GSK plc has announced a breakthrough in the treatment of chronic hepatitis B, reporting a functional cure rate of 19% across two phase III trials of its antisense oligonucleotide bepirovirsen. In comparison, none of the patients in the placebo arms eradicated the virus, which affects 240 million people worldwide and can cause cirrhosis and liver failure – and is the leading cause of liver cancer. The “unprecedented functional cure rates” have the potential “to redefine treatment for chronic hepatitis B,” GSK said. “For the first time, bepirovirsen offers the possibility of significantly better functional cure rates than the current standard of care, and the potential to reduce the risk of long-term liver complications, including cancer,” said Tony Wood, GSK’s chief scientific officer.
Abbvie scores FDA approval for Decnupaz in ultra-rare blood cancer
Abbvie Inc. won U.S. FDA clearance for the CD123-targeting antibody-drug conjugate Decnupaz (pivekimab sunirine) to treat adults with blastic plasmacytoid dendritic cell neoplasm, an ultra-rare and aggressive hematologic malignancy. The go-ahead is backed by data from the phase I/II global Cadenza study. Abbvie gained the compound in the November 2023 buyout of Immunogen Inc. for about $10 billion.
Abbott receives CE marking for dual glucose and ketone sensing systems
Abbott Laboratories received CE mark approval for two dual glucose and ketone sensing systems, bringing to the market sensors which could be transformational to the lives of people with diabetes at risk of diabetic ketoacidosis (DKA). The sensors, Libre Duo and Libre Duo 10 Day, continuously measure glucose and ketone levels every minute, offering real-time insight for day-to-day glucose management as well as early detection of rising ketones that can lead to a DKA emergency.
Longbio to raise HK$1.4B in Hong Kong IPO for immunology work
Chinese biotech Longbio Pharma Co. Ltd. announced its IPO on the Hong Kong Stock Exchange to raise HK$1.362 billion (US$174 million) to progress its lead candidate, LP-003, a next-generation anti-IgE antibody. LP-003 is the company’s flagship candidate and is being developed across multiple allergy indications, including seasonal allergic rhinitis, chronic spontaneous urticaria, asthma, food allergy and chronic rhinosinusitis with nasal polyps. A potential successor or competitor to Genentech Inc./Novartis AG’s Xolair (omalizumab), LP-003 could become the first innovative anti-IgE therapy launched globally in more than 20 years, the company said in its prospectus.
FDA’s VRBPAC faces complex COVID-19 landscape
Landing on the right COVID-19 vaccine formulation for the coming season is becoming more complicated against a backdrop of low vaccination rates, a young generation with little to no immunization, declining surveillance data and a new SARS-COV-2 lineage slowly emerging. Before taking on the task of selecting a formulation today, the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) spent the morning hearing from vaccine manufacturers and poring over data from the CDC. Over the past year, the highest hospitalization rates for COVID-19 in the U.S. were seen among the youngest and oldest age groups. While underlying conditions, along with age, were risk factor for older people, that was not the case for many young children and infants who were hospitalized.
New evidence links autoimmunity to long COVID symptoms
Recent findings are reshaping current understanding of the post-infection landscape of SARS-CoV-2. Although previous studies had already suggested that autoimmunity might underlie the persistent neurological symptoms seen in long COVID, researchers at Yale University and Mount Sinai now reinforce this hypothesis. SARS-CoV-2 infection appears to trigger an autoimmune mechanism that drives chronic pain, fatigue and cognitive impairment in some patients.
TROP2 ADCs progress into first-line for lung, breast cancers
Multiple updates on TROP2-directed antibody-drug conjugates (ADCs) for lung and breast cancers highlight both progress made and opportunities for improvement for the targeted class of cancer therapeutics. Immune checkpoint inhibitors remain a cornerstone of the oncology armamentarium, although ADCs and other novel agents are continually expanding the landscape. Ahead of the American Society of Clinical Oncology annual meeting in Chicago, set to begin May 29, much hype surrounds Summit Therapeutics Inc./Akeso Pharmaceuticals Inc.’s ivonescimab as a potential front-line treatment for squamous non-small-cell lung cancer, where Akeso is set to present Harmoni-6 results at a plenary session.
EASL 2026: Rebuilding the liver, from organoids to engineered ducts
With a historic WHO resolution adopted this week giving countries, for the first time, a mandate to address liver disease affecting 1.5 billion people worldwide, this momentum is strongly reflected at the ongoing European Association for the Study of the Liver 2026 congress in Barcelona. The mandate positions liver disease alongside cancer, cardiovascular disease and diabetes as a core global health priority. The Basic Science seminar that opened this year’s EASL congress focused on decoding liver injury through a new generation of experimental platforms that more closely reflect liver biology and disease.
Drug developers outpace Nasdaq Bio as rezpeg data lifts Nektar
The BioWorld Drug Developers Index outpaced the Nasdaq Biotechnology Index over early 2026, finishing April up 10.69% for the year compared to the NBI's 2.73% gain. Nektar Therapeutics Inc. was a top performer, with shares surging after 52-week data from the Rezolve-AA study showed sustained and deepening efficacy for rezpegaldesleukin (rezpeg) in severe alopecia areata.
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