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JASPER CLASS ACTION ALERT: Bragar Eagel & Squire, P.C. Urges Jasper Therapeutics Stockholders to Contact the Firm Regarding Filed Class Action
Globenewswire· 2025-10-25 17:08
Core Viewpoint - A class action lawsuit has been filed against Jasper Therapeutics, Inc. for allegedly making materially false and misleading statements regarding its business operations and compliance policies during the Class Period from November 30, 2023, to July 3, 2025 [3][8]. Allegation Details - The lawsuit claims that Jasper lacked necessary controls and procedures to ensure third-party manufacturers complied with cGMP regulations, which could negatively impact the results of ongoing studies and the regulatory and commercial prospects of its products, particularly briquilimab [3]. - The failure to maintain proper controls increased the likelihood of disruptive cost-reduction measures and overstated the company's business and financial prospects [3]. Next Steps - Investors who purchased Jasper shares and suffered losses are encouraged to contact the law firm for more information about their rights and potential claims [4][8]. - The deadline for investors to apply to be appointed as lead plaintiff in the lawsuit is November 18, 2025 [8]. About the Law Firm - Bragar Eagel & Squire, P.C. is a nationally recognized law firm that represents individual and institutional investors in complex litigation across the United States [5].
AlphaTON Capital and Cyncado Therapeutics Share New Mesothelioma Data Supporting TT-4's Path to First- Patient Dosing
Globenewswire· 2025-10-25 16:30
Core Insights - AlphaTON Capital Corp and its subsidiary Cyncado Therapeutics presented new findings at the AACR-NCI-EORTC conference, demonstrating that selective adenosine A2B receptor inhibition has a direct anti-tumor effect in mesothelioma cells, reducing PD-L1 expression and modulating YAP signaling [1][2][3] Clinical Development - The new data supports the efficacy of Cyncado's selective A2B receptor antagonist TT-4, which showed better monotherapy activity than anti-PD-1 and improved tumor control when combined with anti-PD-1, leading to increased immune infiltration [2][3] - TT-4 is advancing towards first-patient dosing expected in Q1 2026, with a focus on translating these findings into clinical applications [4][10] Research Collaboration - The research was conducted in collaboration with the Italian Group for Mesothelioma and other institutions, highlighting the importance of partnerships in advancing cancer therapeutics [1][5] Mechanistic Insights - In human mesothelioma models, hypoxia-linked adenosine signaling was found to increase tumor growth and PD-L1 expression, while selective A2B receptor inhibition effectively reduced cell growth and PD-L1 protein levels [3][4] - In vivo studies demonstrated that TT-4 significantly inhibited tumor growth in immunocompetent models, further enhanced by combination therapy with anti-PD-1 [3][4] Company Overview - AlphaTON Capital is focused on building a strategic reserve of TON tokens and developing the Telegram ecosystem, providing institutional-grade exposure to the TON ecosystem while maintaining transparency as a Nasdaq-listed company [6][7] - Cyncado Therapeutics is developing small molecule adenosine receptor antagonists targeting A2A and A2B receptors to overcome immune suppression in oncology, with TT-4 being the lead program [10]
Rosen Law Firm Encourages Tvardi Therapeutics, Inc. Investors to Inquire About Securities Class Action Investigation – TVRD
Businesswire· 2025-10-24 22:00
NEW YORK--(BUSINESS WIRE)--Why: Rosen Law Firm, a global investor rights law firm, announces an investigation of potential securities claims on behalf of shareholders of Tvardi Therapeutics, Inc. (NASDAQ: TVRD) resulting from allegations that Tvardi Therapeutics may have issued materially misleading business information to the investing public. So What: If you purchased Tvardi Therapeutics securities you may be entitled to compensation without payment of any out of pocket fees or costs through. ...
Xencor, Inc. (XNCR) Discusses Initial Phase I Dose Escalation Results for XmAb819 in Advanced Clear Cell Renal Cell Carcinoma Transcript
Seeking Alpha· 2025-10-24 21:37
Core Points - The webcast is focused on the initial Phase I dose escalation results for Xencor's XmAb819 [1] Group 1 - The conference is hosted by Megan, the conference operator, who introduces the event [1] - Charles Liles, Senior Director of Corporate Communications and Investor Relations, is set to take over the call [1]
Arvinas Presents Preclinical Data for ARV-806 Demonstrating Robust and Differentiated Activity in Models of KRAS G12D-mutated Cancer at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
Globenewswire· 2025-10-24 20:00
– In vivo, ARV-806 demonstrated robust and durable KRAS G12D degradation, leading to significant tumor growth inhibition in models of pancreatic, colorectal, and lung cancer – – Data underscore differentiation of ARV-806 from other G12D targeting agents in development and best-in-class potential for KRAS G12D mutated cancers – NEW HAVEN, Conn., Oct. 24, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degr ...
Ford Hutman Media and Pinkergreen Launch Greenford, an Integrated Branding and Communications Firm for Life Science Companies
Businesswire· 2025-10-24 19:58
Core Insights - Greenford is launched as an integrated branding and communications firm aimed at supporting emerging biotech and life-science companies in their growth from stealth to scale [2][3] - The firm was co-founded by Rachel Ford Hutman and Kelley Shaw-Wade, both recognized leaders in the industry [2][3] Company Overview - Greenford combines senior communications counsel, brand strategy, and modern website development to help life-science innovators build their reputation and grow strategically [5] - The firm offers a range of services including media relations, strategic communications planning, brand strategy, and investor-ready websites [3][5] Founders' Vision - Rachel Ford Hutman emphasized the need for clear and credible storytelling in the life sciences, stating that clients have long requested a combination of communications and branding services [3] - Kelley Shaw-Wade highlighted the importance of creating smart and effective work that resonates with the rigor of scientific endeavors [3] Target Market - Greenford focuses on early-stage and emerging life-science teams, aligning their launches and milestones with key industry events while being flexible to meet unique client needs [3]
Syndax Pharmaceuticals (NasdaqGS:SNDX) Update / Briefing Transcript
2025-10-24 19:30
Summary of Syndax Pharmaceuticals Conference Call on Revuforge Approval Company Overview - **Company**: Syndax Pharmaceuticals (NasdaqGS: SNDX) - **Product**: Revuforge, a first-in-class menin inhibitor - **Date of Call**: October 24, 2025 Key Industry and Company Insights FDA Approval and Indications - Revuforge received FDA approval for its second indication, targeting adults and pediatric patients with relapsed or refractory NPM1 mutated acute myeloid leukemia (AML) [6][10] - This approval follows the initial FDA approval in November 2024 for relapsed or refractory acute leukemia patients with KMT2A translocation [6][10] - Revuforge is now the first and only menin inhibitor approved for multiple acute leukemia subtypes in both adults and pediatrics [6][10] Clinical Efficacy and Data - The approval is based on pivotal data showing a 47% overall response rate (ORR) and an 11% transplant rate in patients treated with Revuforge [8][19] - The median overall survival for responders was nearly two years, with a median duration of response of 4.5 months [19][20] - Revuforge demonstrated compelling efficacy across multiple genetic subtypes of acute leukemia, establishing a strong clinical profile [8][20] Market Opportunity - The total addressable population for Revuforge has expanded from approximately 2,000 KMT2A incident patients to 6,500 patients, representing a market opportunity exceeding $2 billion in the relapsed refractory setting [25][26] - Approximately 40-45% of AML patients have either an NPM1 mutation or a KMT2A translocation, indicating a significant market potential [26] Commercial Strategy and Execution - Syndax has established a strong commercial foundation with a trusted presence in leading cancer centers across the U.S. [10][28] - The company has achieved nearly $50 million in net revenue in the first two full quarters post-launch, despite some KMT2A patients pausing treatment for transplants [27][28] - Revuforge is on formulary for 97% of covered lives, facilitating rapid access for patients [29][30] Safety Profile and Monitoring - The updated label includes a boxed warning for QTc prolongation and torsades de pointes, based on a non-fatal case identified during clinical trials [16][51] - Management of QTc prolongation remains straightforward, with physicians already familiar with monitoring protocols [41][51] Future Outlook - Syndax plans to expand Revuforge into additional indications and frontline settings, with ongoing clinical trials [11][35] - The company is positioned for continued growth, with a strong pipeline and a focus on innovative therapies for difficult-to-treat diseases [24][35] Additional Important Points - The NCCN Guideline Committee has added Revuforge as a recommended treatment option for relapsed refractory NPM1 mutated AML, validating the strength of the clinical data [10][11] - The company has a comprehensive clinical development plan aimed at unlocking a market opportunity exceeding $5 billion in the U.S. [11] - Syndax's commercial team has extensive experience in hematology and oncology, enhancing their ability to engage with healthcare providers effectively [32][34] This summary encapsulates the critical insights from the conference call regarding Syndax Pharmaceuticals, its product Revuforge, and the broader implications for the acute leukemia treatment landscape.
Theriva Biologics Provides Response to Unusual Market Action
Globenewswire· 2025-10-24 18:31
ROCKVILLE, Md., Oct. 24, 2025 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, announced today that the Company had become aware of unusual trading activity in its common stock on the NYSE American (the “NYSE”) on October 24, 2025. The Company is issuing this press release pursuant to Section 401(d) of the NYSE Company Guide. The C ...
Xencor (NasdaqGM:XNCR) Update / Briefing Transcript
2025-10-24 18:32
Summary of Xencor XmAb® 819 Initial Phase I Dose Escalation Results Webcast Company and Industry Overview - **Company**: Xencor - **Product**: XmAb® 819 - **Industry**: Oncology, specifically targeting advanced clear cell renal cell carcinoma (ccRCC) Core Points and Arguments 1. **Positive Initial Results**: Xencor announced positive initial results from the Phase I dose escalation study of XmAb® 819 in advanced ccRCC, indicating potential for significant anti-tumor activity in heavily pretreated patients [2][20][29] 2. **T-cell Engager Mechanism**: XmAb® 819 is a first-in-class XmAb® 2+1 T-cell engager targeting ENPP3, designed to selectively engage tumor cells while minimizing effects on normal cells [8][19] 3. **Patient Population**: The study enrolled patients with a median of four prior systemic therapies, with over 36% having prior HIF2 inhibitor therapy, highlighting the advanced nature of the patient population [13][31] 4. **Efficacy Data**: The best overall response rate observed was 25%, with a disease control rate of 70%, which is unprecedented for monotherapy in this heavily pretreated population [20][29] 5. **Safety Profile**: The drug was well tolerated, with a low rate of adverse events (AEs) and only 4% of patients discontinuing due to AEs. The most common AEs included cytokine release syndrome (CRS), rash, and gastrointestinal symptoms [14][18][50] 6. **Dosing Strategy**: The study utilized a priming step followed by a target dose regimen, with pharmacokinetic (PK) profiles supporting biweekly dosing after the first cycle [10][12] 7. **Market Potential**: The global drug sales for renal cell carcinoma are projected to reach $12 billion by 2030, indicating a significant market opportunity for XmAb® 819 [27] 8. **Future Development**: Xencor plans to explore additional development opportunities in other tumor types expressing ENPP3, such as papillary renal cell, colorectal, and lung cancer [31] Additional Important Content 1. **Forward-Looking Statements**: The management made forward-looking statements regarding future product offerings and market conditions, emphasizing the uncertainty and risks involved [3][4] 2. **Dose Preparation Issues**: Initial dose preparation errors led to elevated drug levels and increased rates of CRS, but corrective measures have been implemented to prevent future occurrences [16][52] 3. **Combination Therapy Potential**: There is optimism about the potential for XmAb® 819 to be used in combination therapies, particularly as the drug shows promise in managing AEs and maintaining patient quality of life [25][66] 4. **Clinical Trial Dynamics**: Enrollment has accelerated as the study progresses, with a waitlist for patients indicating strong interest in the trial [55][56] 5. **Next Steps**: Xencor aims to establish a recommended Phase III dose for XmAb® 819 by 2026 and will continue to evaluate the drug's performance in various cohorts [26][79] This summary encapsulates the key points from the conference call regarding XmAb® 819, its clinical trial results, market potential, and future development strategies.