Biopharmaceuticals

Acepodia Wins FDA Clearance for Dual-Payload ADC ACE723 in Liver Cancer

Alameda, Calif. – September 08, 2026 -- Acepodia (6976: TT) said the U.S. Food and Drug Administration has cleared its Investigational New Drug application for ACE723, a GPC3-targeted dual-payload antibody-drug conjugate, clearing the way for a Phase 1 clinical trial in unresectable or metastatic hepatocellular carcinoma (HCC).

FDA clearance advances first candidate from Acepodia's AD2C platform into human trials

ACE723 is built on Acepodia's proprietary Antibody-Dual-Drugs Conjugation (AD2C) platform, which combines antibody engineering, medicinal chemistry and tumor biology to deliver two cytotoxic payloads to a single tumor-targeting antibody. The compound targets GPC3, a tumor-associated antigen frequently expressed in HCC tumor cells.

Insmed Grants Equity Awards to 128 New Hires Under Nasdaq Inducement Plan

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Insmed Grants Equity Awards to 128 New Hires Under Nasdaq Inducement Plan

Bridgewater, N.J. – September 08, 2026 -- Insmed Incorporated (Nasdaq: INSM) has issued inducement equity awards to 128 newly hired employees, a move tied to its ongoing workforce expansion in the biopharmaceutical sector.

Insmed grants 115,320 restricted stock units to new hires as employment inducement

The awards, approved by Insmed's Compensation Committee, were granted on August 31, 2026, under the company's 2025 Inducement Plan. The plan is structured to comply with Nasdaq Listing Rule 5635(c)(4), which permits equity grants as a material inducement for new employees without requiring shareholder approval.

Thryv Licenses Second SGK1 Scaffold, Eyes Parkinson's and Alzheimer's

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Thryv Licenses Second SGK1 Scaffold, Eyes Parkinson's and Alzheimer's

San Francisco – September 08, 2026 -- Thryv Therapeutics Inc. has signed an exclusive, worldwide, royalty-bearing license for a new SGK1 inhibitor chemical series, opening a path toward Parkinson's and Alzheimer's disease treatments alongside its existing cardiac drug programs. The agreement with Spain's Consejo Superior de Investigaciones Científicas (CSIC), the Autonomous University of Madrid (UAM) and Fundación de la Universidad Autónoma de Madrid (FUAM) became effective July 1, 2026, granting Thryv rights across all fields of use and territories, with sublicensing rights included.

Pulnovo's PADN Device Cuts Heart Failure Risk 51% in Trial

Shanghai – September 08, 2026 -- Pulnovo Medical's pulmonary artery denervation (PADN) system reduced the risk of clinical worsening by 51% in patients with pulmonary hypertension linked to left heart disease, according to results from the PADN-HF-PH trial presented at the European Society of Cardiology (ESC) 2026 Congress and published simultaneously in The New England Journal of Medicine (NEJM).

Trial of 264 patients shows 51% risk reduction over two-year follow-up

The multicenter, randomized controlled trial, led by academician Yaling Han of the General Hospital of Northern Theater Command, enrolled 264 patients with pulmonary hypertension associated with left heart disease (PH-LHD). Over a median follow-up of 338 days, the estimated two-year incidence of clinical worsening was 25.7% in the PADN-plus-GDMT group versus 51.5% in the guideline-directed medical therapy (GDMT)-alone group (hazard ratio 0.49; 95% CI, 0.30 to 0.82; p=0.006).

EpiVax Launches AI-Enhanced ISPRI Platform for Biologics Risk

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EpiVax Launches AI-Enhanced ISPRI Platform for Biologics Risk

Providence, R.I. – September 08, 2026 -- EpiVax, Inc. has launched artificial intelligence-driven upgrades to its proprietary ISPRI platform, adding a new JanusMatrix 2.1 model, a tolerance-adjusted immunogenicity score, and an enhanced anti-drug antibody (ADA) prediction model for biotherapeutic developers.

JanusMatrix 2.1 applies AI to weight cross-conservation of human epitopes using expression and prevalence data.
The update is designed to produce more precise characterization of therapeutic epitopes and their tolerance profiles, building on EpiVax's existing EpiMatrix and JanusMatrix algorithms that assess T-cell epitope content and human cross-conservation.

Armata Publishes Cryo-EM Atlas of Ar-KM Phage Tied to AP-PA02

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Armata Publishes Cryo-EM Atlas of Ar-KM Phage Tied to AP-PA02

Los Angeles – September 08, 2026 -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) said a peer-reviewed paper in the Journal of Molecular Biology has mapped near-atomic resolution structures of eleven proteins in its Ar-KM bacteriophage, a Pseudomonas aeruginosa-targeting phage tied to the company's late-stage AP-PA02 program.

Researchers built atomic models of eleven structural proteins using cryo-electron microscopy

The study, titled "Insights into Genome Ejection by a Therapeutic phiKMV-like Bacteriophage," combined cryo-electron microscopy, proteomics and bioinformatics to capture three distinct states of the Ar-KM phage particle from a single purified preparation. The paper is published as J Mol Biol. 2026 Nov 1; 438(21):169993. AP-PA02, an inhaled bacteriophage candidate, has completed Phase 2 studies in cystic fibrosis and non-CF bronchiectasis patients with chronic pulmonary P. aeruginosa infection.

Superluminal Medicines Closes $60M Series B for Obesity Drug

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Superluminal Medicines Closes $60M Series B for Obesity Drug

Boston – September 08, 2026 -- Superluminal Medicines has closed an oversubscribed $60 million Series B financing led by BVF Partners, L.P., to fund a Phase 1 clinical trial for rare genetic forms of obesity expected to begin by the end of 2026.

New investors Deep Track Capital and Perceptive Advisors join the round

The financing includes participation from new investors Deep Track Capital and Perceptive Advisors, alongside existing backers RA Capital Management, Insight Partners, NVIDIA, Catalio Capital Management, Eli Lilly and Company, Cooley, and Gaingels.

Gan & Lee, Menarini Ink EUR726M Deal for GLP-1 Obesity Drug

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Gan & Lee, Menarini Ink EUR726M Deal for GLP-1 Obesity Drug

Beijing – September 08, 2026 -- Gan & Lee Pharmaceuticals (603087.SH) has signed an exclusive license agreement with Italy's Menarini Group worth up to EUR 726 million, excluding royalties, to register and commercialize its GLP-1 receptor agonist bofanglutide for obesity and overweight treatment across 39 countries.

Deal structure delivers EUR 62 million upfront with EUR 664 million in milestones

Gan & Lee will receive an upfront payment of EUR 62 million, milestone payments totaling up to EUR 664 million, and double-digit royalties on net sales in the licensed territory. Menarini takes responsibility for regulatory submissions and commercialization across the 27 EU Member States plus the United Kingdom, Switzerland, Norway, Iceland, Liechtenstein and Balkan countries.

Lundbeck Presents Bexicaserin Dual-Action Data at Epilepsy Congress

Valby, Denmark – September 07, 2026 -- Lundbeck will present preclinical data at the European Epilepsy Congress in Athens showing its investigational drug bexicaserin simultaneously increases inhibitory and decreases excitatory neuronal activity in hippocampal brain tissue, a dual mechanism the company says supports broad-spectrum antiseizure potential across multiple epilepsy types.

Preclinical study links dual mode of action to broader seizure control
The data, to be shown in an oral presentation at the September 5-9 congress, indicate bexicaserin's effects in preclinical models span focal, generalized motor and absence seizures across different underlying etiologies. Researchers attribute the effects to the compound's high affinity and selectivity for the 5-HT2C receptor, where it acts as a superagonist.

Insilico Medicine Joins HKEX Tech 100 Index Amid Record AI Drug Pipeline

Cambridge – September 07, 2026 -- Insilico Medicine (HKEX: 3696) will join the HKEX Tech 100 Index effective September 14, 2026, following methodology changes announced August 18, 2026, that widen the benchmark's exposure to the AI value chain. Index changes take effect after market close on September 11, 2026 (Friday).

HKEX Tech 100 Index tracks 100 leading Hong Kong tech names across six themes

The index measures 100 of the largest Hong Kong-listed companies with high exposure to technology themes eligible for Southbound Stock Connect. It spans artificial intelligence, biotech and pharmaceutical, electric vehicles and smart driving, information technology, internet, and robotics.