Regulatory Compliance

Washington – September 30, 2026 -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) reported positive topline results from a pivotal Phase III study of HETLIOZ® (tasimelteon) 20 mg in adults with Delayed Sleep-Wake Phase Disorder (DSWPD), setting up a supplemental New Drug Application (sNDA) filing with the U.S. Food and Drug Administration (FDA).

Trial meets primary endpoint with statistically significant sleep-timing shift

The study, VP-VEC-162-3502 (NCT04652882), shifted sleep onset 42.5 minutes earlier in the HETLIOZ® arm (n=20) versus 5.4 minutes on placebo (n=20), a 37.1-minute difference (p=0.022). In an exploratory responder analysis, 60% of tasimelteon-treated participants (12/20) advanced sleep onset by at least 30 minutes, compared with 15% on placebo (3/20) (p=0.008).

Indianapolis – September 30, 2026 -- Eli Lilly and Company (NYSE: LLY) reported that its investigational triple hormone receptor agonist retatrutide produced an average weight loss of 49.6 lbs (20.8%) over 80 weeks at the 12 mg dose in patients with type 2 diabetes and obesity, with more than half of participants no longer meeting BMI criteria for obesity. The Phase 3 TRIUMPH-2 results were presented at the 62nd Annual Meeting of the European Association for the Study of Diabetes in Milan and simultaneously published in The Lancet.

Highest dose delivers weight loss up to 23.4% in heavier patients

Across the three tested doses, participants lost an average of 29.8 lbs (12.7%) at 4 mg, 45.4 lbs (19.1%) at 9 mg, and 49.6 lbs (20.8%) at 12 mg. Among patients with a baseline BMI of 35 or higher, the 12 mg dose produced an average loss of 60.8 lbs (23.4%), with 59.5% of all 12 mg participants no longer classified as having obesity by trial end.

Phnom Penh – September 30, 2026 -- Cambodia, Indonesia, the Philippines, and Thailand are shipping raw critical minerals abroad while processing and value capture happen elsewhere, according to a new report from Fair Finance Asia (FFA) and research partner Profundo.

Local-benefit clauses are consistently absent from mining agreements

The report, titled Extraction to Equity, examined critical minerals trade agreements and memoranda of understanding (MoUs) across the four ASEAN states using public data through December 2025. It found that local-benefits clauses, sustainability standards, and equitable value-sharing provisions were consistently missing, leaving source countries without leverage to demand better terms.

Washington – – September 30, 2026 -- Fannie Mae has completed the sale of its twenty-eighth Community Impact Pool (CIP) of non-performing loans, with VRMTG ACQ, LLC emerging as the winning bidder for a package of 24 loans carrying $6,200,360 in unpaid principal balance.

Dallas-Fort Worth pool draws cover bid at 94.07% of unpaid balance

The single pool, geographically concentrated in the Dallas-Fort Worth area, was originally announced on September 30, 2026, and is scheduled to close on September 30, 2026. The average loan size in the pool stood at $258,348, with a weighted average note rate of 4.26% and a weighted average broker's price opinion loan-to-value ratio of 59%. The cover bid -- the second-highest offer received -- came in at 94.0740% of UPB, equivalent to 55.22% of BPO value.

Woburn, Mass. – – September 30, 2026 -- Cytrellis Biosystems, Inc. has signed a commercialization agreement with KoreAx Co. Ltd. to launch its ellacor skin-removal device in South Korea, marking the company's second international market entry of 2026 after Australia.

South Korea's Ministry of Food and Drug Safety cleared ellacor in 2025

Ellacor is described as the first and only FDA-cleared, minimally invasive, in-office procedure that removes sagging skin without surgery or thermal energy. The device uses Micro-Coring technology and is approved for adults aged 22 and older with Fitzpatrick skin types I-IV.

The Bronx, N.Y. – September 30, 2026 -- The International Organization for Standardization published the third revision of ISO 3941 on September 30, 2026, introducing Class L as a distinct fire classification for lithium-ion cell and battery fires, arriving as New York City enforces a 1 kWh threshold for lithium-ion energy storage systems under its amended NFPA 855 code. Allstate Sprinkler, a Bronx-based fire protection contractor operating since 1972, released an analysis linking the new global standard to New York's existing regulatory posture and to FDNY incident data spanning 2023 through mid-2026.

New York – September 30, 2026 -- MyComplianceOffice (MCO), a compliance management software provider for financial services, has appointed John Schobel as President, adding a 25-year RegTech veteran to lead its global go-to-market strategy following a $100 million-plus strategic financing round.

MCO's revenue climbed 22% from 2024 to 2025 as client base expanded

The compliance software firm now serves more than 1,500 client companies across over 125 countries, onboarding more than 100 new firms during the same period. The growth trajectory coincides with recent strategic growth financing from Accel-KKR Credit Partners, which MCO says will fund continued expansion and product development.

Kista, Sweden – September 30, 2026 -- Sivers Semiconductors AB has called an Extraordinary General Meeting for 22 October 2026 to replace auditor Deloitte AB with Ernst & Young AB, a move tied to the company's plan for a dual listing on U.S. capital markets expected in the first half of 2027.

Nomination committee cites EU rotation rule and US listing prep for auditor switch

Deloitte has served as Sivers' auditor for ten years, the maximum term allowed under Article 17 of EU Regulation No 537/2014 for public-interest entities. The Audit Committee recommended the change, which the Nomination Committee approved unanimously, framing EY's experience with SEC reporting requirements and U.S. capital markets activity for Swedish listed companies as the deciding factor. The Nomination Committee stated the switch does not stem from any disagreement over accounting or financial reporting.

Knoxville, Tenn. – – September 30, 2026 -- The U.S. Nuclear Regulatory Commission has issued a construction permit for Clinch River Unit 1, making the Tennessee Valley Authority the first U.S. utility cleared to build a GE Vernova Hitachi Nuclear Energy BWRX-300 small modular reactor (SMR). The permit, granted for TVA's Clinch River Nuclear Site near Oak Ridge, Tenn., marks only the second advanced reactor construction permit ever issued in the country.

NRC clears path for 300-megawatt reactor ahead of schedule

TVA said the NRC's evaluation process allowed the permit to be issued earlier than anticipated, a move officials framed as evidence of streamlined federal licensing for advanced nuclear technology. No construction start date has been announced.

"This construction permit is more than a regulatory achievement – it's foundational for America's nuclear future," said Mike Skaggs, TVA Interim President & CEO.

Washington – September 29, 2026 -- The Pharmaceutical Research and Manufacturers of America (PhRMA) has named former House Majority Leader Eric Cantor as its next president and chief executive officer, effective November 9. Cantor succeeds Stephen J. Ubl, who has led the trade group since 2015 and will remain as a strategic advisor through January 15, 2027.