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Immunocore presents Phase 1 data for hepatitis B candidate at AASLD's The Liver Meeting
Globenewswire· 2025-11-07 13:00
Core Insights - The article discusses the Phase 1 trial results of IMC-I109V, a bispecific T cell receptor designed to target HBV-infected hepatocytes, demonstrating a manageable safety profile and antiviral activity [1][2][3] Company Overview - Immunocore Holdings plc is a commercial-stage biotechnology company focused on developing immunomodulating medicines for cancer, infectious diseases, and autoimmune diseases [1][11] - The company is advancing clinical candidates aimed at achieving functional cures for HIV and hepatitis B virus (HBV) [10] Trial Details - The Phase 1 trial enrolled 20 participants, evaluating ascending doses of IMC-I109V (0.8 mcg, 2.4 mcg, 7 mcg, 20 mcg) administered as a single IV infusion [3][4] - Participants were assessed for safety, tolerability, pharmacokinetics, and pharmacodynamic activity up to week 4 [4] Efficacy Results - Dose-dependent decreases in serum HBsAg were observed, with reductions meeting the threshold of ≥ 0.2 log10 IU/ml in 4 individuals, indicating potential for resolving hepatitis B infection [5][6] - Consistent pharmacodynamic activity was noted at doses ≥ 7 mcg, with HBsAg levels typically reaching a nadir by day 8 [5] Safety Profile - Treatment-related adverse events were reported in 8 participants, primarily transient systemic symptoms, with ALT elevations resolving within 14 days [6][7] - One participant in the 20 mcg cohort experienced Grade 2 cytokine release syndrome, which resolved rapidly with treatment [7] Mechanism of Action - IMC-I109V is designed to recruit non-exhausted T cells to eliminate hepatocytes harboring HBV DNA, addressing HBV-specific T cell exhaustion [8] Future Directions - The company believes the initial evidence of HBsAg reduction supports further evaluation of IMC-I109V in multiple dose regimens [8]
BioHarvest Sciences Announces Pricing of $17.4 Million Upsized Public Offering of Common Stock
Newsfile· 2025-11-07 12:30
Core Points - BioHarvest Sciences Inc. has announced a public offering of 2,485,000 shares of common stock priced at $7.00 per share, aiming for gross proceeds of approximately $17.4 million [1][2] - The company has granted underwriters a 30-day option to purchase an additional 372,750 shares at the public offering price [1] - The offering is being conducted under a shelf registration statement filed with the SEC, which was declared effective on September 8, 2025 [3] Use of Proceeds - The net proceeds from the offering are expected to be utilized for research and development, manufacturing, marketing, advancing the CDMO business unit, debt reduction or refinancing, capital expenditures, and general corporate purposes, including funding working capital [2] Company Overview - BioHarvest is a leader in Botanical Synthesis, utilizing its patented technology to grow plant-based compounds without the need for the underlying plants [5] - The company operates in two major business verticals: as a contract development and production organization (CDMO) and as a creator of proprietary nutraceutical health and wellness products [5]
BriaCell Presents Robust Anti-Cancer Activity of Bria-OTS+™ at SITC 2025
Globenewswire· 2025-11-07 12:30
Core Insights - BriaCell Therapeutics Corp. is presenting strong evidence of immune system engagement and anti-cancer activity of its Bria-OTS+ platform at the Society for Immunotherapy of Cancer Annual Meeting [1][2] Preclinical Findings - Bria-OTS+ demonstrates fast-acting and potent anti-cancer immune system activation, inducing coordinated innate and adaptive immune responses to kill cancer cells [3][7] - The platform produces sustained and durable anti-cancer immune responses, potentially leading to prolonged clinical benefits for patients [4][6] - Positive results from lead candidates Bria-BRES+ (breast cancer) and Bria-PROS+ (prostate cancer) indicate broad applicability of the Bria-OTS+ platform across multiple solid tumor indications [5][7] Platform Overview - Bria-OTS+ is an advanced immunotherapy platform, enhancing the previous Bria-OTS™ version, designed to express multiple immune-activating cytokines and co-stimulatory molecules [6][8] - The platform's unique mechanism of action supports the development of personalized cancer immunotherapies, with planned clinical trials for Bria-BRES+ and Bria-PROS+ [2][6]
Kezar Life Sciences Announces Presentation of PORTOLA Data at the American Association for the Study of Liver Disease (AASLD) – The Liver Meeting® 2025
Businesswire· 2025-11-07 12:01
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases, today announced two presentations from the completed Phase 2a PORTOLA clinical trial in patients with autoimmune hepatitis (AIH) at The Liver Meeting 2025 held by the American Association for the Study of Liver Disease (AASLD) and taking place November 7-11, in Washington, DC. ...
IREN Q1 Results: Valuation Is Highly Sensitive To Execution Risk
Seeking Alpha· 2025-11-07 11:11
I hold a Master’s degree in Cell Biology and began my career working for several years as a lab technician in a drug discovery clinic, where I gained extensive hands-on experience in cell culture, assay development, and therapeutic research. That scientific foundation gave me an appreciation for the rigor and challenges behind drug development, which I now bring into my work as an investor and analyst. For the past five years, I have been active in the investing space, with the last four years dedicated to ...
Harvard Bioscience targets $22.5M–$24.5M Q4 revenue as backlog reaches two-year high, expanding product rollouts and distribution (NASDAQ:HBIO)
Seeking Alpha· 2025-11-07 07:16
Group 1 - The article does not provide any specific information or insights regarding a company or industry [1]
MRNA Q3 Deep Dive: Cost Controls and Pipeline Progress Amid Declining COVID Vaccine Demand
Yahoo Finance· 2025-11-07 05:31
Core Insights - Moderna reported Q3 CY2025 revenue of $1.02 billion, a 45.4% year-on-year decline, but exceeded Wall Street expectations by 32% [1][6] - The company's full-year revenue guidance was lowered to $1.8 billion, 4.4% below analysts' estimates [1][6] - GAAP loss per share was $0.51, significantly better than the consensus estimate of -$2.38, representing a 78.6% beat [1][6] Financial Performance - Revenue: $1.02 billion vs analyst estimates of $769.6 million, reflecting a 45.4% decline year-on-year [6] - EPS (GAAP): -$0.51 vs analyst estimates of -$2.38, a 78.6% beat [6] - Adjusted EBITDA: -$208 million vs analyst estimates of -$911.9 million, indicating a 77.2% beat [6] - Operating Margin: -25.6%, down from -3.8% in the same quarter last year [6] - Market Capitalization: $9.50 billion [6] Management Commentary - Management attributed the outperformance to cost discipline, with a 34% reduction in combined costs compared to last year [3][5] - Future growth is expected to rely on expanding the commercial portfolio, particularly in respiratory and oncology segments [4] - The company aims to reach cash breakeven by 2028 through revenue growth and further cost reductions [4]
1 Growth Stock with All-Star Potential and 2 That Underwhelm
Yahoo Finance· 2025-11-07 04:35
Growth is a hallmark of all great companies, but the laws of gravity eventually take hold. Those who rode the COVID boom and ensuing tech selloff in 2022 will surely remember that the market’s punishment can be swift and severe when trajectories fall. The risks that can come from buying these assets is precisely why we started StockStory - to isolate the long-term winners from the losers so you can invest with confidence. On that note, here is one growth stock with significant upside potential and two tha ...
BioLife Solutions raises 2025 revenue guidance to $96M as cell processing momentum accelerates (NASDAQ:BLFS)
Seeking Alpha· 2025-11-07 04:06
Group 1 - The article does not provide any specific content related to a company or industry [1]
Emergent BioSolutions Stock: Solid Q3, Expecting Better Days To Come (NYSE:EBS)
Seeking Alpha· 2025-11-07 04:00
Core Insights - The article emphasizes the importance of staying updated on stocks within the biotech, pharma, and healthcare sectors, highlighting key trends and catalysts that influence market valuations [1]. Group 1: Industry Overview - The biotech, pharma, and healthcare industries are experiencing significant movements, necessitating investors to track developments closely [1]. - The Haggerston BioHealth investing group provides insights into catalysts for investment decisions, including buy and sell ratings, product sales forecasts, and financial analyses [1]. Group 2: Analyst Background - Edmund Ingham, a biotech consultant with over 5 years of experience, has compiled detailed reports on more than 1,000 companies in the biotech and healthcare sectors [1]. - The investing group led by Ingham caters to both novice and experienced investors, offering comprehensive market analyses and forecasts [1].