https://www.bioworld.com/rss en-us Despite the Biosecure Act’s five-year wind-down period that isn’t expected to start until mid-2028, Wuxi Apptec is already feeling the repercussions of being added last month to the U.S. Department of War’s Section 1260H list. Instead of just waiting for its June 11 challenge to its listing as a “Chinese military company” to play out in court, the Shanghai-based contract research, development and manufacturing organization (CRDMO) is now seeking a preliminary injunction to suspend the designation during the court proceedings. http://www.bioworld.com/articles/732276 Thu, 02 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732276-wuxi-apptec-seeks-immediate-relief-from-us-listing Legal scales and clipboard Roche Holding AG’s Genentech unit achieved superior phase III results with its KRAS G12C inhibitor divarasib over approved therapies in previously treated non-small-cell lung (NSCLC) cancer patients. http://www.bioworld.com/articles/732269 Thu, 02 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732269-genentechs-kras-g12c-inhibitor-divarasib-shines-in-nsclc-phase-iii Illustration of lungs with cancer inset Alebund Pharmaceuticals (Jiangsu) Ltd. was the third Chinese biotech company to debut in Hong Kong this month, with June IPO proceeds from Alebund, Longbio Pharma Co. Ltd. and Shaanxi Micot Pharmaceutical Technology Co. Ltd. totaling about HK$4.7 billion (US$600 million). http://www.bioworld.com/articles/732393 Thu, 02 Jul 2026 08:00:00 -0400 https://www.bioworld.com/articles/732393-hk-biotech-listings-gain-traction-in-q2-with-trio-of-june-ipos HKEX on phone, digital stock chart Credit: piter2121 - stock.adobe.com Otsuka Pharmaceutical Co. Ltd. reported another clinical study win with once-daily centanafadine, a non-stimulant compound targeting attention deficit hyperactivity disorder (ADHD). Top-line results of a dedicated phase IIIb study in patients with ADHD and comorbid anxiety found that centanafadine met the primary endpoint, defined as score improvements on the Adult Investigator Symptom Rating Scale, compared with placebo at week 8. http://www.bioworld.com/articles/732352 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732352-otsukas-centanafadine-scores-in-adhd-comorbid-anxiety-trial Illustration of woman with anxiety, ADHD Corxel Pharmaceuticals Ltd.’s oral small-molecule GLP-1 receptor agonist, CX-11, met the primary endpoints in a phase II trial evaluating the candidate in obese and overweight patients in the U.S., according to top-line results. http://www.bioworld.com/articles/732349 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732349-corxel-vincentages-oral-glp-1-meets-phase-ii-obesity-endpoints Glass of water and tablets Nuvectis Pharma Inc.’s shares climbed further after the oncology-focused biotech nabbed select rights to a late-stage complement factor B inhibitor (HSK-39297/NXP-100) and a phase I BRAF inhibitor (HSK-42360/NXP-200) from Haisco Pharmaceutical Group Co. Ltd. for $40 million up front. http://www.bioworld.com/articles/732348 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732348-nuvectis-shares-continue-to-rally-after-146b-haisco-deal Dollar symbol with arrow graph Abbisko Therapeutics Co. Ltd. has entered a research collaboration and license agreement with Eli Lilly and Co. to discover and develop innovative medicines across multiple targets, with the aim of advancing novel drug candidates with global potential. http://www.bioworld.com/articles/732347 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732347-lilly-taps-abbisko-for-19b-discovery-deal Microscope The academic authors of the paper describing the pivotal trial of Amgen Inc.’s Tavneos (avacopan) have retracted it from The New England Journal of Medicine because the primary endpoint assessments of nine patients were “re-adjudicated” after the database was locked and the study unblinded. The New England Journal of Medicine because the primary endpoint assessments of nine patients were “re-adjudicated” after the database was locked and the study unblinded.]]> http://www.bioworld.com/articles/732242 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732242-nejm-paper-on-tavneos-pivotal-trial-retracted-by-academic-authors Photo of pen and marker on science journal article One company was looking to add to its royalty stream and R&D portfolio. The other was seeking strategic alternatives in the wake of clinical misfires over the last few years. In an agreement aimed at satisfying both goals, Zymeworks Inc. will acquire Theravance Biopharma Inc., paying $17 per share, or about $929 million, though the transaction is structured in a way that minimizes the former’s current capital position. http://www.bioworld.com/articles/732226 Mon, 29 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732226-zymeworks-bolsters-royalty-stream-with-theravance-buy Acquisition puzzle Otsuka Pharmaceutical Co. Ltd. reported another clinical study win with once-daily centanafadine, a non-stimulant compound targeting attention deficit hyperactivity disorder (ADHD). Top-line results of a dedicated phase IIIb study in patients with ADHD and comorbid anxiety found that centanafadine met the primary endpoint, defined as score improvements on the Adult Investigator Symptom Rating Scale, compared with placebo at week 8. http://www.bioworld.com/articles/732174 Fri, 26 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732174-otsukas-centanafadine-scores-in-adhd-comorbid-anxiety-trial Illustration of woman with anxiety, ADHD The EMA is recommending withdrawing Amgen Inc.’s complement inhibitor Tavneos (avacopan) from the market in Europe, saying data provided at the time it assessed the MAA “were found to be incorrect and misleading and could no longer be relied upon for demonstrating Tavneos’ effectiveness.” http://www.bioworld.com/articles/732171 Fri, 26 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732171-ema-to-pull-amgens-tavneos-over-incorrect-and-misleading-data Tavneos Credit: Amgen Inc. Abbisko Therapeutics Co. Ltd. has entered a research collaboration and license agreement with Eli Lilly and Co. to discover and develop innovative medicines across multiple targets, with the aim of advancing novel drug candidates with global potential. http://www.bioworld.com/articles/732203 Thu, 25 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/732203-lilly-taps-abbisko-for-19b-discovery-deal Microscope Nuvectis Pharma Inc.’s shares climbed further after the oncology-focused biotech nabbed select rights to a late-stage complement factor B inhibitor (HSK-39297/NXP-100) and a phase I BRAF inhibitor (HSK-42360/NXP-200) from Haisco Pharmaceutical Group Co. Ltd. for $40 million up front. http://www.bioworld.com/articles/732081 Wed, 24 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732081-nuvectis-shares-continue-to-rally-after-146b-haisco-deal Dollar symbol with arrow graph Antares Therapeutics Inc. drew Novartis AG to the table for a potential $1.9 billion collaboration, including a $105 million up-front payment, to discover small-molecule programs against oncology targets considered to be undruggable. It’s Antares’ first partnership since spinning out of Scorpion Therapeutics Inc. about a year ago. http://www.bioworld.com/articles/732077 Wed, 24 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732077-antares-novartis-pursuing-undruggable-cancer-targets-in-19b-deal Cancer cell in the cross-hairs Abbisko Therapeutics Co. Ltd. has entered a research collaboration and license agreement with Eli Lilly and Co. to discover and develop innovative medicines across multiple targets, with the aim of advancing novel drug candidates with global potential. http://www.bioworld.com/articles/732075 Wed, 24 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732075-lilly-taps-abbisko-for-19b-discovery-deal Microscope Corxel Pharmaceuticals Ltd.’s oral small-molecule GLP-1 receptor agonist, CX-11, met the primary endpoints in a phase II trial evaluating the candidate in obese and overweight patients in the U.S., according to top-line results. http://www.bioworld.com/articles/732050 Wed, 24 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732050-corxel-vincentages-oral-glp-1-meets-phase-ii-obesity-endpoints Glass of water and tablets J-Pharma Co. Ltd. is progressing the most clinically advanced L-type amino acid transport 1 (LAT1) inhibitor, nanvuranlat (JPH‑203), in a global phase III Beacon-BTC study of biliary tract cancer following U.S. FDA alignment. http://www.bioworld.com/articles/732153 Tue, 23 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732153-j-pharma-drives-first-cancer-lat1-to-phase-iii-study-with-fda-nod Illustration of cancer in the bile ducts SK Biopharmaceuticals Co. Ltd. is doubling down on AI-powered drug discovery through a new collaboration with Insilico Medicine Inc. valued at more than $2.5 billion. The milestone-heavy deal, announced at the BIO International Convention in San Diego June 22, will pair Insilico’s Pharma.AI platform with SK Biopharm’s central nervous system (CNS) drug development and commercialization capabilities, underscoring Korean and global biopharma efforts to embed AI across the entire R&D lifecycle. http://www.bioworld.com/articles/732063 Tue, 23 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732063-sk-biopharm-taps-insilico-in-25b-ai-cns-drug-discovery-deal Capsule with brain on programming background.jpg Details were scant, but Biogen Inc. snagged a portfolio of early stage immunology-focused candidates by way of an acquisition deal for Raythera Inc. that could total as much as $1 billion. http://www.bioworld.com/articles/731923 Thu, 18 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731923-biogen-pads-immune-pipeline-with-1b-raythera-buy J-Pharma Co. Ltd. is progressing the most clinically advanced L-type amino acid transport 1 (LAT1) inhibitor, nanvuranlat (JPH‑203), in a global phase III Beacon-BTC study of biliary tract cancer following U.S. FDA alignment. http://www.bioworld.com/articles/731921 Thu, 18 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731921-j-pharma-drives-first-cancer-lat1-to-phase-iii-study-with-fda-nod Illustration of cancer in the bile ducts Alturos Therapeutics BV has advanced its lead candidate, ALT-0135, into IND-enabling studies. Alturos is targeting the earliest toxic triggers in Alzheimer’s disease, particularly protein oligomers that drive synaptic loss and neuronal death. http://www.bioworld.com/articles/732016 Thu, 18 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/732016-alturos-therapeutics-advances-alt-0135-into-ind-enabling-studies Elderly woman holding illustration of brain with missing puzzle piece Three years on from the rebuff of a U.S. FDA complete response letter, F2G Ltd. now has the data needed to resubmit the NDA for the first novel antifungal drug in more than two decades. Along with partner Shionogi & Co. Ltd., F2G has released positive phase III results for orally administered olorofim, showing noninferiority against I.V.-administered Ambisome (amphotericin B, Gilead Sciences Inc.) in patients with refractory aspergillosis infections, or who were unsuitable for mainstay azole therapy. http://www.bioworld.com/articles/731918 Thu, 18 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/731918-f2g-preps-nda-for-first-new-antifungal-in-20-years-on-solid-phase-iii Aspergillus fumigatus HMNC Brain Health GmbH has raised $50 million in the first close of a series B, enabling the company to prepare the way for phase III trials of its two lead programs. http://www.bioworld.com/articles/731906 Wed, 17 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731906-hmnc-raises-50m-series-b-to-prep-depression-drugs-for-phase-iii Blue-gray dollar sign Elixiron Immunotherapeutics Inc. announced positive interim open-label phase II Alzheimer’s disease (AD) study findings of enrupatinib, an oral brain-penetrant colony-stimulating factor 1 receptor inhibitor, with plans to move the asset into a biomarker-based and placebo-controlled study. http://www.bioworld.com/articles/731984 Tue, 16 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731984-elixirons-enrupatinib-shows-upbeat-interim-phase-ii-ad-results Illustration of amyloid plaques in Alzheimer's disease Takeda Pharmaceutical Co. Ltd.’s oral TYK2 inhibitor zasocitinib (TAK-279) demonstrated statistical superiority over Bristol Myers Squibb Co.’s first-in-class Sotyktu (deucravacitinib) in a top-line phase III Latitude Atlas readout of moderate to severe plaque psoriasis. http://www.bioworld.com/articles/731981 Tue, 16 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731981-takedas-zasocitinib-bests-sotyktu-in-phase-iii-psoriasis-trial Dermatology exam Dimerix Ltd. has signed an exclusive licensing deal with Everest Medicines Ltd. to commercialize its phase III kidney disease candidate DMX-200 in a transaction worth up to AU$481 million (US$340 million), plus sales royalties. http://www.bioworld.com/articles/731893 Tue, 16 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731893-dimerix-out-licenses-dmx-200-to-everest-in-au481m-deal Kidneys Demonstrating better tolerability and safety in comparison with standard of care, Edgewise Therapeutics Inc.’s EDG-7500 is moving toward a phase III trial for both obstructive and nonobstructive hypertrophic cardiomyopathy (HCM), the most common form of genetic heart disease. Boulder, Colo.-based Edgewise reported top-line phase II results from part D of the Cirrus-HCM trial, showing meaningful responses in terms of hemodynamics, biomarkers and patient-reported measures. http://www.bioworld.com/articles/731889 Tue, 16 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731889-edgewise-heads-to-phase-iii-with-solid-edg-7500-data-in-hcm Abstract blue human heart with red cardio pulse line and red circle Elixiron Immunotherapeutics Inc. announced positive interim open-label phase II Alzheimer’s disease (AD) study findings of enrupatinib, an oral brain-penetrant colony-stimulating factor 1 receptor inhibitor, with plans to move the asset into a biomarker-based and placebo-controlled study. http://www.bioworld.com/articles/731877 Mon, 15 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731877-elixirons-enrupatinib-shows-upbeat-interim-phase-ii-ad-results Illustration of amyloid plaques in Alzheimer's disease Takeda Pharmaceutical Co. Ltd.’s oral TYK2 inhibitor zasocitinib (TAK-279) demonstrated statistical superiority over Bristol Myers Squibb Co.’s first-in-class Sotyktu (deucravacitinib) in a top-line phase III Latitude Atlas readout of moderate to severe plaque psoriasis. http://www.bioworld.com/articles/731816 Fri, 12 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731816-takedas-zasocitinib-bests-sotyktu-in-phase-iii-psoriasis-trial Dermatology exam Tolerability is a key factor in the appeal of Enliven Therapeutics Inc.’s ELVN-001 for previously treated chronic myeloid leukemia (CML), which yielded positive updated phase I data from the Enable trial. Dennis Kim, hematologist from Princess Margaret Cancer Center in Toronto, said he would use the drug for a patient “who doesn’t have any other options.” http://www.bioworld.com/articles/731799 Thu, 11 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731799-enlivens-phase-i-cml-data-enable-phase-iii-with-bcr-abl1-bid Microscopic image of chronic myeloid leukemia