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EXPLAINED: 15 - The Real Truth

Dyne's Shares Gain After FDA Removed Clinical Hold On Muscular Disease Study

Dyne Therapeutics (NASDAQ: DYN) announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold and cleared its Investigational New Drug (IND) application to initiate a clinical trial of its drug DYNE-25.

Benzinga

Clinical trial into potential cancer vaccine 'shows early promising results'

The vaccine, which has been codenamed TG4050, uses similar technology to that of the coronavirus jabs.

Daily Record

Edinburgh mum's persistent cough turned out to be advanced breast cancer

Lesley Stephen was diagnosed with incurable secondary breast cancer in 2014 and just as she thought her time was coming to an end, she found a 'miracle' in a patient trial.

Edinburgh Live

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Indian-origin woman gets cancer-free following drug trial in UK

Miracles happen when science progresses! Jasmin David, a 51-year-old Indian-origin woman from Manchester, was given just months to live a few years ago due to breast cancer. Now, doctors have declared that she is showing no evidence of cancer, after undergoing a clinical trial at a UK hospital.

The Times of India

Woman given one year to live is now cancer-free after experimental treatment

Jasmin David took part in a clinical trial with experimental medicines

The Independent UK

Meet the NI woman aiming to improve lives of cancer patients with innovative technology

The technology is preparing for its first human clinical trial

Belfast Live

Global Primordium prostate cancer trial begins with Bundaberg man the first participant

When John Adams' cancer resurfaced last year, he thought he would have to travel hundreds of kilometres for treatment. But with promising early results, an Australian-first clinical trial is allowing him to receive care from the comfort of his home.

ABC News

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NeuroSense Shares Surge On Encouraging Data From Alzheimer's-Associated Biomarker Study

NeuroSense Therapeutics Ltd (NASDAQ:NRSN) has announced results from a biomarker study to evaluate the potential of CogniC, a combination drug for Alzheimer's disease (AD). Earlier this week, NeuroSense reported results from a stage III ALS Biomarker study evaluating PrimeC. Preliminary results showed that levels of disease-related biomarkers in people with ALS were unchanged, in contrast…

Benzinga

Corcept Therapeutics Commences Late-Stage Ovarian Cancer Study

Corcept Therapeutics (NASDAQ: CORT) has initiated pivotal Phase 3 clinical trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer.

Benzinga

FDA Green Lights Ceruvia's Phase 2 Psilocybin Trial Program For Obsessive-Compulsive Disorder Treatment

Clinical-stage biopharma company Ceruvia Lifesciences recently received FDA approval for its Investigational New Drug (IND) application for a Phase 2 clinical trial to determine the efficacy and safety of proprietary synthetic psilocybin (SYNP-101) in treating obsessive-compulsive disorder (OCD).&nbs

Benzinga

Revive Therapeutics Data Access Plan Approved By The FDA; Partial Unblinded Data In Company Hands

Revive Therapeutics Ltd. (OTC: RVVTF) moved closer towards potential endpoint change in their Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine to treat COVID-19.

Benzinga

Oyster Point Outlines Restructuring Plan With Savings Of Up To $48M In 2023

Oyster Point Pharma Inc (NASDAQ:OYST) will implement an operating expense streamlining plan to reduce employee and non-employee expenses (up to 50 roles) across the organization. The company plans to continue to drive the launch of Tyrvaya with approximately 150-200 field-based sales resources. The plan is expected to reduce operating expenses by approximately $6…

Benzinga

Jazz Pharmaceuticals' Late-Stage Multiple Sclerosis Study Misses Primary Endpoint

Jazz Pharmaceuticals (NASDAQ: JAZZ) announced top-line results from the Phase 3 clinical trial investigating nabiximols oromucosal spray (JZP378) on clinical measures of spasticity in individuals with multiple sclerosis (MS).

Benzinga

Soligenix Gets FDA Nod For Mid-Stage Psoriasis Study

The U.S. Food and Drug Administration (FDA) has cleared Soligenix’s (NASDAQ: SNGX) Investigational New Drug (IND) application for Phase 2a clinical trial Evaluating SGX302 in the treatment of patients with Mild-to-Moderate Psoriasis.

Benzinga

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Benzinga

Why Kezar Life Sciences Stock Is Soaring Today

Kezar Life Sciences Inc (NASDAQ: KZR) shares are surging Tuesday after the company announced topline results from the MISSION Phase 2 clinical trial evaluating zetomipzomib.

Benzinga

Cybin's Psilocybin Analog CYB003 Gets FDA Clearance For Trial To Potentially Treat Major Depressive Disorder

Psychedelic biopharma company Cybin Inc. (NEO: CYBN) has received FDA Investigational New Drug Application (IND) approval for a Phase 1/2a clinical trial evaluating its proprietary CYB003 for treating major depressive disorder (MDD).

Benzinga

Why Is Kezar Life Sciences Surging By 78%? 25 Stocks Moving In Tuesday's Pre-Market Session

Gainers Kezar Life Sciences, Inc. (NASDAQ: KZR) rose 78% to $10.29 in pre-market trading after the company reported positive topline results from the MISSION Phase 2 clinical trial evaluating zetomipzomib in patients with active lupus nephritis (LN).

Benzinga

Kezar Life Shares Shoot Higher After Positive Results From Mid-Stage Study Of Kidney Disease Candidate

Kezar Life Sciences, Inc. (NASDAQ: KZR) reported positive topline results from the MISSION Phase 2 clinical trial evaluating zetomipzomib in patients with active lupus nephritis (LN).

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Benzinga

After-Hours Action: Why Kezar Life Sciences Stock Is Soaring

Kezar Life Sciences Inc (NASDAQ: KZR) shares are surging in Monday's after-hours session after the company announced topline results from the MISSION Phase 2 clinical trial evaluating zetomipzomib.

Daily Mirror

Covid vaccines saved 20 million lives in year - but slow rollout saw 600k die

Almost two-thirds of the world's population has now received at least one dose since the first Covid-19 vaccine was administered outside of a clinical trial

Benzinga

Calithera Commences Mid-Stage Study Of DLBCL Candidate

Calithera Biosciences, Inc. (NASDAQ: CALA) initiates dosing first patient in the phase 2 clinical trial evaluating its spleen tyrosine kinase (SYK) inhibitor mivavotinib (CB-659) in patients with relapsed/refractory non-germinal center B-cell like (non-GCB) diffuse large B-cell lymphoma (DLBCL).

Benzinga

UniQure Shares Are Up After Low-Dose Cohort Data From Huntington's Gene Therapy Trial

UniQure N.V. (NASDAQ:QURE) announced safety and biomarker data from 10 patients enrolled in the low-dose cohort of the ongoing Phase 1/2 trial of AMT-130 gene therapy for Huntington's disease. Six of the ten enrolled patients received AMT-130, and four received an imitation surgical procedure in this randomized, blinded clinical trial in the U.S.…

Benzinga

Evaxion Biotech To Test EVX-03 DNA Vaccine For Non-Small Cell Lung Cancer

Evaxion Biotech A/S (NASDAQ:EVAX) has selected EVX-03 as the product candidate within its DNA technology platform to target a new indication with planned regulatory filing in H2 2022. We currently have two product candidates in the DNA technology platform, EVX-02, and EVX-03. Based on preclinical results, the company has decided to move EVX-03…

Benzinga

Rockwell Medical Receives Additional FDA Feedback On Anemia Candidate

Last week, Rockwell Medical Inc (NASDAQ:RMTI) closed the second $7.5 million tranche of the previously announced DaVita Inc (NYSE:DVA) stock purchase agreement of up to $15 million in convertible preferred stock in two tranches. This investment, in addition to the recently announced $15 million financings, brings the total gross amount raised by Rockwell this quarter to $30 million. …

Benzinga

Biomea Fusion Commences Initial-Stage Study For Plasma Cell Cancer Setting

Biomea Fusion (NASDAQ: BMEA) has dosed the the first patient in the multiple myeloma (MM) cohort of the Phase I clinical trial evaluating BMF-219, a covalent menin inhibitor. Multiple myeloma (MM) is a cancer of plasma cells, which make antibodies (immunoglobulins) and are mainly located in the bone marrow.

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