Group 1 - U.S. stock futures are higher, with Nasdaq futures gaining approximately 1.5% on Monday [1] - Monday.Com Ltd is expected to report quarterly earnings of 88 cents per share, an increase from 85 cents per share in the previous year [2] - The consensus estimate for monday.com's quarterly revenue is $312.26 million, up from $251 million a year earlier [2] Group 2 - Monday.Com shares fell 2.6% to $184.70 in pre-market trading [2] - Metsera Inc shares dipped 15% to $70.68 after Pfizer secured a $10 billion deal to acquire the company [4] - Ionis Pharmaceuticals Inc declined 11.5% to $65.00 following the disclosure of pivotal Phase 3 study results [4] - Other companies such as UniQure NV, Oscar Health Inc, Centene Corp, and Immunovant Inc also experienced declines in pre-market trading [4]

Core Viewpoint - uniQure N.V. is set to report its third quarter 2025 financial results on November 10, 2025, highlighting its ongoing commitment to advancing gene therapies for severe medical conditions [1]. Company Overview - uniQure is recognized for its pioneering work in gene therapy, particularly with its approved treatment for hemophilia B, marking a significant achievement in genomic medicine [3]. - The company is developing a pipeline of proprietary gene therapies targeting various severe diseases, including Huntington's disease, refractory temporal lobe epilepsy, ALS, and Fabry disease [3]. Event Details - The earnings call will take place at 8:30 a.m. ET and will be accessible via webcast on uniQure's website, with a replay available for 90 days post-event [2]. - Analysts can participate in the Q&A session by dialing the provided numbers and entering the specified passcode [2].

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against uniQure N.V. regarding possible violations of federal securities laws and unlawful business practices following a significant drop in share price due to FDA concerns about the adequacy of data for a BLA submission [1][2]. Investigation Details - On November 3, 2025, uniQure announced that the FDA no longer believes that the data from Phase I/II studies of AMT-130 is sufficient for a BLA submission, leading to a share price decline of over 57% in morning trading on the same day [2]. Next Steps - Investors who purchased uniQure shares and experienced losses are encouraged to contact Bragar Eagel & Squire for more information regarding their rights and potential claims [3]. About Bragar Eagel & Squire, P.C. - Bragar Eagel & Squire, P.C. is a law firm recognized nationally, representing individual and institutional investors in various types of litigation across state and federal courts [4].

Core Points - U.S. stock futures are lower, with Dow futures falling over 50 points [1] - Super Micro Computer Inc reported disappointing first-quarter results, with earnings of 35 cents per share, missing the consensus estimate of 40 cents, and revenue of $5.01 billion, below the expected $5.99 billion [2] - Super Micro's revenue decreased from $5.93 billion in the same period last year [2] - The company's shares fell 9.2% to $43.12 in pre-market trading [2] Company-Specific Movements - Biohaven Ltd experienced a significant drop of 46.2% to $7.51 after receiving an FDA Complete Response Letter for VYGLXIA [4] - Trex Company Inc declined 31.9% to $32.02 following worse-than-expected third-quarter results and lowered FY25 sales guidance [4] - Soleno Therapeutics Inc fell 22.2% to $49.65 after reporting third-quarter results [4] - Axon Enterprise Inc's shares dropped 19.6% to $567.50 after mixed third-quarter results and an acquisition announcement [4] - Pinterest Inc dipped 18.8% to $26.69 after posting disappointing third-quarter earnings [4] - SSR Mining Inc fell 17.5% to $17.90 after its third-quarter results [4] - Uniqure NV's shares decreased by 15.8% to $25.61 after a prior gain [4] - Clover Health Investments Corp fell 15.5% to $2.97 after mixed third-quarter results [4] - Upstart Holdings Inc declined 15.3% to $39.15 after mixed results and lowered FY25 guidance [4] - Corsair Gaming Inc fell 12.4% to $6.59 following worse-than-expected third-quarter results [4] - Advanced Micro Devices, Inc. declined 5% to $237.80 despite reporting better-than-expected third-quarter results and projecting fourth-quarter revenue of approximately $9.6 billion [4]

Core Viewpoint - Kirby McInerney LLP is investigating potential claims against uniQure N.V. regarding possible violations of federal securities laws or unlawful business practices [1][3]. Group 1: Company Disclosure - On November 3, 2025, uniQure announced that the FDA no longer agrees that data from Phase I/II studies of AMT-130 may be adequate for a Biologics License Application (BLA) submission [3]. - The timing of the BLA submission for AMT-130 is now unclear following the FDA's stance [3]. Group 2: Market Reaction - Following the announcement, uniQure's share price fell by $33.40, a decline of approximately 49.33%, from $67.69 on October 31, 2025, to $34.29 on November 3, 2025 [3].

Core Viewpoint - The law firm Kessler Topaz Meltzer & Check, LLP is investigating potential violations of federal securities laws on behalf of investors of uniQure N.V. following a press release from the company regarding its investigational gene therapy AMT-130 for Huntington's disease [1]. Group 1 - On November 3, 2025, uniQure announced that the FDA informed the company that the data for AMT-130 did not provide sufficient evidence to support its Biologics License Application [1].

Core Viewpoint - UniQure N.V. is under investigation for potential securities law violations following a significant drop in its stock price after the FDA deemed its clinical data for an experimental gene therapy insufficient [2][4]. Group 1: Company Overview - UniQure's shares fell by as much as 66% after the FDA's announcement regarding its gene therapy for Huntington's disease [2]. - The FDA's decision represents a considerable shift from previous communications between the regulator and UniQure [2]. Group 2: Investigation Details - Block & Leviton is investigating UniQure's disclosures to determine if there were any violations of securities laws [4]. - The firm is reaching out to investors who have lost money in their UniQure investments to discuss potential recovery options [1][3]. Group 3: Investor Actions - Investors who purchased UniQure common stock and experienced a decline in share value may be eligible to participate in the investigation [3]. - Block & Leviton encourages affected investors to contact them for more information on recovery [5][7].

Core Insights - Holzer & Holzer, LLC is investigating uniQure N.V. for potential compliance issues with federal securities laws following a recent FDA meeting [1] - uniQure disclosed that the FDA no longer agrees that data from Phase I/II studies of AMT-130 may be adequate for a Biologics License Application submission [1] - The announcement led to a decline in uniQure's stock price [1] Company Summary - uniQure N.V. is involved in the development of gene therapies, specifically AMT-130, which is under scrutiny due to regulatory feedback from the FDA [1] - The company had a pre-BLA meeting with the FDA, which raised concerns about the adequacy of its clinical data [1] Legal Context - Holzer & Holzer, LLC is a law firm specializing in securities litigation and is reaching out to investors who may have suffered losses due to the recent developments with uniQure [2][3] - The firm has a history of recovering significant amounts for shareholders affected by corporate misconduct [3]

Market Overview - U.S. stocks showed mixed performance, with the Dow Jones index falling by 0.41% to 47,369.42, while the NASDAQ rose by 0.54% to 23,853.68 and the S&P 500 gained 0.22% to 6,855.42 [1] - Consumer discretionary shares increased by 1.8%, while materials stocks decreased by 0.6% [1] Economic Indicators - The ISM manufacturing PMI decreased to 48.7 in October from 49.1 in the previous month, falling short of market expectations of 49.5 [2][11] - The S&P Global manufacturing PMI rose to 52.5 in October from 52.0 in September, surpassing the preliminary reading of 52.2 [11] Commodity Market - Oil prices fell by 0.1% to $60.93, while gold prices increased by 0.4% to $4,011.80 [5] - Silver prices decreased by 0.5% to $47.905, and copper prices fell by 0.9% to $5.0420 [5] Company News - Cipher Mining Inc. shares surged by 22% to $22.82 following a $5.5 billion, 15-year lease agreement with Amazon Web Services for 300 MW of AI workload space and power [9] - Resolute Holdings Management, Inc. saw an 88% increase in shares to $138.76 after reporting quarterly financial results [9] - Tharimmune, Inc. shares rose by 14% to $3.35 after entering a $540 million private placement for its Canton Network Blockchain strategy [9] - uniQure N.V. shares dropped by 50% to $33.64 after receiving FDA feedback regarding its investigational gene therapy AMT-130 [9] - Alvotech shares fell by 33% to $5.13 after the FDA issued a complete response letter for its biosimilar candidate AVT05 [9] - ALPS Group Inc shares decreased by 50% to $1.29 following the announcement of a public offering pricing [9]

Core Viewpoint - The FDA's feedback on uniQure's investigational gene therapy AMT-130 for Huntington's disease has led to a significant decline in the company's stock, indicating a shift in regulatory expectations and uncertainty regarding the BLA submission timeline [1][3][4]. Group 1: FDA Feedback and Company Response - The FDA expressed disagreement with uniQure's interpretation of data from Phase 1/2 studies of AMT-130, suggesting it may not be sufficient for a BLA submission [2][4]. - This feedback represents a notable change from previous communications with the FDA, which had indicated that the data could support a BLA submission under the Accelerated Approval pathway [3][4]. - The company plans to urgently engage with the FDA to explore options for the timely accelerated approval of AMT-130 [3][5]. Group 2: Market Reaction - Following the FDA's feedback, uniQure's stock price fell by 53.98%, trading at $31.15 at the time of publication [6]. Group 3: Future Plans - In addition to working with the FDA, uniQure intends to engage with other regulatory agencies, including those in the European Union and the United Kingdom, to advance discussions regarding AMT-130 [5].