Rocky Brands beats Q2 estimates with $1.90 EPS on $118M revenue

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Jul 29 2026, 18:08

uniQure targets Q3 2026 BLA submission after FDA accelerated-approval alignment

uniQure N.V. (NASDAQ: QURE) reached alignment with the U.S. Food and Drug Administration on an accelerated-approval pathway for AMT-130, its investigational gene therapy for Huntington's disease, clearing a regulatory path for what would be the first disease-modifying treatment for the fatal neurodegenerative disorder. The company remains on track to submit a Biologics License Application in the third quarter of 2026. "Following a productive Type B meeting with the FDA, we remain on track to submit our BLA for AMT-130 in the third quarter — a milestone that reflects years of rigorous science, disciplined execution, and an unwavering commitment to the patients and families living with this devastating disease," Chief Executive Officer Matthew Kapusta said on the company's second-quarter earnings call. The FDA indicated that three-year Phase I/II data could serve as the primary basis for an accelerated-approval application, a reversal from its November 2024 refusal to accept uniQure's filing over insufficient data. The agency now seeks alignment on a confirmatory study design before the BLA submission, recommending a randomized standard-of-care control rather than a sham procedure, with Total Functional Capacity at 36 months as the primary endpoint, Chief Medical Officer Walid Abi-Saab said. uniQure plans to present four-year follow-up data in September from 24 patients — 12 at the high dose and 12 at the low dose — including changes in cerebrospinal fluid neurofilament light chain, a biomarker of neuronal damage. The regulatory shift matters because Huntington's disease affects about 75,000 people in the U.S., Europe and the U.K., with no approved therapies that slow its progression. The FDA often convenes an advisory committee when evaluating the first drug for a disease, and uniQure said it expects one is likely and is preparing accordingly. The company also plans to submit a marketing authorization application to the U.K. Medicines and Healthcare products Regulatory Agency in the third quarter, with European Medicines Agency engagement expected in 2027. **Pipeline progress and financial position** Beyond AMT-130, uniQure reported early clinical data for AMT-260, its gene therapy for refractory mesial temporal lobe epilepsy. Three of six patients in the first low-dose cohort achieved reductions in disabling seizures of 79 percent to 100 percent from baseline during months four through six, while the remaining three had outcomes ranging from a 33 percent decline to a 36 percent increase. No serious adverse events related to the therapy or surgical procedure were reported. Enrollment in a second, higher-dose cohort is expected to be completed in the third quarter, with updated results due in the first half of 2027. For AMT-191 in Fabry disease, all 11 dosed patients showed dose-dependent elevations in alpha-Gal A activity, with levels reaching as high as 229.6-fold above the mean normal range at the mid dose. Plasma lyso-Gb3 levels remained stable after dosing, and all patients were withdrawn from enzyme replacement therapy. However, additional dosing in the mid- and high-dose cohorts remains paused after grade 3 liver enzyme elevations in two patients were classified as dose-limiting toxicities. The elevations resolved after immunosuppression as of the end of May. uniQure held $810.3 million in cash, cash equivalents and investment securities as of June 30, up from $622.5 million at the end of 2025, following a $259 million follow-on offering in June. Chief Financial Officer Christian Klemt said the resources are expected to fund operations into 2030, including the confirmatory trial, potential commercial launches and continued pipeline investment. The company posted a net loss of $81.1 million for the second quarter, compared with $37.7 million a year earlier, driven partly by a $20.4 million unfavorable swing in foreign currency and a $16 million loss from changes in the fair value of pre-funded warrant liabilities. **What's at stake for investors** The FDA's willingness to consider accelerated approval for AMT-130 marks a meaningful de-risking of uniQure's lead asset after the agency rejected Biohaven Pharmaceutical's troriluzole for spinocerebellar ataxia in July, citing concerns about bias in a real-world study using external historical controls — the same type of data the FDA initially questioned in uniQure's case. The contrast highlights the agency's case-by-case approach to rare disease therapies and underscores the importance of uniQure's upcoming four-year data in September, which will include comparisons against a propensity-score-matched natural-history control from the Enroll-HD database. If approved, AMT-130 would address a market with no approved competitors and a desperate patient population. uniQure is already preparing for a potential launch, mapping institutional processes at Huntington's disease centers of excellence in the U.S. and U.K. and engaging with payers. The company's cash runway into 2030 provides a buffer for the confirmatory study and early commercialization, though the path to profitability depends on AMT-130's approval timeline and pricing. Shares of uniQure trade on the Nasdaq, and the stock has been volatile as the regulatory narrative shifted over the past year. This article is for informational purposes only and does not constitute investment advice.

Jul 29 2026, 18:03

Fed holds rates at 3.75% for fifth meeting, oil surge complicates outlook

The Federal Reserve held its benchmark lending rate at 3.5% to 3.75% for a fifth straight meeting Wednesday, opting against a hike even as renewed US-Iran hostilities pushed oil above $84 a barrel and inflation remained above the 2% target. "While we know Chairman Kevin Warsh is not a fan of forward guidance — or showing his hand with respect to his opinion on the direction of rates — I think collectively, the written statement and news conference will be used to signal what's coming next," said Mark Hamrick, senior economic analyst at Bankrate. The decision came as stocks sold off sharply, with the Dow dropping as much as 750 points and the S&P 500 falling 0.75%, while the 10-year Treasury yield climbed to 4.65%. Oil prices surged more than 6% after President Donald Trump vowed to hit Iran "hard" following an attempted attack on US forces, pushing Brent crude above $89 a barrel and West Texas Intermediate to about $84. The hold leaves the Fed in a holding pattern as Warsh's five task forces study how the central bank handles inflation, jobs data and communications — with recommendations not expected until year-end. Markets are pricing in two rate hikes by December, according to the CME FedWatch Tool, which would effectively undo two of the three cuts delivered late last year under former Chair Jerome Powell. The decision was the second under Warsh, who took office in May after being nominated by Trump. Unlike his predecessor, who faced relentless White House pressure to lower rates, Warsh has so far avoided public criticism from the president. Trump called Warsh "fantastic" on Monday while accusing other Fed board members of having "bad intentions." White House adviser Kevin Hassett expressed confidence in Warsh less than an hour before the decision, saying the administration expects the chair to "do the right thing" and projecting downward pressure on prices. Inflation has proved stubbornly above the Fed's 2% target since 2022, accelerating in recent months as the Iran conflict drove up energy costs. Consumer prices rose 3.5% year-over-year in June, down from 4.2% in May, but economists warn that renewed hostilities could push inflation higher again. Core inflation, which excludes volatile food and energy prices, also fell last month. **Rate Differentials Widen as Dissent Risks Grow** Cleveland Fed President Beth Hammack and Dallas Fed President Lorie Logan had signaled before the meeting that they favored action on inflation. Hammack said she saw "no conflict" in the Fed's dual mandate, while Logan warned that "one month of relief is not enough" after the June CPI report. KPMG Chief Economist Diane Swonk had predicted two dissents if the committee held rates steady. The last time the Fed raised rates was July 2023, when the federal funds rate stood at 5.25% to 5.5% and inflation ran at 3%. The central bank delivered three quarter-point cuts late last year as the labor market softened, but hiring has since picked up, with employers adding an average of about 111,000 jobs per month in the second quarter. For consumers, the hold means borrowing costs on credit cards, auto loans and mortgages are likely to remain elevated. The average 30-year fixed mortgage rate climbed to 6.58% last week, the highest in 11 months, according to Freddie Mac. Higher energy costs are also eating into household budgets, with the national average for a gallon of regular gasoline at $4.09, up from $3.14 a year ago. Warsh's press conference at 2:30 p.m. ET will be closely watched for clues on whether the Fed is leaning toward a hike at its September meeting. The chair has declined to provide forward guidance, arguing that markets should react to incoming data rather than central bank signals. *This article is for informational purposes only and does not constitute investment advice.*

Jul 29 2026, 18:00

Fed rate decision puts $16 trillion in consumer debt at crossroads

The Federal Reserve's interest rate decision Wednesday carries more uncertainty than any meeting in recent memory, with markets pricing just a 65% probability of a hold at 3.5% to 3.75% and a 35% chance of a hike — the widest dispersion ahead of a Fed decision in years. "The level of uncertainty is unprecedented for a decision day, and that itself has consequences for how consumers and businesses plan their borrowing," said James Okafor, a macro analyst at Edgen. "If Warsh hikes, it would be the first increase since July 2023 and would immediately reset expectations for the entire rate path through 2027." The stakes for American households are enormous. U.S. consumer debt stands at roughly $16 trillion, according to Federal Reserve data, with credit card balances exceeding $1.1 trillion and mortgage debt above $12 trillion. A quarter-point hike would add approximately $25 billion in annual interest costs across variable-rate consumer debt, based on Fed estimates of floating-rate exposure. Fed Chair Kevin Warsh has kept his cards hidden, breaking with the tradition of telegraphing rate decisions through speeches and interviews. His repeated声明 that he has "no tolerance" for inflation running above the 2% target for more than five years has given hawks ammunition, even as the Consumer Price Index slowed to 3.5% in June from 4.2% in May. The transmission mechanism for consumers is direct. Credit card rates, already near 22% on average according to Bankrate data, would rise within one to two billing cycles of a Fed hike. Adjustable-rate mortgages, which account for about 8% of outstanding home loans, would reset higher at the next adjustment date. Auto loan rates, averaging 7.2% for new cars, would follow suit. For savers, the picture is more nuanced. High-yield savings accounts have been paying 4% to 5%, and a rate hike would push those yields higher. Money market fund assets, which have swelled to a record $6.5 trillion partly on the back of attractive short-term rates, would see yields climb further. A hold, however, would likely keep savings rates where they are. The bond market is already pricing in the tension. The 10-year Treasury yield rose 3 basis points to 4.641% Wednesday, while the 2-year yield climbed 4 basis points to 4.324%. The 30-year bond yielded 5.116%, up 2 basis points. Options flows show unusual activity: traders bought 171,000 calls on the iShares 20+ Year Treasury Bond ETF on Tuesday, compared with fewer than 63,000 puts, with 72% of the $50 million in premium flowing into calls. The last time the Fed faced this level of pre-decision uncertainty was in July 2023, when it delivered what proved to be the final hike of the previous tightening cycle. That 25-basis-point increase pushed the fed funds rate to 5.25% to 5.5%, where it remained until the first cut in September 2024. The S&P 500 fell 0.6% on the day of that decision before rallying 12% over the following six months. Oil prices complicate the inflation outlook further. West Texas Intermediate crude jumped 6.9% to $89.88 a barrel Wednesday after President Donald Trump said the U.S. would hit Iran "hard" following ballistic missile attacks on American forces in the Middle East. Higher energy prices feed directly into headline inflation and could keep pressure on the Fed even if it holds rates steady today. The next scheduled meeting is Sept. 15-16, by which point the Fed will have two more CPI readings and one more PCE report. If the central bank holds Wednesday, the CME FedWatch tool shows markets pricing a 76% probability of a hike at that September meeting — a bet that will either be validated or upended by Warsh's decision this afternoon. This article is for informational purposes only and does not constitute investment advice.