Group 1: Company Performance - Gelteq Ltd (NASDAQ:GELS) shares rose sharply by 50.1% to $1.25 in pre-market trading after reporting positive preclinical results for its cannabinoid oral gel delivery platform [1][2] - The proprietary oral gel platform achieved a greater than 22% increase in the bioavailability of cannabidiol compared to an existing FDA-approved oil-based product [1] Group 2: Other Notable Stock Movements - Inspire Veterinary Partners Inc (NASDAQ:IVP) gained 141.3% to $0.056 after filing a Certificate of Amendment to increase its authorized Class A common stock from 100 million to 700 million shares [5] - Oriental Culture Holding Ltd (NASDAQ:OCG) rose 40.8% to $0.016 following the board's approval of a special cash dividend of 5 cents per share [5] - XCF Global Inc (NASDAQ:SAFX) gained 30.2% to $0.22 after announcing expansion financing plans [5] - AiRWA Inc (NASDAQ:YYAI) rose 15.8% to $1.46 after a director purchased 1.109 million shares at an average price of $1.35 per share [5] - Autolus Therapeutics PLC (NASDAQ:AUTL) gained 7.3% to $1.47 after announcing preliminary fourth-quarter and FY25 revenue results [5] Group 3: Declining Stocks - Briacell Therapeutics Corp (NASDAQ:BCTX) fell 53.1% to $5.12 after announcing the pricing of a $30 million public offering [5] - Moolec Science SA (NASDAQ:MLEC) fell 19.8% to $3.94 after a previous jump of 19% [5] - Hub Cyber Security Ltd (NASDAQ:HUBC) fell 19.1% to $0.43 after gaining 56% on the previous day [5] - Trip.com Group Ltd (NASDAQ:TCOM) dipped 9.3% to $68.55 amid an investigation by China's SAMR for potential anti-monopoly violations [5]

Core Insights - Autolus Therapeutics plc reported preliminary unaudited net product revenue from AUCATZYL® sales, with fourth quarter 2025 revenue expected to be approximately $24 million and full year 2025 revenue around $75 million, significantly exceeding expectations [3][6] - The company anticipates 2026 net product revenue for AUCATZYL to be between $120 million and $135 million, driven by a successful launch and positive real-world data [4][6] Commercial Updates - AUCATZYL was successfully launched in the US, with over 60 treatment centers established, and received regulatory approvals in the UK and EU [2][3] - The ROCCA consortium's real-world data confirmed AUCATZYL's high clinical activity and favorable safety profile, which is expected to enhance future growth [2][6] Pipeline Updates - Autolus reported strong initial clinical data from the Phase 1 CATULUS trial in pediatric r/r B-ALL patients, showing a 95.5% overall response rate, and plans to advance to Phase 2 [5][12] - The company is also progressing studies in lupus nephritis and multiple sclerosis, with initial data from the BOBCAT trial expected by the end of 2026 [7][12] Operational Focus - The company aims to optimize manufacturing operations to improve gross margins and drive top-line growth for AUCATZYL in 2026 [8][9] - Autolus has initiated a manufacturing life cycle plan to reduce costs and enhance capacity, with updates expected in mid-2026 [9][10] Financial Outlook - Based on current projections, Autolus expects its cash and marketable securities to fund operations into Q4 2027, supporting ongoing development and commercialization efforts [10]

SOUTH SAN FRANCISCO, Calif. and LONDON, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, and Cellares Corp, the first Integrated Development and Manufacturing Organization (IDMO), today announced that Autolus will assess the feasibility of Cellares’ Cell Shuttle platform to complement its commercial manufacturing operations at the Nucleus facility in St ...

Market Overview - U.S. stock markets are experiencing mixed premarket activity as 2025 comes to a close, following a three-day losing streak, despite significant annual gains driven by the AI and technology sectors [1][2] - Major U.S. market indexes are set to close 2025 with impressive annual gains: Nasdaq Composite is up approximately 21%, S&P 500 is up around 17%, and Dow Jones Industrial Average has climbed roughly 14% [5] Individual Stock Movements - Nike (NKE) shares rose 1.54% due to a significant stock purchase by CEO Elliott Hill [3] - Intel (INTC) gained 1.34% in premarket trading [3] - Autolus Therapeutics (AUTL) surged 5.35% after receiving a strategic upgrade from Needham & Co. [3] - Vanda Pharmaceuticals (VNDA) experienced a significant jump of 18.7% following FDA approval for its drug [3] - DigitalBridge Group (DBRG) shares surged 9.6% on news of acquisition by SoftBank Group Corp. valued at approximately $4 billion [13] - Ultragenyx Pharmaceutical (RARE) shares plunged 42.3% after disappointing Phase 3 trial results [13] - Tesla (TSLA) forecasted a decrease in fourth-quarter sales, expecting to sell 1.64 million vehicles in 2025 [13] Technology Sector Highlights - Nvidia (NVDA) remains a dominant player in AI, with ByteDance planning to increase spending on Nvidia's AI chips to ¥100 billion ($14 billion) in 2026 [13] - Meta Platforms (META) acquired AI startup Manus for over $2 billion [13] - Caterpillar (CAT) saw stock surges attributed to sales of generators related to AI infrastructure [13] Economic Data and Federal Reserve Insights - Initial Jobless Claims reported at 199,000, below the expected 220,000, indicating a slowing but stable labor market [7] - The Federal Reserve's recent meeting minutes revealed a divided debate on interest rate cuts, with expectations for further reductions in 2026 [6]

Group 1 - Needham raised the price target on Autolus Therapeutics (AUTL) to $11 from $10 and maintains a Buy rating on the shares [1] - Autolus is named a top pick for 2026, with impressive sales of $76 million from the launch of Aucatzyl [1] - Despite skepticism from investors regarding Autolus reaching breakeven, Needham believes the shares offer an attractive valuation and strong opportunity for value creation in 2026 [1] Group 2 - Data from the FELIX study and results from obe-cel in relapsed/refractory acute lymphoblastic leukemia indicate an expanding addressable market for Autolus [1] - Needham's modeling suggests Autolus could reach breakeven by 2028 based solely on Aucatzyl sales [1] - The potential of obe-cel in lupus nephritis is currently underappreciated, which may change with clinical updates expected in the first half of 2026 [1]

Group 1 - U.S. stocks experienced a decline, with the Nasdaq Composite dropping over 100 points on Monday [1] - DigitalBridge Group Inc announced its acquisition by SoftBank Group for an enterprise value of approximately $4.0 billion, resulting in a 9.9% increase in its shares to $15.30 [1] Group 2 - Eightco Holdings Inc shares surged 29.1% to $2.15 following the announcement of a share buyback program for up to $125 million [2] - Palisade Bio Inc saw an 18.6% increase to $2.55 after Piper Sandler initiated coverage with an Overweight rating and a price target of $25 [2] - Regencell Bioscience Holdings Ltd gained 16.3% to $24.60 [2] - Praxis Precision Medicines Inc surged 13% to $304.00 after receiving Breakthrough Therapy Designation from the FDA for ulixacaltamide [2] - Zura Bio Ltd increased by 13% to $5.26 [2] - Precigen Inc rose 8.6% to $4.52 [2] - Autolus Therapeutics PLC jumped 7.8% to $1.80, with Needham analyst raising the price target from $10 to $11 [2] - LightPath Technologies Inc gained 6.6% to $9.62 [2] - NGL Energy Partners LP surged 6.3% to $9.98 [2] - Six Flags Entertainment Corp increased by 5% to $15.64 [2]

Group 1 - Autolus Therapeutics plc (NASDAQ:AUTL) is currently viewed as a consensus buy among eleven analysts, with a median price target of $10, indicating an upside potential of 495.24% [1] - Analyst Yanan Zhu from Wells Fargo reaffirmed a 'Buy' rating for Autolus, setting a price target of $5, which represents an upside potential of approximately 198% [1] - The company recently presented preliminary data from its Phase 1 CARLYSLE trial, showing positive responses in patients with refractory systemic lupus erythematosus (srSLE) treated with CAR-T cell therapy obecabtagene autoleucel (obe-cel) [2] Group 2 - In the CARLYSLE trial, three patients achieved a complete response, while five patients met DORIS response criteria, with a median onset of 5.1 months [3] - Nine patients were assessable for safety across both the 50 million and 100 million cell dose cohorts, indicating a thorough evaluation of the treatment's safety profile [3] - Autolus Therapeutics is focused on developing next-generation T-cell immunotherapies for cancer and autoimmune diseases, highlighting its commitment to innovative biopharmaceutical solutions [3]

Core Insights - Autolus Therapeutics plc has presented preliminary data from the Phase 1 CARLYSLE trial for its CD19-targeting CAR T-cell therapy, obe-cel, in patients with severe refractory systemic lupus erythematosus (srSLE) at the American Society of Hematology Annual Meeting [1][2] Group 1: Trial Data and Efficacy - The CARLYSLE trial shows a high rate of DORIS responses and a significant reset in the B cell compartment, indicating potential for immune reset in srSLE patients [2][5] - In the 50 million cell dose cohort, 50% of patients achieved complete response rates (CRR) and 83% achieved DORIS, with a median onset of 5.1 months and no new disease activity observed at a median follow-up of 12 months [5][6] - The 100 million cell cohort data is consistent with the 50 million cohort, supporting the progression of obe-cel as a treatment for srSLE, with the 50 million dose selected for the Phase 2 trial [6][7] Group 2: Safety Profile - Obe-cel was well tolerated, with no dose-limiting toxicities or cases of immune effector cell-associated neurotoxicity syndrome (ICANS) observed at the 50 million dose [4][7] - Grade one cytokine release syndrome (CRS) occurred in three patients at both the 50 million and 100 million doses, while transient Grade three liver toxicity was noted in one patient from the 100 million cohort [4][5] - The safety profile of obe-cel is supported by a robust database from previous clinical trials in other indications, indicating deep and durable responses [7][8] Group 3: Future Developments - Autolus has initiated the LUMINA trial, a Phase 2 trial in lupus nephritis with registrational intent, based on the positive initial experience from the CARLYSLE trial [2][6] - The company has aligned with the U.S. Food and Drug Administration (FDA) on the Phase 2 trial design and potential path to approval [6][8] - Autolus is positioned for a successful entry into the autoimmune disease market, leveraging its existing clinical data and manufacturing capabilities [8]

Core Insights - Autolus Therapeutics presented preliminary data from the CATULUS Phase 1 trial of obe-cel for pediatric patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) at the ASH Annual Meeting, highlighting high remission rates and a favorable safety profile [1][2][3] Group 1: Pediatric Trial Insights - The CATULUS trial showed an overall response rate (ORR) of 95.5% in pediatric patients, with 90.9% achieving complete response (CR) [3] - The safety profile of obe-cel in pediatric patients was consistent with adult data, showing low rates of high-grade cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), both at 8.7% [3][4] - Twenty patients remained in ongoing remission at the data cut-off with a median follow-up of 8.8 months, supporting further exploration of obe-cel in this population [3] Group 2: Adult Trial Insights - Insights from the FELIX pivotal trial indicated that the detection of obe-cel in the blood three months post-treatment may predict long-term outcomes in adult patients with r/r B-ALL [2][4] - The analysis of the FELIX study revealed that a higher percentage of central memory cells in the drug product was an independent predictor of positive clinical outcomes, including overall survival [7] Group 3: Real-World Data - Real-world data from the ROCCA consortium corroborated the safety profile of obe-cel, showing low rates of high-grade CRS and ICANS, consistent with clinical trial results [2][4] Group 4: Product Characteristics - The unique features of the CAR T product, including the CAT19 binder, were highlighted as important for tracking CAR T expansion and persistence, which are critical for predicting treatment outcomes [6][7] - The study emphasized the need for further investigations to understand the impact of tumor characteristics and product features on clinical outcomes [7]

LONDON and GAITHERSBURG, Md., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, today announced the appointment of Ryan Richardson to the Company’s Board of Directors. Mr. Richardson brings more than 20 years of strategy and corporate development experience and in the healthcare and investment banking industries to Autolus’ Board. “Autolus has ent ...