https://www.bioworld.com/rss en-us News of the first-ever successful head-to-head phase III study testing an oral antiviral therapy for hepatitis C virus (HCV) might not have had much impact on Atea Pharmaceuticals Inc.’s share price, but analysts remained optimistic for the future of the once-daily fixed-dose combination of bemnifosbuvir and ruzasvir. http://www.bioworld.com/articles/732943 Wed, 29 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732943-ateas-hep-c-pill-looks-solid-in-phase-iii-head-to-head-hcv-study Illustration of liver infection The saga of Capricor Therapeutics Inc.’s allogeneic cell therapy deramiocel for cardiomyopathy in Duchenne muscular dystrophy (DMD) added another bleak chapter as the U.S. FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee voted on the question of whether the available data provide “substantial evidence” that the drug works. Balloting turned out 9 no, 3 yes. http://www.bioworld.com/articles/732941 Wed, 29 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732941-resin-peace-capricor-sap-spat-weak-data-foil-dmd-adcom-bid 3D rendering of human cells or embryonic stem cells After repeatedly invoking the Fifth Amendment to every question asked during the July 29 hearing of the U.S. Senate Homeland Security Committee, Anthony Fauci, the now retired head of the NIH’s National Institute of Allergy and Infectious Diseases, faces a committee vote next week on a resolution citing him for contempt. http://www.bioworld.com/articles/732940 Wed, 29 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732940-faucis-silence-may-put-him-in-contempt-of-congress Anthony Fauci at Senate hearing 7-29 Anthony Fauci, retired NIAID director, at the July 29 hearing of the U.S. Senate Homeland Security Committee. Credit: hsgac.senate.gov Shape Therapeutics Inc. has been awarded a research grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to advance SHP-201, the company’s lead gene therapy candidate. http://www.bioworld.com/articles/733003 Wed, 29 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/733003-mjff-grant-supports-shapes-shp-201-through-ind-enabling-studies Parkinson's disease illustration showing neurons containing alpha-synuclein Torrey Pines Medicine (Shenzhen) Ltd. has completed an angel financing round as it advances next-generation ultralong-acting peptide therapeutics for metabolic diseases. http://www.bioworld.com/articles/733002 Wed, 29 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/733002-torrey-pines-medicine-secures-funding-to-advance-metabolic-programs Art concept for metabolism Researchers from Jacobio Pharmaceuticals Co. Ltd. recently presented preclinical data on JAB-BX600, an EGFR-directed antibody-drug conjugate (ADC) that selectively delivers a KRAS G12D inhibitor to tumor cells, allowing dual inhibition of the EGFR-KRAS pathway. http://www.bioworld.com/articles/733000 Wed, 29 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/733000-jab-bx600-shows-promise-in-kras-g12d-cancers Taiwan’s biotechnology sector was built around domestic health needs, including vaccines and drug manufacturing, but it is increasingly looking outward – to international partnerships, licensing, clinical development and a bigger role in the global biomedical ecosystem. http://www.bioworld.com/articles/733044 Tue, 28 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/733044-taiwan-biotech-looks-outward-in-next-phase-of-growth Lee-Cheng Liu, chairman, Taiwan BIO Lee-Cheng Liu, chairman, Taiwan BIO New drug approvals, financings and deals were seen across the Asia-Pacific biotech sector this week, with China’s National Medical Products Administration (NMPA) granting clearances to Takeda Pharmaceutical Co. Ltd.’s oral orexin receptor 2 agonist oveporexton for narcolepsy, as well as Haisco Pharmaceutical Group’s ciprocopan (HSK-39297) for paroxysmal nocturnal hemoglobinuria. http://www.bioworld.com/articles/733043 Tue, 28 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/733043-apac-roundup-nmpa-nods-lupins-16m-spinoff-car-t-data-more Globe isolated on white background with focus on Asia and Australia Kolon Tissuegene Inc.’s TG-C, an allogeneic cell and gene therapy candidate for knee osteoarthritis (OA), missed both co-primary endpoints and all key secondary endpoints in a highly anticipated top-line phase III clinical trial readout. http://www.bioworld.com/articles/733042 Tue, 28 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/733042-kolon-tissuegene-shares-fall-as-tg-c-misses-knee-oa-endpoints 3D illustration of knee joint Otsuka Pharmaceutical Co. Ltd. will likely look next to expand the label of Simtriyo (centanafadine) into patients with comorbid anxiety, having won the U.S. FDA’s green light as a once-daily extended-release capsule for attention deficit hyperactivity disorder (ADHD) in adults plus pediatrics age 6 years and older who weigh at least 20 kg (about 44 lbs.). http://www.bioworld.com/articles/733041 Tue, 28 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/733041-otsukas-simtriyo-nod-qelbree-vs-three-in-adhd Tangled lines above silhouette Altimmune Inc. and Wall Street are mulling the size and scope of a phase III trial after positive top-line results were made public from the Reclaim phase II trial with pemvidutide (pemvi), a balanced glucagon/GLP-1 dual receptor agonist, in patients with moderate to severe alcohol use disorder (AUD). CEO Jerry Durso called the Reclaim data “the most robust we’ve seen” in the condition. http://www.bioworld.com/articles/732929 Tue, 28 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732929-altimmune-on-peth-to-phase-iii-in-aud-with-pemvi Bottles of alcohol with hand pouring into glass Suggesting Replimune Group Inc.’s statistical analysis method inflated responses in the single-arm phase II Ignyte trial of RP-1 (suvolimogene oderparepvec), briefing documents ahead of the U.S. FDA’s Cellular, Tissue, and Gene Therapies advisory committee meeting on July 30 sent the company’s shares spiraling downward by about 38%. http://www.bioworld.com/articles/732927 Tue, 28 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732927-replimunes-rollercoaster-fda-adcom-signals-another-bumpy-ride Path shaped like a fluctuating arrow graph Ascletis Pharma Inc. has released preclinical data for ASC-37, a next-generation glucagon-like peptide 1 receptor (GLP-1R)/gastric inhibitory polypeptide receptor (GIPR)/glucagon receptor (GCGR) triple peptide agonist. http://www.bioworld.com/articles/732982 Tue, 28 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732982-ascletis-pharmas-asc-37-shows-weight-loss-in-dio-mice Doctor measuring patient's waist Biomarin Pharmaceutical Inc. and the n-Lorem Foundation have signed a strategic collaboration and global exclusive license agreement to develop a first-in-disease antisense oligonucleotide (ASO) medicine for people with ReNU syndrome, a rare neurodevelopmental condition caused by variants in the RNU4-2 gene. http://www.bioworld.com/articles/732981 Tue, 28 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732981-biomarin-and-n-lorem-partner-on-aso-for-renu-syndrome Silhouette made of gears Promatix Biosciences Ltd. has been awarded an Innovate UK Biomedical Catalyst grant to support development of its lead program, PBS-293-exatecan, a first-in-class EGFR x EphA2 cis-bispecific antibody-drug conjugate. http://www.bioworld.com/articles/732979 Tue, 28 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732979-promatix-advances-pbs-293-exatecan-with-innovate-uk-grant Colon cancer illustration Taiwan’s biotechnology sector was built around domestic health needs, including vaccines and drug manufacturing, but it is increasingly looking outward – to international partnerships, licensing, clinical development and a bigger role in the global biomedical ecosystem. http://www.bioworld.com/articles/732918 Mon, 27 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732918-taiwan-biotech-looks-outward-in-next-phase-of-growth Lee-Cheng Liu, chairman, Taiwan BIO Lee-Cheng Liu, chairman, Taiwan BIO Maplight Therapeutics Inc. is betting that the next competitive battleground in schizophrenia will be less about whether muscarinic agonists work and more about whether patients can stay on them and whether they offer benefits beyond psychosis. http://www.bioworld.com/articles/732916 Mon, 27 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732916-maplight-aims-to-differentiate-muscarinic-agonist-from-competitors Brain with puzzle piece removed Otsuka Pharmaceutical Co. Ltd. will likely look next to expand the label of Simtriyo (centanafadine) into patients with comorbid anxiety, having won the U.S. FDA’s green light as a once-daily extended-release capsule for attention deficit hyperactivity disorder (ADHD) in adults plus pediatrics age 6 years and older who weigh at least 20 kg (about 44 lbs.). http://www.bioworld.com/articles/732915 Mon, 27 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732915-otsukas-simtriyo-nod-qelbree-vs-three-in-adhd Tangled lines above silhouette With its stock price falling as much as 70% July 27, Capricor Therapeutics Inc. took the rare step of issuing a news release to explain the negative tone of the U.S. FDA’s briefing document for the July 29 Cellular, Tissue and Gene Therapies Advisory Committee meeting to discuss the company’s BLA for deramiocel to treat cardiomyopathy in Duchenne muscular dystrophy. http://www.bioworld.com/articles/732914 Mon, 27 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732914-adcom-cage-match-in-store-for-capricor FDA logo on textured paper Credit: Araki Illustrations - stock.adobe.com Fortvita Biologics Inc. and Innovent Biologics (Hangzhou) Co. Ltd. have patented bispecific antibody-drug conjugates (ADCs) comprising a bispecific humanized monoclonal antibody targeting EGFR and hepatocyte growth factor receptors (HGFR; MET) linked to cytotoxic drugs reported to be useful for the treatment of cancer. http://www.bioworld.com/articles/732970 Mon, 27 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732970-fortvita-biologics-and-innovent-biologics-disclose-new-bispecific-adcs-targeting-egfr-and-hgfr Veraxa Biotech AG has reported the advancement of its bispecific antibody-drug conjugate (bsADC) program VXA-222, following achievement of a technical milestone in its alliance with Omniab Inc. The program is moving into its next collaboration phase. http://www.bioworld.com/articles/732960 Mon, 27 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732960-veraxa-biotech-advances-bispecific-adc-from-omniab-collaboration 3D rendering of a drug capsule and flying antibodies Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. said its IND application was approved in China for SKB-565, its dual-payload antibody-drug conjugate (ADC), for the treatment of advanced solid tumors. http://www.bioworld.com/articles/732959 Mon, 27 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732959-kelun-biotechs-skb-565-cleared-to-enter-clinic-in-china Antibody-drug conjugate illustration New drug approvals, financings and deals were seen across the Asia-Pacific biotech sector this week, with China’s National Medical Products Administration (NMPA) granting clearances to Takeda Pharmaceutical Co. Ltd.’s oral orexin receptor 2 agonist oveporexton for narcolepsy, as well as Haisco Pharmaceutical Group’s ciprocopan (HSK-39297) for paroxysmal nocturnal hemoglobinuria. http://www.bioworld.com/articles/732867 Fri, 24 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732867-apac-roundup-nmpa-nods-lupins-16m-spinoff-car-t-data-more Globe isolated on white background with focus on Asia and Australia Sanofi SA will not seek approval of amlitelimab in atopic dermatitis (AD) as previously planned, stating that the OX40-ligand monoclonal antibody “would not represent a meaningful improvement to the standard of care” for patients with moderate to severe disease. The company said the decision, which marks an about-face as Sanofi had been looking to amlitelimab as a possible successor to its Regeneron Pharmaceuticals Inc.-partnered blockbuster AD drug Dupixent (dupilumab), comes as part of an ongoing assessment of the pipeline. http://www.bioworld.com/articles/732866 Fri, 24 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732866-sanofi-scraps-plans-for-amlitelimab-filings-in-atopic-dermatitis Hand holding elbow Bioray Pharmaceutical Co. Ltd. has prepared and tested new antibody-drug conjugates consisting of antibodies covalently linked to payloads. They are reported to be potentially useful for the treatment of cancer, infections, inflammatory and immunological disorders. http://www.bioworld.com/articles/732910 Fri, 24 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732910-antibody-drug-conjugates-reported-in-bioray-pharmaceutical-patent Jiangsu Hengrui Pharmaceuticals Co. Ltd. and Shanghai Hengrui Pharmaceutical Co. Ltd. have divulged new antibody-drug conjugates comprising antibodies targeting carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5; CEA; CD66e) covalently linked to a cytotoxic drug potentially useful for the treatment of colorectal cancer. http://www.bioworld.com/articles/732908 Fri, 24 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732908-hengrui-synthesizes-new-adcs-targeting-ceacam5 Apertura Gene Therapy LLC has announced its participation in a consortium selected to receive funding from the Advanced Research Projects Agency for Health (ARPA-H) THRIVE program to develop gene therapies for rare childhood diseases. http://www.bioworld.com/articles/732900 Fri, 24 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732900-apertura-gene-therapy-joins-thrive-consortium Brain and DNA HCW Biologics Inc. has requested a type B (pre-IND) meeting with the FDA to discuss the development and regulatory strategy for its investigational tetravalent T-cell engager (TCE), HCW-11-018b, for solid tumors. http://www.bioworld.com/articles/732898 Fri, 24 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732898-hcw-biologics-seeks-pre-ind-meeting-with-fda-for-hcw-11-018b 3D illustration of T cells fighting cancer The nomination of Erica Schwartz as the next director of the U.S. CDC moved incrementally forward, gaining the support of a key Republican senator. Meanwhile, a delay in the scheduled committee vote July 23 to send her nomination to the Senate floor suggested she will need all the support she can get. http://www.bioworld.com/articles/732854 Thu, 23 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732854-schwartz-picks-up-critical-support-on-path-to-cdc-confirmation Senate HELP Chair Bill Cassidy In a brief session Thursday, Senate HELP Committee Chair Bill Cassidy said he would vote to confirm Erica Schwartz as CDC director. Credit: help.senate.gov Scoring high marks on two more phase III obesity trials, this time involving serious type 2 diabetes and cardiovascular complications, Eli Lilly and Co. has cleared the path for a BLA filing for its triple-G candidate retatrutide, which many expect will eventually surpass the top two marketed drugs in the space. http://www.bioworld.com/articles/732852 Thu, 23 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732852-lillys-triple-g-retatrutide-best-in-class-as-bla-filing-nears Feet on scale