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Innate Pharma Releases Its 2026 Financial Calendar
Businesswire· 2025-12-11 06:00
Core Viewpoint - Innate Pharma SA has announced its financial calendar for 2026, detailing key dates for financial statements and shareholder meetings [1] Financial Calendar Summary - March 26, 2026: Publication of 2025 financial statements [1] - May 13, 2026: Publication of revenue and cash position for Q1 2026 [1] - May 21, 2026: Annual General Shareholders Meeting [1] - September 17, 2026: Publication of half-year financial statements [1] - November 5, 2026: Publication of revenue and cash position for Q3 2026 [1]
Roche expands automated mass spectrometry menu with antibiotics drug monitoring CE mark approval offering industry’s broadest in vitro diagnostic menu
Globenewswire· 2025-12-11 06:00
Core Viewpoint - Roche has received CE Mark approval for its mass spectrometry reagent pack for antibiotics drug monitoring, establishing the broadest in-vitro diagnostics (IVD) menu for automated mass spectrometry platforms with 39 frequently tested targets [1][7]. Group 1: Product and Technology - The cobas® Mass Spec solution Ionify® reagent portfolio includes tests for therapeutic drug monitoring for immunosuppressants and antibiotics, as well as steroid hormones and vitamin D metabolites, enabling a transition to fully automated and standardized solutions [2][4]. - The high specificity, sensitivity, and accuracy of mass spectrometry are recognized as the diagnostic 'gold standard' for various clinical situations, making it accessible to routine laboratories through the cobas Mass Spec solution [4][7]. - The automated mass spectrometry platform reduces turnaround times and supports faster, standardized, high-quality care by replacing labor-intensive manual workflows [7]. Group 2: Market Availability and Regulatory Status - The cobas Mass Spec solution is currently available in selected markets accepting the CE mark, including the UK, Canada, and Japan, and has achieved "moderate complexity" categorization under CLIA in the US [3]. - Roche is actively working with regulatory authorities worldwide to expand the availability of its systems and assays [3]. Group 3: Future Developments - Roche is committed to expanding its mass spectrometry menu with additional assays, including the first panel for drugs of abuse testing and further therapeutic drug monitoring parameters in the coming years [2][7].
After-Hours Gainers: Biotech Stocks Climb On Data Anticipation And Momentum Buying
RTTNews· 2025-12-11 04:49
Core Insights - After-hours trading in the U.S. saw significant gains in small-cap and micro-cap biotech stocks, driven by a mix of catalyst-driven moves and sentiment-based rebounds following the Fed's rate cut Group 1: Notable After-Hours Gainers - Agape ATP Corp. (ATPC) surged 29.41% after hours to $0.088, despite no specific news, reflecting a broader risk-on sentiment in micro-cap stocks [1] - Corbus Pharmaceuticals Holdings, Inc. (CRBP) rose 12.76% after hours to $11.57, driven by anticipation of a key clinical update on its Phase 1a study of CRB-913 [2] - Anebulo Pharmaceuticals, Inc. (ANEB) increased 8.37% after hours to $2.33, aligning with the overall positive sentiment in small-cap biotech [3] - Cue Biopharma, Inc. (CUE) gained 13.12% after hours to $0.54, with no new developments, indicating a macro-driven recovery in biotech [4] - Curis, Inc. (CRIS) saw a 7.68% increase after hours to $1.3999, following positive clinical data presented at the ASH Annual Meeting [5] - Skye Bioscience, Inc. (SKYE) rose 7.02% after hours to $1.22, benefiting from the overall biotech market lift [6] - Cerus Corporation (CERS) increased 3.17% after hours to $1.95, continuing its upward trend after announcing a purchasing agreement with Blood Centers of America [7]
MLTX DEADLINE: ROSEN, TRUSTED INVESTOR COUNSEL, Encourages MoonLake Immunotherapeutics Investors to Secure Counsel Before Important December 15 Deadline in Securities Class Action - MLTX
Newsfile· 2025-12-11 04:03
Core Viewpoint - Rosen Law Firm is encouraging investors of MoonLake Immunotherapeutics to secure legal counsel before the December 15, 2025 deadline for a securities class action related to the company's stock performance during the specified class period [1][2]. Group 1: Class Action Details - Investors who purchased MoonLake common stock between March 10, 2024, and September 29, 2025, may be eligible for compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - The lawsuit claims that during the class period, the defendants made false or misleading statements regarding the efficacy of their product SLK compared to traditional monoclonal antibodies, leading to investor damages when the truth was revealed [5]. Group 2: Legal Representation - Investors are advised to select qualified legal counsel with a proven track record in securities class actions, as many firms may not have the necessary experience or resources [4]. - The Rosen Law Firm has a history of successful settlements in securities class actions, including a notable settlement against a Chinese company and has recovered hundreds of millions for investors over the years [4].
Stoke Therapeutics' Chief Medical Officer Sold Over 5,000 Shares in the Company. Should Shareholders Sell?
The Motley Fool· 2025-12-11 01:59
Core Insights - Stoke Therapeutics, a biotech company focused on rare genetic diseases, experienced a notable insider sale by Chief Medical Officer Barry Ticho, who sold 5,358 shares for approximately $167,115 following significant share price gains in 2025 [1][8]. Company Overview - Stoke Therapeutics specializes in developing antisense oligonucleotide (ASO) medicines targeting severe genetic diseases, with lead candidates STK-001 for Dravet syndrome (currently in Phase I/IIa trials) and STK-002 for autosomal dominant optic atrophy (in preclinical stage) [5][7]. - As of December 5, 2025, the company's stock price was $31.19, with a market capitalization of $1.74 billion and a revenue of $205.63 million for the trailing twelve months (TTM) [4]. Financial Performance - The company reported $328.6 million in cash, cash equivalents, and marketable securities, alongside $183 million in year-to-date revenue, indicating a strong financial position expected to fund operations until 2028 [9]. Insider Activity - Barry Ticho's recent sale of shares, while smaller than his historical median sale, represented a larger proportion of his remaining holdings (21.30% compared to a long-term median of 6.84%), reflecting a decline in his available share base [6]. - The shares were sold at a weighted average price of approximately $31.19, closely aligning with recent trading levels, indicating minimal price slippage [6]. Market Context - Stoke Therapeutics' stock price has appreciated significantly, reaching a 52-week high of $38.69 on October 16, 2025, and remaining above $30 per share in December, driven by favorable clinical trial data and strategic collaborations, particularly with Biogen [8][9].
Phase III PALLAS Study Shows Signatera™ MRD Testing Provides Powerful Post‑Surgical Prognostic Information in Patients with High and Intermediate Risk HR+/HER2‑ Breast Cancer
Businesswire· 2025-12-11 00:57
Core Insights - Natera, Inc. announced initial translational research results from the Phase III PALLAS study in collaboration with Alliance Foundation Trials, LLC and the Austrian Breast and Colorectal Cancer Study Group [1] Group 1 - The PALLAS study is an international randomized trial focusing on breast cancer [1] - Initial data was presented at the San Antonio Breast Cancer Symposium, highlighting findings from a U.S. biomarker cohort consisting of 420 patients [1]
Samsung Biologics recognized as a global leader in water security
Prnewswire· 2025-12-10 23:30
INCHEON, South Korea, Dec. 10, 2025 /PRNewswire/ -- Samsung Biologics (KRX: 207940.KS), a leading contract development and manufacturing organization (CDMO), today announced that it has received from the Carbon Disclosure Project (CDP) an 'A' rating in Water Security. Two years into its participation in CDP assessments, Samsung Biologics has earned the top rating in Water Security, one rating higher than last year. The CDP 'A List' recognizes companies demonstrating exceptional leadership in environmental s ...
Medicenna Therapeutics Corp. (MDNA:CA) Discusses New Clinical Data From ABILITY-1 Study Evaluating MDNA11 in Cancer Immunotherapy Transcript
Seeking Alpha· 2025-12-10 22:02
PresentationWelcome to Medicenna Therapeutics KOL Webinar. [Operator Instructions] As a reminder, this conference call is being recorded. If you have any objections, please disconnect at this time. I'd now like to turn the call over to Dr. Fahar Merchant, President and CEO.Fahar MerchantFounder, Chairman, President & CEO Good morning, good afternoon, everyone, and thank you for joining us today. My name is Dr. Fahar Merchant, President and CEO of Medicenna Therapeutics. We are thrilled to welcome you to thi ...
Serina Therapeutics Submits Complete Response to FDA Clinical Hold Letter for SER-252 Program
Globenewswire· 2025-12-10 21:30
Core Insights - Serina Therapeutics has submitted a complete response to the FDA regarding the clinical hold on its lead drug candidate SER-252 for advanced Parkinson's disease, addressing concerns related to a formulation excipient [1][2][3] - The company is targeting the first patient in for the registrational Phase 1b study in Q1 2026, contingent on FDA feedback and resolution of the clinical hold [1][3] Company Overview - Serina Therapeutics is a clinical-stage biotechnology company focused on developing drug candidates for neurological diseases, utilizing its proprietary POZ Platform for drug optimization [4] - The POZ technology is based on a synthetic polymer that enhances drug delivery and stability, potentially improving the efficacy and safety profiles of various therapeutic modalities [5] Drug Development Details - SER-252 is an investigational apomorphine therapy designed to provide continuous dopaminergic stimulation, which may reduce levodopa-related motor complications in Parkinson's disease [8] - The complete response to the FDA includes a detailed data package supporting the use of trehalose as a subcutaneous excipient and a revised protocol for the single ascending dose phase of the trial [7]
Clearmind Medicine Announces 1-for-40 Reverse Share Split
Globenewswire· 2025-12-10 21:15
Core Viewpoint - Clearmind Medicine Inc. will conduct a reverse share split at a ratio of 1-for-40 to regain compliance with the Nasdaq Minimum Bid Price Rule, effective December 15, 2025 [1][2]. Group 1: Reverse Share Split Details - The reverse share split was approved by the Company's board of directors on November 12, 2025 [2]. - Following the reverse split, the number of issued and outstanding Common Shares will decrease from 59,991,852 to 1,499,796 [3]. - No fractional Common Shares will be issued; all fractional shares will be rounded up to the nearest whole share [4]. Group 2: Company Overview - Clearmind is a clinical-stage biotech company focused on developing novel neuroplastogen-derived therapeutics for under-treated health issues, including alcohol use disorder [5]. - The Company holds an intellectual property portfolio consisting of nineteen patent families and 31 granted patents, with plans to seek additional patents as needed [5].