H.C. Wainwright analyst Yi Chen raised the firm’s price target on Alpha Tau (DRTS) to $12 from $9 and keeps a Buy rating on the shares after Japan’s Ministry of Health, Labour and Welfare granted marketing approval for Alpha DaRT for the treatment of unresectable locally advanced or locally recurrent head and neck cancer. The approval in Japan further validates the Alpha DaRT platform and helps de-risk the clinical development in the U.S., the analyst tells investors. Published first on TheFly – the ulti ...

TOKYO--(BUSINESS WIRE)--HekaBio K.K., (Headquarters: Chuo-ku, Tokyo) announces that the innovative solid tumor treatment device 'Alpha DaRT (Diffusing Alpha Radiation Therapy),' developed by Alpha Tau Medical Ltd. (Headquarters: Jerusalem, Israel) has received official approval in Japan. HekaBio led the approval process as the Designated Marketing Authorization Holder (DMAH) and will be responsible for launching the product in the Japanese market. With this approval, Japan becomes the first country in the w ...

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 Insights - U.S. stocks experienced a decline, with the Nasdaq Composite dropping over 200 points on Wednesday [1] - TG Therapeutics Inc reported preliminary total global revenue for fiscal year 2025 of approximately $616 million, leading to a significant increase in its stock price [2] Company Performance - TG Therapeutics reported U.S. net product revenue for BRIUMVI of approximately $182 million for Q4 and $594 million for the full year, with these figures being unaudited [2] - TG Therapeutics shares surged by 11.6% to $31.10 following the revenue announcement [2] Other Notable Stock Movements - Rich Sparkle Holdings Ltd shares increased by 13.5% to $95.31 [3] - Cerus Corp gained 12.7% to $2.84 [3] - Clover Health Investments Corp saw an 11.2% rise to $2.82, driven by year-over-year membership growth in its Medicare Advantage PPO plans [3] - Highpeak Energy Inc shares rose by 8.3% to $5.07 [3] - Nutrien Ltd gained 7% to $65.62 after an upgrade from Morgan Stanley analyst Vincent Sinisi, with a price target increase from $70 to $77 [3]

Core Insights - Alpha Tau Medical Ltd. announced final results from its first-in-human pancreatic cancer study, showing an 81% disease control rate and 87% when excluding the first two patients [1][2] - The study indicates that Alpha DaRT preserves the immune system and has potential anti-inflammatory effects, differing from conventional radiation therapies [1][4] - Alpha DaRT is currently being evaluated in a U.S. multi-center pilot trial in combination with chemotherapy for newly diagnosed pancreatic cancer patients [1][3] Study Results - The trial involved 32 patients with Stage II, III, or IV pancreatic ductal adenocarcinoma (PDAC), achieving a 22% objective response rate (ORR) and an 81% disease control rate (DCR) [2] - Excluding the first two patients, the ORR improved to 23% and the DCR to 87% [2] Immune Response - The immune markers indicated that Alpha DaRT treatment preserved the immune system, with no significant changes in various inflammatory indices post-treatment [4][5] - A significant reduction in IL-6 cytokine levels was observed, suggesting a potential decrease in inflammation [4] Future Trials - The company is pursuing further studies, including the IMPACT trial, to explore Alpha DaRT's efficacy in combination with chemotherapy for patients with unresectable locally advanced or metastatic PDAC [3][6] - The CEO emphasized the importance of pancreatic cancer treatment in the company's strategy and the ongoing recruitment pace for clinical trials [6] Technology Overview - Alpha DaRT utilizes radium-224 for targeted alpha-irradiation of solid tumors, aiming to minimize damage to surrounding healthy tissue [7]

Core Insights - Several biotechnology and pharmaceutical companies experienced significant stock price increases in after-hours trading due to clinical trial updates, regulatory advancements, and investor anticipation for upcoming data releases [1] Company Updates - Alumis Inc. (ALMS) saw a surge of 17.33% to $9.75, gaining $1.44 after announcing that topline data from its Phase 3 ONWARD clinical program for envudeucitinib in moderate-to-severe plaque psoriasis will be reported on January 6, 2026, along with a conference call to discuss the results [2] - Genelux Corp. (GNLX) climbed 10.92% to $3.86, up $0.38, following interim results from ongoing trials evaluating Olvi-Vec in patients with progressive small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) [3] - Bright Minds Biosciences Inc. (DRUG) rose 8.42% to $86.75, gaining $6.74, and announced a conference call on January 6, 2026, to report topline results from its Phase 2 trial of BMB-101 in patients with drug-resistant Absence Seizures [4] - Context Therapeutics Inc. (CNTX) shares increased by 8.36% to $1.68, adding $0.13, despite no specific news released [4] - BioAtla, Inc. (BCAB) gained 3.95% to $0.44, up $0.017, after announcing a special purpose vehicle transaction to advance ozuriftamab vedotin in a Phase 3 study for oropharyngeal squamous cell carcinoma, receiving $5 million in initial funding [5] - Femasys Inc. (FEMY) added 7.09% to $0.6223, up $0.04, with no new updates reported [5] - Acumen Pharmaceuticals, Inc. (ABOS) jumped 11.62% to $2.21, gaining $0.23, also without new corporate updates [6] - Alpha Tau Medical Ltd. (DRTS) rose 5.36% to $5.50, up $0.28, after submitting the first module of its pre-market approval application to the FDA for Alpha DaRT in treating recurrent cutaneous squamous cell carcinoma [7]

Core Insights - CPI Aerostructures Inc. shares increased by 17.52% in after-hours trading, reaching a price of $3.69 [1] Management Changes - CPI Aerostructures appointed Robert Mannix as Chief Financial Officer and Secretary, effective Tuesday [2] - Mannix has a background as Executive Vice President, Chief Accounting Officer, and Head of Tax and Treasury at West Technology Group LLC, and has held senior finance roles at Verint Systems Inc. and Motorola Inc. [2] - Mannix succeeds Pamela Levesque, who served as Interim CFO and Secretary [3] Compensation Details - Mannix's annual base salary is set at $300,000 [3] - Starting from fiscal 2026, he is eligible for a 40% target bonus and a 40% long-term incentive award, both based on his base salary and payable in restricted stock [3] Trading Performance - CPI Aerostructures' stock is down 27.15% year to date but has increased by 7.53% over the past six months [4] - The company has a market capitalization of $41.40 million, with a stock price range of $2.02 to $5.85 over the past year [4] - Current trading metrics indicate long-term consolidation with medium- and short-term upward movement [4]

Group 1: Market Movements - Biotech stocks experienced significant fluctuations in after-hours trading, with several companies rebounding after substantial losses during regular sessions, driven by fresh clinical data, FDA designations, and financing announcements [1] - Stoke Therapeutics, Inc. (STOK) saw its stock rise to $33.95 (+11.42%) in post-market hours after closing at $30.47 (-7.67%), following positive data presentations with Biogen regarding zorevunersen for Dravet syndrome [2] - Alpha Tau Medical Ltd. (DRTS) experienced a notable increase in share price, climbing to $5.30 (+25.26%) after closing at $4.23 (+8.74%), following the treatment of the first patient in its pilot study for recurrent glioblastoma multiforme [3] Group 2: Company Announcements - Absci Corp. (ABSI) rose to $3.65 (+3.69%) after hours, building on a close of $3.52 (+2.03%), with no new announcements but previously reported first volunteer dosing in its Phase 1/2a HEADLINE study of ABS-201 [4] - Senti Biosciences, Inc. (SNTI) surged to $1.60 (+3.92%) after hours, despite a sharp decline to $1.54 (-35.56%) during regular trading, driven by the FDA granting RMAT designation to its investigational CAR-NK cell therapy for AML and other hematologic malignancies [5] - TuHURA Biosciences, Inc. (HURA) edged up to $1.18 (+0.85%) after hours, following a significant decline to $1.17 (-40.91%) at the close, announcing a registered direct offering of 9.4 million shares priced at $1.65 per share [6]

Core Insights - Oramed Pharmaceuticals Inc. reported a strong financial performance for the nine months ended September 30, 2025, with total assets increasing by 42% to $220.5 million [1][7] - The company achieved a net income of $65 million, a significant turnaround from a net loss of $6.1 million in the same period last year, primarily due to cash returns from Scilex Holding Company and unrealized gains from investments in Alpha Tau Medical Ltd. [3][4][7] Financial Highlights - Net income (pre-tax) reached $65.0 million, compared to a net loss of $6.1 million in the same period last year [7] - The company completed a full repayment from Scilex, receiving approximately $27 million during the period, totaling $100 million in principal return from this strategic investment [4][7] - Basic earnings per share were reported at $1.30, while diluted earnings per share were $1.26 [7] - Total assets grew from $155.3 million to $220.5 million year-over-year, marking a 42% increase [7] - Research and Development (R&D) expenses decreased from $4.9 million to $4.4 million, while General and Administrative (G&A) expenses increased from $4.3 million to $5.0 million [7] Management Commentary - CEO Nadav Kidron emphasized that the disciplined investment strategy is yielding strong results, providing the company with greater financial flexibility to pursue strategic opportunities while advancing its oral drug delivery platform [4]

Core Insights - Alpha Tau Medical Ltd. is participating in the Jefferies Global Healthcare Conference in London on November 18-19, 2025, where CFO Raphi Levy will hold 1x1 investor meetings [1] Company Overview - Alpha Tau Medical Ltd. was founded in 2016 and is an Israeli oncology therapeutics company focused on the research, development, and potential commercialization of Alpha DaRT for treating solid tumors [2] - The technology behind Alpha DaRT was developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University [2] Technology Details - Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed for highly potent and conformal alpha-irradiation of solid tumors through intratumoral delivery of radium-224 impregnated sources [3] - The therapy works by releasing short-lived daughter isotopes from radium-224, which emit high-energy alpha particles aimed at destroying tumors while minimizing damage to surrounding healthy tissue [3]