• Sign In
  • Sign Out
  • My Account
Subscribe
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
  • Special reports
Clarivate
  • Data Snapshots
  • BioWorld
  • BioWorld MedTech
  • Infographics: Dynamic digital data analysis
  • Special reports
  • Infographics: Dynamic digital data analysis
  • Trump administration impacts
  • Biopharma M&A scorecard
  • BioWorld 2024 review
  • BioWorld MedTech 2024 review
  • BioWorld Science 2024 review
  • Women's health
  • China's GLP-1 landscape
  • PFA re-energizes afib market
  • China CAR T
  • Alzheimer's disease
  • Israel
  • Rise of obesity
  • Radiopharmaceuticals
  • Biosimilars
  • Aging
  • IVDs on the rise
  • Coronavirus
  • Artificial intelligence

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Biopharma M&A scorecard
    • BioWorld 2024 review
    • BioWorld MedTech 2024 review
    • BioWorld Science 2024 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Israel
    • Rise of obesity
    • Radiopharmaceuticals
    • Biosimilars
    • Aging
    • IVDs on the rise
    • Coronavirus
    • Artificial intelligence

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe

BioWorld

Fri, May 23, 2025
Breaking News: 100 days of uncertaintyBreaking News: 100 days of uncertaintyBreaking News: 100 days of uncertainty
  • Woman holding neck

    Merus combo trounces Keytruda in head-and-neck phase II

    Investor hopes rose sharply for Merus NV’s phase III trials – data should roll out next year – with bispecific antibody petosemtamab after mid-stage results impressed Wall Street in head and neck squamous cell carcinoma. Shares of Utrecht, the Netherlands-based Merus (NASDAQ:MRUS) jumped, too, closing May 23 at $55.14, up $13.54, or 33%, on interim data as of the Feb. 27 cutoff date.
  • Imunon ovarian cancer prospect impresses with survival benefits

  • Yanked from the market in 2022, GSK’s Blenrep gets an EU redo

  • Adalta sees promise in new 'East to West' strategy for T-cell therapies

  • Tectonic, Tenax, others aim for shift in heart failure

  • Today's news in brief

  • Merus combo trounces Keytruda in head-and-neck phase II

    Investor hopes rose sharply for Merus NV’s phase III trials – data should roll out next year – with bispecific antibody petosemtamab after mid-stage results impressed Wall Street in head and neck squamous cell carcinoma. Shares of Utrecht, the Netherlands-based Merus (NASDAQ:MRUS) jumped, too, closing May 23 at $55.14, up $13.54, or 33%, on interim data as of the Feb. 27 cutoff date.
  • Imunon ovarian cancer prospect impresses with survival benefits

    Imunon Inc. soared by 179% on the heels of phase II Ovation 2 data showing that its IMNN-001 immunotherapy led to a 13-month increase in overall survival among women with ovarian cancer. Patients in the intent-to-treat population, receiving the drug plus standard-of-care neoadjuvant and adjuvant chemotherapy (N/ACT), achieved median overall survival (OS) at 46 months vs. 33 months with N/ACT alone. Increased activity was seen among patients treated with poly ADP-ribose polymerase inhibitors, with the median OS not yet reached after more than five years vs. 37 months in the control arm.
  • Yanked from the market in 2022, GSK’s Blenrep gets an EU redo

    GSK plc’s Blenrep (belantamab mafodotin) is heading back to the market three years after being withdrawn, with the EMA’s Committee for Medicinal Products for Human Use recommending approval of the antibody-drug conjugate in combination therapy for the treatment of adults with relapsed or refractory multiple myeloma.
  • Adalta sees promise in new 'East to West' strategy for T-cell therapies

    Adalta Ltd. is outlicensing all of its internal products and focusing instead on inlicensing early stage T-cell assets from Asia, mostly from China, Adalta CEO Tim Oldham told BioWorld. Dubbed its “East to West” strategy, Adalta is integrating Asia's prowess in T-cell therapy development with the efficiency and quality of Australia's clinical and manufacturing ecosystem to create a pathway connecting Eastern innovation in cellular immunotherapies with Western regulated markets and patients.
  • Tectonic, Tenax, others aim for shift in heart failure

    News from Tectonic Therapeutic Inc. in January took away some of Wall Street’s jitters about the relaxin pathway brought about by Eli Lilly and Co.’s recent moves, but another big pharma player – Astrazeneca plc – is still providing suspense in pulmonary hypertension in heart failure with preserved ejection fraction.
  • Today's news in brief

    BioWorld briefs for May 23, 2025.
  • Alteogen merges two subsidiaries, forming Alteogen Biologics

    Alteogen Inc. completed a merger between two subsidiaries – Altos Biologics Inc. and Alteogen Healthcare Inc. – branding the new entity as Alteogen Biologics Inc.
  • Cinclus and Zentiva have a plan for reflux in Europe

    Cinclus Pharma Holding AB has chosen Zentiva k.s. to handle manufacturing and commercialization duties in Europe for linaprazan glurate, which is being developed to treat severe erosive gastroesophageal reflux disease.
  • In search of lower prices, FDA enhances Rx import program

    It’s been nearly five years since the U.S. FDA, under the first Trump administration, issued a final rule and guidance on state importation plans (SIP) for importing less expensive prescription drugs from Canada. Yet only one state, Florida, has an approved SIP. In hopes of adding to that number, the FDA is enhancing its drug importation program to ease the way for states and tribes to bring prescription medicines in from Canada, at Canadian prices.
  • Holiday notice

    BioWorld's offices will be closed in observance of Memorial Day in the U.S. No issue will be published Monday, May 26.

Sponsored content

Analysis and data insight

  • Samsung Biologics plant

    Samsung Biologics to spin off biosimilar subsidiary Samsung Bioepis

    Newco news
    Samsung Biologics Co. Ltd. plans to establish a new holding company and to spin off its biosimilar division, Samsung Bioepis Co. Ltd., by October. The corporate restructuring will draw clear lines between Samsung Biologics’ CDMO operations and Samsung Bioepis’ biosimilar business.
  • Chikungunya-virus

    Chikungunya wins boost Valneva; overall infectious disease stocks fall

    Infection
    Infectious disease stocks stumbled in the early months of 2025, with the BioWorld Infectious Disease Index (BIDI) plunging 17.83% by the end of April, well behind the broader markets. By comparison, the Nasdaq Biotechnology Index slipped just 1.16%, and the Dow Jones Industrial Average declined...
  • Abstract molecules illustration

    Atzumi and Vanrafia among 3 NMEs approved by US FDA in April

    Regulatory
    The U.S. FDA approved 20 drugs for market in April, slightly down from 22 in March, 16 in February and 12 in January. This brings the total number of FDA approvals for the first four months of 2025 to 70, a decrease from 77 in the same period last year but higher than the 50 drugs approved during...
  • Handshake in office setting

    Female C-suite representation stalling, says BIA report

    Europe
    Even before the Trump administration’s executive order wiping out the concept of diversity, equity and inclusion, the statistics on female representation in the biotech industry painted a story of stagnating progress. But for Jane Wall, managing director of the U.K. Bioindustry Association (BIA),...
More in Analysis and data insight

Today's news in brief

  • Appointments and advancements for May 23, 2025

  • Financings for May 23, 2025

  • In the clinic for May 23, 2025

  • Other news to note for May 23, 2025

  • Regulatory actions for May 23, 2025

Deals and M&A

  • Like glue: Orionis and Genentech begin their second collaboration

  • Vigil takeover brings TREM2 Alzheimer’s prospect to Sanofi

  • Pfizer bets $6B+ on 3Sbio’s bispecific PD-1/VEGF antibody

  • Protagenic and Phytanix merger prompts a stock surge

  • Regeneron plans to buy 23andme from bankruptcy for $256M

  • Biomarin snags potential ‘first-in-disease’ ERT in $270M Inozyme buy

  • Rznomics in $1.3B Lilly pact to make hearing loss RNA editor drug

  • Yes siRNA: Adarx/Abbvie tie-up worth “several billion” dollars

  • GSK pays $1.2B up front for Boston Pharma’s efimosfermin in MASH

  • Septerna joins a $2.2B obesity deal with Novo

Financings

  • Immuneoncia Kosdaq debut

    Cancer drug specialist Immuneoncia raises $24M in Kosdaq listing

    Cancer
    Immuneoncia Therapeutics Inc. raised ₩33.9 billion (US$24 million) from its Kosdaq listing May 19. Shares closed at ₩7,500 – 108% higher than its offering price of ₩3,600 per share. Immuneoncia, a joint venture founded in 2016 between Seoul, South Korea-based Yuhan Corp. and San Diego-based...
  • Juvenescence's $76M+ to advance CD38, ketone drugs to clinic

    Science
  • Repronovo’s $65M series A gives new life to nolasiban

    Clinical
  • China’s Pegbio launches HK$300M Hong Kong IPO

    Diabetes
  • Therini Bio locks in another $39M for its fibrin-targeting immunotherapies

    Neurology/psychiatric
More in Financings

Science

  • Woman receiving radiotherapy treatments for cancer

    Amphiregulin drives metastasis through a paradoxical ‘badscopal’ effect of radiotherapy

    Cancer
    Researchers at the University of Chicago have shed light on the role of tumor-promoting factors induced by radiotherapy and their potential impact on future therapeutic strategies. The article, published in Nature on May 14, 2025, points to radiation-induced amphiregulin as a key driver of tumor...
  • ASGCT 2025: Overcoming kidney complexity in gene and cell therapy

    Conferences
    Gene and cell therapies (GCTs) can target the kidney to treat congenital, acute or chronic diseases affecting this organ. However, its complex structure poses a challenge for these technologies. To be precise and effective in the long term, new approaches should circumvent the specificities of...
  • First bespoke gene editing therapy treats rare metabolic disease

    Conferences
    Using a customized gene editing therapy, researchers at the Children’s Hospital of Philadelphia have reported success in treating an infant with a severe metabolic disorder. Kiran Musunuru, Barry J. Gertz Professor for Translational Research in the University of Pennsylvania’s Perelman School of...
  • Liver is also immune organ, influenced by microbiome

    Conferences
  • Organoids plus gene editing bring insights into pediatric metabolic disease

    Conferences
  • Nuevocor draws $45M series B for gene therapy in rare heart disease

    Clinical
  • AACR 2025: Induced proximity strategy, beyond degraders

    Conferences
More in Science

Newco news

  • Bispecific antibodies with heavy chain in green and pink, light chain in blue and yellow

    AP Bio heads to phase II with bispecific for HER2-resistant tumors

    Cancer
    Although HER2-targeted therapies have become a mainstay in cancer treatment, some tumors evade them by stripping away the portion of the HER2 receptor that most therapies are built to recognize and bind to, but Taiwan’s AP Biosciences Inc. is developing bispecific antibody AP-402 to address...
  • Cancer cells being destroyed by immunotherapy

    Avidicure boosting immune activation with $50M seed round

    Financings
    Newco Avidicure NV arrived on the scene with a hefty $50 million in seed funding to advance novel antibody formats the company says will surpass the best qualities of first-generation antibodies, checkpoint inhibitors, T-cell engagers and antibody-drug conjugates.
  • Blue dollar sign on white background

    Granite Bio emerges with $100M raised and two immunology assets

    Financings
    Named after Swiss mountains, Granite Bio AG emerged from stealth with $70 million in funds through a series B to advance two immunology treatments incubated at Versant Ventures.
  • Dan Chen, founder and CEO, Synthetic Design Lab

    Synthetic Design emerges with $20M and next-gen ADC platform

    Financings
    Synthetic Design Lab Inc., which emerged from stealth with a $20 million seed round and a platform technology aimed at advancing the antibody-drug conjugate (ADC) space, began with its founders identifying a single clear goal: how to deliver more payload to a target cancer cell.
  • Genetic editing with CRISPR

    Brink’s recombinase enzymes offer new gene editing approach

    Financings
    Newco Brink Therapeutics SAS is poised to work on the next chapter in genome editing after raising €3.5 million (US$4 million) in seed funding to discover and develop programmable recombinase enzymes.
More in Newco news

Regulatory

  • Split adcom vote not what Urogen envisioned

  • GAO sees need for FDA guidance for organ-on-a-chip

  • White House eyes 11% cut in FDA budget authority for 2026

  • ODAC Starglo vote could impact universe of trials

  • US FDA rethinks COVID-19 boosters

  • US HHS calls for MFN pricing commitments

  • Street a bit uneasy ahead of Urogen adcom

  • With FDA vaccine nod, Novavax takes ACIP of new COVID-19 rules

  • Incyte adds more FDA approvals for Zynyz in cancer

  • US threat of most-favored-nation Rx pricing intensifies

U.S.

  • Man sitting on bed holding head

    Beckley’s psychedelic reduces depression

    Clinical
    The credibility gap in psychedelic drug development continues to narrow with positive top-line data from a Beckley Psytech Ltd. phase IIa study in depression. The results keep the treatment into a tight race with GH Research plc, which also has an inhalable drug in development.
  • Semi-precious? Tourmaline stock rocked on phase II heart data

    Clinical
  • Apnimed’s oral sleep apnea candidate hits phase III endpoints

    Clinical
  • Inozyme’s INZ-701 shows promise for rare disease ENPP1 deficiency

    Clinical
  • US FDA clears Abbvie’s c-Met lung cancer ADC

    Regulatory
More in U.S.

Europe

  • Tilt’s $25.6M series B advances TILT-123 for ovarian cancer

    Clinical
    Tilt Biotherapeutics Ltd. has raised $25.6 million in a series B round that will fund phase II development of the lead oncolytic virus in the treatment of platinum-resistant ovarian cancer.
  • Azafaros raises €132M in series B for parallel phase III trials

    Clinical
    Lysosomal storage disorder specialist Azafaros NV has raised €132 million (US$146.7 million) in a series B to fund two phase III studies of its lead product, a small-molecule glycosidase inhibitor that the company says has shown disease-modifying effects.
  • Little bite from voluntary most-favored nation Rx pricing order

    Regulatory
    After a week of hype, the most-favored nation (MFN) drug pricing executive order (EO) U.S. President Donald Trump signed May 12 has a lot of bark but little bite, as one analyst put it. Brian Abrahams, head of global healthcare research at RBC Capital Markets LLC, said the EO is unlikely to rattle...
  • Sirius bags $50M series B2 for cardiovascular siRNA pipeline

    Clinical
  • With trade agreement secured, US and UK await section 232 outcome

    Regulatory
  • Swiss biotech: Private investments drive industry growth in 2024

    Analysis and data insight
  • Haya doing well with a $65M series A for precision medicine

    Financings
More in Europe

Clinical

  • Annji's phase I/II positive in spinal, bulbar muscular atrophy

    Musculoskeletal
    Annji Pharmaceutical Co. Ltd.’s rosolutamide (AJ-201, JM-17) achieved positive results in a phase I/II trial in adults with spinal and bulbar muscular atrophy, also known as Kennedy’s disease.
  • More TIGIT trouble: GSK and Iteos part ways

    Deals and M&A
    TIGITs took another tumble with GSK plc’s decision to end a development program and a collaboration with Iteos Therapeutics Inc. New top-line results from a phase II study in non-small-cell lung cancer using belrestotug, an anti-TIGIT monoclonal...
  • FOS-tering patience: Xenon moves azetukalner data to next year

    Neurology/psychiatric
    Xenon Pharmaceuticals Inc. is delaying the phase III data readout from the X-tole2 trial with azetukalner in focal onset seizures (FOS) from the second half of 2025 to early 2026 but remains busy with NDA plans.
  • Lilly pads Zepbound data set, ponding the drum in obesity

    Endocrine/metabolic
    Eli Lilly and Co. gained more oomph in its weight-loss battle with Novo Nordisk A/S, as the firm highlighted another batch of results from Surmount-5, a phase IIIb open-label trial evaluating the safety and efficacy of Zepbound (tirzepatide), a...
  • Cynata’s MSC cells show positive results across variety of delivery systems

    Inflammatory
    The promise of mesenchymal stem cells (MSCs) to heal heart disease could be around the corner thanks to a new delivery method tested by regenerative medicine company Cynata Therapeutics Ltd.
  • Gyre widening in pancreatic? Revolution offers lung data, too

    American Association for Cancer Research
    Revolution Medicines Inc. followed the results offered last month with zoldonrasib (RMC-9805), a RAS G12D (ON) inhibitor, with plenty more about pipeline progress – “an embarrassment of riches,” CEO Mark Goldsmith said – during the firm’s...
More in Clinical

BioWorld Insider Podcast

One-on-one with medical innovators

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.


Recent episodes:

  • Two CEOs discuss bracing for tariffs, NIH grant cuts and
    gifting China biopharma leadership position
  • As biopharma investments stumble, med tech surges
  • Mega money well spent? Mammoth mergers fall short of the dream
  • Healing the health divide for women
  • Modifi gets creative on the rocky road to a multibillion-dollar buyout
  • A quantum leap into the future of drug development
  • Gene and cell therapies will propel innovation, says Astellas CCO
  • Capricor’s CEO pursues a BLA and talks rare disease
  • The first half of 2024 was strong as M&As and financings dominate
  • The cost of delays in development and sales: It’s probably not what you think

View all

BioWorld

The news source of record covering the development of innovative human therapies for 25+ years
Subscribe

BioWorld MedTech

Actionable and timely intelligence on advances in medical devices and technologies for 20+ years
Subscribe

BioWorld Asia

A weekly monitor of biopharmaceutical news from the industry’s fastest-growing region
Subscribe

BioWorld Science

Essential discovery and preclinical research news to support crucial drug R&D decisions at the earliest stages
Subscribe

BioWorld Premium

Enjoy extended coverage for the most complete market view with BioWorld, BioWorld MedTech, and BioWorld Asia in a single, easy to access subscription
Subscribe
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/Metabolic
    • Immune
    • Infection
    • Neurology/Psychiatric
    • Patents
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2025. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Biopharma M&A scorecard
    • BioWorld 2024 review
    • BioWorld MedTech 2024 review
    • BioWorld Science 2024 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Israel
    • Rise of obesity
    • Radiopharmaceuticals
    • Biosimilars
    • Aging
    • IVDs on the rise
    • Coronavirus
    • Artificial intelligence

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe