regulatory_update

Austin, Texas – September 13, 2026 -- Findhelp has become the first specialty exchange to register with the Maryland Health Care Commission (MHCC), enabling social care referral and reporting support for the state's Rural Health Transformation Program (RHTP).

Findhelp registers as Maryland's first specialty exchange under MHCC oversight

The registration allows Findhelp to help RHTP grant awardees manage social risk screening, referrals, data exchange, and reporting requirements. Health care providers and community-based organizations (CBOs) gain specialized technical capabilities intended to reduce barriers in care coordination for rural patients.

Vancouver – September 13, 2026 -- Century Lithium Corp. has submitted its Mine Plan of Operations and Nevada Reclamation Permit Application for the 100%-owned Angel Island lithium project in Esmeralda County, Nevada, starting the federal environmental review clock on one of the largest known sedimentary lithium deposits in the United States.

Company files 5,379-acre plan with U.S. Bureau of Land Management

The Plan of Operations was submitted September 3, 2026, to the BLM's Battle Mountain District, Tonopah Field Office, by wholly owned subsidiary Cypress Holdings (Nevada), Ltd. The document, prepared under 43 CFR Subpart 3809 and Nevada's NAC 519A regulations, will serve as the basis for the BLM's National Environmental Policy Act analysis. The Project Area covers 5,379 acres of BLM-administered public land, with approximately 2,364 acres of proposed disturbance.

Ramat Gan, Israel – September 13, 2026 -- Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) will rebrand as Eocene Ltd. and begin trading under the ticker EOCN on the Nasdaq Capital Market starting September 10, 2026, after terminating its $20 million standby equity purchase agreement with Yorkville and regaining compliance with Nasdaq's minimum bid price rule.

Company terminates $20 million Yorkville equity facility after raising $7.3 million

Galmed terminated its Standby Equity Purchase Agreement with YA II PN, Ltd. (Yorkville), effective September 8, 2026. The facility had provided up to $20 million in equity financing; the company raised approximately $7.3 million through the issuance of 437,947 ordinary shares before termination.

Berlin – September 13, 2026 -- Four of Germany's leading scientific and health organizations have issued a joint call for a cross-departmental national prevention strategy, warning that roughly 40 percent of new cancer cases remain preventable despite decades of research.

Four organizations unite behind a joint policy statement

The Leopoldina National Academy of Sciences, the German Council of Science and Humanities (Wissenschaftsrat), the German Cancer Research Center (DKFZ) and German Cancer Aid (Deutsche Krebshilfe) presented a shared statement demanding that prevention be embedded across all policy fields -- including education, labor, transport, urban planning, environment and social affairs -- rather than confined to the health ministry alone.

Toronto – September 13, 2026 -- Canada Nickel Company Inc. (TSXV: CNC) (OTCQB: CNIKF) has filed independent NI 43-101 technical reports on SEDAR+ supporting the initial mineral resource estimate for its Nesbitt Nickel Sulphide Project and an updated estimate for the Deloro Nickel Sulphide Project, both located near Timmins, Ontario and 100% owned by the company.

Technical reports confirm resource figures disclosed July 23, 2026

The two reports, issued September 8, 2026, carry mineral resource estimates with an effective date of July 23, 2026, and show no material differences from the figures the company disclosed in its July 23, 2026 news release. The estimates were prepared following CIM Definition Standards for Mineral Resources and Reserves dated November 29, 2019.

Dublin – – September 13, 2026 -- LUMA Vision has secured an expanded FDA clearance for VERAFEYE, its procedural intelligence platform for minimally invasive cardiac procedures, moving the company closer to a planned commercial launch in early 2027.

VERAFEYE now unifies digital anatomy creation, catheter tracking, and guidance on a single platform

The new clearance allows VERAFEYE to reconstruct 3D models of the left and right atria with CT-like accuracy using a single 360° imaging catheter that captures raw ultrasound data. The platform lets physicians visualize and document ablation delivery directly on the anatomy while maintaining continuous tracking of both imaging and ablation catheters through electromagnetic tracking and automated imaging.

Toronto – – September 13, 2026 -- Denarius Metals Corp. (Cboe CA: DMET; OTCQX: DNRSF) has secured a preferential option from the Regional Government of Castilla and Leon to acquire up to 28 new mining grids covering approximately 800 hectares adjacent to its Toral Project in Spain, a move that would expand its total land position in the Leon Mining District to roughly 3,700 hectares. The company separately disclosed a maiden NI 43-101 Mineral Resource Estimate for the 100%-owned Toral Project, prepared by Resource Development Associates with an effective date of July 24, 2026.

Vancouver – September 13, 2026 -- OceanaGold Corporation (TSX: OGC, NYSE: OGC) has lodged an application under New Zealand's Fast-track Approvals Act 2024 to extend the operating life of its Macraes gold mine from the current 2032 reserve horizon into the late 2030s.

OceanaGold targets late-2030s mine life through Phase 4 permitting

The Macraes Phase 4 Project (MP4) application, filed September 9, 2026, covers permitting for the existing reserve mine plan, development of the Southern Pit Innes Mills (SPIM) extension, extensions to the Golden Point Underground (GPUG), and flexibility to add further Mineral Resources to future production. Under New Zealand's 'one-stop shop' fast-track process, OceanaGold expects full permitting by mid-2027, subject to appeals. The company previously used the same mechanism to secure approval for its Waihi North Project in 2025.

Dallas – September 13, 2026 -- The U.S. Food and Drug Administration has accepted and filed the Biologics License Application for MOGENRY, an optogenetic gene therapy from Nanoscope Therapeutics designed to restore vision in retinitis pigmentosa patients with severe vision loss. If approved, MOGENRY would become the first gene-agnostic treatment available for this patient population, which currently has no approved therapy.

RESTORE trial data anchors the regulatory filing

The BLA is supported by the Phase 2b/3 RESTORE trial (NCT04945772), a multicenter, randomized, double-masked, sham-controlled study that met its primary and key secondary endpoints, showing improvements in visual acuity at weeks 52 and 76. No treatment-related serious adverse events were reported. Additional efficacy and safety data come from the earlier Phase 1/2a trial (NCT04919473).

Taipei – September 12, 2026 -- HanchorBio Inc. (TWSE: 7827) said the U.S. Food and Drug Administration has cleared its HCB101 Single-Patient Expanded Access Protocol (HCB101-EA-001) as "safe to proceed," allowing a Phase 1 patient who showed clinical benefit to continue receiving the investigational drug beyond the parent trial.

FDA authorizes continued treatment for a single Phase 1 patient

The clearance permits the patient to keep receiving HCB101 outside the standard clinical trial structure under the FDA's Expanded Access, or compassionate use, framework. The agency's review weighed the patient's clinical circumstances, including whether the potential benefit justified the risks given the severity of the disease. HanchorBio noted the determination applies only to this individual-patient protocol and does not constitute approval of HCB101 or an FDA finding on its broader safety or efficacy.