Regulatory Update

Nutshell Therapeutics Wins FDA IND Clearance for NRF2 Degrader NTS231

Shanghai – September 25, 2026 -- Nutshell Therapeutics (Shanghai) Co., Ltd. has received FDA clearance of its Investigational New Drug (IND) application for NTS231, a covalent allosteric molecular glue degrader targeting NRF2, allowing the company to begin clinical development in the United States. NTS231 is the first NRF2 degrader originating from China and only the second such molecule worldwide to reach clinical-stage development.

XtalPi Files FDA IND for First Gut-Restricted Pan-TRK Pain Drug

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XtalPi Files FDA IND for First Gut-Restricted Pan-TRK Pain Drug

Boston and Shenzhen – September 25, 2026 -- XtalPi Holdings Limited (HKEX: 2228) has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for KQTD-126, a potential first-in-class gut-restricted pan-tropomyosin receptor kinase (pan-TRK) inhibitor targeting chronic intestinal pain in irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD).

KQTD-126 marks XtalPi's first proprietary pipeline candidate to reach IND stage

The submission represents the inaugural IND filing from XtalPi's internally developed pipeline, which the company disclosed in its recent interim results. It confirms the company's transition from a discovery-services provider to a clinical-stage drug developer built on AI and robotics.

HouseCanary Wins Court Nod for Chapter 11 Financing, Operations Continue

San Francisco – September 25, 2026 -- The U.S. Bankruptcy Court for the District of New Jersey approved HouseCanary's first-day motions, granting the property intelligence provider access to debtor-in-possession financing and clearing the way for uninterrupted operations during its Chapter 11 reorganization.

Court clears customer, employee and financing relief on first-day hearing

The approved motions cover continuation of customer programs, employee obligations and ordinary-course business operations, alongside debtor-in-possession financing to bolster liquidity. A further hearing is scheduled for October to consider additional debtor-in-possession financing for the company.

NAIC Details Capital Rule Overhaul After Warren Inquiry on Insurer Risk

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NAIC Details Capital Rule Overhaul After Warren Inquiry on Insurer Risk

Washington – September 25, 2026 -- State insurance regulators leading the National Association of Insurance Commissioners (NAIC) responded to a letter from U.S. Senator Elizabeth Warren (D-Mass.) by detailing a series of capital and oversight changes made in recent years to address insurers' shifting investment strategies, ownership structures, and risk-transfer arrangements.

Regulators impose a 45% risk-based capital charge on structured security residuals
NAIC leadership confirmed it instituted a 45% risk-based capital charge specifically for residual interests in structured securities, a move designed to ensure capital requirements reflect the investment risk embedded in these complex holdings.

1911 Gold Files NI 43-101 Report for 712,000-oz Ogama-Rockland Resource

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1911 Gold Files NI 43-101 Report for 712,000-oz Ogama-Rockland Resource

Vancouver, BC – September 25, 2026 -- 1911 Gold Corporation has filed a National Instrument 43-101 Technical Report confirming an Inferred Mineral Resource of 3,314,000 tonnes grading 6.68 grams per tonne gold, containing 712,000 ounces, at its 100%-owned Ogama-Rockland Gold Project in southeastern Manitoba.

Updated resource estimate follows August 11 disclosure

The Technical Report, dated September 25, 2026 with an effective date of September 25, 2026, formalizes the 2026 Mineral Resource Estimate first announced by the company on September 25, 2026. It has been filed on SEDAR+ and posted to the company's website. The report was prepared by Tim Maunula, P.Geo, of T. Maunula & Associates Consulting Inc., and Roselyn Yeboah, P.Eng, of 1911 Gold, both designated Qualified Persons under NI 43-101.

NORD Honors Six Firms for First-of-Kind Rare Disease Therapy Approvals

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NORD Honors Six Firms for First-of-Kind Rare Disease Therapy Approvals

Norwell, Mass. – September 25, 2026 -- The National Organization for Rare Disorders (NORD) has named six companies and nonprofits as 2026 Industry Innovator honorees for delivering first-of-their-kind FDA-approved therapies to patients with rare diseases that affect a fraction of the more than 30 million Americans living with such conditions.

Six FDA approvals mark milestones across ultra-rare indications

Mighty Therapeutics was recognized for FORZINITY, the first therapy for Barth syndrome, a rare mitochondrial disease, shown to improve muscle strength and quality of life. UCB earned recognition for KYGEVVI, the first and only approved treatment for thymidine kinase 2 deficiency in patients whose symptoms began at or before age 12. Fondazione Telethon was honored for Waskyra, a gene therapy for Wiskott-Aldrich syndrome that stands as the first FDA-approved gene therapy for a primary immunodeficiency disorder and the first developed by a nonprofit.

AWC Publishes 2027 SDPWS Standard With New Seismic Wood Systems

Leesburg, Va. – September 25, 2026 -- The American Wood Council (AWC) has published the 2027 edition of the Special Design Provisions for Wind and Seismic (ANSI/AWC SDPWS-2027), adding two new construction systems for engineers designing in high-hazard wind and seismic zones. The standard has been approved as an American National Standard by the American National Standards Institute (ANSI) and will be referenced in the 2027 I-Codes.

Five-year technical process yields ANSI approval after 13 balloting rounds

The 2027 SDPWS resulted from five years of technical development and two years of balloting under ANSI's consensus-based process, including 13 rounds of balloting and a full public review period. SDPWS is typically updated every six years to keep pace with new research and align with other design references.

Jiro: CMS Modifier 25 Plan Would Shift $889M, Hit Private Practices

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Jiro: CMS Modifier 25 Plan Would Shift $889M, Hit Private Practices

Austin, Texas – September 25, 2026 -- A proposed Medicare payment change involving Modifier 25 would reallocate approximately $889 million in annual fee-for-service payments, with private practices and solo physicians absorbing $724.4 million, or 81.5%, of the modeled reductions, according to a new analysis from Jiro Health.

Six specialties bear 82.3% of the total reduction

Jiro's Practice Impact Analysis, titled "Who Pays for CMS's Modifier 25 Proposal?", found that six medical specialties account for roughly $732 million of the modeled impact. Dermatology alone represents $395.4 million, or 44.5% of the total reallocation. Podiatric medicine and surgery, orthopaedic surgery, otolaryngology, ophthalmology and family medicine together account for an additional $336 million.

Celebree CEO Pushes American Franchise Act at IFA Summit

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Celebree CEO Pushes American Franchise Act at IFA Summit

Baltimore – September 25, 2026 -- Richard Huffman, founder, president and CEO of Celebree School, joined U.S. Rep. Johnny Olszewski and a local Chick-fil-A owner on a featured panel at the 2026 International Franchise Association Advocacy Summit in Washington, D.C., pressing for passage of the American Franchise Act.

Record crowd of 500 franchise executives lobbies Congress

The Summit, hosted by IFA Senior Director of Federal Government Relations Haider Murtaza, drew more than 500 franchise executives, owners and Franchisees of the Year to the capital. Attendees spent the week urging lawmakers to pass the bipartisan American Franchise Act, which would establish a single, permanent federal joint-employer standard for the franchise industry after a decade of shifting rules.

KuCoin Wallet Services Reach CCSS Level 3, Top Security Tier

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KuCoin Wallet Services Reach CCSS Level 3, Top Security Tier

Providenciales – – September 24, 2026 -- KuCoin has upgraded its Wallet Management Services from CCSS v8.1 Level 2 to CCSS v8.1 Level 3, the highest tier of the Cryptocurrency Security Standard, the exchange announced.

KuCoin secures full-system certification under the CCSS v8.1 framework

The Level 3 rating, assessed under the same v8.1 standard as the prior certification, verifies stronger controls across the full cryptographic key lifecycle, from generation and storage to access, backup and recovery.

New controls target key-compromise response and personnel access

Compared with Level 2, the Level 3 certification requires greater separation of responsibilities, stricter access and personnel controls, regular testing of key-compromise response procedures, broader independent assurance, and continual backup of operational logs. KuCoin said the measures reduce single points of failure and improve traceability and resilience.