Clinical Trials News - Candlesense

Akeso Announces First Patient Dosed in Phase III Trial of Ivonescimab as Consolidation Therapy for Limited-Stage SCLC After Definitive Radiotherapy

HONG KONG, Aug. 10, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that the first patient has been dosed in its multicenter, randomized, double-blind Phase III stud...

Symbol: 9926.HK

14 days ago

Arvinas Announces FDA Acceptance of the New Drug Application for Vepdegestrant for the Treatment of ESR1m, ER+/HER2- Advanced Breast Cancer

– Filing based on pivotal Phase 3 VERITAC-2 clinical trial demonstrating statistically significant and clinically meaningful improvement in median progression-free survival versus fulvestrant –

What are the implications for ARVS’s cash runway and need for additional financing if the drug requires a larger commercial launch budget? How might the trial’s safety profile and adverse event data influence investor sentiment and potential pricing strategies? What regulatory or reimbursement hurdles could affect Vepdegestrant’s commercialization in key markets (US, EU, Asia)?

Symbol: ARVS

16 days ago

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Anixa Biosciences Announces Dr. Robert Wenham will speak about Immunotherapy in surviving Ovarian Cancer at the 13th Annual Ovarcoming Cancer Conference

Dr. Wenham is Principal investigator on Anixa's CAR-T therapy for Ovarian Cancer SAN JOSE, Calif., Aug. 8, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a ...

How does the sentiment score of 70 influence market perception, and could it lead to a re‑rating by analysts? Are there any indications of additional indications or expansion of the CAR‑T technology beyond ovarian cancer? What is the anticipated impact of the conference news on short‑term trading volume and price volatility for ANIX?

Symbol: ANIX

16 days ago

Assembly Biosciences Reports Positive Interim Results from Phase 1b Clinical Study of Long-Acting Helicase-Primase Inhibitor Candidate ABI-5366 Showing Reductions in Viral Shedding Rate and Genital Lesion Rate in Recurrent Genital Herpes

– 94% reduction in HSV-2 shedding rate and 98% reduction in high viral load shedding rate, both statistically significant, observed in cohort evaluating 350 mg weekly oral dose compared to placebo ...

Are there plans to evaluate ABI‑5366 in other HSV‑1/HSV‑2 indications or broader antiviral indications? How might analysts adjust their coverage and consensus estimates for ASMB in response to these results? What regulatory pathway and timeline does the FDA anticipate for a new class of herpes therapeutics?

Symbol: ASMB

16 days ago

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Incannex Receives Positive Patient-Reported Outcomes and Compelling Phase 2 Efficacy Data for IHL-42X in Obstructive Sleep Apnoea

Exit interviews and clinical results reinforce strong potential for meaningful improvements in sleep quality, cognitive function, and daily life Exit interviews and clinical results reinforce stro...

What are the risks that the Phase 2 data may not be replicated in larger, pivotal trials? How could this news influence analyst coverage, target price revisions, and institutional sentiment toward ICAN? What is the size of the target market for IHL-42X and the realistic market share the company can capture?

Symbol: ICAN

16 days ago

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Orchestra BioMed Announces Rollout of FDA-Approved BACKBEAT Global Pivotal Study Protocol Update Significantly Expanding Patient Eligibility

NEW HOPE, Pa., Aug. 08, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to...

What are the potential implications for the valuation of OBIO's pipeline if the BACKBEAT study demonstrates positive outcomes with the larger patient pool? Are there any anticipated changes in operating expenses or capital requirements associated with the expanded trial that could affect profitability margins? How might the market react to the news sentiment score of 70 and the potential for higher trial enrollment numbers?

Symbol: OBIO

16 days ago

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Genmab Announces Phase 3 EPCORE® FL-1 Clinical Trial Met Dual Primary Endpoints in Patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL)

COPENHAGEN, Denmark--(BUSINESS WIRE)--Genmab A/S (Nasdaq: GMAB) today announced positive results of the Phase 3 EPCORE® FL-1 trial evaluating subcutaneous epcoritamab, a bispecific antibody, in com...

Will the dual primary endpoints lead to an upgrade in analyst coverage or target price revisions by sell‑side analysts? How does the efficacy of the epcoritamab+R2 combo influence potential market share against competing bispecifics like Blincyto (blinatumomab) or other emerging FL therapies? Are there any upcoming catalyst events (e.g., FDA advisory committee, submission dates) we should watch for?

Symbol: GMAB

17 days ago

Genmab Announces Phase 3 EPCORE® FL-1 Clinical Trial Met Dual Primary Endpoints in Patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL)

Company Announcement

What are the potential risks or uncertainties that could still affect the trial's commercial rollout? How could this news affect analyst coverage and consensus estimates for Genmab? Will the dual primary endpoint success trigger any milestone payments in existing collaborations?

Symbol: GEN

17 days ago

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Palisade Bio Reports 100% Clinical Response in Phase 1b Ulcerative Colitis Cohort with Novel PDE4 Inhibitor, PALI-2108

PALI-2108 demonstrated to be safe and well tolerated with no serious adverse events (SAEs)

Symbol: PBIO

17 days ago

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Mass General Brigham Launches Two Clinical Trials to Study Haystack MRD ctDNA as Guide for Post-surgical Treatment for Two Cancer Types

SECAUCUS, N.J. and BOSTON, Aug. 7, 2025 /PRNewswire/ -- Haystack Oncology, a Quest Diagnostics (NYSE: DGX) company, today announced a research collaboration with Mass General Brigham investigators ...

If the trials demonstrate clinical benefit, what is the expected timeline for market launch and adoption by oncologists? What regulatory pathways (e.g., Breakthrough Device, Fast Track) is Haystack pursuing for this technology, and what are the associated risks? How might the trial outcomes influence the pricing and reimbursement landscape for MRD‑guided treatments?

Symbol: DGX

17 days ago