Clinical Trials News

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Tiziana Life Sciences Doses First Patient in Phase 2a Trial of Intranasal Foralumab for Multiple System Atrophy

BOSTON, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with ...

What are the risks of trial setbacks or adverse events in this early‑stage study that could negatively impact the stock? How might the Phase 2a enrollment update influence analyst coverage, consensus estimates, and target price revisions for TLSA? Are there any partnership or licensing agreements in place that could be triggered by positive trial data, potentially affecting liquidity or dilution?
Symbol: TLSA
10 days ago
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Investigational Device Exemption (IDE) Application for Human Clinical Trials at Mayo Declined By FDA

Kennewick, WA, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL) Following the 30-day review period, the FDA declined approval of the Radiogel® IDE submission.

Could this event trigger any covenant breaches or affect debt covenants in Vivos Inc.'s financing agreements? What is the market's perception of management's ability to navigate regulatory hurdles moving forward? How might this news influence analyst ratings and target price revisions for RDGL?
Symbol: RDGL
10 days ago
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24/7 Market News: LIXTE Biotech Advances Precision Oncology Pipeline with Multiple Phase 1B/2 Trial Readouts Expected in 2H 2025

2025 is shaping up to be a defining year for LIXTE (Nasdaq: LIXT) and its lead compound LB-100

How might macroeconomic conditions in 2025 affect the funding environment for biotech companies like LIXTE? What impact could a positive readout have on institutional ownership or short interest levels? How does the timing of LIXTE's readouts align with broader market or sector trends in precision oncology?
Symbol: LIXT
10 days ago
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Apreo Health Announces First Patient Treated in BREATHE-3, Pivotal Clinical Trial of Company’s BREATHE Airway Scaffold

MENLO PARK, Calif.--(BUSINESS WIRE)--Apreo Health, a clinical-stage medical device company pioneering a novel, tissue-sparing approach for treating severe emphysema, today announced that the first ...

What is the anticipated pricing strategy for the BREATHE Airway Scaffold upon potential market launch? How will the enrollment rate and total patient cohort size for BREATHE-3 compare to Apreo's previous trials (BREATHE-1, BREATHE-2)? What are the potential risks or failure points identified for the BREATHE-3 trial that could impact investor sentiment?
Symbol: APRE
10 days ago
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Orchestra BioMed Announces Publication of AVIM Therapy Clinical Data in JACC: Advances Demonstrating Potential to Improve Cardiac Function in Patients with Hypertension and Diastolic Dysfunction

NEW HOPE, Pa., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical innovation company accelerating high-impact tech...

What reimbursement pathways are anticipated for AVIM therapy, and what timeline is expected for coverage decisions? How might the data influence the company's earnings guidance or revenue forecasts for the next fiscal year? Is there potential for strategic partnerships, licensing deals, or acquisition interest following the publication in JACC: Advances?
Symbol: OBIO
10 days ago
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MeiraGTx Reports Second Quarter 2025 Financial and Operational Results

-  Gained alignment with U.S. Food and Drug Administration (FDA) on the ongoing Phase 2 AQUAx2 randomized double-blind, placebo-controlled pivotal study in Grade 2/3 radiation-induced xerostomia (R...

What are the key milestones and risk factors that could cause the data readout to be delayed or the trial to fail? How might the FDA alignment impact the timing of any partnership or licensing negotiations with larger pharmaceutical firms? What is the anticipated cash burn rate through the end of 2026, and will the company need additional financing to fund the trial?
Symbol: MGTX
10 days ago
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Pivotal SAPPHIRE Trial Data Published in The Lancet Neurology: Apitegromab Demonstrated Significant Motor Function Gains for Children and Adults with SMA on SMN-Targeted Treatment

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal musc...

What partnership or commercial alliance opportunities could arise from the successful trial outcomes? Does Scholar Rock have sufficient manufacturing capacity and supply chain robustness to meet anticipated demand? How might this data influence existing analyst coverage, target price revisions, and institutional ownership?
Symbol: SRRK
10 days ago
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Xilio Therapeutics Announces Pipeline and Business Updates and Second Quarter 2025 Financial Results

Announced updated Phase 2 data at ASCO for vilastobart, a tumor-activated, Fc-enhanced, anti-CTLA-4, demonstrating deep and durable responses and a meaningfully differentiated safety and tolerabili...

How does this data update affect the probability of success for future Phase 3 trials and overall portfolio risk? What are the potential reimbursement and commercial launch timelines if the data support further development? How might the Phase 2 results influence the company's cash burn rate and need for additional financing?
Symbol: XILO
10 days ago
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Athira Pharma Presents ATH-1105 Phase 1 Trial Results at ALS Nexus 2025

BOTHELL, Wash., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a clinical stage biopharmaceutical company focused on developing small molecules to restore neuronal health a...

What impact could this news have on the broader neurodegeneration sector and related biotech stocks? How might the results influence analyst rating upgrades/downgrades or target price revisions for ATHA? Will the Phase 1 data trigger any partnership or licensing discussions with larger pharmaceutical firms?
Symbol: ATHA
10 days ago
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