Latest Regulatory Incentives News

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Island Pharmaceuticals will host a webinar to discuss the FDA's feedback on the clinical development and regulatory approval of its antiviral drug Galidesivir, including key considerations under the FDA's Animal Rule and Priority Review Voucher eligibility.
Ada Torres
Ada Torres
13 Nov 2025
Osmond Resources has completed geological logging of its first drill hole at the Orión EU Critical Minerals Project, identifying seven promising mineral layers. A second drill rig is now operational to further test the continuity of these layers.
Maxwell Dee
Maxwell Dee
15 Oct 2025
Dimerix Limited’s lead drug candidate DMX-200 has been granted Orphan Drug Designation in Japan for treating Focal Segmental Glomerulosclerosis (FSGS), enhancing its regulatory and commercial prospects in a key market.
Ada Torres
Ada Torres
30 Sept 2025
Island Pharmaceuticals has won a crucial FDA Type C meeting to discuss fast-tracking its antiviral Galidesivir for Marburg virus treatment, with written feedback expected by November.
Victor Sage
Victor Sage
19 Sept 2025
Neurotech International reported a 23% revenue drop and a doubling of its net loss to $10.6 million for FY25, driven by reduced R&D grants and high development costs. Despite financial pressures, the company marked significant clinical and regulatory progress for its NTI164 cannabinoid therapy.
Ada Torres
Ada Torres
29 Aug 2025
Neurizon Therapeutics reported a $16.6 million loss for FY2025 amid significant progress in its lead neurodegenerative therapy NUZ-001, including regulatory milestones and a global licensing deal. The company is poised to enter a pivotal ALS clinical trial pending FDA clearance.
Ada Torres
Ada Torres
26 Aug 2025
Prescient Therapeutics has launched a $7 million Share Purchase Plan at a notable discount to fund the next phase of clinical trials for its promising PTX-100 cancer therapy. The capital raise aims to accelerate progress toward regulatory approval and patient access.
Ada Torres
Ada Torres
1 July 2025
Island Pharmaceuticals has reported encouraging Phase 2a/b trial results for ISLA-101, demonstrating meaningful reductions in dengue viral load and symptoms in humans. The findings support further clinical development of this antiviral candidate.
Ada Torres
Ada Torres
12 June 2025
Dimerix has activated the first clinical trial site in Japan for its pivotal Phase 3 ACTION3 study targeting FSGS, triggering a significant milestone payment from its Japanese partner FUSO Pharmaceutical.
Ada Torres
Ada Torres
30 May 2025
Dimerix Limited’s ACTION3 Phase 3 trial for DMX-200 in treating FSGS kidney disease has passed its sixth independent safety review with no concerns, reinforcing the drug’s promising safety profile.
Ada Torres
Ada Torres
22 May 2025
Pantera Lithium has identified six high-priority drilling locations for its Smackover Lithium Brine Project, supported by promising Arkansas legislation offering fiscal and regulatory incentives that could reshape the project's economics.
Maxwell Dee
Maxwell Dee
29 Apr 2025
Neuren Pharmaceuticals has received a significant cash inflow of approximately US$50 million following the sale of a Priority Review Voucher linked to its Rett syndrome treatment. This milestone underscores the growing value of Neuren’s neurological drug portfolio and its partnership with Acadia Pharmaceuticals.
Victor Sage
Victor Sage
7 Feb 2025