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ALX Oncology Advances Separate Clinical Trials Evaluating Investigational CD47-Inhibitor Evorpacept and Novel EGFR-Targeted Antibody-Drug Conjugate ALX2004
Globenewswire· 2026-01-08 13:30
- First patient dosed in Phase 2 ASPEN-09-Breast trial evaluating evorpacept in combination with trastuzumab and physician’s choice of chemotherapy in HER2-positive metastatic breast cancer; interim analysis anticipated Q3 2026 – - Third dose cohort initiated in Phase 1 trial of ALX 2004; study remains on track to provide initial safety data in 1H 2026 - SOUTH SAN FRANCISCO, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. (“ALX Oncology,” Nasdaq: ALXO), a clinical-stage biotechnology co ...
Tonix Pharmaceuticals to Present at Two Investor Conferences in January 2026
Globenewswire· 2026-01-06 12:00
BERKELEY HEIGHTS, N.J., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully integrated, commercial biotechnology company, announced today that Tonix management will present and host investor meetings at the following January 2026 investor conferences. Sachs Associates 9th Annual Neuroscience Innovation Forum Company Presentation Presenter: Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals Date: Sunday, January ...
Can BMY's Growth Portfolio Drive Top-Line Expansion in 2026?
ZACKS· 2025-12-31 13:35
Key Takeaways BMY's growth portfolio rose 17% in the first nine months, while legacy drug sales fell 16% on generics.BMY's Opdivo momentum and Qvantig approval support projected high single- to low double-digit growth.BMY's Reblozyl topped a $2B run rate, Breyanzi passed $1B, while legacy drugs still made up 47% of sales.Bristol Myers Squibb’s (BMY) performance in 2025 reflects an ongoing transition in its revenue base, with growth from newer products partially offsetting continued declines in legacy drugs. ...
Coherus Oncology (NasdaqGM:CHRS) Conference Transcript
2025-12-17 19:32
Coherus Oncology Conference Summary Company Overview - **Company**: Coherus Oncology (NasdaqGM:CHRS) - **Focus**: Transitioned from a biosimilar company to a commercial-stage innovative oncology company with a focus on immuno-oncology pipeline, particularly PD-1 inhibitors and novel therapies [3][4][5] Key Products and Pipeline - **Toripalimab**: FDA-approved next-generation PD-1 inhibitor, cornerstone of the oncology pipeline [4][5] - **Casdozokitug**: First-in-class anti-IL27 therapy showing promise in liver cancer and other tumor types [11][12] - **Tagmukitug**: Cytolytic antibody targeting CCR8, showing potential in various solid tumors [53][54] Clinical Data and Efficacy - **Casdozokitug**: - Phase 1 trial showed manageable safety profile with no dose-limiting toxicities (DLTs) [16] - Monotherapy activity observed in squamous non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC) [17] - In combination with Atizo and Bev for hepatocellular carcinoma (HCC), showed an overall response rate (ORR) of 38% and a complete response (CR) rate of 17%, compared to historical controls of 30% and 8% respectively [20][21] - Responses observed irrespective of viral etiology, indicating broad applicability [22] - **Tagmukitug**: - Demonstrated ability to deplete CCR8-positive T regulatory cells in tumors, leading to increased CD8 T cell activity [56] - Early data from head and neck cancer patients showed promising responses in heavily pre-treated individuals [62] Safety and Tolerability - **Casdozokitug**: Safety profile encouraging, with no significant increase in immune-related adverse events compared to standard treatments [26][27] - **Tagmukitug**: Selective targeting of CCR8 with a favorable safety profile, avoiding off-target toxicity seen in other CCR8 programs [58][59] Market Position and Future Outlook - **Market Strategy**: Coherus aims to leverage its innovative pipeline to establish a strong position in the oncology market, focusing on underserved patient populations [5][9] - **Upcoming Milestones**: - Initial data for the Casdozokitug triplet combination expected in mid-2026 [47] - Continued development of Tagmukitug across multiple tumor types with data anticipated throughout 2026 [65] Conclusion - Coherus Oncology is positioned for a data-rich 2026 with promising clinical trials and innovative therapies that could significantly impact cancer treatment, particularly in HCC and other solid tumors [71]
Bristol Myers vs Gilead Sciences: Which Biotech Stock Is a Better Bet Now?
ZACKS· 2025-11-28 14:36
Core Insights - Bristol Myers Squibb (BMY) and Gilead Sciences, Inc. (GILD) are prominent biotechnology companies with diverse portfolios and global reach [1][2] - GILD is a leader in the HIV market, with significant revenue contributions from its key drugs [4][10] - BMY has a strong oncology portfolio, with drugs like Opdivo driving revenue despite facing generic competition [12][17] Gilead Sciences (GILD) - GILD's flagship HIV drug, Biktarvy, holds over 52% of the U.S. treatment market and is the most prescribed regimen for HIV-1 infection [4][10] - The company has received FDA approval for lenacapavir, a twice-yearly injectable HIV prevention drug, which generated $39 million in sales in Q3 [5][6] - GILD forecasts a 5% revenue growth in HIV for 2025, up from a previous estimate of 3% [7] - The liver disease portfolio has been bolstered by the FDA approval of Livdelzi, which exceeded $100 million in quarterly sales for the first time [9] - GILD's oncology portfolio includes Trodelvy and a Cell Therapy franchise, although the latter faces competitive pressures [10][11] - GILD's total debt-to-total-capital ratio was 53.8% as of September 30, 2025, with $9.4 billion in cash and $25 billion in long-term debt [11] Bristol Myers Squibb (BMY) - BMY's growth portfolio includes drugs like Opdivo, which is the top revenue generator and shows strong sales momentum [12][13] - The approval of Opdivo Qvantig has further strengthened BMY's immuno-oncology portfolio, with projected global sales growth [14] - BMY's Reblozyl and Breyanzi have also contributed significantly to revenue, with Reblozyl annualizing over $2 billion in sales [15] - BMY is facing challenges from generic competition for legacy drugs, impacting overall revenue growth [17] - The company announced the acquisition of Orbital Therapeutics for $1.5 billion, which will enhance its pipeline with promising candidates [18][19] - BMY's total debt-to-total-capital ratio was 72.5% as of September 30, 2025, with $15.7 billion in cash and $44.5 billion in long-term debt [20] Financial Estimates and Performance - The Zacks Consensus Estimate for BMY's 2025 sales indicates a decrease of 0.82%, while EPS is expected to increase by 466.96% [21] - GILD's 2025 sales are projected to grow by 1.05%, with EPS expected to improve by 76.84% [22] - GILD has outperformed BMY in price performance, gaining 38% compared to BMY's loss of 12.9% [24] - GILD's shares trade at a forward P/E ratio of 15.15, while BMY's is at 8.17, indicating GILD is more expensive [25] - BMY offers a higher dividend yield of 5.04% compared to GILD's 2.48% [26] Investment Outlook - Both companies hold a Zacks Rank 3 (Hold), making the choice between them complex [29] - GILD's innovation in the HIV portfolio and recent approvals position it for growth [29] - BMY's efforts to stabilize revenue amid generic competition are noted, but significant challenges remain [30]
ALX Oncology Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-11-07 13:15
Core Insights - ALX Oncology reported financial results for Q3 2025, highlighting advancements in its clinical pipeline and financial position [1][3][13] Financial Performance - Cash, cash equivalents, and investments as of September 30, 2025, were $66.5 million, sufficient to fund operations into Q1 2027 [13][18] - R&D expenses for Q3 2025 were $17.4 million, a decrease from $26.5 million in Q3 2024, primarily due to reduced stock-based compensation and clinical development costs [13][16] - GAAP net loss for Q3 2025 was $22.1 million, or $0.41 per share, compared to a net loss of $30.7 million, or $0.58 per share, in Q3 2024 [13][16] Clinical Developments - Data from the ASPEN-06 trial showed that evorpacept combined with trastuzumab, ramucirumab, and paclitaxel achieved a 65.0% objective response rate in HER2-positive gastric cancer patients with high CD47 expression [5][6] - The Phase 2 ASPEN-09-Breast Cancer trial is set to begin enrollment in Q4 2025, evaluating evorpacept's efficacy based on CD47 expression levels [4][8] - The Phase 1 trial for ALX2004, an EGFR-targeted antibody-drug conjugate, is currently enrolling patients and is on track to deliver initial safety data in the first half of 2026 [4][9] Upcoming Milestones - Initial safety data for ALX2004 is expected in 1H 2026, with interim data for ASPEN-09-Breast Cancer anticipated in Q3 2026 [4][7] - The company appointed Barbara Klencke, M.D., as Chief Medical Officer, bringing over 30 years of experience in oncology drug development [4][8]
Atlantic stal Acquisition II(ACAB) - Prospectus
2025-11-07 12:41
As filed with the U.S. Securities and Exchange Commission on November 7, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Abpro Holdings, Inc. (Exact Name of Registrant as Specified in its Charter) (Primary Standard Industrial Delaware 2834 87-1013956 (I.R.S. Employer Identification No.) (State or other jurisdiction of incorporation or organization) Classification Code Number) 100 Summit Drive ...
Tonix Pharmaceuticals to Participate in the Stifel 2025 Healthcare Conference
Globenewswire· 2025-11-06 12:00
Core Insights - Tonix Pharmaceuticals Holding Corp. is a fully-integrated biotechnology company with a focus on developing and marketing products for various medical conditions, including fibromyalgia and acute migraine [3]. Company Overview - Tonix has received FDA approval for Tonmya, a first-in-class, non-opioid analgesic for fibromyalgia, marking the first new prescription medicine approval for this condition in over 15 years [3]. - The company markets two treatments for acute migraine in adults and has a diverse development portfolio targeting central nervous system disorders, immunology, rare diseases, and infectious diseases [3]. - Key products in development include TNX-102 SL for acute stress reaction and major depressive disorder, TNX-1500 for organ transplant rejection and autoimmune diseases, and TNX-2900 for Prader-Willi syndrome [3]. - Tonix is also developing vaccines and monoclonal antibodies for infectious diseases, including TNX-801 for mpox and smallpox, and TNX-4800 for Lyme Disease prevention [3]. - The company has a contract with the U.S. Department of Defense for TNX-4200, a broad-spectrum antiviral agent, valued at up to $34 million over five years [3]. Upcoming Events - Seth Lederman, M.D., the CEO of Tonix, will present at the Stifel 2025 Healthcare Conference on November 13, 2025 [1][2]. - Investors can arrange meetings with the company's management during the conference through their Stifel representative [2]. Additional Information - A webcast of the presentation will be available on the company's website, with a replay accessible for 90 days post-event [2]. - Tonix operates a state-of-the-art infectious disease research facility in Frederick, Maryland [3].
Tonix Pharmaceuticals Announces Presentation at BIO-Europe 2025
Globenewswire· 2025-10-28 11:00
Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully-integrated commercial biopharmaceutical company with marketed products and a pipeline of development candidates [3] - The company has received FDA approval for Tonmya™, a first-in-class, non-opioid analgesic for the treatment of fibromyalgia, marking the first approval for a new prescription medicine for this condition in over 15 years [3] - Tonix also markets two treatments for acute migraine in adults and focuses on central nervous system disorders, immunology, immuno-oncology, rare diseases, and infectious diseases [3] Pipeline and Development - The company’s development portfolio includes TNX-102 SL for acute stress reaction and major depressive disorder, funded by the U.S. Department of Defense [3] - Tonix's immunology portfolio features TNX-1500, a monoclonal antibody for preventing organ transplant rejection and treating autoimmune diseases [3] - The rare disease portfolio includes TNX-2900 for Prader-Willi syndrome, while the infectious disease portfolio includes TNX-801 for mpox and smallpox, and TNX-4800 for Lyme Disease prevention [3] - TNX-4200 is a broad-spectrum antiviral agent with a contract from the U.S. DoD for up to $34 million over five years [3] Upcoming Events - Seth Lederman, M.D., CEO of Tonix Pharmaceuticals, will present at BIO-Europe 2025 on November 4, 2025, highlighting the company's strategy and pipeline [1][2]
Innovent Biologics Announces Global Strategic Partnership with Takeda to Bring Innovent's Next Gen IO Backbone Therapy and ADC Molecules to the Global Market
Prnewswire· 2025-10-22 00:25
Core Insights - Innovent Biologics has entered a strategic global collaboration with Takeda to advance next-generation immuno-oncology (IO) and antibody-drug conjugate (ADC) cancer therapies aimed at developing transformative cancer treatments for patients worldwide [1][2]. Collaboration Details - The partnership will focus on several investigational medicines within Innovent's IO+ADC pipeline, including IBI363, IBI343, and IBI3001, with IBI363 currently in Phase 3 clinical stage [2][4]. - Innovent and Takeda will co-develop IBI363 globally, sharing development costs at a ratio of 40/60, and will co-commercialize it in the U.S. [5][7]. - Takeda will receive exclusive commercialization rights for IBI343 outside Greater China, while also having an option for IBI3001 [5][10]. Financial Aspects - Innovent will receive an upfront payment of US$1.2 billion, which includes a strategic equity investment of US$100 million at a 20% premium to the average share price [13][14]. - The total deal value could reach up to US$11.4 billion, including potential milestone payments and royalties [14]. Product Highlights - IBI363 is a first-in-class PD-1/IL-2 bispecific antibody fusion protein that has shown promising results in clinical trials, particularly in immunotherapy-resistant lung cancer [4][6]. - IBI343 is an innovative ADC targeting CLDN18.2, currently in Phase 3 trials for gastric and gastroesophageal cancers, and has received Breakthrough Designation in China [9][10]. - IBI3001 is a first-in-class bispecific ADC targeting B7-H3 and EGFR, currently in Phase 1 clinical trials [11][12]. Strategic Goals - The collaboration aims to redefine cancer treatment globally by leveraging Innovent's R&D capabilities and Takeda's extensive experience in drug development and commercialization [3][5]. - This partnership is a significant step in Innovent's strategic roadmap to expand its global footprint and enhance its position as a leading biopharmaceutical company [3].