Latest Gmp Manufacturing News

Island Pharmaceuticals has begun GMP production of Galidesivir, with the first 5kg batch targeted for an investigational Ebola treatment program in Uganda. A second batch is intended to support a pivotal Marburg animal study under the FDA’s Animal Rule pathway.

Patrys has dosed the first participants in the Phase 1a trial of RLS-2202, moving its intravenous quetiapine formulation into human clinical evaluation. The next test comes in October, when an independent safety committee will decide whether the program can advance to Cohort 2.

Telix will acquire ITM in a proposed US$1.65 billion deal that combines a commercial radioisotope supplier with Telix’s precision medicine and therapeutic pipeline. The transaction could give Telix greater supply-chain control and entry into a validated cancer treatment market, but it also brings dilution, integration risk and an unresolved FDA pathway for ITM-11.

ECS Botanics boosted revenue by 10% to $21.4 million in FY26, delivering positive EBITDA and operating cash flow while advancing international market entry and branded product growth.

NeuroScientific Biopharmaceuticals posted a $4.69 million loss for FY2026, driven by R&D ramp-up and clinical progress with its StemSmart™ platform, while halting independent development of its glaucoma drug EmtinB to pursue licensing deals.

Island Pharmaceuticals has commissioned a second manufacturing run of its antiviral Galidesivir, aiming to stockpile up to 800 treatment courses by late 2026 to support rapid response to the fast-spreading Bundibugyo Ebola outbreak and biodefence efforts.

Entropy Neurodynamics has partnered with BioCina to establish GMP manufacturing for its intravenous psilocin formulation TRP-8803, a critical step toward late-stage clinical trials and commercialisation.

Island Pharmaceuticals has marked a major step forward in its antiviral program with the start of GMP manufacturing for Galidesivir, expanded USAMRIID collaboration, and FDA orphan drug designation. Regulatory approvals for compassionate use in Uganda’s Ebola outbreak and a new dose optimisation study with Texas Biomed further de-risk the pathway to approval.

BLS Pharmaceuticals capped FY2026 with record quarterly revenue and operating cash flow, driven by international expansion and new supply agreements across regulated markets.

Argent BioPharma has eliminated US$5.5 million in secured debt through a global licensing agreement for its CannEpil® epilepsy therapy, while completing a key acquisition and advancing clinical trials in veterinary therapeutics.

BLS Pharmaceuticals capped FY26 with record revenue and EBITDA, boosted by international expansion and major contracts, setting the stage for further growth in FY27.

ECS Botanics delivered a fourth consecutive quarter of positive operating cash flow in Q4 FY26, with a full-year turnaround of $5.9 million. The company’s branded B2C revenue surged 31% year-on-year, supported by product launches and European market expansion.