Clinical Trials News - Candlesense

24/7 Market News: LIXTE Biotechnology Spotlight- Revisiting the “Too Much of a Good Thing” Strategy for LB-100

LIXTE’s (Nasdaq: LIXT) lead compound, LB 100, was featured in Nature Reviews Cancer editorial titled “Too Much of a Good Thing”

Symbol: LIXT

3 days ago

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Mabwell's CDH17-targeting ADC 7MW4911 Receives IND Clearance from FDA

SHANGHAI, Aug. 19, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its self-developed CDH17-targeting ADC (R&D code: 7MW...

Symbol: 688062.SH

4 days ago

Delcath Systems Announces First Patient Dosed in Phase 2 Clinical Trial of HEPZATO™ in Liver-Dominant Metastatic Colorectal Cancer

QUEENSBURY, N.Y.--(BUSINESS WIRE)--Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced that th...

How might this data influence Delcath's competitive positioning and potential partnership or acquisition interest from larger oncology firms? What are the key safety and efficacy endpoints expected from the HEPZATO™ trial, and how do they compare to existing liver‑directed therapies for metastatic colorectal cancer? How will the Phase 2 trial results and timeline affect Delcath's near‑term revenue outlook and share price volatility?

Symbol: DCTH

4 days ago

ImmunityBio Announces Phase 2 Study of ANKTIVA® in Patients with Long COVID

CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced the opening of a new Phase 2 study to assess the BioShield™ platform, anchor...

How does ImmunityBio’s BioShield™ platform and ANKTIVA pipeline differentiate from competitor efforts in long COVID, and what could that mean for the company's competitive positioning? What is the estimated market size and revenue upside if ANKTIVA receives approval for long COVID, and how does that compare to existing treatment options? How will the upcoming Phase 2 results timeline and potential outcomes influence IBRX's short‑term stock price and volatility?

Symbol: IBRX

4 days ago

Butterfly Network Joins Research Project Studying the Impact of AI-Assisted POCUS on Early Tuberculosis Detection in Sub-Saharan Africa

BURLINGTON, Mass. & NEW YORK--(BUSINESS WIRE)--Butterfly Network, Inc. (“Butterfly”, “the Company”) (NYSE: BFLY), a digital health company transforming care with handheld, whole-body ultrasound, to...

Symbol: BFLY

4 days ago

Viking Therapeutics Announces Positive Top-Line Results from Phase 2 VENTURE-Oral Dosing Trial of VK2735 Tablet Formulation in Patients with Obesity

Study Achieves Primary and Secondary Endpoints, Demonstrating Statistically Significant Reductions in Body Weight with Once-Daily VK2735 Dosing as Compared to Placebo Up to 12.2% (26.6 lbs) Mean We...

What are the potential risks (regulatory, safety, reimbursement) that could offset the upside from the reported weight‑loss efficacy? What are the timelines and probability of moving to Phase 3, and how does that compare to other obesity‑treatment pipelines? How will the positive Phase 2 results affect VKN's short‑term price movement and trading volume?

Symbol: VKN

4 days ago

BioXcel Therapeutics Announces Database Lock in SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia

Data from more than 2,600 agitation episodes collected

How does BioXcel's SERENITY trial compare to competitor pipelines targeting agitation in bipolar disorder and schizophrenia? What are the expectations for regulatory approval timelines based on the SERENITY trial data? How will the database lock and upcoming results affect BXY's valuation in the short term?

Symbol: BXY

4 days ago

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Greenwich LifeSciences Announces Plan to Build Out Internal Clinical Operations Team

STAFFORD, Texas, Aug. 19, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial,...

Symbol: GLSI

4 days ago

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REGENXBIO Announces FDA Review Extension of BLA for RGX-121 to Treat Patients with MPS II

RGX-121 would be the first and only potential one-time commercially-available therapy designed to directly address the underlying genetic cause of Hunter syndrome, if approved Commercial launch pla...

What are the risks to the commercial launch timeline and reimbursement landscape if the BLA is not approved on the first submission? What is the potential market size and pricing power for a one‑time gene therapy for Hunter syndrome compared to existing treatments and pipeline competitors? How will the FDA review extension and upcoming data presentation affect RGNX's short‑term price volatility?

Symbol: RGNX

4 days ago

Invivyd Announces Continued Neutralizing Activity of PEMGARDA® (pemivibart) and VYD2311 Against Currently Dominant SARS-CoV-2 Variant XFG (“Stratus”)

WALTHAM, Mass., Aug. 18, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced positive, continued, clinically meaningful in vitro neutralization data for PEMGARDA® (pemivibart) a...

What are the potential regulatory, manufacturing, and reimbursement risks that could affect the timing and scale of commercial rollout for PEMGARDA and the upcoming VYD2311? What competitive advantage does Invivyd gain versus other monoclonal antibody providers and next‑generation oral antivirals given the XFG variant’s dominance? How will the confirmed neutralization of the XFG variant by PEMGARDA and VYD2311 influence IVVD's revenue outlook and valuation multiple?

Symbol: IVVD

4 days ago

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