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BioWorld - Monday, June 16, 2025
Breaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sector
  • Art concept for bladder

    Zusduri flurry ends; ‘set up’ at ODAC, Urogen prevails with FDA

    During a conference call after the U.S. FDA approval of Zusduri (mitomycin), Urogen Pharma Ltd. CEO Liz Barrett offered candid observations about a “roller-coaster ride” sparked by a mixed-outcome advisory panel meeting held May 21. Zusduri is designed to treat recurrent low-grade, intermediate-risk, non-muscle invasive bladder cancer.
  • Celldex’s urticaria candidate impresses in post-treatment findings

  • Safety scares and trial misses drag down neuro biotechs into Q2

  • At EHA 2025, ways to bring immune therapy to AML

  • Today's news in brief

  • Zusduri flurry ends; ‘set up’ at ODAC, Urogen prevails with FDA

    During a conference call after the U.S. FDA approval of Zusduri (mitomycin), Urogen Pharma Ltd. CEO Liz Barrett offered candid observations about a “roller-coaster ride” sparked by a mixed-outcome advisory panel meeting held May 21. Zusduri is designed to treat recurrent low-grade, intermediate-risk, non-muscle invasive bladder cancer.
  • Celldex’s urticaria candidate impresses in post-treatment findings

    Celldex Inc.’s KIT inhibitor, barzolvolimab, which hit its phase II endpoints in late 2023, kicking off phase III development in chronic spontaneous urticaria, offered up some impressive long-term findings at the EAACI Congress 2025, including complete responses in patients for as long as seven months after the cessation of therapy, which analysts said could position the drug as a potentially best-in-class option.
  • Safety scares and trial misses drag down neuro biotechs into Q2

    The BioWorld Neurological Diseases Index continued its downward slide into 2025, with 15 of the 20 component stocks posting losses. After dipping into negative territory in late February, the index dropped 15.99% by the end of March and closed May down 22.34%.
  • At EHA 2025, ways to bring immune therapy to AML

    “The lack of therapeutic precision in treatment of myeloid malignancies is in sharp contrast with the fact that myeloid cancers represent the perhaps best characterized cancers of all at the cellular, molecular, and genetic levels,” Johanna Olweus told her audience at the Friday plenary session of the European Hematology Association 2025 Annual Congress.
  • Today's news in brief

    BioWorld briefs for June 13, 2025.
  • Korea biotech roundup: four financings, six R&D deals mid-June

    Four biotech companies from South Korea announced new or planned financings mid-June, including GC Genome Corp. Rznomics Inc., G2Gbio Inc. and Mezzion Pharma Co. Ltd. Six major mid-June deals included R&D pacts between Y-Biologics Inc. and Crosspoint Therapeutics, Daewoong Pharmaceutical Co. Ltd. and Salipro Biotech AB, Next & Bio Inc. and GC Cell Corp., Galux Inc. and Hanall Biopharma Co. Ltd., Celltrion Inc. and Onconic Therapeutics Inc., and SK Plasma Co. Ltd. and Aimedbio Inc.
  • Pfizer’s $6.15B 3Sbio deal tops May’s biopharma activity

    Biopharma deal activity continued its record-breaking pace in 2025, reaching $103.76 billion in total value through the first five months, the highest year-to-date total in BioWorld’s records. That figure marks a nearly 20% increase over the $86.68 billion recorded during the same period in 2024.
  • Enterome raises $19M to advance non-Hodgkin lymphoma therapy

    As it prepares to present the latest data from the phase I/II clinical trial of EO-2463, Enterome SA has secured $19 million to expand and complete the study, and to scope phase III development of the microbiome-derived off-the-shelf immunotherapy in the treatment of non-Hodgkin lymphoma.

BioWorld Insider Podcast

Play buttonRobert Williamson, CEO of Triumvira Immunologics, and Hernan Bazan, CEO of South Rampart Pharma, discuss bracing for tariffs, NIH grant cuts and gifting China a biopharma leadership position.
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Analysis and data insight

  • Multiple myeloma illustration

    Another BiTE in autoimmune: Cullinan deals $712M for Genrix asset

    Deals and M&A
    Cullinan Therapeutics Inc. swept up ex-China rights to a multiple myeloma-targeting BCMAxCD3 bispecific T-cell engager (BiTE) velinotamig from Chongqing Genrix Biopharmaceutical Co. Ltd. via a potential $712 million deal June 4. The plan is to repurpose the cancer drug to autoimmune disease.
  • Red and blue bispecific antibodies

    3Sbio revs on with phase II data in tight PD-1/VEGF bispecific race

    Clinical
    3Sbio Inc. reported interim phase II study results of its PD-1/VEGF bispecific antibody, SSGJ-707 – a “fabulous” asset, according to Pfizer Inc. CEO Albert Bourla, that landed in Pfizer’s cancer arsenal via a potential $6 billion deal in May, of which $1.2 billion was paid up front.
  • Handshake with cityscape

    Ligachem inks two mystery ADC deals with CSPC subsidiary Novarock

    Deals and M&A
    Ligachem Biosciences Inc. signed two license agreements with Novarock Biotherapeutics Inc., a subsidiary of CSPC Pharmaceutical Group Ltd., to bring in two of Novarock’s antibodies and create antibody-drug conjugate (ADC) candidates with novel cancer targets.
  • Coin stacks, dollar signs and up arrow

    Biopharma financings rise to $5.55B in May, with VC deals at $1.83B

    Financings
    Biopharma financings totaled $21.38 billion through May 2025, down sharply from $62.57 billion during the same period in 2024, but roughly in line with levels seen in 2023 and 2022. Biopharma companies raised $5.55 billion in May, more than doubling the $2.4 billion raised in April.
More in Analysis and data insight

Today's news in brief

  • Appointments and advancements for June 13, 2025

  • Financings for June 13, 2025

  • In the clinic for June 13, 2025

  • Other news to note for June 13, 2025

  • Regulatory actions for June 13, 2025

Deals and M&A

  • Biontech’s $1.25B Curevac buyout removes mRNA lawsuit uncertainty

  • Philochem, BMS ink $1.35B deal for prostate cancer candidate OncoACp3

  • Deep Apple signs big Novo deal for cardiometabolic small molecules

  • Aribio fortifies Arcera alliance with $600M AR-1001 supply deal

  • Ligachem inks two mystery ADC deals with CSPC subsidiary Novarock

  • Regeneron boosts obesity pipeline with Hansoh’s GLP-1/GIP for $2B

  • Atai in $370M merger deal with psychedelic drug specialist Beckley

  • Sanofi buying Blueprint and its TKI BLU-808 for $9.5B

  • Biontech trades half of bispecific BNT-327 to BMS for potential $11B+

  • Astellas nabs Evopoint’s CLDN18.2-targeting ADC for $1.34B

Financings

  • Two silhouettes with tangle, gear, spiral

    Startup Elkedonia raises €11M to advance neuroplastogen in depression

    Newco news
    Newco Elkedonia SAS has raised €11 million (US$12.7 million) in a seed round, which will fund it to take a potentially first-in-class ELK-1 inhibitor into the clinic in the treatment of refractory depression. ELK-1 plays a pivotal role in neuroplasticity and in reward circuits in the brain, which...
  • Mosanna launches with $80M to develop its sleep apnea drug

    Newco news
  • Series B brings Splicebio $135M for Stargardt disease asset

    Ocular
  • Allay’s $57.5M extends postsurgical pain relief with ATX-101

    Neurology/psychiatric
  • Aimedbio’s ₩51B pre-IPO round to fuel new cancer ADCs

    Aging
More in Financings

Science

  • Model of fecal microbiota transplantation with glowing microbiota flowing between a donor and recipient

    Gut microbiome leads to metabolic and immune changes after transplant

    Gastrointestinal
    Is fecal microbiota transplant effective? Is it really safe? And is it really all the same? Scientists at the University of Chicago have investigated the regional differences in gut environments to question these interventions to analyze the microbiome differences and their effects after...
  • Open-source AI model can predict small-molecule binding affinity

    Artificial intelligence
    Researchers at the Massachusetts Institute of Technology and Recursion Pharmaceuticals Inc. have released an open-source AI model that can predict the binding strength of small molecules as well as structures of proteins and biomolecular complexes. The model, which is called Boltz-2 and was...
  • Loss of Y chromosome in cancer, immune cells: a new clue to cancer outcomes

    Cancer
    Researchers from the University of Arizona have unveiled that coordinated Y chromosome loss in both cancer cells and immune cells may explain the worse prognosis in people with this alteration. The loss of the Y chromosome (LOY) is one of the most frequent somatic mutations in men, particularly...
  • Taurine aging biomarker story gets more complicated

    Biomarkers
  • More mutations than previously thought in childhood cancers

    Cancer
  • Precision medicine approach identifies culprit in alcohol-associated hepatitis

    Gastrointestinal
  • Juvenescence's $76M+ to advance CD38, ketone drugs to clinic

    Clinical
More in Science

Newco news

  • Neuronata-R

    Corestemchemon preps US BLA filing for stem cell ALS therapy

    Clinical
    Corestemchemon Inc. is planning to file a BLA for Neuronata-R (lenzumestrocel) by the end of 2025 to gain accelerated approval from the U.S. FDA, company officials confirmed to BioWorld during a June 2 interview. Neuronata-R is an autologous bone marrow-derived mesenchymal stem cell therapy that...
  • Signify Daniel-Siegwart and RA Session II

    Signify Bio’s $15M round advances in situ protein therapeutics

    Protein
    Turning the human body into a biofactory of precision protein therapeutics is the focus of newly launched Signify Bio, which emerged with an oversubscribed $15 million initial financing to advance three platforms with broad potential across therapeutic areas.
  • Nibec stock soars 30% on $435M peptide deal with US biotech

    Deals and M&A
    Nibec Co. Ltd. announced May 28 the signing of a potential $435 million license deal for NP-201, its phase II-ready peptide-based pulmonary fibrosis therapy candidate, with an undisclosed U.S.-based biotech company.
  • Handshake with globe background and digital overlay

    Epimab sells bispecific T-cell engager to Juri in $210M deal

    Analysis and data insight
    Epimab Biotherapeutics Inc. licensed out a development-ready KLK2/CD3 bispecific T-cell engager (TCE) for advanced prostate cancer to Juri Biosciences Inc. through a potential $210 million deal.
  • Alteogen headquarters in Daejeon, South Korea

    Alteogen merges two subsidiaries, forming Alteogen Biologics

    Analysis and data insight
    Alteogen Inc. completed a merger between two subsidiaries – Altos Biologics Inc. and Alteogen Healthcare Inc. – branding the new entity as Alteogen Biologics Inc.
More in Newco news

Regulatory

  • New ACIP members to review data for current vaccine schedules

  • Win for ROS1 as Nuvation’s Ibtrozi cleared for NSCLC

  • ABPI: UK’s rebate rates ‘send a terrible message’ to global investors

  • US drug security will come at a price

  • Vaccines meeting to go on in wake of ACIP demolition

  • Merck wins FDA approval in pediatric RSV and steps into CDC uncertainty

  • Canceling claims not an appropriate sanction, USPTO says

  • MHRA offers clarity for bacteriophage development, licensing

  • EMA warns Ozempic linked to ‘very rare’ side effect

  • Regulatory, financial hurdles the gap between science and access

U.S.

  • DNA double helix under a magnifying glass

    23andme genetic privacy concerns garner Congressional scrutiny

    Policy
    The bankruptcy of genetic testing service 23andme Holding Corp. prompted a reaction from many quarters, but a June 11 Senate hearing highlighted an interest in federal privacy legislation that would be directed toward genetic privacy as well as comprehensive and preemptive federal privacy legislation.
  • Ascletis’ denifanstat meets phase III endpoints in acne

    Clinical
  • Phase II home run: Insmed’s TPIP hits hypertension endpoints

    Clinical
  • Metsera’s long-acting amylin analogue delivers in phase I

    Clinical
  • Ascletis’ denifanstat meets phase III endpoints in acne

    Clinical
More in U.S.

Europe

  • Pregnant woman

    EMA: New clinical guideline includes pregnant, breastfeeding patients

    Clinical
    The EMA has issued a new guideline on how to include and/or retain pregnant and breastfeeding women in clinical trials, in a move that it says “marks a change in the paradigm.” The aim is to ensure that trial sponsors generate robust clinical data in these populations.
  • Korea pharma exports rise to quarterly high of $2.5B in Q1

    Analysis and data insight
    South Korea’s pharmaceutical exports rose nearly 18% year-on-year to reach $2.56 billion in the first quarter (Q1) this year, according to the Korea Health Industry Development Institute. Medical device exports, however, dropped about 5% in Q1 2025 to $1.39 billion, attributed to a drop in trade of...
  • Pharma execs speak out: UK pricing rebates scare investors

    Regulatory
    The row between pharma companies and the U.K. government over rebates has intensified, with the Association of the British Pharmaceutical Industry calling up its members to speak on the record, as it ramps up the campaign against paying back over 23% on sales of branded drugs.
  • EU launches new strategy supporting growth of innovative startups

    Analysis and data insight
  • Glycoera raises a $130M series B to advance GE-8820

    Clinical
  • Prothena sinks on phase III miss in amyloidosis

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

    Clinical
More in Europe

Clinical

  • In two phase IIIs, Merck’s PCSK9 inhibitor cuts cholesterol

    Cardiovascular
    In two phase III studies, Merck & Co. Inc.’s oral, once monthly proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor produced statistically significant and clinically meaningful cuts in low-density lipoprotein cholesterol levels. The...
  • Regenxbio’s Duchenne gene therapy data positive as shares falter

    Musculoskeletal
    Regenxbio Inc.’s gene therapy in treating Duchenne muscular dystrophy (DMD) produced positive initial phase I/II results from its first five patients. However, the company’s stock (NASDAQ:RGNX) shuddered on June 5 as shares closed at $8.36 each, a...
  • ASCO 2025: Dizal's new chemical entities for lung, blood cancers

    Conferences
    Dizal (Jiangsu) Pharmaceutical Co. Ltd.’s LYN/BTK dual inhibitor, DZD-8586, saw tumor shrinkage in 94.1% of patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma following Bruton's tyrosine kinase inhibitors,...
  • Kymera’s phase I data lead big week for STAT6 space

    Gastrointestinal
    It’s a good week to be working on drugs targeting STAT6. Kymera Therapeutics Inc.’s, KT-621, the first oral STAT6 degrader candidate to enter the clinic, surpassed expectations with impressive safety, pharmacokinetic and biomarker data from a...
  • Next IgAN contenders line up; Vera preps a BLA for atacicept

    Immune
    With a 42% placebo-adjusted reduction in proteinuria at week 36, Vera Therapeutics Inc. met its primary endpoint in the Origin phase III trial with BAFF and APRIL dual inhibitor atacicept in treating immunoglobulin A nephropathy (IgAN) in adults.
  • ASCO 2025: Verastem has positive cancer data but stock sags

    Conferences
    New dose-escalation data from Verastem Oncology’s phase I/II cancer study in China prompted the company to say it was encouraged by the efficacy results. However, investors felt otherwise, as the stock lost about 20% of its value the day the...
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:

  • The importance of balancing AI and people in drug development
  • 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

View all

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