Clinical Trials News - Candlesense

Spinogenix Announces Positive First Cohort Results from Phase 2a Trial Evaluating SPG302 for Alzheimer's Disease

SPG302, a Potential First-in-Class Synaptic Regenerative Therapy, Showed Progress in Cognitive Outcome Measures and a Favorable Safety Profile LOS ANGELES, Calif., Aug. 7, 2025 /PRNewswire/ -- Spin...

Could the data trigger insider trading activity, warrant exercises, or other capital‑structure events that traders should monitor? How will the trial results affect the company’s cash runway and need for additional financing or equity raises? What is the projected market size for a first‑in‑class synaptic regenerative therapy in Alzheimer’s disease and potential revenue upside?

Symbol: SGIX

17 days ago

SELLAS Life Sciences Announces Independent Data Monitoring Committee Periodic Review and Positive Recommendation to Continue Pivotal Phase 3 REGAL Trial of GPS in AML Without Modification

- Final Analysis Anticipated by Year-End Upon Occurrence of 80 Events -

Symbol: SELLAS

17 days ago

Cybin Receives European Approval for EMBRACE, a Multinational Phase 3 Study Evaluating CYB003 for the Adjunctive Treatment of Major Depressive Disorder

TORONTO--(BUSINESS WIRE)--Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage breakthrough neuropsychiatry company committed to advancing mental healthcare b...

What is the potential upside in market share and revenue if CYB003 receives approval for adjunctive treatment of major depressive disorder? How does CYBIN’s adjunctive MDD therapy prospectus compare to existing standard‑of‑care treatments and to other pipeline candidates in the neuropsychiatry space? Are there any known safety or efficacy signals from earlier Phase 2 data on CYB003 that could influence investor sentiment?

Symbol: CYBN

17 days ago

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REGENXBIO Announces Pivotal Program for Surabgene Lomparvovec in Diabetic Retinopathy

A pivotal Phase IIb/III clinical trial using suprachoroidal delivery for treatment of diabetic retinopathy will be initiated New Phase II ALTITUDE® trial data demonstrate a durable safety and effic...

What are the potential upside and downside scenarios for RGNX based on the upcoming pivotal trial outcomes? How does the suprachoroidal delivery platform differentiate RGNX from other gene‑therapy companies pursuing ocular indications? What is the likely impact on RGNX's valuation multiples (e.g., EV/Revenue, P/E) if the trial meets its primary endpoints?

Symbol: RGNX

17 days ago

Lilly's oral GLP-1, orforglipron, delivers weight loss of up to an average of 27.3 lbs in first of two pivotal Phase 3 trials in adults with obesity

In ATTAIN-1, the investigational once-daily oral pill showed significant efficacy, and a safety and tolerability profile consistent with injectable GLP-1 therapies at 72 weeks Orforglipron achieved...

How sensitive is the stock to any upcoming data releases or updates from the ATTAIN‑2 trial? What potential partnership or licensing opportunities could arise from this oral GLP‑1 platform? Could the oral formulation create a competitive advantage in patient adherence versus injectables?

Symbol: LLY

17 days ago

Tenaya Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update

Enrollment Complete in Cohorts 1 and 2 of MyPEAK™-1 Phase 1b/2 Trial of TN-201 for MYBPC3-associated HCM; Positive DSMB Safety Review Enables Enrollment of Expansion Cohorts

What are the potential risks and uncertainties associated with the trial's statistical endpoints and patient enrollment timelines? How will the new data influence analyst coverage, consensus estimates, and target price adjustments for TENX? What potential partnership, licensing, or acquisition opportunities could arise from positive safety data and what are the market expectations for those deals?

Symbol: TENX

18 days ago

CareDx Announces Landmark KOAR Study Published in the American Journal of Transplantation

BRISBANE, Calif.--(BUSINESS WIRE)--CareDx, Inc. (Nasdaq: CDNA), — The Transplant Company™ — a leading precision medicine company focused on the discovery, development, and commercialization of clin...

How might the KOAR study influence investor sentiment ahead of upcoming earnings releases or conference presentations? Will the KOAR results lead to updates in guidance or recommendations from transplant societies, potentially increasing adoption rates? What is the anticipated impact of the KOAR study on CareDx's earnings forecasts for the next 12‑24 months?

Symbol: CDNA

18 days ago

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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

18 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

18 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

18 days ago

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