QT interval

Olema Oncology Announces Promising New Data for Palazestrant in Combination with Ribociclib Presented at the 2024 ESMO Breast Cancer Congress

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星期三, 五月 15, 2024
Ribociclib, Half-life, Neutropenia, Pharmacokinetics, MTD, DNA, Plasma, Data, Toxicity, Index, Circulating tumor DNA, Safety, QT interval, Breast cancer, Neoplasm, Congress, Incidence, Partial, ESR1, Poster, Woman, Fatigue, CBR, Breast, Webcast, Pharmaceutical industry

These results, as of the data cut-off of March 13, 2024, will be presented on May 16, 2024, in a poster session at the 2024 ESMO Breast Cancer Annual Congress in Berlin, Germany (ESMO Breast).

Key Points: 
  • These results, as of the data cut-off of March 13, 2024, will be presented on May 16, 2024, in a poster session at the 2024 ESMO Breast Cancer Annual Congress in Berlin, Germany (ESMO Breast).
  • Palazestrant did not affect ribociclib drug exposure and ribociclib had no clinically meaningful effect on palazestrant drug exposure.
  • Findings from this study support the continued clinical development of palazestrant in combination with ribociclib for the first-line treatment of ER+/HER2- advanced or metastatic breast cancer.
  • Olema will host a webcast and conference call for analysts and investors to review the data being presented at ESMO Breast Cancer Annual Congress 2024 today, Wednesday, May 15, 2024, at 8:00 a.m.

Aptose Reports Results for the First Quarter 2024

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星期二, 五月 14, 2024
RAS, Patient, Prognosis, QT interval, Survival, FLT3, CPK, HMA, VEN, Venetoclax, Food, TUS, Letter, Exercise, FDA, Poster, TP53, SAN, Safety, APS, AML, EHA, Death, Drug resistance, European Hematology Association, SYK, TSX, KIT, Quality of life, Acute myeloid leukemia, Pharmaceutical industry

SAN DIEGO and TORONTO, May 14, 2024 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral targeted agents to treat hematologic malignancies, today announced financial results for the first quarter ended March 31, 2024.

Key Points: 
  • SAN DIEGO and TORONTO, May 14, 2024 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral targeted agents to treat hematologic malignancies, today announced financial results for the first quarter ended March 31, 2024.
  • Clinical sites are now preparing to open the TUS+VEN+HMA triplet study, which is expected to commence enrollment early next quarter.
  • Tuspetinib Preclinical Studies Elucidate Mechanistic Cooperativity Among TUS and VEN – Aptose continues to investigate the mechanisms underlying the complementary activity between TUS and VEN.
  • Aptose intends to submit a compliance plan on or before May 17, 2024, to monitor stockholders’ equity and, if appropriate, consider further available options to evidence compliance with the requirement.

Atea Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Business Update

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星期二, 五月 14, 2024
Plasma, SOC, Risk, FDA, Ageing, Electrocardiography, Week, Fast Track, HCV, Kinetics, RNA, Research, QRS, Standard of care, QT, Bemnifosbuvir, Patient, QT interval, Infection, Cardiotoxicity, SVR4, Security (finance), Second generation, Administration, COVID-19, Food, Clinical trial, Viral, Safety, Hospital, Viral load, SVR, Doctor of Philosophy, NS5A, EASL, BID, Heart rate, Tax, NS5B, Immunodeficiency, Death, Cirrhosis, PR, Development, Pharmaceutical industry

BOSTON, May 14, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today reported financial results for the first quarter ended March 31, 2024 and provided a business update.

Key Points: 
  • BOSTON, May 14, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today reported financial results for the first quarter ended March 31, 2024 and provided a business update.
  • Final results from the 60-patient lead-in cohort confirmed a 98% SVR4 rate across all genotypes from 58 of 59 patients.
  • Topline results from all patients enrolled in the Phase 2 study are anticipated in the second half of 2024.
  • In April 2024, Atea presented Phase 1 data showing that bemnifosbuvir does not alter cardiac repolarization.

Kura Oncology Reports First Quarter 2024 Financial Results

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星期四, 五月 2, 2024
FDA, Cancer, KURA, Investment, Venetoclax, HNSCC, Food, Prognosis, Research, Renal cell carcinoma, FTI, AML, Webcast, Disease, LDAC, Patient, Azacitidine, QT interval, BTD, Acute myeloid leukemia, FLT3, Head, Initiate, ID, Breakthrough therapy, Pharmaceutical industry

ET –

Key Points: 
  • ET –
    SAN DIEGO, May 02, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today reported first quarter 2024 financial results and provided a corporate update.
  • Research and development expenses for the first quarter of 2024 were $36.3 million, compared to $25.2 million for the first quarter of 2023.
  • General and administrative expenses for the first quarter of 2024 were $18.2 million, compared to $11.4 million for the first quarter of 2023.
  • ET / 1:30 p.m. PT today, May 2, 2024, to discuss the financial results for the first quarter 2024 and to provide a corporate update.

AstraZeneca caps patient out-of-pocket costs at $35 per month for its US inhaled respiratory portfolio

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星期一, 三月 18, 2024
Biotechnology, Medical Devices, Health, Pharmaceutical, Health Insurance, Diabetes, Blood pressure, Depression, Arrhythmia, Hypokalemia, ICS, Anaphylaxis, Angioedema, Congress, Moyamoya disease, AstraZeneca, MAOI, Hyperthyroidism, Risk, ECG, Incidence, Headache, Immunosuppression, Patient, QT interval, Chronic obstructive pulmonary disease, Inhalation, Chickenpox, Research, Budesonide, System, Liver, Cough, Rash, Infection, Salbutamol, Water, Cataract, Adrenal gland, Measles, Safety, Bronchospasm, COPD, Glaucoma, Use, Catherine Disher, Fatality, Monoamine oxidase inhibitor, Hypertension, Medicine, Pharmaceutical industry

AstraZeneca announced it will expand the savings programs for its entire US inhaled respiratory portfolio, helping eligible patients pay no more than $35 per month for their medicine.

Key Points: 
  • AstraZeneca announced it will expand the savings programs for its entire US inhaled respiratory portfolio, helping eligible patients pay no more than $35 per month for their medicine.
  • We remain dedicated to addressing the need for affordability of our medicines, but the system is complex and we cannot do it alone.
  • The Company will continue to provide discounts and rebates off the list price to help patients afford its inhaled respiratory medicines.
  • AstraZeneca remains dedicated to transforming patient outcomes, while ensuring access and affordability of our innovative medicines.

FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy

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星期四, 三月 21, 2024
Research, HDAC, Neurological disorder, Walking, Abdominal pain, Dietary supplement, Risk, Inflammation, Patient, QT interval, Public, Animal, Duchenne muscular dystrophy, Diarrhea, Food, Human services, Platelet, Facial muscles, Life expectancy, Heated tobacco product, Fever, Atrophy, Safety, Division, NSAA, Muscle weakness, Cosmetics, Vaccine, Multimedia, FDA, DMD, Muscular dystrophy, Triglyceride, Pharmaceutical industry

SILVER SPRING, Md., March 21, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older.

Key Points: 
  • SILVER SPRING, Md., March 21, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older.
  • Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD.
  • "This approval provides another treatment option to help reduce the burden of this progressive, devastating disease for individuals impacted by DMD regardless of genetic mutation."
  • DMD is the most common childhood form of muscular dystrophy and typically affects males.

Kura Oncology Reports Fourth Quarter and Full Year 2023 Financial Results

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星期二, 二月 27, 2024
NSCLC, Leukemia, Research, AML, Pedal, QT interval, FTI, Mirati Therapeutics, Investment, Postcholecystectomy syndrome, Physician, Clinical trial, ID, HRAS, Mirati, Prognosis, Renal cell carcinoma, FLT3, Webcast, Patient, KURA, Disease, G&A, LDAC, HNSCC, Cancer, Pharmaceutical industry

ET –

Key Points: 
  • ET –
    SAN DIEGO, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today reported fourth quarter and full year 2023 financial results and provided a corporate update.
  • Research and development (R&D) expenses for the fourth quarter of 2023 were $32.5 million, compared to $22.7 million for the fourth quarter of 2022.
  • General and administrative (G&A) expenses for the fourth quarter of 2023 were $14.2 million, compared to $12.5 million for the fourth quarter of 2022.
  • ET / 1:30 p.m. PT today, February 27, 2024, to discuss the financial results for the fourth quarter and full year 2023 and to provide a corporate update.

TAGRISSO® (osimertinib) demonstrated overwhelming efficacy benefit for patients with unresectable, Stage III EGFR-mutated lung cancer in LAURA Phase III trial

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星期一, 二月 19, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, NSCLC, Fever, Progression-free survival, PFS, AstraZeneca, Heart, Periodic breathing, QT interval, MD, Chemoradiotherapy, Cough, Pemetrexed, Winship Cancer Institute, QT, OS, Electrolyte, Cardiomyopathy, Lung cancer, Safety, Emory University, CRT, LAURA, ILD, Patient, LVEF, Brain, Pharmaceutical industry

In addition, TAGRISSO plus chemotherapy was recently approved in the US based on the FLAURA2 Phase III trial.

Key Points: 
  • In addition, TAGRISSO plus chemotherapy was recently approved in the US based on the FLAURA2 Phase III trial.
  • Interstitial lung disease (ILD)/pneumonitis occurred in 4% of the 1813 TAGRISSO-treated patients; 0.4% of cases were fatal.
  • TAGRISSO is the only targeted therapy to improve patient outcomes in both early-stage disease in the ADAURA Phase III trial and late-stage disease in the FLAURA Phase III trial and FLAURA2 Phase III trial .
  • AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

TAGRISSO® (osimertinib) with the addition of chemotherapy approved in the US for patients with EGFR-mutated advanced lung cancer

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星期六, 二月 17, 2024
Oncology, FDA, Health, General Health, Pharmaceutical, Biotechnology, Heart, QT interval, Food, Pemetrexed, Risk, Cardiomyopathy, Electrolyte, Death, Patient, LVEF, Priority review, Pharmaceutical industry

This approval reinforces TAGRISSO as the backbone of EGFR-mutated lung cancer treatment either as monotherapy or in combination with chemotherapy.

Key Points: 
  • This approval reinforces TAGRISSO as the backbone of EGFR-mutated lung cancer treatment either as monotherapy or in combination with chemotherapy.
  • The safety profile of TAGRISSO with the addition of chemotherapy was generally manageable and consistent with the established profiles of the individual medicines.
  • Adverse event (AE) rates were higher in the TAGRISSO plus chemotherapy arm, driven by well-characterized chemotherapy-related AEs.
  • AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

Kura Oncology Reports Positive Preliminary Ziftomenib Combination Data in Acute Myeloid Leukemia

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星期二, 一月 30, 2024
KURA, Failure, Acute myeloid leukemia, Venetoclax, Research, Division, MHS, Patient, Safety, QT interval, AML, Bone marrow, MBBS, QD, Yale Cancer Center, Disease, Therapy, Postcholecystectomy syndrome, Risk, ID, Cancer, Kura, Pharmaceutical industry

Continuous daily dosing of ziftomenib at 200 mg QD has been well tolerated and the safety profile consistent with features of underlying disease and backbone therapies.

Key Points: 
  • Continuous daily dosing of ziftomenib at 200 mg QD has been well tolerated and the safety profile consistent with features of underlying disease and backbone therapies.
  • The overall response rate (ORR) among R/R patients treated with ziftomenib and ven/aza was 53% (8/15).
  • As of the data cutoff, 80% (16/20) of patients remain on trial, including 100% (11/11) of all NPM1-m patients.
  • “We are highly encouraged by these preliminary combination data for ziftomenib and believe they support advancement into the frontline AML population,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology.