https://www.bioworld.com/rss en-us Vera Therapeutics Inc. looks to get an almost five-month head start over a competitor, Vertex Pharmaceuticals Inc., as the U.S. FDA cleared its Trutakna (atacicept) as the first dual BAFF/APRIL inhibitor for treating immunoglobulin A nephropathy (IgAN). The accelerated approval, which came on the July 7 PDUFA date, indicates Trutakna for use in reducing proteinuria in adults with primary IgAN at risk for disease progression. The drug is administered once weekly via auto-injector. http://www.bioworld.com/articles/732416 Tue, 07 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732416-veras-trutakna-wins-fda-nod-as-first-dual-inhibitor-for-igan Kidneys Telum Therapeutics SL has completed an €18 million (US$24 million) series A financing to advance its lead program targeting hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by the multidrug-resistant gram-negative pathogen Acinetobacter baumannii. Acinetobacter baumannii.]]> http://www.bioworld.com/articles/732332 Wed, 01 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732332-telum-therapeutics-advances-antimicrobials-with-series-a-funding Euro symbol in piggy bank A U.S. biotechnology company founded by Deerfield Management Company L.P. licensed exclusive rights to Metis Techbio Co. Ltd.’s preclinical trispecific T-cell engager (TCE) for autoimmune disorders in a potential $1.62 billion deal. http://www.bioworld.com/articles/732310 Tue, 30 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/732310-deerfield-backed-boulevard-metis-pen-16b-trispecific-tce-deal Handshake, businessmen holding dollar sign, lightbulb MPM Bioimpact-spawned K2 Therapeutics Inc. inked a license deal plus option agreement, worth $980.5 million apiece, to gain ex-China rights to two of Antengene Corp. Ltd.’s preclinical anticancer bispecific T-cell engager (TCE) assets. The deal, announced June 21, will grant Singapore-based K2 exclusive rights to develop and commercialize Antengene’s ATG-106 outside of mainland China, Hong Kong, Macau and Taiwan. http://www.bioworld.com/articles/732152 Tue, 23 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/732152-k2-nabs-two-antengene-bispecific-tces-in-2b-license-option-deal Photo of two people shaking hands near lab equipment Lu-AG-22515, also known as velaprumig, is a recombinant fusion protein that targets CD40 ligand (CD40L) and human serum albumin (HSA), thereby blocking the binding between CD40 and CD40L, a known signaling pathway involved in several autoimmune diseases. Researchers at H. Lundbeck A/S evaluated the pharmacokinetic (PK) and pharmacodynamic (PD) profile of Lu-AG-22515 in cynomolgus monkeys, as well as the impact of its inhibitory effect in the preclinical setting of thyroid eye disease (TED). http://www.bioworld.com/articles/732119 Tue, 23 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/732119-lundbecks-lu-ag-22515-shows-promise-in-thyroid-eye-disease Close up of eye and vision test MPM Bioimpact-spawned K2 Therapeutics Inc. inked a license deal plus option agreement, worth $980.5 million apiece, to gain ex-China rights to two of Antengene Corp. Ltd.’s preclinical anticancer bispecific T-cell engager (TCE) assets. The deal, announced June 21, will grant Singapore-based K2 exclusive rights to develop and commercialize Antengene’s ATG-106 outside of mainland China, Hong Kong, Macau and Taiwan. http://www.bioworld.com/articles/732090 Mon, 22 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/732090-k2-nabs-two-antengene-bispecific-tces-in-2b-license-option-deal Photo of two people shaking hands near lab equipment Modulating G protein-coupled receptors (GPCRs) is one of the major challenges in biomedicine. These are flexible proteins with small, deep binding pockets. The scientific community has explored small molecules, antibodies and nanobodies to develop ligands. Skape Bio Inc. is betting on creating miniproteins, a strategy that brings precise solutions for different functions. http://www.bioworld.com/articles/731737 Mon, 08 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/731737-skape-bio-unlocks-gpcr-targets-with-de-novo-designed-miniproteins 3D rendering of β2-Adrenergic receptor GPCR protein molecule embedded in lipid bilayer membrane. β2-Adrenergic receptor GPCR protein molecule embedded in lipid bilayer membrane. Although CAR T-cell therapy has been highly effective in hematological cancers, its activity in solid tumors is still constrained by inhibitory checkpoints such as PD-1, LAG-3 and TIM-3, together with the lack of locally available cytokines such as IL-2 needed to sustain T-cell function. Anwita Biosciences Inc. and collaborators aimed to overcome these challenges by developing a strategy integrating an immune checkpoint inhibitor (ICI) with a T-cell stimulatory cytokine. http://www.bioworld.com/articles/730696 Mon, 27 Apr 2026 09:00:00 -0400 https://www.bioworld.com/articles/730696-anti-lag-3-il-2-fusion-protein-enhances-ici-and-car-t-response-in-solid-tumors 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. http://www.bioworld.com/articles/730089 Tue, 31 Mar 2026 12:00:00 -0400 https://www.bioworld.com/articles/730089-innovents-ibi-302-meets-phase-iii-endpoints-in-neovascular-amd Woman taking Amsler grid eye exam Repeated promotional claims Patrick Soon-Shiong made about Immunitybio Inc.’s Anktiva – such as “We have now discovered and developed this drug … approved for bladder cancer, but it actually can treat all cancers” – landed the Culver City, Calif., company a strongly worded warning letter from the U.S. FDA. http://www.bioworld.com/articles/729842 Wed, 25 Mar 2026 12:00:00 -0400 https://www.bioworld.com/articles/729842-unapproved-anktiva-claims-earn-immunitybio-fda-warning Anktiva Credit: Business Wire 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. http://www.bioworld.com/articles/729841 Wed, 25 Mar 2026 12:00:00 -0400 https://www.bioworld.com/articles/729841-innovents-ibi-302-meets-phase-iii-endpoints-in-neovascular-amd Woman taking Amsler grid eye exam Immutep Ltd.’s stock on Australia’s Securities Exchange plummeted nearly 90% on March 13 on the news that its phase III TACTI-004 trial evaluating eftilagimod alfa (IMP-321, efti) in first-line non-small-cell lung cancer was discontinued due to futility. http://www.bioworld.com/articles/729716 Tue, 17 Mar 2026 11:00:00 -0400 https://www.bioworld.com/articles/729716-immutep-stock-plummets-90-on-efti-phase-iii-failure-in-nsclc Stock market crash illustration Immutep Ltd.’s stock on Australia’s Securities Exchange plummeted nearly 90% on March 13 on the news that its phase III TACTI-004 trial evaluating eftilagimod alfa (IMP-321, efti) in first-line non-small-cell lung cancer was discontinued due to futility. http://www.bioworld.com/articles/729493 Fri, 13 Mar 2026 12:00:00 -0400 https://www.bioworld.com/articles/729493-immutep-stock-plummets-90-on-efti-phase-iii-failure-in-nsclc Stock market crash illustration Vertex Pharmaceuticals Inc. is on track to complete a BLA by the end of March seeking potential U.S. accelerated approval for povetacicept, its dual inhibitor of the BAFF and APRIL cytokines, to treat immunoglobulin A nephropathy (IgAN), following a successful phase III Rainier trial. http://www.bioworld.com/articles/729449 Tue, 10 Mar 2026 12:00:00 -0400 https://www.bioworld.com/articles/729449-vertex-filing-bla-for-best-in-class-igan-drug-on-rainier-win Kidneys GSK plc is paying $950 million cash to acquire 100% of 35Pharma Inc.’s equity and pipeline, including phase II-ready candidate HS-235 for pulmonary hypertension. The acquisition agreement comes a day after GSK added two small interfering RNA assets from Nanjing, China-based Frontier Biotechnologies Inc. through a license deal reaching up to $1 billion. http://www.bioworld.com/articles/729368 Tue, 03 Mar 2026 12:00:00 -0500 https://www.bioworld.com/articles/729368-returning-to-pulmonary-hypertension-gsk-buys-35pharma Lungs, heart anatomy Eli Lilly and Co. got a breather when the U.S. Ninth Circuit Court of Appeals agreed that the company doesn’t owe Research Corporation Technologies Inc. (RCT) royalties on its diabetes drugs under a licensing agreement Lilly had made with Phillips Petroleum Co. in 1990 and that Phillips later sold to RCT. http://www.bioworld.com/articles/729246 Thu, 26 Feb 2026 12:00:00 -0500 https://www.bioworld.com/articles/729246-ninth-circuit-agrees-with-lilly-in-royalty-dispute Coming off a U.S. FDA approval of the first GLP-1 in pill format, Novo Nordisk A/S leaned further into oral drug delivery efforts, partnering with Vivtex Corp. to develop next-generation oral formulations of peptide and protein therapeutics in a potential $2.1 billion deal that marks the highest-profile news for Vivtex since the firm spun out of MIT in 2018. http://www.bioworld.com/articles/729200 Wed, 25 Feb 2026 12:00:00 -0500 https://www.bioworld.com/articles/729200-vivtexs-oral-drug-delivery-approach-draws-novo-in-21b-deal GI-ORIS-pic-Vivtex-2-25.jpg GI-ORIS, or “GI tract on a chip” screening system. Credit: Vivtex Corp. GSK plc is paying $950 million cash to acquire 100% of 35Pharma Inc.’s equity and pipeline, including phase II-ready candidate HS-235 for pulmonary hypertension. The acquisition agreement comes a day after GSK added two small interfering RNA assets from Nanjing, China-based Frontier Biotechnologies Inc. through a license deal reaching up to $1 billion. http://www.bioworld.com/articles/729199 Wed, 25 Feb 2026 12:00:00 -0500 https://www.bioworld.com/articles/729199-returning-to-pulmonary-hypertension-gsk-buys-35pharma Lungs, heart anatomy Marking an important day for those with atopic dermatitis, shares of two biopharmas surged on clinical data suggesting new biologics are on their way to help address 40% of patients with uncontrolled disease. http://www.bioworld.com/articles/728714 Tue, 10 Feb 2026 12:00:00 -0500 https://www.bioworld.com/articles/728714-evommune-nektar-soar-on-atopic-dermatitis-phase-ii-data Woman itching wrist Galux closed a ₩42 billion (US$29 million) series B round Feb. 10, led by Yuanta Investment to bring AI-driven “rational design” to the protein drug development process, already heavily influenced by human engineering. http://www.bioworld.com/articles/728806 Tue, 10 Feb 2026 11:00:00 -0500 https://www.bioworld.com/articles/728806-ai-meets-antibody-design-galux-draws-29m-series-b-for-drug-r-and-d Park Tae-yong, vice president and cofounder, Galux Park Tae-yong, vice president and cofounder, Galux Inc. Galux closed a ₩42 billion (US$29 million) series B round Feb. 10, led by Yuanta Investment to bring AI-driven “rational design” to the protein drug development process, already heavily influenced by human engineering. http://www.bioworld.com/articles/728800 Tue, 10 Feb 2026 09:00:00 -0500 https://www.bioworld.com/articles/728800-ai-meets-antibody-design-galux-draws-29m-series-b-for-drug-r-and-d Park Tae-yong, vice president and cofounder, Galux Park Tae-yong, vice president and cofounder, Galux Inc. Galux closed a ₩42 billion (US$29 million) series B round Feb. 10, led by Yuanta Investment to bring AI-driven “rational design” to the protein drug development process, already heavily influenced by human engineering. http://www.bioworld.com/articles/728701 Mon, 09 Feb 2026 12:00:00 -0500 https://www.bioworld.com/articles/728701-ai-meets-antibody-design-galux-draws-29m-series-b-for-drug-r-and-d Park Tae-yong, vice president and cofounder, Galux Park Tae-yong, vice president and cofounder, Galux Inc. IL-10-based approaches have shown promise in cancer immunotherapy by activating exhausted CD8+ T cells, but severe hematological toxicities have limited their clinical use. Recent strategies aim to harness IL-10’s antitumor effects while reducing these toxicities. http://www.bioworld.com/articles/728604 Wed, 04 Feb 2026 08:00:00 -0500 https://www.bioworld.com/articles/728604-first-in-class-fusion-protein-reverses-t-cell-exhaustion-across-multiple-models Illustration of a T cell China’s National Medical Products Administration (NMPA) has cleared Shanghai Henlius Biotech Inc. to initiate a phase Ib/II trial of HLX-701 in combination with cetuximab and chemotherapy for the treatment of patients with advanced RAS/BRAF wild-type colorectal cancer. http://www.bioworld.com/articles/728207 Thu, 22 Jan 2026 08:00:00 -0500 https://www.bioworld.com/articles/728207-chinas-nmpa-clears-clinical-trial-of-henlius-hlx-701 After raising AU$29 million (US$19.44 million) in a series A round, Rage Biotech Pty Ltd. is beginning phase I trials of its lead candidate, RB-042, an inhaled splice-switching oligonucleotide for treating chronic obstructive pulmonary disease (COPD) and other inflammatory lung diseases. http://www.bioworld.com/articles/728046 Wed, 14 Jan 2026 09:00:00 -0500 https://www.bioworld.com/articles/728046-rage-bio-enters-clinic-with-inhaled-oligonucleotide-in-copd AI generated illustration of lungs in the human body After raising AU$29 million (US$19.44 million) in a series A round, Rage Biotech Pty Ltd. is beginning phase I trials of its lead candidate, RB-042, an inhaled splice-switching oligonucleotide for treating chronic obstructive pulmonary disease (COPD) and other inflammatory lung diseases. http://www.bioworld.com/articles/727978 Tue, 13 Jan 2026 00:00:00 -0500 https://www.bioworld.com/articles/727978-rage-bio-enters-clinic-with-inhaled-oligonucleotide-in-copd AI generated illustration of lungs in the human body After raising AU$29 million (US$19.44 million) in a series A round, Rage Biotech Pty Ltd. is beginning phase I trials of its lead candidate, RB-042, an inhaled splice-switching oligonucleotide for treating chronic obstructive pulmonary disease (COPD) and other inflammatory lung diseases. http://www.bioworld.com/articles/727869 Mon, 12 Jan 2026 12:00:00 -0500 https://www.bioworld.com/articles/727869-rage-bio-enters-clinic-with-inhaled-oligonucleotide-in-copd AI generated illustration of lungs in the human body Things once done in laboratories can now be done with computers and AI, said Kim Woo-youn, CEO and cofounder of Hits Inc. “We live in the age of ‘digital alchemy,’” Kim told BioWorld, describing how AI is shifting some drug discovery processes from physical to virtual spaces. BioWorld, describing how AI is shifting some drug discovery processes from physical to virtual spaces.]]> http://www.bioworld.com/articles/727277 Wed, 17 Dec 2025 09:00:00 -0500 https://www.bioworld.com/articles/727277-hits-hyperlab-launches-as-virtual-ai-lab-for-new-drug-discovery Kim Woo-youn, CEO and cofounder, Hits Kim Woo-youn, CEO and cofounder, Hits Things once done in laboratories can now be done with computers and AI, said Kim Woo-youn, CEO and cofounder of Hits Inc. “We live in the age of ‘digital alchemy,’” Kim told BioWorld, describing how AI is shifting some drug discovery processes from physical to virtual spaces. BioWorld, describing how AI is shifting some drug discovery processes from physical to virtual spaces.]]> http://www.bioworld.com/articles/727003 Tue, 16 Dec 2025 12:00:00 -0500 https://www.bioworld.com/articles/727003-hits-hyperlab-launches-as-virtual-ai-lab-for-new-drug-discovery Kim Woo-youn, CEO and cofounder, Hits Kim Woo-youn, CEO and cofounder, Hits Two Flagship Pioneering Inc. biopharma companies founded in the last five years and focused on proteomic and genomic technologies entered agreements to help discover new therapeutics for respiratory and liver diseases under a framework collaboration with GSK plc. Under that agreement, Profound Therapeutics Inc. and Quotient Therapeutics Inc. would use their platform technologies to discover novel proteins and targets for developing drugs to treat chronic obstructive pulmonary disease and idiopathic pulmonary fibrosis, with Quotient taking on a third indication with metabolic dysfunction-associated steatohepatitis. http://www.bioworld.com/articles/726321 Thu, 20 Nov 2025 12:00:00 -0500 https://www.bioworld.com/articles/726321-gsk-flagship-deal-validates-profound-quotient-platforms Hands holding gears