M&A
  • Sun Pharma to acquire Merck spinoff Organon for $11.75B

    Deals and M&A
  • Neuro deals aplenty: UCB’s $1B+ takeover of Neurona the latest

    Analysis and data insight
More in Europe

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...
More in Clinical

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podcast microphone, sound waves on purple backgroundBreakthrough medicines, billion-dollar deals, spectacular clinical successes and crushing failures all play a part in biopharma’s dynamic story. Developers make scientific advancements with the potential to change everything, only to face regulatory conundrums and ever-fluctuating markets. BioWorld tracks key events in the fast-moving sector every business day. Now, the BioWorld Insider podcast lets you hear directly from the movers and shakers whose collective work is changing how we all live. Join us each week for a new conversation.


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  • Two CEOs discuss bracing for tariffs, NIH grant cuts and
    gifting China biopharma leadership position
  • As biopharma investments stumble, med tech surges
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