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Mon, Aug 17
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REGULATORY & CLINICAL>CLINICAL TRIAL

40 headlines · 20260817
BENZINGA20:012h agobearish

Amylyx Pharmaceuticals To Announce Phase 3 LUCIDITY Trial Topline Results For Avexitide In Post-Bariatric Hypoglycemia On August 18 At 8:00 a.m. ET

Amylyx Pharmaceuticals To Announce Phase 3 LUCIDITY Trial Topline Results For Avexitide In Post-Bariatric Hypoglycemia On August 18 At 8:00 a.m. ET | 4:01 PM EDT, August 17, 2026 (Benzinga Newswire) Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") will announce topline results…
REGULATORY & CLINICAL / CLINICAL TRIAL
BUSINESS_WIRE20:012h agobullish

Amylyx Pharmaceuticals to Announce Topline Results from its Phase 3 LUCIDITY Clinical Trial of Avexitide in Post-Bariatric Hypoglycemia on August 18, 2026

Amylyx Pharmaceuticals to Announce Topline Results from its Phase 3 LUCIDITY Clinical Trial of Avexitide in Post-Bariatric Hypoglycemia on August 18, 2026 | CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) will announce topline results from…
REGULATORY & CLINICAL / CLINICAL TRIAL
BUSINESS_WIRE19:442h agobullish

Nanochon Receives Regulatory Approval from Panamá’s Ministry of Health to Initiate First-in-Human Clinical Study of Chondrograft™

Nanochon Receives Regulatory Approval from Panamá’s Ministry of Health to Initiate First-in-Human Clinical Study of Chondrograft™ | WASHINGTON--(BUSINESS WIRE)-- Nanochon, a medical device company developing Chondrograft™, a novel patented implant for the treatment of articular cartilage defects of…
REGULATORY & CLINICAL / CLINICAL TRIALREGULATORY & CLINICAL / FDA/APPROVALREGULATORY & CLINICAL / REGULATORY
DOW_JONES15:167h agobearish

EyePoint Stock Craters 71% After Drug Trial Failure. It May Be an Overreaction.

EyePoint Stock Craters 71% After Drug Trial Failure. It May Be an Overreaction. | EyePoint's experimental treatment for an advanced eye disease yielded what management called "clinically meaningful results" in a late-stage trial. Shares were pacing toward their worst day on record anyway. The small…
REGULATORY & CLINICAL / CLINICAL TRIAL
BUSINESS_WIRE14:447h agobullish

iGov Technologies Selected to Advance to Phase 2 of U.S. Marine Corps EWGIR Prototype Program

iGov Technologies Selected to Advance to Phase 2 of U.S. Marine Corps EWGIR Prototype Program | TAMPA, Fla.--(BUSINESS WIRE)-- iGov Technologies, Inc., a leading provider of advanced federal tactical communications solutions, has been selected to advance to Phase 2 of the U.S. Marine Corps’ Electro…
REGULATORY & CLINICAL / CLINICAL TRIAL
BENZINGA13:229h agobullish

Argenx’s Next Blockbuster? Stock Jumps 12% After Phase 3 Myositis Trial Hits Key Goal

Argenx’s Next Blockbuster? Stock Jumps 12% After Phase 3 Myositis Trial Hits Key Goal | 9:22 AM EDT, August 17, 2026 (Benzinga Newswire) Argenx SE (NASDAQ:ARGX) stock jumped about 12% in Monday’s premarket trading after the company reported positive topline results from its Phase 3 ALKIVIA study. T…
REGULATORY & CLINICAL / CLINICAL TRIAL
BENZINGA13:199h agobearish

Galmed Pharmaceuticals Announces Results From Pre-Clinical Study Of Combination Of Aramchol And Xtandi For Prostatic Cancer; New Data Demonstrated That A Combination Of Aramchol With Enzalutamide Resulted In Three- To Four-Fold Increase In Cell Death Compared With Enzalutamide As A Single Agent

Galmed Pharmaceuticals Announces Results From Pre-Clinical Study Of Combination Of Aramchol And Xtandi For Prostatic Cancer; New Data Demonstrated That A Combination Of Aramchol With Enzalutamide Resulted In Three- To Four-Fold Increase In Cell Death Compared With Enzalutamide As A Single Agent | 9…
REGULATORY & CLINICAL / CLINICAL TRIAL
PR_NEWS_WIRE13:009h agobullish

Leal Therapeutics Announces $30 Million Series A Extension and Initiation of Phase 1b/2a Clinical Trial of LTX-001 in Schizophrenia

Leal Therapeutics Announces $30 Million Series A Extension and Initiation of Phase 1b/2a Clinical Trial of LTX-001 in Schizophrenia | Phase 1b/2a clinical trial assessing safety and efficacy of LTX-001 in adults with schizophrenia initiated Financing advances LTX-001 through initial readout from Ph…
REGULATORY & CLINICAL / CLINICAL TRIAL
PR_NEWS_WIRE13:009h agobullish

Connext Completes Enrollment in Phase 2 Trial of CNT201 in Dupuytren's Contracture

Connext Completes Enrollment in Phase 2 Trial of CNT201 in Dupuytren's Contracture | - All 56 planned participants enrolled approximately five months after first patient dosing - Topline Phase 2 data expected in late 2026 - Positive data could support expansion of CNT201 into Peyronie's disease and…
REGULATORY & CLINICAL / CLINICAL TRIAL
BENZINGA12:569h agobullish

Artelo Biosciences Says USPTO Issues Notice Of Allowance For U.S. Patent Application Covering Intended Commercial Formulation Of ART27.13, Peripherally Selective Cannabinoid Agonist Currently In Phase 2 Studies

Artelo Biosciences Says USPTO Issues Notice Of Allowance For U.S. Patent Application Covering Intended Commercial Formulation Of ART27.13, Peripherally Selective Cannabinoid Agonist Currently In Phase 2 Studies | 8:56 AM EDT, August 17, 2026 (Benzinga Newswire) The Patent Claims are for the Intende…
REGULATORY & CLINICAL / CLINICAL TRIAL
GLOBE_NEWS_WIRE12:529h agobullish

Artelo Biosciences Receives a Notice of Allowance from the U.S. Patent and Trademark Office for its Lead Investigational Drug Currently in Two Phase 2 Studies

Artelo Biosciences Receives a Notice of Allowance from the U.S. Patent and Trademark Office for its Lead Investigational Drug Currently in Two Phase 2 Studies | The Patent Claims are for the Intended Commercial Formulation of ART27.13 Expected to Extend Patent Protection for ART27.13 through 2041 S…
REGULATORY & CLINICAL / CLINICAL TRIAL
BENZINGA12:439h ago

EyePoint shares are trading lower after the company announced topline results from LUGANO, the first pivotal Phase 3 clinical trial for DURAVYU. The primary endpoint of change from baseline in best corrected visual acuity versus 2 mg aflibercept on-label control was not achieved in the full dataset.

EyePoint shares are trading lower after the company announced topline results from LUGANO, the first pivotal Phase 3 clinical trial for DURAVYU. The primary endpoint of change from baseline in best corrected visual acuity versus 2 mg aflibercept on-label control was not achieved in the full dataset…
REGULATORY & CLINICAL / CLINICAL TRIAL
MIDNIGHT_TRADER11:5710h agobearish

EyePoint Misses Primary Goal in Phase 3 Wet AMD Trial of Duravyu; Shares Drop Pre-Bell

EyePoint Misses Primary Goal in Phase 3 Wet AMD Trial of Duravyu; Shares Drop Pre-Bell | 07:57 AM EDT, 08/17/2026 (MT Newswires) -- EyePoint (EYPT) said Monday its Phase 3 Lugano trial testing Duravyu in patients with wet age-related macular degeneration failed to achieve its primary endpoint. The…
REGULATORY & CLINICAL / CLINICAL TRIAL
MIDNIGHT_TRADER11:4111h agobullish

United Therapeutics Completes Enrollment in Phase 3 PPF Trial of Tyvaso

United Therapeutics Completes Enrollment in Phase 3 PPF Trial of Tyvaso | 07:41 AM EDT, 08/17/2026 (MT Newswires) -- United Therapeutics (UTHR) said Monday that its Phase 3 TETON-PPF study evaluating nebulized Tyvaso in patients with progressive pulmonary fibrosis has fully enrolled 754 participant…
REGULATORY & CLINICAL / CLINICAL TRIAL
BENZINGA11:3911h agobullish

AstraZeneca And Daiichi Sankyo Report DESTINY‑Lung04 Phase III Trial Results; ENHERTU Improves Progression‑Free Survival Versus Standard Of Care In HER2‑Mutant NSCLC

AstraZeneca And Daiichi Sankyo Report DESTINY‑Lung04 Phase III Trial Results; ENHERTU Improves Progression‑Free Survival Versus Standard Of Care In HER2‑Mutant NSCLC | 7:39 AM EDT, August 17, 2026 (Benzinga Newswire) AstraZeneca and Daiichi Sankyo’s ENHERTU is the first and only HER2-directed medic…
REGULATORY & CLINICAL / CLINICAL TRIAL
BENZINGA11:3611h agobullish

Radiopharm Theranostics Schedules An FDA End-Of-Phase 2 For October 1, 2026, To Align On The Design Of A Pivotal Phase 3 Trial To Evaluate RAD101 In Patients With Suspected Recurrence Of Brain Metastases Following Radiotherapy

Radiopharm Theranostics Schedules An FDA End-Of-Phase 2 For October 1, 2026, To Align On The Design Of A Pivotal Phase 3 Trial To Evaluate RAD101 In Patients With Suspected Recurrence Of Brain Metastases Following Radiotherapy | 7:36 AM EDT, August 17, 2026 (Benzinga Newswire) RAD101 is the Company…
REGULATORY & CLINICAL / CLINICAL TRIALREGULATORY & CLINICAL / FDA/APPROVAL
GLOBE_NEWS_WIRE11:3011h agobullish

Radiopharm Theranostics To Meet with U.S. FDA to Align on Pivotal Phase 3 Trial Design for RAD 101 in Diagnosis of Brain Metastases

Radiopharm Theranostics To Meet with U.S. FDA to Align on Pivotal Phase 3 Trial Design for RAD 101 in Diagnosis of Brain Metastases | RAD 101 Phase 2b trial demonstrated 93% concordance with MRI across all evaluable lesions, meeting the Phase 2 trial's primary endpoint End-of-Phase 2 meeting with t…
REGULATORY & CLINICAL / CLINICAL TRIALREGULATORY & CLINICAL / FDA/APPROVAL
BUSINESS_WIRE11:3011h agobearish

ENHERTU® (fam-trastuzumab deruxtecan-nxki) demonstrated statistically significant and clinically meaningful improvement in PFS as 1st-line treatment of patients with HER2-mutant advanced non-small cell lung cancer in DESTINY-Lung04 Phase III trial

ENHERTU® (fam-trastuzumab deruxtecan-nxki) demonstrated statistically significant and clinically meaningful improvement in PFS as 1st-line treatment of patients with HER2-mutant advanced non-small cell lung cancer in DESTINY-Lung04 Phase III trial | AstraZeneca and Daiichi Sankyo’s ENHERTU is the f…
REGULATORY & CLINICAL / CLINICAL TRIAL
BENZINGA11:1011h agobullish

AstraZeneca And HUTCHMED’s Savolitinib, In Combination With TAGRISSO, Delivers Significant Survival Benefits In SAFFRON Phase III EGFRm Lung Cancer Trial

AstraZeneca And HUTCHMED’s Savolitinib, In Combination With TAGRISSO, Delivers Significant Survival Benefits In SAFFRON Phase III EGFRm Lung Cancer Trial | 7:10 AM EDT, August 17, 2026 (Benzinga Newswire) First global Phase III trial to show significant progression-free and overall survival benefit…
REGULATORY & CLINICAL / CLINICAL TRIAL
BENZINGA11:0411h agobullish

EyePoint Announces Topline Results From LUGANO, First Pivotal Phase 3 Clinical Trial For DURAVYU For Treatment Of Wet Age-Related Macular Degeneration

EyePoint Announces Topline Results From LUGANO, First Pivotal Phase 3 Clinical Trial For DURAVYU For Treatment Of Wet Age-Related Macular Degeneration | 7:04 AM EDT, August 17, 2026 (Benzinga Newswire) – DURAVYU was non-inferior to on-label aflibercept control (nominal p-value = 0.0096) in an ad ho…
REGULATORY & CLINICAL / CLINICAL TRIAL
GLOBE_NEWS_WIRE11:0011h agobullish

EyePoint Announces Topline Data from LUGANO, the First of Two Pivotal Phase 3 Clinical Trials for DURAVYU™ 2.7mg in Wet AMD

EyePoint Announces Topline Data from LUGANO, the First of Two Pivotal Phase 3 Clinical Trials for DURAVYU™ 2.7mg in Wet AMD | – DURAVYU was non-inferior to on-label aflibercept control (nominal p-value = 0.0096) in an ad hoc analysis excluding a 4% asymmetric cohort (9 of 211 patients) who experien…
REGULATORY & CLINICAL / CLINICAL TRIAL
MIDNIGHT_TRADER09:0113h agobullish

Update: argenx Says Autoimmune Myositis Drug Meets Main Goal in Phase 3 Study

Update: argenx Says Autoimmune Myositis Drug Meets Main Goal in Phase 3 Study | 05:01 AM EDT, 08/17/2026 (MT Newswires) -- (Updates with reporting date in the first paragraph and the latest stock move in the last paragraph) argenx (ARGX) said Monday a phase 3 study evaluating its experimental drug,…
REGULATORY & CLINICAL / CLINICAL TRIAL
MIDNIGHT_TRADER08:2514h agobullish

argenx Says Autoimmune Myositis Drug Meets Main Goal in Phase 3 Study

argenx Says Autoimmune Myositis Drug Meets Main Goal in Phase 3 Study | 04:25 AM EDT, 08/17/2026 (MT Newswires) -- argenx (ARGX) said a phase 3 study evaluating its experimental drug, Vyvgart Hytrulo, in adults with autoimmune myositis met main goal. The company said the patients treated with the d…
REGULATORY & CLINICAL / CLINICAL TRIAL
MIDNIGHT_TRADER08:1314h agobearish

Mesoblast Completes Patient Treatment in Phase 3 Trial of Chronic Low Back Pain

Mesoblast Completes Patient Treatment in Phase 3 Trial of Chronic Low Back Pain | 04:13 AM EDT, 08/17/2026 (MT Newswires) -- Mesoblast (MESO) said Sunday it has completed patient treatment in a phase 3 trial of its experimental rexlemestrocel-L for chronic low back pain associated with degenerative…
REGULATORY & CLINICAL / CLINICAL TRIAL
MIDNIGHT_TRADER07:3515h agobearish

AstraZeneca Discontinues Phase 3 Lung Cancer Trial for Volrustomig Combination

AstraZeneca Discontinues Phase 3 Lung Cancer Trial for Volrustomig Combination | 03:35 AM EDT, 08/17/2026 (MT Newswires) -- AstraZeneca (AZN) is stopping a phase 3 trial evaluating volrustomig in combination with chemotherapy for patients with metastatic non-small cell lung cancer, the company said…
REGULATORY & CLINICAL / CLINICAL TRIAL
BENZINGA06:5415h agobullish

Daiichi Sankyo And AstraZeneca's Enhertu Shows Significant PFS Improvement As First-Line HER2 Mutant NSCLC Treatment In DESTINY-Lung04 Phase 3 Trial

Daiichi Sankyo And AstraZeneca's Enhertu Shows Significant PFS Improvement As First-Line HER2 Mutant NSCLC Treatment In DESTINY-Lung04 Phase 3 Trial | 2:54 AM EDT, August 17, 2026 (Benzinga Newswire) Daiichi Sankyo and AstraZeneca’s Enhertu is the first and only HER2 directed medicine to improve pr…
REGULATORY & CLINICAL / CLINICAL TRIAL
BUSINESS_WIRE06:3016h agobullish

Enhertu® Demonstrated Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival as First-Line Treatment of Patients with HER2 Mutant Advanced Non-Small Cell Lung Cancer in DESTINY-Lung04 Phase 3 Trial

Enhertu® Demonstrated Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival as First-Line Treatment of Patients with HER2 Mutant Advanced Non-Small Cell Lung Cancer in DESTINY-Lung04 Phase 3 Trial | Daiichi Sankyo and AstraZeneca’s Enhertu is the first and onl…
REGULATORY & CLINICAL / CLINICAL TRIAL
BENZINGA05:2217h agobullish

Argenx's Efgartigimod Becomes First Phase 3 Therapy To Show Statistically Significant, Clinically Meaningful Improvement In IMNM, A Subtype With No Approved Treatment

Argenx's Efgartigimod Becomes First Phase 3 Therapy To Show Statistically Significant, Clinically Meaningful Improvement In IMNM, A Subtype With No Approved Treatment | 1:22 AM EDT, August 17, 2026 (Benzinga Newswire) Study met primary endpoint of mean Total Improvement Score (TIS) at Week 52 in th…
REGULATORY & CLINICAL / CLINICAL TRIALREGULATORY & CLINICAL / FDA/APPROVAL