Clinical Trials News - Candlesense

Lantern Pharma's Subsidiary, Starlight Therapeutics, Announces U.S. Food and Drug Administration Clearance of IND for Phase Ib/2a Glioblastoma Multiforme (GBM) Trial

DALLAS--(BUSINESS WIRE)--Starlight Therapeutics, a wholly owned subsidiary of Lantern Pharma Inc. (NASDAQ: LTRN), today announced that the U.S. Food and Drug Administration (FDA) has cleared its In...

What is the expected cost of the Phase Ib/2a trial and its impact on Lantern Pharma’s cash runway and financing needs? How might the partnership or licensing structure (if any) for STAR‑001 affect future revenue streams or margin assumptions? Will the trial results be disclosed in upcoming investor presentations or conference calls, and what impact could that have on market perception?

Symbol: LTRN

20 days ago

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Vir Biotechnology Successfully Initiates all Trials in ECLIPSE Registrational Program for Chronic Hepatitis Delta

SAN FRANCISCO--(BUSINESS WIRE)--Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the enrollment of the first participant in ECLIPSE 3. All three trials in the Company’s registrational ECLIPSE ...

How could potential regulatory setbacks or trial delays impact the stock’s upside/downside potential? Will the outcomes of ECLIP2 and ECLIP3 provide sufficient data to support a robust FDA or EMA filing strategy? What are the key enrollment milestones and risk factors that could trigger volatility in VIR stock?

Symbol: VIR

20 days ago

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Precision BioSciences Announces Phase 1 Safety and Efficacy for Cohort 1, Lowest Dose Level in ELIMINATE-B, a First-In-Human Trial of PBGENE-HBV for Chronic Hepatitis B

DURHAM, N.C.--(BUSINESS WIRE)--Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing ther...

Are there any hedging or short‑position opportunities based on the disclosed data? How might this affect the competitive landscape with other CRISPR/Cas‑based hepatitis B candidates? Does the release provide any insight into manufacturing scalability and cost of goods for the therapy?

Symbol: DTIL

20 days ago

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Janux Therapeutics Announces Clinical Milestone Achievement in TRACTr Collaboration With Merck

SAN DIEGO--(BUSINESS WIRE)---- $JANX--Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying it...

What is the estimated market size for the TRACTr therapy and its potential long‑term impact on Janux's valuation? What are the projected patient enrollment rates and trial size, and could any challenges in enrollment delay timelines? How will this clinical milestone be incorporated into Janux's revised earnings forecasts and revenue projections?

Symbol: JANX

21 days ago

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Butterfly Network Advances AI-Powered Aortic Valve and Aorta Screening with New Research and Training Tools

BURLINGTON, Mass. & NEW YORK--(BUSINESS WIRE)--Butterfly Network, Inc. (NYSE: BFLY), a digital health company transforming care with handheld, whole-body ultrasound and intuitive software, today an...

How does this AI‑driven capability compare to competitor offerings in terms of accuracy, workflow integration, and cost‑effectiveness? Will the new tools lead to increased device utilization and unit sales, thereby expanding the addressable market and market share? What potential reimbursement challenges exist for AI‑assisted aortic stenosis screening, and how might they impact profitability?

Symbol: BFLY

21 days ago

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Nuvation Bio To Present New Data on IBTROZI™ (taletrectinib) in Advanced ROS1-Positive Non-Small Cell Lung Cancer at WCLC and ESMO Annual Congresses

NEW YORK--(BUSINESS WIRE)--Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that new data will be p...

What are the anticipated pricing and reimbursement scenarios for IBTROZI™ if it receives approval? What are the key risk factors (e.g., safety concerns, enrollment delays) that could affect investor confidence? How will the results affect the valuation of NUVB relative to its peers (e.g., Incyte, Merck, Bristol‑Myers Squibb) in the oncology space?

Symbol: NUVB

21 days ago

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Harmony Biosciences Reports Strong Q2 2025 Financial Results and Reaffirms 2025 Revenue Guidance; On Track to Announce Fragile X Topline Data From Phase 3 Registrational Trial in Q3 2025

PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced plans to announce topline data from its phase 3 registrational clinical trial of ZYN002 in ...

How might the Q2 2025 WAKIX revenue growth influence the company's 2025 revenue guidance revisions? Will the company need to raise additional capital to fund commercialization of ZYN002, and what impact could that have on dilution? What is the competitive landscape for Fragile X treatments and how might ZYN002’s results position HRMY against peers?

Symbol: HRMY

21 days ago

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Cadrenal Therapeutics Announces Clinical Trial Initiation Plans for Tecarfarin in Patients with End-Stage Kidney Disease (ESKD) Transitioning to Dialysis

PONTE VEDRA, Fla.--(BUSINESS WIRE)---- $CVKD #AFib--Cadrenal announces clinical trial initiation plans for tecarfarin in patients with end-stage kidney disease (ESKD) who are transitioning to dialysis

How does the expected cost of the trial compare to previous clinical programs run by Cadrenal? Will the company’s cash runway be sufficient to fund the trial without diluting existing shareholders? What is the potential competitive landscape if Tecarfarin reaches the market—who are the main rivals?

Symbol: CVKD

21 days ago

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Vertex Announces Results from Phase 2 Study of VX-993 for the Treatment of Acute Pain

BOSTON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced topline results from its recently completed Phase 2, randomized, double-blind, placebo-controlled dose-ra...

How might the market’s perception of Vertex’s R&D capabilities change after this disclosure? What are the implications for Vertex's overall pipeline valuation given this setback? Could the results lead to a strategic partnership, licensing deal, or asset divestiture for Vertex?

Symbol: VRTX

22 days ago

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Lineage Announces Dosing of First Patient in New Clinical Study of OPC1 for Subacute and Chronic Spinal Cord Injury

CARLSBAD, Calif.--(BUSINESS WIRE)---- $LCTX #LineageCellTherapeutics--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel allogen...

What are the company’s projected costs for advancing the DOSED trial through Phase 2/3, and how will this affect runway and potential dilution? Are there any disclosed adverse events or safety signals from this first patient that could raise concerns among investors? What is the estimated market size for subacute and chronic spinal cord injury treatments, and what share can Lineage realistically capture if trials are successful?

Symbol: LCTX

22 days ago

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