Biotechnology
Search documents
AC Immune Trial Shows Early Signs Immunotherapy May Slow Parkinson's
Benzinga· 2025-12-11 17:47
Core Insights - AC Immune SA has released interim results from the Phase 2 VacSYn trial for its anti-alpha-synuclein immunotherapy ACI-7104.056, indicating potential disease modification in early Parkinson's disease [1][2] - The results show stabilization of disease-related biomarkers, suggesting a slowing of neuronal damage and progression of Parkinson's disease [2][3] Biomarker Results - Elevated levels of neurofilament light (NfL) are associated with neuronal damage; stabilization of NfL levels indicates a potential slowing of neurodegeneration [2] - Plasma glial fibrillary acidic protein (GFAP) and dopamine transporter (DaT) SPECT imaging trends also suggest disease modification [3] Antibody Response - ACI-7104.056 demonstrated a 100% responder rate in generating antibodies against the a-syn target antigen, with serum antibody titers over 500-fold higher than the placebo group at week 76 [3][4] - Antibody responses were boosted with each immunization, and average IgG antibody levels in cerebrospinal fluid (CSF) were also over 500-fold higher than in the placebo group [4] Clinical Measures - Clinical measures of motor symptoms indicate a trend toward stabilization in the active treatment group, with no meaningful progression in the MDS-UPDRS Part III score compared to an expected increase in the placebo group [5][6] - The difference in change from baseline scores between the active treatment and placebo groups was enhanced when stratified by levodopa (L-DOPA) ON/OFF state [6] Safety and Tolerability - Interim results from weeks 50 and 76 show that ACI-7104.056 is generally safe and well-tolerated [6] - Final data from Part 1 of the VacSYn trial are anticipated in mid-2026 [6] Market Reaction - Following the announcement, AC Immune's stock price increased by 12.43%, reaching $3.14 [6]
Why I Wouldn't Touch Novavax With a 10-Foot Pole
The Motley Fool· 2025-12-11 17:41
This stock could be a wealth destroyer in the next five years.Novavax (NVAX +0.63%) was once a leading contender to dominate the coronavirus vaccine market. The company faced several challenges, however, and although it successfully launched its vaccine, Nuvaxovid, revenue and earnings have remained inconsistent for years, and the stock has delivered subpar returns. Unfortunately for Novavax, it is unlikely to perform significantly better over the medium term.Here's why it'd be best for investors to avoid t ...
Diamond Hill Investment Group, Rhythm Pharmaceuticals, Vail Resorts And Other Big Stocks Moving Higher On Thursday - Candel Therapeutics (NASDAQ:CADL), Centene (NYSE:CNC)
Benzinga· 2025-12-11 17:18
Group 1 - U.S. stocks showed mixed performance, with the Dow Jones increasing by over 600 points on Thursday [1] - Diamond Hill Investment Group Inc's shares surged 45.3% to $170.74 after First Eagle announced an acquisition for $175 per share in a $473 million all-cash deal [1] Group 2 - Planet Labs PBC's stock rose 29.7% to $16.79 following better-than-expected third-quarter sales results and an optimistic fourth-quarter sales guidance [2] - Nextdoor Holdings Inc experienced a gain of 22.9% to $3.11 [2] - Gemini Space Station Inc's shares jumped 19.2% to $13.54 after regulatory approval for its subsidiary to offer prediction markets to U.S. customers [2] - Rhythm Pharmaceuticals Inc's stock increased by 13.5% to $119.00 after announcing preliminary results from a Phase 2 trial for setmelanotide in Prader-Willi syndrome patients [2] - Candel Therapeutics Inc gained 12.4% to $6.52 [2] - VersaBank's shares rose 12.34% to $14.52 [2] - Perpetua Resources Corp's stock increased by 10.4% to $28.37 [2] - iHeartMedia Inc jumped 10.1% to $5.19 [2] - NovaBay Pharmaceuticals Inc gained 9.5% to $2.65 [2] - Idaho Strategic Resources Inc's shares rose 9.3% to $43.62 [2] - Immunovant Inc's stock increased by 8.5% to $25.57 after pricing a $550 million common stock offering [2] - Vail Resorts Inc gained 8.3% to $153.30 following first-quarter results [2] - Mosaic Co's shares surged 7.2% to $25.47 amid higher fertilizer stock prices after reports of Ukraine attacking Russian fertilizer plants [2] - Wayfair Inc's stock rose 6.9% to $99.76 [2] - Centene Corp gained 5.3% to $40.72 [2]
Exousia Pro, Inc. Announces Executed LOI for Strategic Acquisition of High-Revenue Telehealth Platform to Accelerate Nutraceutical Commercialization
Accessnewswire· 2025-12-11 17:15
ORLANDO, FL / ACCESS Newswire / December 11, 2025 / Exousia Pro, Inc. (OTCID:MAJI), a clinical-stage biotechnology company focused on proprietary exosome-based delivery systems, is excited to announce that it has executed a Letter of Intent to acquire a high-growth, established telehealth organization. Once acquired the Telehealth Platform will operate under Exousia Pro's newly-formed subsidiary, Exousia Health, Inc. This strategic transaction is designed to immediately generate substantial revenue, expand ...
OS Therapies (NYSEAM:OSTX) 2025 Conference Transcript
2025-12-11 16:32
Summary of OS Therapies Conference Call Company Overview - **Company Name**: OS Therapies - **Ticker Symbol**: OSTX - **Industry**: Clinical-stage drug development, specifically oncology immunotherapy - **Focus**: Developing a Listeria-based cancer vaccine targeting tumor cells to enhance immune response [2][3] Core Points and Arguments - **Lead Program**: OST-HER2, targeting pediatric osteosarcoma, a type of bone cancer with no approved therapies for recurrent cases [3][4] - **Market Size**: Osteosarcoma affects approximately 1,000 cases annually in the U.S. and 20,000 globally, with a significant unmet medical need [8][22] - **Regulatory Milestones**: - Recent meetings with FDA, UK MHRA, and EMA to discuss approval pathways [4][12] - Expecting to file for Biologics License Application (BLA) in Q1 2026 [13] - **Clinical Data**: - Phase 2b study showed event-free survival of 36% at 12 months compared to a historical control of 20% [11] - Overall survival at 75% at the two-year mark, significantly higher than the 40% historical control [12] - **Priority Review Voucher (PRV)**: - Anticipated value of PRV could exceed $150 million, which could significantly fund further development [13][20] - PRV allows expedited review for drugs targeting rare diseases, making it attractive for larger pharmaceutical companies [20][21] Additional Important Information - **Spinout Company**: K9 Animal Health Program, which has received conditional approval from USDA for canine use, leveraging the same Listeria technology [4][14] - **Scientific Advisory Board**: Composed of top-tier university hospitals and foundations, indicating strong backing and credibility [7] - **Institutional Investors**: Recent filings show interest from notable institutional investors such as Millennium, State Street, and BlackRock [18] - **Future Focus**: While there are other potential indications for HER2, the company is currently focused on osteosarcoma before expanding to other cancers [16][17] Conclusion OS Therapies is positioned in a niche market with a promising lead program targeting pediatric osteosarcoma, backed by significant clinical data and regulatory milestones. The potential financial impact of the PRV and the interest from institutional investors further enhance the company's outlook.
Roche's Breast Cancer Drug Cuts Risk of Death by 30% in Phase III
ZACKS· 2025-12-11 16:31
Core Insights - Roche announced positive interim analysis data for giredestrant, a next-generation SERD, in its late-stage breast cancer study, indicating significant efficacy in reducing disease recurrence risk [1][3][10] Study Results - The phase III lidERA Breast Cancer study showed that giredestrant treatment reduced the risk of invasive disease recurrence or death by 30% compared to standard-of-care endocrine therapy [3][7] - At the three-year mark, 92.4% of patients treated with giredestrant were alive and free of invasive disease, compared to 89.6% on standard care [5][7] - The therapy also demonstrated a 31% reduction in distant recurrence-free interval, with safety profiles remaining manageable [5][7] Market Performance - Following the announcement of the positive data, Roche's shares increased by 3.6% [3] - Over the past year, Roche's shares have risen by 41.7%, significantly outperforming the industry growth of 7.2% [6] Competitive Landscape - Giredestrant is the first oral SERD to show superior invasive disease-free survival in the adjuvant setting, building on previous positive outcomes from the evERA Breast Cancer study [10] - Roche's breast cancer franchise includes established products like Herceptin, Perjeta, and Kadcyla, with recent approvals enhancing its portfolio [11][12] Ongoing Development - Roche is conducting an extensive clinical development program for giredestrant across five phase III studies, targeting multiple treatment settings and lines of therapy [13]
Vaxcyte, Inc. (PCVX) Makes Strides on Pneumonia Treatment, Plots Coverage Extension
Yahoo Finance· 2025-12-11 16:23
Vaxcyte, Inc. (NASDAQ:PCVX) is one of the best biotech stocks to buy, according to Wall Street analysts. On December 8, the company confirmed the dosing of the first patients in its Phase 3 OPUS trial. The company is evaluating VAX-31 in the prevention of invasive pneumococcal disease and pneumonia in adults. It plans to enroll 4,000 participants in consultation with the US Food and Drug Administration. Vaxcyte, Inc. (PCVX) Makes Strides on Pneumonia Treatment, Plots Coverage Extension Topline safety and ...
Wall Street Firms Tout Corcept Therapeutics Incorporated (CORT) Prospects on Korlym Medication Prospects
Yahoo Finance· 2025-12-11 16:17
Corcept Therapeutics Incorporated (NASDAQ:CORT) is one of the best biotech stocks to buy according to Wall Street analysts. On November 25, H.C. Wainwright reiterated a Buy rating and a $145 price target on the stock, citing its strong growth prospects despite commercial challenges. Wall Street Firms Tout Corcept Therapeutics Incorporated (CORT) Prospects on Korlym Medication Prospects The research firm has reiterated its confidence in the company’s Korlym medication, whose sales are projected to grow by ...
Crinetics Pharmaceuticals (CRNX) Poised for Transformational Growth in 2026: Piper Sandler
Yahoo Finance· 2025-12-11 16:17
Crinetics Pharmaceuticals Inc. (NASDAQ:CRNX) is one of the best biotech stocks to buy according to Wall Street analysts. On December 8, Piper Sandler reiterated that Crinetics Pharmaceuticals Inc. (NASDAQ:CRNX) is one of the stocks to own as the company is poised for transformational growth in 2026. Crinetics Pharmaceuticals, Inc. (CRNX) Poised for Transformational Growth in 2026: Piper Sandler According to the research firm, the company is staring at tremendous opportunities and a transformational year ...
Genmab (NasdaqGS:GMAB) 2025 Earnings Call Presentation
2025-12-11 16:00
2025 R&D Update and ASH Data Review December 11, 2025 © Genmab 2025 This presentation contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. All statements other than statements of historical facts included in this presentation, including, without limitation, those regarding our financial position, business strategy, plans and objectives of management for future operations (including development plans ...