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BioWorld - Wednesday, April 29, 2026
Breaking News: Read BioWorld's AACR 2026 coverageBreaking News: Best of BioWorld: Q1
  • 3D rendering of a molecular glue mediating the interaction between two proteins

    Death a sticking point in Erasca molecular glue phase I

    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 non-small-cell lung and pancreatic ductal adenocarcinoma.
  • Biggest overhaul of UK clinical trials rules in 20 years comes into force

  • Adcoms off to sluggish start with ODAC meeting on Astrazeneca drugs

  • Thermo Fisher sells microbiology business for $1B

  • Nervonik raises $52.5M to advance PNS system

  • Pilatus PLT-012 takes immunometabolic approach to reprogram TME

  • Chinese biotechs gain leverage as partners in dealmaking

  • Death a sticking point in Erasca molecular glue phase I

    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 non-small-cell lung and pancreatic ductal adenocarcinoma.
  • Biggest overhaul of UK clinical trials rules in 20 years comes into force

    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 sponsors will be able to submit a single application for regulatory review by the Medicines and Healthcare products Regulatory Agency and ethics review by the Health Research Authority, the body responsible for managing ethics committees.
  • Adcoms off to sluggish start with ODAC meeting on Astrazeneca drugs

    After a hiatus of more than nine months, the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) will meet April 29 to discuss two Astrazeneca plc applications – an NDA for camizestrant used in combination with a CDK4/6 inhibitor to treat HR+HER2- locally advanced or metastatic breast cancer and an sNDA for Truqap (capivasertib) to treat metastatic castration-resistant prostate cancer.
  • Thermo Fisher sells microbiology business for $1B

    Thermo Fisher Scientific Inc. agreed to sell its microbiology business to Astorg, a private equity firm, for approximately $1.075 billion, consisting of cash and a $50 million seller note. The business unit provides antimicrobial susceptibility testing and culture media solutions for clinical, pharmaceutical and food safety testing.
  • Nervonik raises $52.5M to advance PNS system

    Nervonik Inc. raised $52.5 million in a series B financing round for its peripheral nerve stimulation (PNS) system designed to treat patients with chronic pain and other neurological conditions. The funds will be used to support the continued development Nervonik's PNS system, including enhancements to the system’s sensing capabilities, as well as preparations for commercialization.
  • Pilatus PLT-012 takes immunometabolic approach to reprogram TME

    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 said. “That’s why more than 60% of solid tumor patients do not respond to treatment.”
  • Chinese biotechs gain leverage as partners in dealmaking

    China’s biotech ecosystem has crossed an inflection point, and Chinese biotechs are gaining leverage in dealmaking, executives from multinational companies said during the Chinabio Partnering Forum in Shanghai April 28.
  • Today's news in brief

    BioWorld briefs for April 28, 2026.
  • Takeda takes rusfertide’s US rights; Protagonist opts out for cash

    More than two years after signing a $1.7 billion deal with Takeda Pharmaceutical Co. Ltd., Protagonist Therapeutics Inc. has opted out of a 50-50 U.S. profit-and-loss sharing arrangement for its hepcidin mimetic peptide, rusfertide, a priority review drug developed to treat adults with polycythemia vera.
  • Soligenix plummets on trial halt for Hybryte in lymphoma

    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 lymphoma.
  • FDA proposes withdrawing Amgen’s Tavneos

    Alleging “untrue statements” included in the approval application for vasculitis drug Tavneos (avacopan), the U.S. FDA’s Center for Drug Evaluation and Research is proposing to withdraw the NDA for small-molecule C5aR antagonist at the center of Amgen Inc.’s 2022 buyout of Chemocentryx Inc. for $3.7 billion.
  • Criminal charges filed against top Fauci aide

    An alleged coverup of NIH-funded gain-of-function research at China’s Wuhan Institute of Virology has led to criminal charges against a former career scientist and top aide to Tony Fauci, the head of the National Institute of Allergy and Infectious Diseases in the time of the COVID-19 pandemic.

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Analysis and data insight

  • 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.
  • Health professional pointing stethoscope at Clinical Trial words, icons

    Xenon spikes, Theravance sinks after phase III readouts in March

    Clinical
    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 failed to meet key endpoints. By phase, March updates...
  • Epileptic brain and abnormal EEG wave discharges

    Neuro deals aplenty: UCB’s $1B+ takeover of Neurona the latest

    Deals and M&A
    A flurry of deals focused on the neurological disease space in 2026 suggest large biopharma companies are searching for the next best therapeutics for everything from epilepsy and narcolepsy to post-traumatic stress disorder and hyperphagia.
  • Chart of arrows pointing upward

    China partnerships lead biopharma deal surge in Q1 2026

    Deals and M&A
    Biopharma deal value reached $79.22 billion in the first quarter (Q1) 2026, marking a strong start to the year and an increase of about 17% from $67.6 billion in Q1 2025 and similar to $78.93 billion in Q4 2025. The total is the highest first-quarter tally in recent years, and the highest quarter...
More in Analysis and data insight

Today's news in brief

  • Appointments and advancements for April 28, 2026

  • Financings for April 28, 2026

  • In the clinic for April 28, 2026

  • Other news to note for April 28, 2026

  • Regulatory actions for April 28, 2026

Deals and M&A

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

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

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

  • Pleased to own ya, Kelonia: Lilly’s $7B CAR T deal

  • A free gene therapy? Regeneron’s Otarmeni approved for hearing loss

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

  • Aiming to Jimi the regulatory lock in psychedelics

  • Daiichi to divest consumer health unit to Suntory for $1.5B

  • Foundation Medicine buying Saga Dx and its MRD test for $595M

  • Abbott’s Exact acquisition drives med-tech M&A to $23.7B in March

Financings

  • Hong Kong stock market illustration

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

    Medical technology
    Ribo Life Science Co. Ltd.’s HK$1.8 billion (US$230 million) raise on Jan. 9 was the sole Chinese biotech IPO on the Hong Kong Stock Exchange in the first quarter (Q1) of 2026, despite a growing backlog of more than 70 filings from China life science firms in 2025. Among med-tech companies,...
  • Tortugas launches with $106M for neurology, neuropsychiatric drugs

    Newco news
  • Medtronic leads $100M financing round for Pulnovo

    Medical technology
  • Xuanzhu shares dip despite phase III ALK inhibitor data

    Clinical
  • Mabwell turns to Hong Kong to fund ADC ambitions

    Cancer
More in Financings

Medical technology

  • Atrial fibrillation illustration

    Med-tech companies highlight PFA data as competition intensifies

    Clinical
    New data on pulsed field ablation (PFA) presented at Heart Rhythm 2026 in Chicago over the weekend continue to show the benefits and superiority of the technologies in treating patients with atrial fibrillation. The PFA landscape is fast-evolving and med-tech players are jostling for market share...
  • Edwards raises 2026 guidance on strong TAVR performance

    U.S.
    Edwards Lifesciences Corp. raised its full-year 2026 guidance after seeing strong sales in the first quarter, particulalry from its transcatheter aortic valve replacement (TAVR) business. The company now expects sales growth of 9% to 11%, up from prior outlook of 8% to 10%, and adjusted earnings...
  • Cochlear’s 39% stock plunge resets ‘defensive growth’ narrative

    Analysis and data insight
    Shares in Aussie hearing implant maker Cochlear Ltd. plummeted nearly 39% April 22 after the company slashed fiscal 2026 earnings guidance and warned that weaker-than-expected demand in developed markets was exposing a more cyclical and discretionary side to its business than investors had assumed.
  • FDA, CMS partner to deliver RAPIDly for innovative devices

    Analysis and data insight
  • Forsight’s robot-assisted platform to transform cataract surgery

    Ocular
  • Pharma industry faces long haul to get return on investment from AI

    Conferences
  • Boston Sci’s CEO ‘disappointed’ as company cuts 2026 guidance

More in Medical technology

Newco news

  • 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...
  • 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...
  • Photo of hands holding a baby

    Realta secures another $40M for its hypoxic ischemic encephalopathy treatment

    Financings
    Realta Life Sciences Inc. raised an additional $40 million in the final tranche of its series A investment, bringing the total the company has raised to more than $150 million through mission-driven investors and a family-office model.
  • Multicolor peptide illustration

    New China biotech Syneron chases macrocycle frontier

    Financings
    Syneron Bio is emerging as one of the most heavily backed new entrants in the macrocyclic peptide space, raising more than $250 million in venture funding and securing a multibillion-dollar deal with Astrazeneca plc as it builds a platform spanning several of the most competitive frontiers in drug...
More in Newco news

Regulatory

  • CHMP gives nod for Sanofi’s Cenrifki for multiple sclerosis

  • Grace Therapeutics hits CRL setback with GTx-104 despite positive trial

  • Citizen petition asks for clarity in CRL disclosures

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

  • CMS to Bridge coverage for obesity drugs as BALANCE teeters

  • Merck wins US FDA nod for Idvynso, a two-drug HIV regimen

  • Former Jazz employee settles insider trading charge

  • Fed Circuit hands headache patent win back to Teva

  • Xeltis secures CE mark for Axess, its hemodialysis conduit

  • Targeted therapies dominate March’s five NME approvals

U.S.

  • Illustration of cancer in the bile ducts

    S-OS? Compass phase II/III biliary data mixed; ahoy, FDA

    Clinical
    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 plans to meet with the U.S. FDA to discuss a BLA....
  • MANE event: Veradermics beats expectations in pattern hair loss trial

    Clinical
  • Revolution rocks on with first-line PDAC data at AACR

    Clinical
  • Walking the talk, Kyverna phase II stiffens miv-cel CAR T case

    Clinical
  • Novo’s Forma acquisition pays off with mitapivat competitor

    Clinical
More in U.S.

Europe

  • Health care worker with IV drip

    Netrin-1 inhibitor blocks chemo resistance in pancreatic cancer

    Clinical
    Netris Pharma SA has delivered positive phase Ib data showing its first-in-class netrin-1 inhibitor NP-137 alleviates resistance to chemotherapy in pancreatic cancer. This could represent an important advance in treating these tumors, which are notoriously resistant to chemotherapy.
  • Whole genome sequencing unveils blood cancer trajectory

    Conferences

    A new study tracking the genomic evolution of chronic myeloproliferative neoplasms has shown that progression to myelofibrosis or acute myeloid leukemia is encoded in mutations that occur years before the transformation is clinically evident.

  • Ebenbuild’s tech for predicting lung drug deposition validated

    Clinical
    The ability of Ebenbuild GmbH’s digital twin technology to predict the deposition of inhaled drugs across the lungs has been validated in a study published in Nature Communications Medicine. The platform, which combines AI-driven image analysis and physics-based computational modeling, demonstrated...
  • Roche plots route to EMA approval for DMD gene therapy

    Regulatory
  • Meta-analysis: Anti-amyloid Alzheimer’s drugs not ‘clinically meaningful’

    Neurology/psychiatric
  • Storm raises $56M series C for phase II RNA inhibitor trial in sarcoma

    Financings
  • Alivecor receives CE mark for AI-powered, portable ECG system

    Medical technology
More in Europe

Clinical

  • Akeso sets durability bar as immuno-oncology 2.0 race heats up

    Conferences
    Akeso Pharmaceuticals Inc. has raised the bar for next-generation immuno-oncology, reporting more than 23 months median overall survival in pancreatic cancer with its PD-1/CTLA-4 bispecific antibody cadonilimab, as emerging competitors begin to...
  • Early data position Junshi in next-gen immuno-oncology race

    Conferences
    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...
  • Nektar’s rezpeg more than worth its SALT in alopecia phase IIb

    Dermatologic
    With rezpegaldesleukin (rezpeg) phase IIb data in alopecia areata holding strong over time, backers of Nektar Therapeutics Inc. are hopeful that the biologic can do for the hair loss market what Dupixent (dupilumab, Regeneron Pharmaceuticals...
  • Delta-Fly eyes NDA path despite AML phase III miss

    Regulatory
    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...
  • Lilly’s GLP-1 Foundayo aces MACE in DILI of a phase III

    Diabetes
    Wall Street met with satisfaction but not surprise Eli Lilly and Co.’s undeniably positive top-line results from the phase III Achieve-4 study testing the efficacy and safety of Foundayo (orforglipron) compared to insulin glargine in adults with...
  • Cortec prepares to implant BCI tech into third stroke patient

    Medical technology
    Cortec GmbH is preparing to implant its brain-computer interface (BCI) technology into a third stroke patient, with early clinical data showing that the device leads to significant improvement in hand and arm function. The company believes its...
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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    gifting China biopharma leadership position
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