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 ...

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.

Core Viewpoint - A new class action lawsuit has been filed against aTyr Pharma, Inc. and its executives, expanding the alleged class period for investors who suffered losses due to misleading statements about the efficacy of its drug, Efzofitimod [1][2][4]. Group 1: Class Action Details - The new class action, King v. aTyr Pharma Inc., covers investors who acquired aTyr securities between November 7, 2024, and September 12, 2025, significantly extending the previous class period that began in January 2025 [2][4]. - The lawsuit alleges that aTyr and its executives made false statements regarding the drug's efficacy, leading to inflated stock prices [4][7]. Group 2: Drug Study and Allegations - The allegations center around aTyr's Phase 3 study, EFZO-FIT, which evaluated Efzofitimod in patients with pulmonary sarcoidosis, aimed at reducing steroid dependency [5][6]. - Throughout the class period, aTyr executives reportedly expressed confidence in the study's design while allegedly concealing adverse facts about the drug's efficacy [6][7]. Group 3: Market Reaction - The truth about the drug's failure to meet its primary endpoint was revealed on September 15, 2025, leading to a drastic decline in aTyr's stock price from $6.03 to $1.02, a drop of 83.2% in one day [8][9]. - Following the announcement, aTyr indicated plans to engage with the FDA to determine a path forward after the setback [9]. Group 4: Investigation and Legal Actions - Hagens Berman, a prominent shareholders rights firm, is investigating whether aTyr misled investors about the drug's data and trial design, emphasizing its potential multi-billion-dollar market opportunity [10]. - The firm is urging affected investors to submit their losses and is seeking information from individuals who may assist in the investigation [3][11].

Initial Results from Ongoing Dose -Escalation Study of XmAb819 & Oncology Pipeline Update October 24, 2025 ® Today's Speakers Xencor Management Guest Speaker Bassil Dahiyat, Ph.D. President & Chief Executive Officer Co-director, Kidney Cancer Program City of Hope Comprehensive Cancer Center 2 John Desjarlais, Ph.D. Executive Vice President & Chief Scientific Officer Dane Leone Executive Vice President & Chief Strategy Officer Sumanta Pal, M.D., F.A.S.C.O. Professor, Department of Medical Oncology & Therapeu ...

Atai’s pipeline is designed to transform mental health care. Key assets include VLS-01 (DMT-based for treatment-resistant depression), EMP-01 (MDMA-based for social anxiety), and novel non-hallucinogenic 5-HT2A receptor agonists. With convenient administration methods and short in-clinic times, Atai is positioning itself as a market leader in next-gen psychedelic medicine.Based in both Berlin, Germany and the Netherlands, Atai Life Sciences is pushing the boundaries of mental health treatment. This clinical ...

Relay Therapeutics, Inc. (NASDAQ: RLAY ) is working at the cutting edge of precision oncology. RLY-2608, its lead asset, is an allosteric and pan-mutant PI3Kα inhibitor targeting breast cancer. This molecule is currently in phase 3 trials after producingDubai-based investor focused on building a resilient, income-generating portfolio with a long-term growth mindset. My approach is primarily long-only, blending dividend-paying equities, REITs, and other income strategies with selective growth opportunities. ...

Relay Therapeutics (NASDAQ: RLAY ) is working at the cutting edge of precision oncology. RLY-2608, its lead asset, is an allosteric and pan-mutant PI3Kα inhibitor targeting breast cancer. This molecule is currently in phase 3 trials, after producing positive interimDubai-based investor focused on building a resilient, income-generating portfolio with a long-term growth mindset. My approach is primarily long-only, blending dividend-paying equities, REITs, and other income strategies with selective growth opp ...

Core Insights - Whitehawk Therapeutics presented data on Protein Tyrosine Kinase 7 (PTK7) as a promising target for antibody-drug conjugates (ADCs) at the 2025 AACR-NCI-EORTC International Conference, highlighting its expression in approximately 70% of solid tumors [1][6][3] Group 1: PTK7 Characteristics - PTK7 is the third most highly expressed tumor marker among ADC targets, following HER2 and HER3, with stable expression across various cancer types and stages [6][1] - The analysis involved over 157,000 tumor samples, confirming PTK7's broad expression in solid tumors, particularly in endometrial (7.4), ovarian (7.2), head and neck (7.1), non-small cell lung cancer (NSCLC) (6.9), and breast (6.7) tumors [6][3] Group 2: Development of HWK-007 - Whitehawk is advancing HWK-007, a PTK7-targeting ADC that utilizes a stable yet cleavable linker to deliver a Topoisomerase I (TOPO1) inhibitor payload, with plans to submit an Investigational New Drug application to the FDA by year-end [5][6] - The company aims to initiate clinical evaluations of HWK-007 in NSCLC, ovarian, and endometrial cancers, targeting nearly 750,000 patients in the US with PTK7-expressing cancers [7][5] Group 3: Collaboration and Future Outlook - The analysis was conducted in collaboration with Tempus AI, utilizing real-world data to characterize PTK7 expression for the first time [1][7] - The findings underscore the potential of PTK7 as a clinically meaningful target for ADCs, reinforcing Whitehawk's strategic focus on developing next-generation ADCs for a wide range of patients [5][6]

Market Performance - U.S. stocks experienced a positive trading session, with the Dow Jones index increasing by more than 500 points, closing up 1.19% at 47,289.61. The NASDAQ rose 1.27% to 23,232.48, and the S&P 500 gained 0.98% to 6,804.28 [1] - Communication services sector saw a rise of 1.2%, while energy stocks declined by 0.4% [1] Economic Indicators - The University of Michigan consumer sentiment index was revised down to 53.6 in October from a preliminary reading of 55 and compared to 55.1 in September [2][11] - The S&P Global services PMI increased to 55.2 in October from 54.2 in the previous month, exceeding market expectations of 53.5 [11] - The S&P Global manufacturing PMI rose to 52.2 in October from 52.0, also surpassing estimates of 52.0 [11] - The S&P Global composite PMI jumped to 54.8 in October from 53.9 in September [11] - Year-ahead inflation expectations in the U.S. decreased to 4.6% in October from 4.7% in September [11] Commodity Prices - Oil prices increased by 0.7% to $62.19, while gold prices decreased by 0.1% to $4,143.10. Silver fell by 0.4% to $48.530, and copper dropped by 0.2% to $5.0985 [5] International Markets - European shares were mostly higher, with the eurozone's STOXX 600 rising by 0.07%. Spain's IBEX 35 gained 0.15%, London's FTSE 100 rose by 0.32%, Germany's DAX 40 increased by 0.14%, while France's CAC 40 fell by 0.30% [6] - Asian markets closed mostly higher, with Japan's Nikkei 225 gaining 1.35%, Hong Kong's Hang Seng index up by 0.74%, and China's Shanghai Composite rising by 0.71%. India's BSE Sensex, however, fell by 0.41% [7] Company News - Wellgistics Health, Inc. shares surged by 229% to $1.3501 after signing a non-binding letter of intent with Datavault AI Inc. to integrate blockchain technology [9] - Genenta Science S.p.A. shares increased by 108% to $6.81 following an expanded collaboration with ANEMOCYTE [9] - Inhibrx Biosciences, Inc. shares rose by 74% to $49.26 after positive trial results for Ozekibart in chondrosarcoma [9] - Deckers Outdoor Corporation shares fell by 13% to $89.00 after reporting second-quarter results that missed revenue estimates [9] - MultiSensor AI Holdings, Inc. shares dropped by 46% to $0.7340 due to a $14 million private placement announcement [9] - MaxLinear, Inc. shares decreased by 13% to $15.31 following third-quarter results [9]

Accessibility StatementSkip Navigation BETHESDA, Md., Oct. 24, 2025 /PRNewswire/ -- Northwest Biotherapeutics, Inc. (OTCQB:NWBO) (the "Company" or "NWBio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced that its acquisition of Advent BioServices Ltd. ("Advent") has closed. As a result of this acquisition, Advent is now a wholly owned subsidiary of NWBio. The Company anticipates that this acquisition will help enable efficiencies and scale-up of op ...