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BioWorld - Friday, April 24, 2026
Breaking News: Best of BioWorld: Q1Breaking News: Best of BioWorld: Q1
  • Global handshake silhouette

    Biogen amasses full felzartamab rights with $850M TJ deal

    Biogen Inc. has consolidated full global rights to felzartamab through an $850 million deal with TJ Biopharma Co. Ltd. April 20, closing the chapter on a complex 10-year license saga.
  • Early data position Junshi in next-gen immuno-oncology race

  • Delta-Fly eyes NDA path despite AML phase III miss

  • FDA grants priority review to Merck-Daiichi’s B7-H3 cancer ADC

  • Xuanzhu shares dip despite phase III ALK inhibitor data

  • Mabwell turns to Hong Kong to fund ADC ambitions

  • Pricing standoff leaves Australian patients in limbo

  • News in brief

  • Biogen amasses full felzartamab rights with $850M TJ deal

    Biogen Inc. has consolidated full global rights to felzartamab through an $850 million deal with TJ Biopharma Co. Ltd. April 20, closing the chapter on a complex 10-year license saga.
  • Early data position Junshi in next-gen immuno-oncology race

    Shanghai Junshi Biosciences Co. Ltd reported early clinical signals across its next-generation immuno-oncology pipeline, including response rates of up to 71% in metastatic colorectal cancer and 45.5% in hepatocellular carcinoma, at the American Association for Cancer Research meeting in San Diego.
  • Delta-Fly eyes NDA path despite AML phase III miss

    Delta-Fly Pharma Inc. is pressing ahead with discussions with the FDA for its lead acute myeloid leukemia (AML) candidate, radgocitabine (DFP-10917), despite a phase III miss on its primary endpoint, instead leaning on earlier-stage efficacy signals and emerging combination data to support a potential path toward conditional approval.
  • FDA grants priority review to Merck-Daiichi’s B7-H3 cancer ADC

    The U.S. FDA has accepted and granted priority review to Daiichi Sankyo Co. Ltd. and Merck & Co. Inc.’s BLA of ifinatamab deruxtecan, a B7-H3-directed antibody-drug conjugate (ADC) to treat patients with advanced extensive-stage small-cell lung cancer.
  • Xuanzhu shares dip despite phase III ALK inhibitor data

    Xuanzhu Biopharmaceutical Co. Ltd. reported positive data from a local phase III study of dirozalkib (Xuan Fei Ning), an ALK inhibitor approved in China to treat patients with advanced non-small-cell lung cancer.
  • Mabwell turns to Hong Kong to fund ADC ambitions

    Following its 2022 debut on Shanghai’s STAR Market, Mabwell (Shanghai) Bioscience Co. Ltd. is aiming to raise up to HK$1.44 billion (US$184.78 million) in an IPO on the Hong Kong Stock Exchange to advance its Nectin4-targeting antibody-drug conjugate (ADC) 9MW-2821 (bulumtatug fuvedotin).
  • Pricing standoff leaves Australian patients in limbo

    A pricing standoff between Pfizer Inc. and the Australian government has left women with advanced breast cancer facing tens of thousands of dollars in out-of-pocket costs, underscoring a growing global trend in which access to life-extending drugs is increasingly being shaped by pricing negotiations rather than clinical merit.
  • News in brief

    BioWorld Asia briefs for April 21, 2026
  • Remedy pushes ‘cell-free’ secretome therapy for IPF into phase I

    “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 idiopathic pulmonary fibrosis (IPF) in January.
  • Kaleidoscope-like ‘engineered disorder’ expands imaging potential

    A new metasurface design strategy that replaces rigid order with “engineered disorder” could significantly increase how many optical functions can be integrated into a single ultra-thin device without increasing size or complexity, according to a study published in Nature Communications. The study challenges a longstanding assumption in optical engineering that highly ordered, periodic structures are required to precisely control light.
  • Daiichi to divest consumer health unit to Suntory for $1.5B

    Daiichi Sankyo. Co. Ltd. will begin a phased sale of its consumer health subsidiary, Daiichi Sankyo Healthcare Co. Ltd., to Suntory Holdings Ltd., as the Tokyo-based drugmaker sharpens its focus on oncology.
  • Med-tech financings steady at $8.8B in Q1, despite volume drop

    Total med-tech financings reached $8.81 billion in the first quarter (Q1) 2026, a 6% decline from $9.33 billion in Q1 2025 but well above the post-downturn lows of recent years.

BioWorld Insider podcast

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Analysis and data insight

  • Drug research illustration

    Biologics in development outnumber small molecules for the first time

    Cancer
    More than four decades on from the approval of the first biologic drug, the industry has reached a tipping point, and biotech drugs now outnumber small molecules in the global R&D pipeline.
  • Gold wireframe handshake

    Biopharma deal value gains 17% in early 2026

    Deals and M&A
    Biopharma deal value totaled $18.05 billion in March 2026, a pullback from $30.01 billion recorded in February and $31.16 billion in January, but broadly in line with prior years. The March total exceeds March 2024 ($8.5 billion) and is comparable to March 2023 ($19.68 billion) and 2022 ($15.35...
  • Digital globe illustrating pharma trade, tariffs

    Sector tariff now more than a threat – for some Rx companies

    Regulatory
    After nearly a year of threats and promises of a global biopharma tariff of 25% to 500%, U.S. President Donald Trump finally delivered it. In the name of national security, he imposed a 100% sector tariff on prescription drugs and their associated ingredients beginning in about four months for...
  • Gray and green glass dollar symbols with arrow pointing up

    Biopharma financings nearly double vs. 2025 to $25.1B

    Financings
    Total biopharma financings reached $25.14 billion in the first quarter (Q1) of 2026, nearly doubling the $13.12 billion in the Q1 2025. The early 2026 total comes in above the $13.19 billion recorded in 2023 and $13.66 billion in 2022, though it remains below the $38.27 billion during the same...
More in Analysis and data insight

Today's news in brief

  • Appointments and advancements for April 21, 2026

  • Financings for April 21, 2026

  • In the clinic for April 21, 2026

  • Other news to note for April 21, 2026

  • Regulatory actions for April 21, 2026

Deals and M&A

  • Regeneron enters radiopharma space via Telix deal

  • Everest to acquire Singapore unit of Hasten Bio in $250M deal

  • Abbvie nabs two Nav1.8 pain projects from Haisco in $745M deal

  • Lilly taps Insilico AI in $2.75B deal to expand pipeline options

  • Otsuka to acquire PTSD drugmaker Transcend in $1.2B deal

  • China’s pharma rise rattles US policymakers

  • Gilead pens dual-purpose $2B Ouro M&A deal with Galapagos

  • Samsung is adding trials and EHR access to Galaxy devices

  • Biopharma deal value jumps 60% to start 2026

  • G2Gbio secures license deal, ₩20B investment from Samsung Epis

Financings

  • Liver anatomy on medical background

    Oricell raises $110M in pre-IPO round to advance solid tumor CAR Ts

    Cancer
    Oricell Therapeutics Holdings Ltd closed a $110 million pre-IPO round to expand its global footprint and advance its lead candidate, a GPC3-targeted autologous CAR T therapy for liver cancer to registrational trials.
  • New China biotech Syneron chases macrocycle frontier

    Newco news
  • Excalipoint closes $68.7M seed round for cancer T-cell engagers

    Newco news
  • Imbiologics crosses $1B market cap with Kosdaq debut

    Cancer
  • Kanaph’s $27M IPO to aid multi-modality cancer, immune portfolio

    Cancer
More in Financings

Australia

  • Brain scans

    FDA accepts Telix’s resubmitted NDA for brain imaging agent

    Regulatory
    The U.S. FDA has accepted for review Telix Pharmaceuticals Ltd’s resubmitted NDA for TLX101-Px (Pixclara, 18F-floretyrosine, 18F-FET), its radiolabeled glioma imaging product for characterizing progressive or recurrent glioma in adult and pediatric patients. The FDA assigned a Sept. 11, 2026, PDUFA...
  • Amplia halts enrollment in phase II pancreatic cancer trial

    Clinical
    Amplia Therapeutics Ltd. has halted recruitment in its phase II Amplicity trial in advanced pancreatic cancer due to three dose-limiting toxicities related to the chemotherapy regimen, modified FOLFIRINOX (mFOLFIRINOX), which is being administered in combination with lead compound narmafotinib...
  • Australia’s R&D reset puts biotech translation in focus

    Regulatory
    Australia is attempting a once-in-a-generation reset of its innovation system, and biotech industry leaders have lauded the federal government’s independent review into Australia's slipping R&D ranks and its proposals to reverse the decline.
  • Australia publishes first clinical practice guideline for psychedelics

    Clinical
  • Mixed phase II results still point to path forward for AISA-021

    Clinical
  • Telix advances PSMA radiotherapy challenger to Pluvicto

    Clinical
  • CSL taps Lilly to de-risk IL-6 drug following dismal earnings

    Deals and M&A
More in Australia

China

  • Woman taking Amsler grid eye exam

    Innovent’s IBI-302 meets phase III endpoints in neovascular AMD

    Clinical
    Innovent Biologics Inc.’s efdamrofusp alfa (IBI-302) met the primary endpoint in the phase III Star trial in neovascular age-related macular degeneration (nAMD), and the Suzhou, China-based company will submit an NDA to China’s National Medical Products Administration.
  • Illustration of glucose molecules in a bloodstream

    China-developed triple incretin enters global diabetes race

    Clinical
    A next-generation triple incretin therapy jointly developed by Novo Nordisk A/S and China’s United Biotechnology outperformed semaglutide in a phase II trial, signaling intensifying competition in the GLP-1 obesity and diabetes market.
  • Monoclonal antibody illustration

    Simcere’s rademikibart meets phase III endpoints in atopic dermatitis

    Clinical
    Simcere Pharmaceutical Group Ltd.’s monoclonal antibody, rademikibart (CBP-201), met the primary endpoint in a Chinese phase III study in adults and adolescents with moderate to severe atopic dermatitis.
  • 3D illustration of heart cross section

    Braveheart finds phase II positive for cardiac myosin inhibitor

    Clinical
    Braveheart Bio Inc. reported positive results from an open-label randomized phase II dose-ranging study of BHB-1893 (HRS-1893) in obstructive hypertrophic cardiomyopathy. Results presented at the American College of Cardiology’s Annual Scientific Session and Expo in New Orleans showed BHB-1893...
  • Bladder cancer illustration

    Simcere’s PD-L1/IL-15 bispecific sees early edge in bladder cancer

    Clinical
    Early clinical data from Simcere Pharmaceutical Group Ltd. suggest its PD-L1/IL-15 bispecific antibody, SIM-0237, could emerge as a next-generation contender in Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer.
More in China

Clinical

  • Five-drug VIPOR regimen shows promise in aggressive blood cancer

  • Otsuka’s repinatrabit shows phase II efficacy in PKU adolescents

  • Immutep stock plummets 90% on efti phase III failure in NSCLC

  • Kyowa Kirin discontinues rocatinlimab trials due to safety issues

  • Systimmune’s iza-bren hits phase III breast cancer goals in China

  • Ascletis raises $107M to advance oral GLP-1 to phase III trials

  • Australia launches world-first pediatric mRNA brain cancer trial

  • Tanabe’s dersimelagon hits phase III endpoint in rare disorder

  • Early data lift Immunofoco’s solid tumor CAR T program

  • Takeda’s zasocitinib meets phase III psoriasis endpoints

Regulatory

  • Drug vials and syringe

    South Korea streamlines biosimilar review, clinical trials

    Biosimilar
    South Korea is rolling out regulatory changes to speed biosimilar development, including reforms to shorten review timelines, ease phase III trial requirements and simplify oversight of manufacturing changes. 
  • China’s Qyuns moves IL-17 biologic toward first approval

    Immune
  • Hightide wins China NDA acceptance for oral metabolic therapy

    Endocrine/metabolic
  • Japan approves first iPSC therapy for Parkinson’s disease

    Musculoskeletal
  • China approves first noninvasive therapy for cervical precancer

    Medical technology
More in Regulatory
 

Newco news

  • Illustration of CTLA-4 protein structure

    Harbour Biomed spins out newco in $1.2B CTLA-4 deal

    Deals and M&A
    Harbour Biomed is spinning out newco Solstice Oncology and is outlicensing its CTLA-4 antibody, porustobart (HBM-4003), to the newco in a cash and equity deal worth more than $1.2 billion.
  • Quantx raises $85M to advance oral immunology drugs

    Financings
    After closing an oversubscribed $85 million series B round, Quantx Biosciences Inc. is gearing up to begin clinical trials of its two lead immunology compounds, a STAT6 oral small-molecule inhibitor and an IL-17 oral small-molecule inhibitor.
  • Omnigeniq’s journey from space science to drug design

    Cancer
    A project that started as a bioreactor to assist astronauts in deep space to keep medications safe in a microgravity environment could help pharma companies model how drugs behave in the human body.
  • AI meets antibody design: Galux draws $29M series B for drug R&D

    Financings
  • Vibrant aims to tame EGFR tumors with masked TCEs

    Cancer
  • Rage Bio enters clinic with inhaled oligonucleotide in COPD

    Financings
  • Hits’ Hyperlab launches as ‘virtual AI lab’ for new drug discovery

    Protein
More in Newco news

Science

  • Hematopoietic stem cell research points to leukemia’s early roots

    Conferences
    Hematopoietic stem cell research over the past century has shown that leukemia may be driven by an invisible hand of inflammation. The bone marrow and inflammation, then, may hold the keys to preventing blood cancers, according to John E. Dick’s...
  • Targetable ‘high-plasticity cell state’ important for cancer progression, drug resistance

    Cancer
    Cancer cells expand through mutations – but not just through mutations. They also change their behavior in the absence of underlying genetic alterations. Such plasticity helps the cells both adapt to the cellular stress fueled by out-of-control...
  • Sea anemone venom acts as a senolytic tool against cancer

    Aging
    The sea anemone Stichodactyla helianthus, which carpets the Caribbean seafloor, may hold the key to eliminating the senescent cells that survive cancer therapy. A collaboration led by Spanish scientists across several international research...
  • In 2025, autoimmune work notches scientific, economic successes

    Deals and M&A
    In October, the Nobel Committee awarded the 2025 Nobel Prize in Physiology or Medicine to Shimon Sakaguchi, Mary Brunkow and Fred Ramsdell for their discoveries in the field of autoimmunity.
  • Romidepsin offers hope for high-risk neuroblastoma

    Cancer
    Australian researchers have found a drug combination that can bypass the cellular defenses in neuroblastoma that lead to relapse, and the discovery could lead to better treatment strategies for children whose cancers have stopped responding to...
  • HIV remission after heterozygous CCR5Δ32 stem cell transplant

    Cancer
    2025 has been the most challenging year in the efforts to fight HIV since at least the advent of antiretroviral therapy. In a report on “Overcoming disruption, transforming the AIDS response,” released last week ahead of World AIDS Day on Dec. 1,...
More in Science

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.


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  • Finding a better, longer-lasting fix in opioid overdose
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  • 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

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