Pharmaceuticals & Biopharmaceuticals

SOLA Japan Wins ¥6B AMED Grant for ALS Gene Therapy SOL-257

Tokyo – September 28, 2026 -- SOLA Biosciences Japan GK has secured a grant of approximately 6 billion yen over five years from Japan's Agency for Medical Research and Development (AMED) to advance SOL-257, a gene therapy candidate targeting the TDP-43 protein implicated in amyotrophic lateral sclerosis (ALS). The award, granted under AMED's Strengthening Program for Pharmaceutical Startup Ecosystem, was announced June 5, 2026, and positions SOLA Japan as the company's central development hub for the program.

AMED grant targets a pathology present in 97% of ALS cases

SOL-257 is designed to restore the structure and function of misfolded TDP-43, a protein that becomes mislocalized and aggregated in motor neurons in roughly 97% of ALS cases, according to SOLA. The company describes SOL-257 as a potentially first-in-class, disease-modifying gene therapy built on its proprietary JUMP70 platform.

Grünenthal, DKSH Expand Pain Drug Access to Eight Asia-Pacific Markets

Aachen, Germany – September 28, 2026 -- Grünenthal and DKSH Business Unit Healthcare have signed a new commercialisation agreement to bring four pain medicines, Qutenza, Vimovo, Palexia and Zomig, to eight Asia-Pacific markets: Hong Kong, Indonesia, Malaysia, the Philippines, Singapore, Taiwan, Thailand and Vietnam.

DKSH takes over local regulatory filings and distribution across eight markets

Under the agreement, DKSH will seek local marketing authorisations and handle marketing, medical affairs, market access, sales and distribution for the four medicines in each of the eight markets, pending regulatory approval. Grünenthal will retain manufacturing responsibility through its global production network. Each market could gain access to up to four new medicines depending on approval timelines.

Akeso Enrolls First Patient in Global Phase III Gastric Cancer Trial

Hong Kong – September 28, 2026 -- Akeso, Inc. (9926.HK) has enrolled the first patient in COMPASSION-37, a global Phase III head-to-head trial testing its bispecific antibody cadonilimab against nivolumab as first-line treatment for HER2-negative advanced gastric and gastroesophageal junction (G/GEJ) adenocarcinoma.

Trial pits cadonilimab plus chemotherapy against nivolumab-based standard of care

The multicenter study compares cadonilimab combined with chemotherapy to chemotherapy with or without nivolumab in previously untreated, unresectable or metastatic G/GEJ patients. It is co-led by Dr. Yelena Y. Janjigian of Memorial Sloan Kettering Cancer Center, Professor Markus Möhler of Johannes Gutenberg University Mainz, and Professors Jiafu Ji and Lin Shen of Peking University Cancer Hospital. Janjigian, Möhler and Shen were investigators on the earlier CheckMate 649 trial, which established nivolumab plus chemotherapy as a global first-line standard.

FUCASO Hits 95.9% Response Rate in China Real-World Myeloma Study

Shanghai – September 27, 2026 -- IASO Biotechnology's CAR-T therapy FUCASO achieved a 95.9% objective response rate and 77.2% complete/stringent complete response rate in a real-world study of 281 heavily pretreated Chinese patients with relapsed or refractory plasma cell neoplasms, data presented at the 2026 International Myeloma Society Annual Meeting show.

Real-world cohort skews higher-risk than pivotal trial population

The multicenter study tracked patients treated since FUCASO's June 2023 launch across China. Median age was 61 years, with 18.7% aged 70 or older, and patients had received a median of four prior therapy lines, up to 12. Prior anti-CD38 exposure reached 84.0%, 27.4% were penta-exposed, and 46.9% had undergone autologous stem cell transplantation. High-risk cytogenetic abnormalities affected 82.4% of patients, 50.5% were ISS stage III, 7.8% had plasma cell leukemia, and 47.0% presented extramedullary disease.

STEMREGEN Ranks No. 332 on Inc. 5000 With 1,017% Growth

Whitefish, Mont. – September 26, 2026 -- STEMREGEN, a maker of science-backed stem cell supplements, has landed at No. 332 on the 2026 Inc. 5000 list after posting 1,017% revenue growth over three years, far outpacing the list's 130% median.

Company secures third straight Inc. 5000 ranking as growth trajectory accelerates

STEMREGEN previously ranked No. 265 in 2025 and No. 1,765 in 2024, marking three consecutive years on the annual list of America's fastest-growing private companies. The 2026 ranking measures revenue growth from 2022 through 2025.

MAYPHARM Launches HYALMASS AQUATOX, a Five-Active Aesthetic Formula

Seoul – September 26, 2026 -- MAYPHARM has announced the upcoming launch of HYALMASS AQUATOX, a new aesthetic formulation combining five high-interest active ingredients into a single product for the global cosmeceutical market.

MAYPHARM combines five actives into one formulation to meet multifunctional demand

The new product integrates PDRN, Exosomes, Botulinum Peptide, GHK-Cu, and Succinic Acid in one advanced skin solution. Botulinum Peptide is designed to support a smoother skin appearance, while GHK-Cu is studied for skin conditioning and regeneration. Succinic Acid is positioned for antioxidant activity, PDRN for skin regeneration and recovery, and Exosomes for advanced rejuvenation approaches.

AI Clinical Trials Market to Hit $7.32B by 2034, 15.5% CAGR

Pune, India – September 26, 2026 -- The global AI in Clinical Trials Market is set to more than triple from USD 2 billion in 2025 to USD 7.32 billion by 2034, expanding at a 15.5% compound annual growth rate, according to Maximize Market Research.

Pharmaceutical firms accelerate AI adoption to cut trial delays

Pharmaceutical and biotechnology companies, along with contract research organizations, hospitals and research institutes, are deploying machine learning, natural language processing and deep learning to speed patient screening, cohort selection, trial design and large-scale data analysis. These tools are applied across Phase I, Phase II and Phase III trials for patient recruitment, safety monitoring, drug discovery and personalized medicine.

Clinical Trials Market to Hit $99.4B by 2034 on AI, Decentralized Trial Growth

Pune – September 26, 2026 -- The global clinical trials market reached USD 58.19 billion in 2025 and is forecast to grow at a 6.13% compound annual rate through 2034, reaching USD 99.4 billion, according to Maximize Market Research.

North America retains dominant share on trial infrastructure and R&D spend

North America leads global trial activity, underpinned by extensive pharmaceutical and biotechnology infrastructure, significant cancer research burden, and the presence of major contract research organizations. The United States drives the bulk of regional Phase I-IV trial volume, while Canada contributes through government investment in trial infrastructure. Europe holds a substantial share as well, with the UK, France, Germany, Italy, Spain, Sweden and Austria supporting research across oncology, cardiovascular disease, CNS conditions, diabetes, obesity and autoimmune disorders.

NeuroSense Cuts H1 Costs 28%, Targets Dec. 2026 Canada ALS Filing

Cambridge, Mass. – September 26, 2026 -- NeuroSense Therapeutics (NASDAQ: NRSN) cut operating expenses to $3.4 million in the first half of 2026, down from $4.7 million a year earlier, as the biotech pushes its ALS candidate PrimeC toward a Canadian regulatory filing targeted for December 2026.

NeuroSense trims R&D and G&A spending by double digits in H1 2026

Research and development expenses fell 16% to $2,102 thousand from $2,503 thousand, driven by lower subcontractor and consultant costs, partly offset by higher share-based payment expense. General and administrative expenses dropped 38.6% to $1,345 thousand from $2,189 thousand on reduced professional services spending.

IASO Bio's RD140 CAR-T Hits 88.9% Response Rate in Myeloma Trial

Shanghai – September 26, 2026 -- IASO Biotechnology reported an 88.9% objective response rate for its dual-targeted CAR-T therapy RD140 in a first-in-human Phase 1 trial of nine heavily pretreated multiple myeloma and plasma cell leukemia patients, with the response rate reaching 100% in the higher-dose cohort.

RD140 achieves 88.9% MRD negativity in high-risk relapsed patients

The investigator-initiated trial (NCT06655519), led by Professor Jin Lu of Peking University People's Hospital, enrolled patients who had failed at least three prior lines of therapy, including two who had previously received BCMA-targeted treatment. All nine patients were triple-class exposed, and six were penta-exposed. As of the September 26, 2026 data cutoff, with a median follow-up of 6.05 months, 88.9% of patients achieved MRD negativity at the 10−5 threshold, with six reaching this benchmark as early as day 28. Median progression-free survival has not been reached.