NEW YORK, Oct. 09, 2025 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Savara Inc. ("Savara Inc." or the "Company") (NASDAQ: SVRA) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Savara Inc. investors who were adversely affected by alleged securities fraud between March 4, 2024 and May 23, 2025. Follow the link below to get more information and be contacted by a member of our team: https://zlk.com/pslra-1/savara-inc-lawsuit-submission ...

Core Insights - Tenaya Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing potentially curative therapies for heart disease [1][3] - The CEO, Faraz Ali, will participate in a fireside chat at the H.C. Wainwright Genetic Medicines Virtual Conference on October 14, 2025, with virtual 1x1 meetings scheduled for October 15, 2025 [1][2] Company Overview - Tenaya Therapeutics is dedicated to discovering and delivering therapies that target the underlying causes of heart disease [3] - The company's pipeline includes clinical-stage candidates such as TN-201 for MYBPC3-associated hypertrophic cardiomyopathy and TN-401 for PKP2-associated arrhythmogenic right ventricular cardiomyopathy [3] - Tenaya employs integrated capabilities like target validation and capsid engineering to develop novel medicines, including TN-301, a small molecule HDAC6 inhibitor for heart failure [3]

Company Performance - Delta Air Lines Inc. reported better-than-expected adjusted EPS of $1.71 and operating revenue of $16.7 billion, reflecting a 6% year-over-year increase [2] - GAAP EPS for Delta was $2.17, marking a 10% rise from the previous year [2] - Delta anticipates total revenue growth of 2% to 4% for the December quarter, with adjusted EPS projected between $1.60 and $1.90 [3] Market Movements - Turn Therapeutics Inc. shares surged 145% to $17.14 after commencing trading on the Nasdaq Capital Market [9] - Tilray Brands, Inc. saw a 29% increase in shares to $2.2109 following better-than-expected first-quarter financial results [9] - Serve Robotics Inc. shares rose 26% to $17.38 due to a new partnership with DoorDash for autonomous robot deliveries [9] - Helen of Troy Limited shares dropped 21% to $21.90 after reporting second-quarter results and issuing FY26 adjusted EPS guidance below estimates [9] - Ferrari N.V. shares fell 13% to $417.00 after releasing its comprehensive 2030 strategic plan and updated near-term financial guidance [9] - Lucas GC Limited shares decreased by 30% to $0.1082 following a 40-for-1 share consolidation announcement [9] Commodity Prices - Oil prices decreased by 0.1% to $62.52, while gold fell by 0.7% to $4,041.90 [6] - Silver traded down 0.6% to $48.720, whereas copper rose by 1.7% to $5.1790 [6]

Core Insights - Cabaletta Bio, Inc. presented promising initial data from the RESET-PV trial, indicating that rese-cel can achieve complete B cell depletion and significant clinical responses without preconditioning in patients with pemphigus vulgaris [1][2][3] Group 1: Clinical Trial Results - In the RESET-PV trial, three patients received rese-cel at a dose of 1 x 10^6 cells/kg without preconditioning, resulting in complete B cell depletion in two patients and a rapid reduction in autoantibodies [1][3] - All three patients showed improvement in Pemphigus Disease Area Index (PDAI) scores, with notable reductions from baseline: Patient 1 (24 to 10), Patient 2 (83 to 3), and Patient 3 (22 to 2) [9] - The safety profile of rese-cel was favorable, with no cases of immune effector cell-associated neurotoxicity syndrome (ICANS) reported, and only mild transient fever observed in one patient [3][4] Group 2: Future Plans and Strategy - The company plans to expand patient enrollment in the RESET-PV trial and explore higher doses of rese-cel based on the observed clinical activity [2][10] - Cabaletta is considering the incorporation of no preconditioning regimens in other cohorts of the RESET clinical trial program, aiming to broaden treatment options for autoimmune diseases [2][10] - The RESET-PV trial is part of a larger RESET clinical development program that includes trials for various autoimmune diseases, indicating a strategic focus on innovative treatment approaches [6][7]

Core Insights - Black Diamond Therapeutics, Inc. (BDTX) has demonstrated exceptional performance in 2025, with shares reaching a 52-week high of $4.1 on October 8, reflecting an 86.4% increase year-to-date, significantly outperforming the industry growth of 10.4% [1][9]. Company Performance - BDTX's stock has outperformed the sector and the S&P 500 Index during the same period [1]. - The company's success is largely attributed to the promising progress of its lead pipeline candidate, silevertinib [1]. Lead Drug Development - Silevertinib is a fourth-generation epidermal growth factor receptor (EGFR) MasterKey inhibitor targeting EGFR mutant non-small cell lung cancer (NSCLC) and glioblastoma (GBM) [5]. - The drug has shown good tolerability and durable clinical responses in a Phase I study involving patients with recurrent EGFRm NSCLC [6]. - BDTX is currently conducting a Phase II study of silevertinib in both recurrent and frontline settings for EGFRm NSCLC [6][7]. Clinical Trials and Data - Enrollment for frontline patients with non-classical EGFR mutations was completed in July 2025, with plans to disclose response rates and duration of response data in Q4 2025 [7]. - The developmental plan includes seeking FDA feedback on a potential registrational path in the first half of 2026 [8]. Financial Position - As of the end of Q2 2025, BDTX had approximately $142.8 million in cash and cash equivalents [12]. - The company entered a global licensing agreement with Servier Pharmaceuticals for its second clinical-stage asset, BDTX-4933, receiving an upfront payment of $70 million [12]. Valuation Metrics - BDTX shares currently trade at a price/book ratio of 1.71x, which is lower than its historical mean of 1.31x and the biotech industry's average of 3.28x [14]. Market Potential - The oncology market, particularly in the NSCLC space, is highly lucrative, with competition from major players like Johnson & Johnson and AstraZeneca [18]. - Silevertinib has the potential to treat both newly diagnosed and recurrent EGFRm NSCLC patients, targeting over 50 oncogenic driver mutations with greater potency than existing EGFR tyrosine kinase inhibitors [18]. Investment Recommendation - The successful development and commercialization of silevertinib could significantly enhance BDTX's value, making it an attractive investment opportunity [19].

Summary of Key Points Core Viewpoint - U.S. stock futures are slightly lower, with Nasdaq futures down approximately 0.1% on Thursday, indicating a cautious market sentiment [1]. Company-Specific Summaries Helen of Troy Ltd (NASDAQ:HELE) - Helen of Troy reported quarterly earnings of 59 cents per share, surpassing the analyst consensus estimate of 53 cents per share [1]. - The company achieved quarterly sales of $431.781 million, exceeding the analyst consensus estimate of $418.806 million [1]. - For FY2026, Helen of Troy projects adjusted EPS between $3.75 and $4.25, which is below market estimates of $4.58 [1]. - The company anticipates sales in the range of $1.739 billion to $1.780 billion, compared to market estimates of $1.750 billion [1]. - Shares of Helen of Troy fell 16.7% to $23.00 in pre-market trading following the earnings report [2]. Ferrari NV (NYSE:RACE) - Ferrari's shares decreased by 12.4% to $420.00 in pre-market trading after the release of its comprehensive 2030 strategic plan and updated near-term financial guidance [4]. Apogee Therapeutics, Inc. (NASDAQ:APGE) - Apogee Therapeutics' stock tumbled 9.6% to $42.70 in pre-market trading after announcing a $300 million underwritten public offering [4]. AZZ Inc (NYSE:AZZ) - AZZ Inc's shares declined by 9.4% to $96.01 in pre-market trading following weak second-quarter results [4]. Plug Power Inc. (NASDAQ:PLUG) - Plug Power's stock fell 7.8% to $3.37 in pre-market trading after a decline of more than 5% on Wednesday, despite raising $370 million from the immediate exercise of 185.4 million warrants at $2 per share [4]. Other Notable Stocks - Inventiva (NYSE:IVA) shares fell 6.3% to $5.02 in pre-market trading [4]. - NextNRG Inc (NASDAQ:NXXT) saw a decline of 5.8% to $2.59 in pre-market trading [4].

Core Viewpoint - NKGen Biotech, Inc. is addressing shareholder concerns regarding its stock price display of $0.00 on certain financial websites, clarifying that this does not reflect the company's actual value but is due to trading on the OTC Expert Market [1][2][4]. Company Status - The $0.00 stock price is a result of limitations on public quote dissemination for securities traded on the OTC Expert Market, not indicative of any changes in the company's fundamentals or operations [2][4]. - NKGen Biotech's common stock is not delisted and remains tradable, although current financial information is restricted to brokers and market makers [5]. Compliance and Reporting - The company is actively working to regain compliance with reporting obligations under the Securities Exchange Act, having filed its Form 10-K for the year ended December 31, 2024, and is focused on completing its Form 10-Qs for the first three quarters of 2025 [6]. - NKGen Biotech is committed to transparency and corporate compliance, with plans to restore full access to market information for shareholders [7]. Company Overview - NKGen Biotech is a clinical-stage biotechnology company specializing in the development and commercialization of innovative autologous and allogeneic natural killer cell therapeutics, headquartered in Santa Ana, California [8].

Core Insights - Zenas BioPharma, Inc. has entered into a licensing agreement with InnoCare, valued at approximately $2 billion, granting Zenas rights to the global market [1] Company Overview - Zenas BioPharma focuses on biotechnology innovations, particularly in drug development, leveraging scientific expertise to identify promising companies and therapies [1] Market Implications - The licensing deal is expected to enhance Zenas's market position and expand its portfolio in the biotechnology sector, potentially leading to significant financial returns [1]

分组1 - Richardson Electronics, Ltd. reported better-than-expected first-quarter financial results, with earnings of 13 cents per share, surpassing the analyst consensus estimate of 1 cent per share [1] - The company achieved quarterly sales of $54.607 million, exceeding the analyst consensus estimate of $51.510 million [1] - Following the positive earnings report, Richardson Electronics shares increased by 20.2% to $12.76 in pre-market trading [1] 分组2 - Turn Therapeutics Inc. saw a significant gain of 226.3%, reaching $22.84 in pre-market trading after commencing trading on the Nasdaq Capital Market [5] - Baosheng Media Group Holdings Limited surged by 107.7% to $6.88 in pre-market trading [5] - Several other companies also experienced notable pre-market trading gains, including Alaunos Therapeutics, Inc. (+61.5%), Ambow Education Holding Ltd. (+53.2%), and AiRWA Inc. (+45.7%) [5]

With U.S. stock futures trading mixed this morning on Thursday, some of the stocks that may grab investor focus today are as follows:Wall Street expects PepsiCo Inc. (NASDAQ:PEP) to post quarterly earnings at $2.26 per share on revenue of $23.83 billion before the opening bell, according to data from Benzinga Pro. PepsiCo shares rose 0.1% to $139.00 in after-hours trading.Costco Wholesale Corp. (NASDAQ:COST) reported net sales of $26.58 billion for the retail month of September, which includes the five week ...