SEC tokenized-stock exemption, FDA first-in-class approvals, and a $225M Amway order — September 15–21, 2026
A sourced digest of fifteen SEC, FDA and FTC actions from September 15–21, 2026, with the parties, the procedural status, the money at issue, and the dates to calendar.
The September 15–21, 2026 window produced fifteen substantive regulatory actions across the SEC, FDA, and FTC, plus three items noted in brief. The SEC proposed two sets of rules and brought three enforcement matters. The FDA approved two first-in-class therapies and one cancer regimen, redesigned its early clinical-trial pathway, and posted two warning letters. The FTC announced a $100 million fuel-card settlement, a $225 million multilevel-marketing order, and a firearms antitrust consent order.
For a compliance or legal team, the week divides cleanly. The SEC's two proposals are the only items here that invite a written comment. Everything else is a matter to read for control failures and calendar dates.
At a glance
| Agency | Development | Status or amount | Next action |
|---|---|---|---|
| SEC | "Innovation Exemption" for tokenized NMS stock on Tokenized Securities Venues | Order issued Sept. 17; conditional and temporary; expires five years after publication; comment open | Decide whether to operate or trade on a tokenized securities venue. 1 |
| SEC | Rescission of Rule 14a-8 and modernization of proxy solicitation | Two proposing releases issued Sept. 16; comment runs 60 days from Federal Register publication | Map the effect on the coming proxy season. 2 |
| SEC | Jon P. Kipp, former Funko shareholder | Settled action filed Sept. 14; $1,073,009.73 in disgorgement, interest and penalty; judgment subject to court approval | Review trading restrictions covering former insiders and long-time associates. 3 |
| SEC | Jessica Richman and Zachary Apte, co-founders of uBiome | Proposed consent judgments filed Sept. 14; $125,000 each plus three-year officer-and-director bars; subject to court approval | Re-examine diligence on private-company reimbursement claims. 4 |
| SEC | Ellen Polcari, former employee of two venture capital firms | Complaint filed Sept. 18; $28.67 million raised from at least 85 investors, $1.28 million allegedly misappropriated; relief sought | Test wire-instruction verification at the fund level. 5 |
| FDA | Fayuvi (rebisufligene etisparvovec-hopf), Ultragenyx | Approved Sept. 17; first therapy for Sanfilippo syndrome type A | Build AAV9 infusion and corticosteroid protocols before first referrals. 6 |
| FDA | Expedited IND Pilot | Final design announced Sept. 15; applications accepted through Oct. 30, 2026 | Decide whether to apply as a sponsor–qualified research institution pair. 7 |
| FDA | Imlunestrant (Inluriyo) with abemaciclib (Verzenio), Eli Lilly | Approved Sept. 18 for ESR1-mutated advanced or metastatic breast cancer | Confirm companion diagnostic access and prior-authorization language. 8 |
| FDA | Aqneursa (levacetylleucine), IntraBio | Approved Sept. 18; first treatment for ataxia in ataxia-telangiectasia | Route this through rare-disease formulary review. 9 |
| FDA | Bausch & Lomb, Tampa sterile drug site | Warning letter issued Sept. 4, posted Sept. 15; aseptic-processing violations | Reassess environmental monitoring, personnel monitoring and smoke studies. 10 |
| FDA | H2 BEV and H2 RENU, Plano, Texas | Warning letter issued July 31, posted Sept. 15; acidified-food violations and unapproved drug claims | Register the facility, file scheduled processes, and pull disease claims from labeling. 11 |
| FTC | FleetCor Technologies (now Corpay) and CEO Ronald Clarke | $100 million consent agreement announced Sept. 17; comment runs 30 days from Federal Register publication | Review fee disclosure and consent capture in billing flows. 12 |
| FTC | Amway, World Wide Group and Leadership Team Development | $225 million proposed order filed Sept. 17 with the State of Washington | Direct-selling clients: review earnings claims and inventory-loading terms. 13 |
| FTC | Beretta Holding and Sturm, Ruger | Consent order accepted for comment Sept. 16 over a Clayton Act Section 8 interlock | Audit board seats held across competing portfolio companies. 14 |
| FTC | Price transparency FAQs for auto dealers | Published Sept. 15 | Align advertised prices with what a walk-in customer actually pays. 15 |
SEC
The Innovation Exemption lets tokenized NMS stock trade on permissioned venues
On September 17, the SEC granted temporary, conditional relief to "Tokenized Securities Venues," or TSVs, from the Exchange Act definition of "exchange," which allows them to trade tokenized National Market System stock through permissioned automated market maker liquidity pools. 1 A TSV brings buyers and sellers together by running one or more such pools and by setting the standards for who may participate.
The order attaches conditions a venue will have to build against. Tokenized NMS stock traded on a TSV faces limits on the number of symbols and on volume. The venue must verify that the token gives holders the same rights and privileges as the traditional share of the same class. Before listing a token created by an unaffiliated third party, the venue must give the underlying issuer written notice and a chance to object. Smart contracts must be auditable and public, and must sit on a public, permissionless ledger. Trading in the token must stop whenever trading in the underlying stock stops on its primary listing exchange. The venue must publish notice of its operations and of its affiliates' trading. 16
A second, narrower exemption runs alongside the first. Liquidity providers in a TSV pool who commit proprietary capital, quote prices to customers, or sign committed-capital agreements get conditional relief from the Exchange Act definition of "dealer."
Both exemptions expire five years after publication in the Federal Register. The order invites comment on possible modifications, and the Commission has yet to set a comment date. Chairman Paul S. Atkins called the relief "temporary" and described it as a bridge toward further rulemaking. 17
Rule 14a-8 rescission and four changes to proxy practice
On September 16, the SEC proposed to rescind Rule 14a-8, the provision that governs when a company must include a shareholder proposal in its proxy materials. The Commission's stated ground is authority: it says the rule exceeds the Commission's statutory scope and intrudes into state law. Rescinding it would leave the role of shareholder proposals to state law and company governing documents. 2
A separate proposing release would amend Rule 14a-4(c), which governs the discretionary voting authority a company may claim over shareholder proposals, giving companies more flexibility and shareholders more control. 18
A third release takes on proxy solicitation itself. Four changes matter operationally for any company that files a proxy statement:
- Delivery of an annual report to security holders would become optional.
- The delivery deadline for documents incorporated by reference into a proxy statement would be eliminated.
- Notices of Exempt Solicitation would be eliminated.
- The minimum broker search period would shrink from 20 business days to five.
Comment on all three proposals runs for 60 days after the proposing releases are published in the Federal Register. Publication had yet to be recorded as of September 21, so the deadline will land around late November. 19
Jon P. Kipp: a text message, 247,335 shares, and $1,073,009.73
The SEC filed a settled insider-trading action against Jon P. Kipp of Kirkland, Washington, in the Western District of Washington on September 14. 3 The complaint alleges that two days before Funko, Inc. announced on July 13, 2023 that its then-CEO would take a leave of absence and cease serving as CEO, that CEO told Kipp by text message that the board had placed him on sabbatical and that he planned to leave permanently. The two had been friends for decades and had worked together at Funko before Kipp retired.
Kipp sold all 247,335 Funko shares he owned on the morning of July 13, 2023, according to the complaint, avoiding about $483,746.40 in losses when the price fell the day after the announcement. Without admitting the allegations, Kipp consented to a final judgment, subject to court approval, that would permanently enjoin him from violating Section 10(b) of the Exchange Act and Rule 10b-5, and order $483,746.40 in disgorgement, $105,516.93 in prejudgment interest, and a $483,746.40 civil penalty — $1,073,009.73 in total. 20
For issuers, the control gap is the audience: pre-clearance and trading-window rules get written for current employees in sensitive roles, and Kipp was a former employee reading a text message.
uBiome's co-founders settle a five-year-old case
Also filed on September 14 and released on September 16 were consents and proposed final judgments for Jessica Richman and Zachary Apte, co-founders of uBiome, Inc., the San Francisco medical testing company that ceased operations in 2019. 4
The SEC's complaint, filed in March 2021, alleged that Richman, the CEO, and Apte, the chief scientific officer, raised money by portraying uBiome as growing rapidly on the strength of insurance reimbursements for its tests. 21 That claim was misleading, the SEC alleged, because the growth depended on directing doctors to order unnecessary tests; when insurers discovered the practice, they clawed back previous payments.
Without admitting the allegations, both consented to final judgments, subject to court approval, that would permanently enjoin them from violating Section 17(a) of the Securities Act and Section 10(b) of the Exchange Act and Rule 10b-5, bar each of them from serving as an officer or director for three years, bar them from participating in the issuance, purchase, offer or sale of any security for three years other than in their own personal accounts, and order each to pay a $125,000 penalty.
Ellen Polcari: investor wires diverted at the fund level
On September 18, the SEC charged Ellen Polcari, a former employee of two venture capital firms under common ownership, with misappropriating money invested in funds those firms advised. 5
The complaint, filed in the District of New Jersey, alleges that from April 2023 until March 2025 certain funds raised about $28.67 million from at least 85 investors, and that Polcari misappropriated roughly $1.28 million of it. 22 According to the SEC, Polcari talked with prospective investors about participating in the funds' offerings, directed interested investors to wire their investments to bank accounts she controlled, and began misappropriating portions of the money on receipt. The complaint also alleges she transferred stock shares belonging to one of the funds to herself and sold most of them to a third party for $56,000.
The SEC charges Polcari with violating Sections 17(a)(1) and 17(a)(3) of the Securities Act and Section 10(b) of the Exchange Act and Rules 10b-5(a) and (c), and seeks permanent injunctions, disgorgement with prejudgment interest, civil penalties, and a conduct-based injunction. The matter sits at the pleading stage. For fund managers, the control point is the subscription wire: the account an investor is told to use should be a fund account confirmed by a second person.
New administrative proceedings
Between September 15 and September 18 the Commission's administrative-proceedings docket gained twenty entries, most of them naming a single issuer and two of them investment-adviser matters, Hatteras Investment Partners with David B. Perkins and Philip Pursino with Pursino Advisory Group. 23 The docket page links each order.
FDA
Fayuvi: the first therapy for Sanfilippo syndrome type A
On September 17, the FDA approved Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with mucopolysaccharidosis type IIIA, also called Sanfilippo syndrome type A. 6 The disease is inherited and progressively damages the brain and nervous system, causing children to lose cognitive, language and other developmental abilities. Until this approval, care consisted of managing symptoms. Ultragenyx Pharmaceutical holds the approval.
Fayuvi is a one-time intravenous gene therapy that uses an adeno-associated virus serotype 9 vector to deliver a working copy of the SGSH gene, so that cells produce sulfamidase, the enzyme missing in MPS IIIA, and heparan sulfate can be broken down in lysosomes. The FDA evaluated it in an open-label, single-arm, multicenter study measuring mean changes in cognitive scores in children aged 2 to 5. Treated patients maintained or improved cognitive function relative to an untreated historical control cohort, a divergence from the expected decline over that developmental window.
The most common adverse reactions, reported in more than 5% of patients, were increases in the liver enzyme AST, nausea and vomiting, fever, decreased appetite, decreased white blood cell and platelet counts, and increased amylase. Labeling carries a warning for thrombotic microangiopathy, and the FDA flags the long-term risk that AAV-delivered genetic material could integrate into the genome and lead to tumor development. Patients receive corticosteroids starting one day before infusion and continuing for at least eight weeks, and infusion must take place in a setting equipped to manage infusion reactions. Fayuvi received Orphan Drug, Fast Track and Breakthrough Therapy designations.
The Expedited IND Pilot opens with an October 30 deadline
On September 15, the FDA published the final design of its Expedited Investigational New Drug Pilot and began accepting applications. 7 The program pairs drug sponsors with qualified research institutions chosen for scientific expertise, and the FDA will accept applications until October 30, 2026. It expects to select 8 to 10 sponsor–institution pairs for the first cohort.
The mechanism is a change to pre-IND review. With an institution involved, the FDA can review and accept individual components of an application on a rolling basis rather than waiting for a complete package, which the agency says should surface problems earlier and cut the chance of a clinical hold during the 30-day IND window. The FDA keeps authority to decide whether an investigation may proceed and to impose a clinical hold. Drug sponsors and prospective research institutions apply as a pair, with the sponsor submitting the application; eligibility, conflict-of-interest and selection criteria are published on the program page. 24
Imlunestrant with abemaciclib, restricted by biomarker
On September 18, the FDA approved imlunestrant (Inluriyo) in combination with abemaciclib (Verzenio) for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy. Eli Lilly makes both drugs, and the FDA also approved the Guardant360 CDx assay as a companion diagnostic to identify patients with ESR1 mutations. 8
Efficacy came from EMBER-3 (NCT04975308), a randomized, open-label trial of 874 adults previously treated with an aromatase inhibitor. In an exploratory subgroup of 159 patients with ESR1-mutated tumors, the combination produced a progression-free survival hazard ratio of 0.53 (95% CI 0.35–0.80), with median progression-free survival of 11.1 months against 5.5 months for imlunestrant alone, and an objective response rate of 35% against 15%. Overall survival data were immature at the interim analysis, with 35% of deaths recorded in that subgroup.
The FDA's own summary places the benefit in the ESR1-mutated population. Outside that group, imlunestrant alone produced progression-free survival comparable to the investigator's choice of endocrine therapy. The recommended dose is imlunestrant 400 mg orally once daily on an empty stomach, with abemaciclib 150 mg orally twice daily. Payers and oncology networks should treat the companion diagnostic as a prerequisite rather than a step that can follow authorization.
Aqneursa: a second indication, and a first for ataxia-telangiectasia
Also on September 18, the FDA approved Aqneursa (levacetylleucine) oral suspension for ataxia in adults and pediatric patients with ataxia-telangiectasia who weigh at least 15 kg, making it the first treatment approved for that indication. 9 IntraBio holds the approval, which received Orphan Drug designation and Priority Review. The same drug was approved in 2024 for the neurological manifestations of Niemann-Pick disease type C.
Ataxia-telangiectasia is caused by mutations in the ATM gene and causes progressive loss of muscle control and coordination that typically begins in early childhood, along with immune deficiencies and a raised cancer risk. The supporting study was a randomized, double-blind, placebo-controlled, two-period crossover trial (NCT06673056) of 73 patients aged 4 and older, with 12 weeks per period. Patients scored better on the functional Scale for Assessment and Rating of Ataxia while taking Aqneursa than while taking placebo. The most common adverse reactions were falls, skin lacerations and urinary tract infections. Labeling warns of fetal harm based on animal data and advises against concurrent use with N-acetyl-DL-leucine.
Two warning letters posted September 15
The FDA posted a warning letter to Bausch & Lomb Inc. on September 15; the letter itself is dated September 4 and carries reference 320-26-123. 10 It follows a March 12–20, 2026 inspection of the company's Tampa, Florida sterile drug manufacturing site, FDA establishment identifier 1000113778, and cites violations of 21 CFR 211.42(c)(10) and 211.113(b). The Center for Drug Evaluation and Research found the environmental and personnel monitoring program inadequate for classified aseptic areas, including a failure to monitor significant locations such as phones used in the aseptic processing area and the use of cracked media. The FDA noted routine out-of-limit recoveries of microorganisms from ISO 5 areas between 2023 and 2025, including Serratia marcescens and Stenotrophomonas maltophilia, organisms associated with water sources, and a July 2025 media fill failure on line 16. The agency told the company its drug products are adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.
The second letter went to H2 BEV, LLC and H2 RENU, INC of Plano, Texas, also posted September 15, with an issue date of July 31 and CMS number 730567. 11 Following inspections between December 3, 2025 and January 12, 2026, the Human Foods Program cited violations of the Emergency Permit Control regulation at 21 CFR Part 108 and the Acidified Foods regulation at 21 CFR Part 114: the firms skipped registration as food canning establishments, had no scheduled process on file for their hydrogen-infused beverages, left pH testing results unrecorded, and kept pasteurization times and temperatures in a form that could not be tied to an actual process. The letter also reviews the companies' websites and concludes that the H2 RENU Oncology Care Beverage and Hydro Shot hydrogen beverage products are unapproved new drugs under section 201(p) of the Act, because the marketing claims put them to use in curing, mitigating, treating or preventing disease.
The response clock on both letters runs from receipt, so both sit outside the calendar below. Each asks for a written response within 15 working days, and failure to address the violations can lead to seizure or injunction.
FTC
FleetCor and its CEO pay $100 million for unauthorized fees
On September 17, the FTC announced that FleetCor Technologies Inc., now Corpay Inc., and its CEO Ronald Clarke will pay $100 million to settle an administrative action over fuel-card fees charged to small-business customers. The money will fund redress to harmed business customers, and FleetCor and Clarke have agreed not to oppose reimposition of a federal court injunction against Clarke. 12
The case has run since 2019, when the FTC alleged that FleetCor and Clarke imposed unauthorized fees totaling hundreds of millions of dollars on tens of thousands of customers. 25 According to the complaint, FleetCor often waited several billing cycles before starting to charge a fee, so that customers would be less likely to notice, and its invoices left the fees undisclosed. The complaint also alleged late fees charged to customers who had paid on time or been blocked from paying, and misrepresentations about gas savings and fraud-control features.
A district court granted summary judgment to the FTC on all counts in 2023, and a federal appeals court upheld that judgment on all counts in 2026 and affirmed the permanent injunction against FleetCor. 26 The same appeal affirmed the judgment against Clarke on all but one count and vacated the injunction as to him. The court order prohibits FleetCor from billing a customer for any charge without the customer's express informed consent and clear, unavoidable information about the charge, from hiding material information about a charge behind a hyperlink, and from making deceptive claims about its fuel cards.
The Commission vote to accept the consent agreement was 1-0-1, with Chairman Andrew N. Ferguson recused. 27 The agreement is subject to public comment for 30 days after the FTC publishes its description in the Federal Register, which had yet to happen as of September 21. Once an order is final, each violation can carry a civil penalty of up to $53,088.
The order's affirmative duties are the ones to copy: express consent before a charge, and disclosure the customer has to see.
Amway's $225 million order rewrites how the business has to run
The FTC and the State of Washington filed suit against Amway Corp. and two of its largest "approved provider" groups, World Wide Group, L.L.C. and Leadership Team Development Inc., in the Western District of Washington on September 17, alongside a proposed stipulated order imposing a $225 million judgment. The FTC describes it as the largest monetary recovery it has obtained against a multilevel marketing company, with nearly all of the money going to independent business owners recruited by World Wide Group and Leadership Team Development who lost money. 13
The complaint alleges that the three companies told recruits they were likely to earn substantial income exceeding $40,000 a year, or enough to replace a full-time job or retire early, when most people who joined World Wide Group or Leadership Team Development after 2020 spent more on Amway products and training than they received from Amway. 28 The FTC also alleges the companies misled recruits about how many people they would bring in and about access to mentoring from highly successful leaders, and instructed business owners to report sales that never occurred, so the opportunity would look like a product business rather than a recruitment business.
The proposed order changes the economics of the model. 29 It would require business owners to resell at least 70% of the products they buy from Amway each month; substantially reduce compensation to recruiters whose recruits buy without reselling; require prompt reporting of all customer sales at the actual sales price, with Amway sending receipts to customers; require Amway to terminate business owners who fake sales or teach others to; require regular audits of Amway's sales records by an independent outside auditor; require training before a business owner may recruit; and bar approved providers from charging new business owners for training or services during their first year. The Commission vote to authorize the complaint and stipulated order was 2-0. Redress program details will follow later.
The FTC keeps Beretta off Ruger's board
On September 16, the FTC accepted a proposed consent order resolving antitrust concerns arising from Beretta Holding S.A.'s stock purchase agreement with Sturm, Ruger & Co. Inc. The order settles allegations that the deal would create an illegal interlocking directorate under Section 8 of the Clayton Act, which generally bars directors and officers from serving simultaneously on the boards of competitors. 14
Beretta, a subsidiary of Upifra S.A., sought to increase its investment in Ruger to as much as 25% of Ruger's outstanding shares, which would have allowed it to appoint two members of Ruger's board. The proposed order prohibits Beretta from appointing, nominating or otherwise causing anyone to serve on Ruger's board unless that person is independent of Beretta. 30 It also requires Beretta to give the Commission at least 15 days' advance written notice before anyone becomes a Ruger board member, and bars Beretta from hiring or entering into financial or other relationships with an independent director it nominated for one year after that director leaves Ruger's board, where the arrangement would conflict with the director's fiduciary duty or pass nonpublic information about Ruger to Beretta.
The Commission vote was 2-0, and the public has 30 days to comment on the proposed consent agreement package. This is the FTC's latest action against companies sharing directors, following the 2025 resignations of three Sevita board directors.
Auto dealers get a written standard for advertised prices
Staff published price transparency FAQs for the automobile industry on September 15. The guidance states that the advertised price of a vehicle must be the actual price any customer can walk in and pay, excluding only charges a government requires the customer to pay. 15 The FAQs cover document fees, rebates and discounts, price negotiation, optional items, advertising across different media, vehicles in transit, and how to help the FTC's enforcement work. 31
The Commission sent letters to 97 dealership groups nationwide in March 2026 warning them that advertised prices must be the actual price including all mandatory fees, and it continues to sue dealers that advertise one price and charge another.
Also this week
- Kybella labeling warning (Sept. 15). The FDA added a warning to Kybella (deoxycholic acid) injection labeling about adverse reactions when the drug is used outside the submental fat region, the area under the chin, and recommends against that unapproved use. 32 Since the 2015 approval, the agency identified 129 cases of adverse events with use outside the approved site, including blurred or reduced vision with periorbital use, and muscle or nerve injury such as facial paresis. It also identified 117 cases of unresolved injection-site nodules of 3 cm or smaller, or masses larger than 3 cm, present for a mean of about 143 days at the time of reporting.
- Amazon Prime refunds expand (Sept. 17). A federal court approved a revised order that raises the maximum refund under the $2.5 billion Prime settlement from $51 to $200, extends eligibility to consumers who used between 11 and 20 Prime benefits in a year, and makes all future payments automatic, starting October 1, 2026. Amazon has issued more than $845 million in redress as of September 2026, and Amazon administers the program. 3334
Dates to calendar
| Date | Matter | What to do |
|---|---|---|
| September 25, 2026 | FTC proposed enforcement policy statement on personalized pricing | Submit comments through the notice published in the Federal Register. 35 |
| October 1, 2026 | Automatic Amazon Prime redress payments begin | Payments arrive automatically; prepare client-facing guidance, because any outreach claiming to come from the FTC is a scam. 36 |
| October 30, 2026 | FDA Expedited IND Pilot application window closes | Sponsors and qualified research institutions apply as a pair. 24 |
| November 3, 2026 | SEC transfer agent modernization rules, File No. S7-2026-30 | File comments on proposed safeguarding standards and electronic recordkeeping. 37 |
| 60 days from Federal Register publication, expected in late November | SEC proposals to rescind Rule 14a-8 and modernize proxy solicitation, Release Nos. 34-106383 and 33-11439 | Publication had yet to be recorded as of September 21; watch the Federal Register for the clock to start. 2 |
| 30 days from Federal Register publication, date yet to be set | FTC consent agreement with FleetCor and Ronald Clarke | The description of the consent agreement had yet to appear in the Federal Register as of September 21. 12 |
| 30 days from the docket opening on September 16, 2026 | FTC consent order in the Beretta and Ruger matter | File any comments on the consent agreement package through the docket on Regulations.gov. 14 |
What is still open
Several matters turn on a court rather than an agency. The Kipp and uBiome consent judgments need entry by their district courts, the Amway stipulated order takes effect when the District Court for the Western District of Washington signs it, and the Polcari complaint sits at the outset of litigation.
On the rulemaking side, the SEC's Innovation Exemption operates as an order in force while its comment process and any further action run alongside it. The condition that matters most for planning is the five-year expiry: a venue built on this relief is built on a clock. The Beretta and Ruger order becomes effective after its comment window closes and the Commission makes it final, and the FleetCor agreement follows the same path.
The market-facing effect of this week's actions is procedural: tokenized-venue compliance programs, board-interlock screening across portfolio companies, fee-consent controls in billing systems, earnings-claim discipline in direct selling, and the environmental monitoring and process-filing records that decide how a warning letter closes out. Attributing any share-price movement to these documents would require independently verified market data.
References
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- 37Transfer Agent Rules, Federal Register notice
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