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BioWorld - Thursday, May 7, 2026
Breaking News: Read BioWorld's AACR 2026 coverageBreaking News: Best of BioWorld: Q1
  • Hand held near armpit

    Abdakibart phase II graded, puts Avalo in HS upper class

    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 Response 75 endpoint, just what the doctor – and Wall Street – ordered.
  • Bayer buying Perfuse for $300M up front in potential $2.45B deal

  • Resmed boosts sleep health portfolio with Noctrix buy

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

  • Eyes are first prize for newco Link Biologics

  • Today's news in brief

  • Abdakibart phase II graded, puts Avalo in HS upper class

    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 Response 75 endpoint, just what the doctor – and Wall Street – ordered.
  • Bayer buying Perfuse for $300M up front in potential $2.45B deal

    In its first substantial M&A transaction since 2021, Bayer AG is buying Perfuse Therapeutics Inc., a firm that has operated quietly, though it reported positive midstage data last year for PER-001, an endothelin antagonist, in glaucoma and diabetic retinopathy.
  • Resmed boosts sleep health portfolio with Noctrix buy

    Resmed Corp. has agreed to acquire Noctrix Health Inc. for $340 million, boosting its sleep health portfolio. Noctrix has developed Nidra, a wearable neuromodulation device which treats restless legs syndrome (RLS) without disrupting sleep. With RLS impacting approximately 7% of adults globally, including about 17 million people in the U.S., the technology offers a non-drug option that could potentially treat a significant proportion of this patient population.
  • GSK licenses siRNA asset in $1B deal for Siranbio

    In a deal that could be worth up to $1 billion for Suzhou Siran Biotechnology Co. Ltd. (Siranbio), GSK plc licensed exclusive worldwide rights to the siRNA oligonucleotide SA-030, which has recently entered phase I trials for cardiometabolic disease.
  • Eyes are first prize for newco Link Biologics

    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 scientists Tony Day and Caroline Milner while he was on the lookout for “great science that needs help to make it to patients.” The three are now co-founders of Link, which spun out of the University of Manchester in 2021 and has four programs in three indications, all based on TSG-6 biology.
  • Today's news in brief

    BioWorld briefs for May 6, 2026.
  • Swiss Biotech reports record private investment, employment in 2025

    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 investment.
  • Kailera's record IPO headlines strong April for biopharma 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 years of 2021 and 2024, when financings topped $50 billion in the period, the 2026 total shows a strong recovery.
  • Multiple appearances on Priority Watch List leading to action?

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

    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.

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Analysis and data insight

  • Strategy compass

    Bio Korea 2026: US policy risks shift to execution framework

    Conferences
    Regulatory uncertainty that dominated the life science sector in 2025 is transitioning into an execution framework for biotechnology companies, provided companies can tailor regulatory strategies early, and across the entire development cycle.
  • Financial graph

    Day One buyout headlines active Q1 for cancer stocks

    Cancer
    After a standout 2025, the BioWorld Cancer Index (BCI) started 2026 on more measured footing. Early volatility this year saw the BCI drop 11.51% by the end of January before recovering to post a modest 1.39% gain for the first quarter (Q1).
  • AI generated image for researcher developing antisense oligonucleotides

    Bio Korea 2026 kicks off with spotlight on oligonucleotides

    Clinical
    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 Korea 2026 said April 28.
  • U.S. Capitol building

    US legislative reforms needed to make biosimilars competitive

    Regulatory
    Now that the FDA is on board with doing away with the U.S.’ unique two-tier biosimilar pathway, the biosimilar industry is urging Congress to pass the bipartisan Biosimilar Red Tape Elimination Act, which would recognize that biosimilars and interchangeables are one and the same.
More in Analysis and data insight

Today's news in brief

  • Appointments and advancements for May 6, 2026

  • Financings for May 6, 2026

  • In the clinic for May 6, 2026

  • Other news to note for May 6, 2026

  • Regulatory actions for May 6, 2026

Deals and M&A

  • 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

  • Chiesi snags on-demand HAE drug in $1.9B Kalvista buy

  • Takeda takes rusfertide’s US rights; Protagonist opts out for cash

  • Thermo Fisher sells microbiology business for $1B

  • Chinese biotechs gain leverage as partners in dealmaking

  • Lilly buying Ajax for up to $2.3B for next-gen JAK assets

Financings

  • The epidermal growth factor receptor in the inactive (left) and active (right) form.

    Cytospire raises £61M series A to target EGFR in solid tumors

    Science
    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...
  • 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
  • Mists of Avalyn thicken with $300M IPO for inhaled drugs

    Respiratory
More in Financings

Medical technology

  • Symani system

    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
    Sonire Therapeutics Inc. initiated a U.S.-based Sunrise II study of Suizenji, its novel ultrasound-guided high-intensity focused ultrasound (HIFU) system designed to ablate pancreatic tumors, after closing an $18 million series A financing round April 15.
  • EMA launches pilot for breakthrough medical devices in the EU

    Regulatory
    The European Medicines Agency (EMA) has launched a pilot program to fast track breakthrough medical devices in the EU and get lifesaving technologies to patients sooner. The program will allow for companies to obtain scientific advice from the expert panels intended to support evidence generation...
  • Nervonik raises $52.5M to advance PNS system

    Financings
  • Sun Pharma to acquire Merck spinoff Organon for $11.75B

    Deals and M&A
  • Med-tech companies highlight PFA data as competition intensifies

    Clinical
  • Ribo, Diagens tally 2 Hong Kong biotech, medtech IPOs in Q1 2026

    Financings
More in Medical technology

Newco news

  • 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...
  • Cell therapy illustration

    ‘Immune reset’ is ambition of Tr1x’s allogenic Tr1 cell therapy

    Clinical
    Tr1x Inc. was founded with a simple but ambitious goal: to change how autoimmune and inflammatory diseases are treated, moving away from chronic treatment and toward durable cures. “We are trying to flip the script on regulatory T cells (Tregs),” Tr1x CEO David de Vries told BioWorld. “The goal is...
More in Newco news

Regulatory

  • 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

  • FDA looks toward a future of continuous real-time trials

  • Supremes weigh in on skinny labels in long-awaited argument

U.S.

  • Heart illustration

    Cytokinetics metrics satisfy in nHCM phase III

    Clinical
    Thanks to a trial design that, according to Evercore ISI analyst Cory Kasimov, “played out exactly as drawn up,” Cytokinetics Inc. hit both of the phase III co-primary endpoints with aficamten in symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).
  • Viridian’s Reveal-2 beats expectations with elegrobart in TED

    Clinical
  • Celcuity rises on gedatolisib on top-line data in breast cancer

    Clinical
  • Up to BAT in PSC, Mirum base case proven with phase IIb

    Clinical
  • How to Summit up? Dis-Harmoni on ivonescimab NSCLC phase III

    Clinical
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).
  • Biggest overhaul of UK clinical trials rules in 20 years comes into force

    Clinical
    New U.K. clinical trials regulations coming into force today, April 28, aim to reduce the time taken to get approval for studies and introduce a category of lower risk trials which will be automatically assessed in 14 days. The key measure to cut timelines is the Combined Review, under which...
  • UK biotech funding in Q1 2026 hints a recovery is in the offing

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

    Analysis and data insight
  • CHMP gives nod for Sanofi’s Cenrifki for multiple sclerosis

    Regulatory
  • Dupi whoopie: Sanofi/Regeneron cheered for sales, new approval

    Regulatory
More in Europe

Clinical

  • 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...
  • Death a sticking point in Erasca molecular glue phase I

    Cancer
    A patient death marred Erasca Inc.’s phase I dose-escalation efforts with pan-RAS molecular glue ERAS-0015 in cancer, and shares (NASDAQ:ERAS) ended April 28 at $9.90, down $9.25. ERAS-0015 is being tested in RAS-mutant solid tumors, specifically...
  • Soligenix plummets on trial halt for Hybryte in lymphoma

    Cancer
    Soligenix Inc. intends to spend the next weeks further analyzing data and reviewing strategic options in the wake of a disappointing interim analysis from a pivotal phase III study testing Hybryte, its synthetic hypericin, in cutaneous T-cell...
  • S-OS? Compass phase II/III biliary data mixed; ahoy, FDA

    Cancer
    Having already hit the primary endpoint of overall response rate in the phase II/III Companion-002 study testing the bispecific antibody tovecimig in biliary tract cancer, Compass Therapeutics Inc. rolled out new data from the same experiment and...
  • MANE event: Veradermics beats expectations in pattern hair loss trial

    Dermatologic
    Shares of Veradermics Inc. spiked as the first top-line readout from its registrational program for VDPHL-01 showed the oral, extended-release version of minoxidil surpassed expectations in men with mild to moderate pattern hair loss, setting up...
  • Xenon spikes, Theravance sinks after phase III readouts in March

    Analysis and data insight
    BioWorld tracked 209 clinical trial readouts across phases I through III in March 2026, up from 152 in February and 144 in January. Among late-stage programs, 26 phase III trials reported positive results, two produced mixed results, and three...
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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