Group 1 - A class action lawsuit has been filed against uniQure N.V. on behalf of investors who purchased shares between September 24, 2025, and October 31, 2025 [1] - The lawsuit alleges that uniQure misled investors regarding the likelihood of FDA approval for its leading drug candidate, AMT-130, by failing to disclose that the pivotal study design was not fully approved by the FDA [1] - Following the announcement on November 3, 2025, regarding FDA feedback, uniQure's share price dropped by $33.40, or over 49%, from $67.69 to $34.29 [1] Group 2 - Robbins LLP is also investigating a class action lawsuit against POMDoctor Ltd. for investors who acquired securities between October 9, 2025, and December 11, 2025 [1] - Another class action has been filed against Inovio Pharmaceuticals, Inc. for investors who purchased securities between October 10, 2023, and December 26, 2025 [1] - A class action lawsuit has been initiated against Masonite International Corporation for sellers of common stock between June 5, 2023, and February 8, 2024 [1]

Core Viewpoint - Kessler Topaz Meltzer & Check, LLP has filed a securities fraud class action lawsuit against uniQure N.V. on behalf of investors who purchased shares between September 24, 2025, and October 31, 2025, alleging that the company made materially false and misleading statements regarding its drug AMT-130 and its regulatory approval process [1][2]. Group 1: Lawsuit Details - The lawsuit is titled Scocco v. uniQure N.V., filed in the U.S. District Court for the Southern District of New York [1]. - Investors can move to serve as lead plaintiff by April 13, 2026, and the firm encourages those affected to contact them for more information [2]. Group 2: Company Background - uniQure N.V. is a biotechnology company focused on developing gene therapies for rare diseases, particularly Huntington's disease (HD) [1]. - The leading drug candidate, AMT-130, aims to slow the progression of HD, a fatal genetic disorder with no current cure [1]. Group 3: Clinical Trials and FDA Interaction - uniQure completed patient enrollment for two ongoing Phase I/II clinical trials for AMT-130 in March 2022 [1]. - The FDA had previously agreed that the Pivotal Study results could be compared to an external historical dataset (Enroll-HD) for the basis of a Biologics License Application (BLA) submission [1]. Group 4: Stock Performance and Offering - Following the announcement of positive topline results from the Pivotal Study on September 24, 2025, uniQure's stock price surged nearly 250%, from $13.66 to $47.50 per share [1]. - The company subsequently offered over 5.7 million shares and generated approximately $345 million in proceeds, despite uncertainties regarding AMT-130's future [2]. Group 5: Allegations of Misrepresentation - The complaint alleges that uniQure misrepresented the FDA's approval of the Pivotal Study design and downplayed the likelihood of delays in the BLA timeline [2]. - On November 3, 2025, uniQure disclosed that the FDA no longer agreed that the Pivotal Study data would suffice for a BLA submission, leading to a stock price drop of over 49% [2].

Core Insights - uniQure N.V. announced updated preliminary safety and exploratory efficacy data from its Phase 1/2a trial of AMT-191 for Fabry disease, presented at the WORLDSymposium in San Diego, California [1] Trial Data - AMT-191 is an investigational AAV gene therapy for Fabry disease, a rare X-linked lysosomal disorder characterized by excessive lipid deposition in tissues [2] - As of January 8, 2026, all 11 patients in three dose cohorts (6×10^13 gc/kg, 4×10^13 gc/kg, and 2×10^13 gc/kg) showed elevated α-galactosidase A (α-Gal A) activity, which is crucial as deficiency leads to GB3 buildup and Fabry disease [2] Efficacy Observations - Dose-dependent increases in α-Gal A activity were noted, ranging from 0.34- to 82.2-fold at the lowest dose, 1.6- to 312.52-fold at the mid dose, and 27.7- to 223.7-fold at the highest dose [3] - These increases were durable, with follow-up periods ranging from over a year in the high-dose cohort to four months in the mid-dose cohort [3] Patient Outcomes - Six out of 11 patients were withdrawn from enzyme replacement therapy (ERT) after meeting criteria including elevated α-Gal A activity [4] Safety Profile - Stable plasma lyso-Gb3 levels were maintained across all dose cohorts, regardless of ERT status, indicating a manageable safety profile for AMT-191 [5] - No Serious Adverse Events (SAEs) related to AMT-191 were observed at the 4×10^13 gc/kg and 2×10^13 gc/kg doses, although two patients at the 4×10^13 gc/kg dose experienced asymptomatic Grade 3 liver enzyme elevations [5] Dose-Limiting Toxicity - The two liver enzyme elevation cases were confirmed as dose-limiting toxicity, leading to a pause in additional dosing in the mid- and high-dose cohorts pending further evaluation [6] - Both patients responded to corticosteroid therapy and are under follow-up [6] Additional Observations - At the 6×10^13 gc/kg dose, five previously reported SAEs occurred, including two unrelated (stroke, diplopia) and two related (chest pain, increased troponin) to AMT-191, along with one possibly related SAE (leptomeningeal enhancement) [7] - One patient at this dose experienced an asymptomatic Grade 3 liver enzyme elevation that resolved with corticosteroid therapy [7] Market Reaction - Following the announcement, uniQure shares increased by 6.10% to $26.01 [8]

Core Insights - The article discusses updated preliminary safety and exploratory efficacy data from uniQure's Phase I/IIa trial of AMT-191, a gene therapy for Fabry disease, presented at the WORLDSymposium [1][7] Group 1: Efficacy Data - All 11 patients in the trial exhibited elevated α-galactosidase A (α-Gal A) activity across three dosing cohorts [2] - Dose-dependent increases in α-Gal A activity were observed, ranging from 0.34- to 82.2-fold at the lowest dose, 1.6- to 312.52-fold at the mid dose, and 27.7- to 223.7-fold at the highest dose, with durability noted over follow-up periods [3] - Six out of 11 patients discontinued enzyme replacement therapy after meeting pre-specified criteria, including elevated α-Gal A activity, while stable plasma lyso-Gb3 levels were maintained post-dose across all cohorts [4] Group 2: Safety Profile - The safety profile of AMT-191 was manageable, with no serious adverse events (SAEs) related to the therapy observed at the lower doses [5] - Two patients at the mid dose experienced asymptomatic Grade 3 liver enzyme elevations, confirmed as dose-limiting toxicity, leading to a pause in additional dosing in mid- and high-dose cohorts [5][6] - At the highest dose, five SAEs were reported, including two unrelated to AMT-191, and one patient experienced an asymptomatic Grade 3 liver enzyme elevation that resolved with corticosteroid therapy [6] Group 3: Clinical Trial Overview - The Phase I/IIa trial is a multi-center, open-label study in the U.S. with three dosing cohorts, exploring safety, tolerability, and early efficacy signs [8] - Patients were not excluded based on pre-existing neutralizing antibodies to AAV5 and will be followed for 24 months [8] - AMT-191 has received Orphan Drug and Fast Track designations from the U.S. FDA, indicating its potential significance in treating Fabry disease [9] Group 4: Background on Fabry Disease - Fabry disease is an X-linked genetic lysosomal storage disorder caused by α-Gal A deficiency, leading to toxic accumulation of lyso-Gb3, which can damage various organs [10] - The current standard treatment involves bi-weekly enzyme replacement therapy, which has limited effectiveness due to poor cross-correction and substrate clearance [10] Group 5: Company Overview - uniQure is focused on advancing gene therapies for severe diseases, with a history of significant achievements in the field, including a gene therapy for hemophilia B [11] - The company is developing a pipeline of gene therapies for various conditions, including Fabry disease, and aims to deliver potentially curative treatments [11]

Performance Summary - Apis Flagship Fund achieved a net return of 10.0% in Q4 2025 and a total gain of 55.1% for the year, outperforming the MSCI ACWI benchmark by approximately 7.0% in Q4 and 33.0% for the year [1] - Long positions contributed 11.9% gross to the Fund's performance, while short positions added 0.8% gross, with a net long position of around 68% as of December [1] - The Fund's performance was broad-based, with Technology and Healthcare sectors leading returns, and small-cap stocks narrowing their underperformance relative to large caps [1] Investment Focus - The firm emphasized a bottom-up stock selection strategy and structural exposures to niche opportunities in healthcare, semiconductors, and industrials as key drivers for future returns [1] - Non-U.S. markets were highlighted as persistently attractive for potential returns [1] Company Spotlight: uniQure (NASDAQ:QURE) - uniQure is a gene therapy company focused on one-time treatments for rare and neurological diseases, utilizing proprietary AAV-based delivery technology [2] - The stock had a one-month return of 0.44%, trading between $7.76 and $71.50 over the past 52 weeks, and closed at approximately $22.72 per share on January 30, 2026, with a market capitalization of about $1.4 billion [2] - In Q4 2025, uniQure detracted about 1.1% from the Fund's performance, attributed to a technical pause rather than fundamental deterioration [3] Hedge Fund Interest - uniQure was held by 59 hedge fund portfolios at the end of Q3 2025, an increase from 36 in the previous quarter [3] - Despite the potential of uniQure, the firm expressed a stronger conviction in AI stocks for higher returns in a shorter timeframe [3]

Performance Summary - Apis Flagship Fund achieved a net return of 10.0% in Q4 2025 and a total gain of 55.1% for the year, outperforming the MSCI ACWI benchmark by approximately 7.0% in Q4 and 33.0% for the year [1] - Long positions contributed 11.9% gross to the fund's performance, while short positions added 0.8% gross, with a net long position of around 68% as of December [1] - The performance was broad-based, with Technology and Healthcare sectors leading returns, and basic materials also contributing significantly [1] Stock Highlights - uniQure (NASDAQ:QURE) is a gene therapy company focused on rare and neurological diseases, with a one-month return of 0.44% and a market capitalization of approximately $1.4 billion as of January 30, 2026 [2] - The stock traded between $7.76 and $71.50 over the last 52 weeks, closing at about $22.72 per share [2] Key Contributors and Detractors - Celcuity was the top contributor in Q4, adding 3.8% during the quarter and 4.4% for the full year [3] - Memory semiconductor companies contributed over 5.0% to returns, with Kioxia Holdings being a notable performer [3] - uniQure detracted about 1.1% from performance, while Korean defense-related holdings collectively detracted approximately 2.5% in Q4 [3] - The weakness in uniQure and Korean holdings was attributed to a technical pause rather than a decline in fundamentals [3] - Hyundai Rotem, Poongsan, and Hanwha Aerospace were among the top contributors for the year, collectively adding over 11.0% to annual performance [3]

Group 1 - Biotech stocks experienced significant gains in after-hours trading, with several companies showing strong percentage increases despite no new company-specific news [1][2][3][4] - Coherus Oncology, Inc. (CHRS) rose by 9.09% to close at $1.73, adding $0.14 in extended trading [1] - Sensei Biotherapeutics, Inc. (SNSE) surged 10.06% to finish at $12.47, gaining $1.14 [1] - Cue Biopharma, Inc. (CUE) advanced 9.37% to $0.40, increasing by $0.034 [1] - Alpha Tau Medical Ltd. (DRTS) increased by 3.35% to $7.41, up $0.24, with recent focus on new leadership [2] - Cingulate Inc. (CING) edged up 1.49% to close at $5.45, gaining $0.08 [3] - uniQure N.V. (QURE) posted a notable 9.96% jump to $24.95, adding $2.26 in after-hours trading [3] - IO Biotech, Inc. (IOBT) gained 4.19% to $0.50, up $0.020, while exploring strategic alternatives including mergers and asset sales [4]

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against uniQure N.V. for possible violations of federal securities laws and unlawful business practices following a significant drop in share price due to FDA concerns regarding AMT-130 [1][2]. Investigation Details - On November 3, 2025, uniQure announced that the FDA no longer believes that data from Phase I/II studies of AMT-130 may be adequate for a Biologics License Application (BLA) submission, leading to a lack of clarity on the timing of the BLA submission [2]. - Following this announcement, uniQure's shares fell by over 57% during morning trading on the same day [2]. Next Steps - Investors who purchased or acquired uniQure shares and suffered losses are encouraged to contact Bragar Eagel & Squire for more information regarding their rights and potential claims [3].

Core Insights - The Alger Small Cap Focus Fund's fourth-quarter 2025 investor letter highlights a strong performance in the US equity market, with the S&P 500 increasing by 2.7% due to better-than-expected corporate earnings and a supportive macroeconomic environment [1] - The letter notes a divergence in market performance, particularly regarding AI investments, which face skepticism due to various challenges [1] - The Fund's Class A shares outperformed the Russell 2000 Growth Index, with contributions from the Utilities and Financials sectors, while Consumer Discretionary and Information Technology sectors negatively impacted performance [1] Company Insights - UniQure N.V. (NASDAQ:QURE) is a biotechnology company focused on developing treatments for rare diseases, specifically AMT-130 for Huntington's disease, which currently lacks approved disease-modifying treatments [2][3] - The stock of UniQure N.V. experienced a one-month return of -8.57% but gained 62.56% over the past 52 weeks, closing at $22.84 with a market capitalization of $1.42 billion on November 18, 2025 [2] - The company's shares were volatile in 2025, initially surging after promising Phase 1/2 data but later facing regulatory uncertainty due to FDA feedback regarding the adequacy of external-control data for accelerated approval [3]

Core Viewpoint - Kessler Topaz Meltzer & Check, LLP is investigating potential violations of federal securities laws on behalf of investors in uniQure N.V. following significant stock price decline due to FDA feedback on its gene therapy AMT-130 [1][4]. Group 1: Company Developments - On November 3, 2025, uniQure announced that the FDA indicated the data for its investigational gene therapy AMT-130 did not provide sufficient evidence to support its Biologics License Application (BLA) [2]. - The FDA no longer agrees that data from the Phase I/II studies of AMT-130 may be adequate for BLA submission, leading to uncertainty regarding the timing of the BLA submission [2]. Group 2: Market Reaction - Following the FDA's announcement, uniQure's stock price plummeted over 50%, dropping from $67.69 on October 31, 2025, to $34.29 on November 3, 2025 [3].