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Niagen Bioscience Announces Results from First-Ever Randomized Controlled Trial Exploring Niagen (Patented Nicotinamide Riboside, NR) Supplementation in Long COVID
Businesswire· 2025-11-13 00:52
Core Insights - Niagen Bioscience announced results from the first randomized controlled trial demonstrating that daily supplementation with its patented nicotinamide riboside (NR) significantly increased NAD+ levels and improved symptoms of fatigue, depression, and sleep quality in individuals with long COVID [1][3][12] Study Overview - The study involved 58 participants, randomized in a double-blind, placebo-controlled design, led by Dr. Edmarie Guzmán-Vélez [2][9] - Participants received either 2,000 mg/day of Niagen NR for 20 weeks or a placebo for 10 weeks, followed by Niagen NR for an additional 10 weeks [9][10] - The primary endpoint was the change in cognitive performance, while secondary endpoints assessed fatigue, mood, and sleep quality [10] Key Findings - NAD+ levels increased up to 3.1-fold after 5–10 weeks of supplementation, confirming effective NAD+ restoration [14] - Significant within-group improvements were observed in fatigue severity, sleep quality, and depressive symptoms after 10 weeks of Niagen NR supplementation [14] - Although no statistically significant differences were found between the Niagen NR and placebo groups, the study suggests NAD+ restoration as a promising avenue for recovery from long COVID [13][14] Implications for Long COVID - Long COVID is characterized by persistent symptoms such as fatigue, cognitive impairment, and sleep disturbances, affecting a significant number of individuals globally [6][3] - The study highlights the potential of NAD+ augmentation in addressing these symptoms and advancing understanding of recovery mechanisms [4][7] Company Background - Niagen Bioscience, Inc. (NASDAQ: NAGE) is a leader in NAD+ science and healthy aging research, dedicated to advancing healthspan through innovative NAD+-boosting solutions [16][17] - The company emphasizes the importance of NAD+ in cellular energy and repair, particularly in the context of age-related health changes [17][18]
Allogene Therapeutics (NasdaqGS:ALLO) Conference Transcript
2025-11-12 22:30
Summary of Allogene Therapeutics Conference Call Company Overview - **Company**: Allogene Therapeutics (NasdaqGS:ALLO) - **Event**: Conference at TD Cowen's I&I Summit on November 12, 2025 Key Points on ALLO-329 and Autoimmune Research - **Product Introduction**: ALLO-329 is an allogeneic, off-the-shelf CAR T therapy currently in phase 1 clinical trials targeting autoimmune conditions [4][5] - **Differentiation**: ALLO-329 is designed to bypass lymphodepletion requirements, which is a common issue in CAR T therapies. This is expected to enhance safety and broaden its application in autoimmune disorders [5][6] - **Mechanism of Action**: ALLO-329 targets both CD19 and CD70, allowing it to address not only B cells but also T cells and antigen-presenting cells, which are crucial in the development of autoimmunity [6][7] - **Patient Population**: The phase 1 study focuses on patients with rheumatologic disorders, including lupus and lupus nephritis, inflammatory myositis, and scleroderma [10][11] - **Study Design**: The trial includes two cohorts: one with reduced lymphodepletion and another without any lymphodepletion, aiming to establish safety and early efficacy [12][20] Enrollment and Study Progress - **Enrollment Strategy**: The study is primarily enrolling patients at academic centers, with a focus on generating excitement around the unique mechanism of action and off-the-shelf availability of ALLO-329 [19][20] - **Initial Data Expectations**: Initial proof of concept data is anticipated in the first half of the following year, with a focus on biomarkers related to CAR T cell behavior and disease-related biomarkers [21][22] Dagger Technology and Lymphodepletion - **Confidence in Technology**: The ability to reduce or eliminate lymphodepletion is supported by preclinical data and clinical experience with CD70 targeting in other studies [13][14] - **Clinical Outcomes**: The goal is to reset the immune system without permanently depleting B or T cells, allowing for a more manageable immune response [16][17] ALPHA3 Trial and MRD Conversion - **Trial Overview**: The ALPHA3 trial aims to convert MRD-positive patients to MRD-negative status using cema-cel, with a focus on high-risk patients post-R-CHOP treatment [32][34] - **Expected Outcomes**: A MRD conversion rate of around 30% is considered a benchmark for continued pivotal development, with the control arm expected to show minimal spontaneous conversions [40][42] Conclusion - **Overall Sentiment**: There is significant optimism regarding the enrollment and initial data from both ALLO-329 and the ALPHA3 trial, with a strong focus on innovative treatment approaches in the autoimmune and oncology spaces [30][41]
ATYR Investors: Securities Law Firm Robbins LLP Reminds Investors of the Pending Lead Plaintiff Deadline in the Class Action Against aTyr Pharma, Inc.
Globenewswire· 2025-11-12 21:47
Core Viewpoint - aTyr Pharma, Inc. is facing a class action lawsuit due to allegations of misleading investors regarding the efficacy of its drug candidate, Efzofitimod, during a clinical trial for pulmonary sarcoidosis [1][3]. Company Overview - aTyr Pharma, Inc. is a clinical stage biotechnology company focused on developing therapies for fibrosis and inflammation through tRNA synthetase biology [1]. Legal Allegations - The lawsuit claims that aTyr's executives provided misleading information about the Phase 3 study of Efzofitimod, particularly regarding the forced taper approach and the drug's ability to reduce steroid usage in patients [3]. - On September 15, 2025, aTyr announced that the EFZO-FIT study did not meet its primary endpoint, leading to a significant drop in stock price from $6.03 to $1.02, an 83.2% decline in one day [4]. Next Steps - Shareholders interested in participating in the class action must submit their papers by December 8, 2025, to serve as lead plaintiff [5].
Celcuity Inc. Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-11-12 21:01
Core Insights - Celcuity Inc. reported significant clinical and regulatory advancements in Q3 2025, particularly regarding the gedatolisib regimens for advanced breast cancer, with plans to submit a New Drug Application (NDA) to the FDA later this year [2][4][6] Business Highlights - The company presented detailed efficacy and safety results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial at the ESMO Congress, indicating potential practice-changing outcomes for patients with HR+, HER2- advanced breast cancer [4][5] - The gedatolisib triplet (gedatolisib, fulvestrant, and palbociclib) demonstrated a 76% reduction in the risk of disease progression or death compared to fulvestrant, with a median progression-free survival (PFS) of 9.3 months [5] - The gedatolisib doublet (gedatolisib and fulvestrant) showed a 67% reduction in the risk of disease progression or death, with a median PFS of 7.4 months [5] - The PIK3CA mutant cohort of the VIKTORIA-1 trial is fully enrolled, with topline data expected in late Q1 or Q2 2026 [4][8] Financial Results - Total operating expenses for Q3 2025 were $42.8 million, up from $30.1 million in Q3 2024 [6] - Research and development (R&D) expenses increased to $34.9 million from $27.6 million year-over-year, primarily due to higher employee and consulting costs [7] - General and administrative (G&A) expenses rose to $7.9 million from $2.5 million, largely due to increased employee and consulting expenses [9] - The net loss for Q3 2025 was $43.8 million, or $0.92 loss per share, compared to a net loss of $29.8 million, or $0.70 loss per share, in Q3 2024 [10] - Cash, cash equivalents, and short-term investments totaled $455.0 million as of September 30, 2025, expected to fund operations through 2027 [11]
Lyra Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-11-12 21:01
Core Insights - Company plans to initiate a new confirmatory Phase 3 clinical trial for LYR-210 aimed at treating chronic rhinosinusitis (CRS) without nasal polyps, progressing towards a New Drug Application (NDA) submission [1][2] Recent Business Highlights - The company is focused on establishing components for the new Phase 3 clinical trial to advance LYR-210 as a treatment option for CRS patients who do not respond to current therapies [2] - LYR-210 is designed to provide six months of continuous anti-inflammatory therapy for CRS patients [15][16] Financial Highlights - As of September 30, 2025, cash and cash equivalents were $22.1 million, down from $40.6 million at December 31, 2024, with expectations to fund operations into the third quarter of 2026 [4] - Research and development expenses decreased by $1.9 million to $4.0 million for Q3 2025 compared to Q3 2024, primarily due to reduced clinical costs after completing the ENLIGHTEN 2 trial [5][6] - General and administrative expenses also decreased by $1.7 million to $2.2 million for Q3 2025 compared to Q3 2024, driven by lower employee-related costs [7][8] - The net loss for Q3 2025 was $6.0 million, a reduction from $11.9 million in Q3 2024 [9] Clinical Development - The company has established a clinical development plan for an additional trial to support the NDA submission for LYR-210, following positive results from the ENLIGHTEN 2 Phase 3 trial presented at a major medical conference [11]
Biohaven Q3 Earnings: Falling Back To Earth With A Thud
Seeking Alpha· 2025-11-12 20:54
Group 1 - The article promotes a weekly newsletter focused on stocks in the biotech, pharma, and healthcare industries, highlighting key trends and catalysts that influence market valuations [1] - Edmund Ingham, a biotech consultant with over 5 years of experience, leads the Haggerston BioHealth investing group, which caters to both novice and experienced investors [1] - The investing group provides insights such as buy and sell ratings, product sales forecasts, integrated financial statements, discounted cash flow analysis, and market-specific analyses for major pharmaceutical companies [1]
Abeona Therapeutics Q3 2025: Strong Financials And Zevaskyn Launch Ahead
Seeking Alpha· 2025-11-12 19:52
Core Insights - Abeona Therapeutics Inc. reported strong figures for Q3 2025, with a GAAP EPS of -$0.10, surpassing expectations by $0.18, leading to a 22% increase in stock price post-announcement [1] Financial Performance - The company achieved a GAAP EPS of -$0.10 for Q3 2025, which was better than the anticipated figure by $0.18 [1] - The stock price rose by 22% following the announcement of these results [1] Company Background - Abeona Therapeutics is focused on biotechnology, particularly in drug development, with an emphasis on innovative therapies and unique mechanisms of action [1]
Billionaire twins–backed stock surges 100% after buying $50M ‘encrypted Bitcoin’
Yahoo Finance· 2025-11-12 19:00
Core Insights - Leap Therapeutics is rebranding to Cypherpunk Technologies Inc., transitioning from a biotech firm to a crypto treasury firm focused on accumulating Zcash's native coin, ZEC [1] - The company has utilized $50 million from a private placement to acquire 203,775.27 ZEC at an average price of $245.37 per coin [2] - Cypherpunk secured $58.88 million in a private placement led by Winklevoss Capital, resulting in a significant stock price increase of over 100% to $87.55 [4] Company Strategy - Cypherpunk aims to accumulate Zcash, targeting ownership of at least 5% of the total ZEC supply, as stated by CEO Tyler Winklevoss [6] - The company is positioning itself to support privacy-protecting assets and technologies, emphasizing its dedication to privacy and self-sovereignty [6] Market Positioning - Zcash is described as a privacy-focused cryptocurrency, utilizing zero-knowledge proofs (zk-SNARKs) to enhance transaction privacy [5] - Tyler Winklevoss compares Zcash to Bitcoin, suggesting that while Bitcoin serves as digital gold, Zcash functions as encrypted digital cash [7] - The company believes that Zcash could capture a meaningful percentage of Bitcoin's market capitalization as the world enters the AI age [7] Future Outlook - Predictions indicate that Bitcoin could reach a price of $1 million within the next 5-10 years, with Zcash also expected to grow [8]
BeOne Medicines Stock Earns Relative Strength Rating Upgrade
Investors· 2025-11-12 18:15
BREAKING: Futures Rise After Growth-Led Market Sell-Off On Wednesday, BeOne Medicines (ONC) stock received an upgrade to its Relative Strength (RS) Rating, from 89 to 92. Â Here Are 3 Keys For Successful Stock Investing This exclusive rating from Investor's Business Daily identifies share price action with a 1 (worst) to 99 (best) score. The grade shows how a stock's price performance over the last 52 weeks… Related news Get market updates, educational videos, webinars, and stock analysis. Get Started Learn ...
Zealand Pharma to participate in the Jefferies Global Healthcare Conference
Globenewswire· 2025-11-12 16:30
Core Points - Zealand Pharma A/S will participate in the Jefferies Global Healthcare Conference on November 19, 2025, with CEO Adam Steensberg leading a fireside chat [1] - A live audio webcast of the event will be available for public access, along with an archived recording on the company's website [2] - Zealand Pharma focuses on the discovery and development of peptide-based medicines, with over 10 drug candidates in clinical development, including two that have reached the market [3][4] Company Overview - Zealand Pharma was founded in 1998 and is headquartered in Copenhagen, Denmark, with operations in the U.S. [4] - The company has established development and commercial partnerships with various pharmaceutical companies for its marketed products [3]