Pharmaceuticals & Biopharmaceuticals

Alameda, Calif. – September 09, 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.

Bridgewater, N.J. – September 09, 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 September 09, 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.

Beijing/Florence – September 09, 2026 -- Gan & Lee Pharmaceuticals (603087.SH) has signed an exclusive licensing agreement with Italy's The Menarini Group for its GLP-1 receptor agonist bofanglutide, a deal worth up to €726 million excluding royalties.

Gan & Lee secures €62 million upfront payment plus milestone potential of €664 million

Under the terms, Gan & Lee will receive a €62 million upfront payment, up to €664 million in milestone payments, and double-digit royalties on net sales across the licensed territory. Menarini will handle regulatory filings and commercialization in 39 countries, covering all 27 European Union member states, the United Kingdom, Switzerland, Norway, Iceland, Liechtenstein and Balkan nations.

San Francisco – September 09, 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 September 09, 2026, granting Thryv rights across all fields of use and territories, with sublicensing rights included.

Shanghai – September 09, 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).

Beijing/Florence – September 09, 2026 -- Gan & Lee Pharmaceuticals (603087.SH) has signed an exclusive license agreement with Italy's Menarini Group worth up to €726 million, excluding royalties, to develop and commercialize the obesity drug bofanglutida across 39 European markets.

Gan & Lee secures €62 million upfront with milestones reaching €664 million

Under the deal, Gan & Lee will receive an initial payment of €62 million, milestone payments totaling up to €664 million, and double-digit royalties on net sales within the licensed territory. Menarini will handle regulatory filings and commercialization in the 27 European Union member states, the United Kingdom, Switzerland, Norway, Iceland, Liechtenstein and Balkan countries.

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.

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.

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.

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.