SUSAR

Inventiva reports its 2023 full-year results

Retrieved on: 
Wednesday, March 27, 2024
DSM-IV codes, NMPA, Acceleration, Partnership, Patient, Income tax, G&A, BofA Securities, MASH, Equity, SUSAR, IND, Marketing, Bank statement, IRB, Clinical trial, Investigational New Drug, European Investment Bank, Fatty liver disease, Type 2 diabetes, T2D, Euronext Paris, EIB, Phase, Optimism, NAFLD, Sino Biopharmaceutical Limited, Pharmaceutical industry

Frédéric Cren, Chairman, CEO and cofounder of Inventiva, stated: “Inventiva achieved several clinical and financial milestones in 2023.

Key Points: 
  • Frédéric Cren, Chairman, CEO and cofounder of Inventiva, stated: “Inventiva achieved several clinical and financial milestones in 2023.
  • R&D expenses for the fiscal year ended December 31, 2023, amounted to (€110.0) million compared to (€60.5) million in 2022.
  • Net financial income was (€5.1) million for the fiscal year ended December 31, 2023, compared to €2.8 million in 2022.
  • Income tax amounted to (€0.6) million for the 2023 fiscal year, compared to €0 million for 2022.

Inventiva announces that screening in the NATiV3, Phase III, clinical trial evaluating lanifibranor in NASH has resumed

Retrieved on: 
Thursday, March 7, 2024
Data monitoring committee, SUSAR, DMC, Adverse effect, IRB, Fatty liver disease, Patient, United, NASH, ICF, Euronext Paris

Inventiva has lifted the voluntary pause on screening and randomization in the NATiV3 clinical trial following the approval from the US central IRB of the amended protocol and ICF.

Key Points: 
  • Inventiva has lifted the voluntary pause on screening and randomization in the NATiV3 clinical trial following the approval from the US central IRB of the amended protocol and ICF.
  • Other sites and countries are expected to resume screening and randomization activities progressively over the next weeks.
  • Clinical sites located in the United States operating under central IRB have meanwhile resumed screening and randomization activities.
  • Inventiva anticipates the last patient first visit for the NATiV3 clinical trial in the first half of 2024.

Inventiva reports preliminary 2023 fiscal year financial Information¹ and provides an update on its clinical trial NATiV3

Retrieved on: 
Thursday, February 15, 2024
LEGEND, Investigational New Drug, EIB, Data monitoring committee, European Investment Bank, SUSAR, BofA Securities, DMC, Adverse effect, Conference, Autoimmune hepatitis, Observation, Type 2 diabetes, DSM-IV codes, Patient, Fatty liver disease, Acceleration, Clinical trial, NASH, Phase, IND, NMPA, Euronext Paris, Sino Biopharmaceutical Limited, Partnership, Pharmaceutical industry

Frédéric Cren, Chairman, Chief Executive Officer and cofounder of Inventiva, stated: “2023 has been an eventful year for the company.

Key Points: 
  • Frédéric Cren, Chairman, Chief Executive Officer and cofounder of Inventiva, stated: “2023 has been an eventful year for the company.
  • This allowed us to draw down the second tranche of €25 million of the €50 million EIB loan in January 2024.
  • We have advanced our pivotal NATiV3 Phase III clinical trial with lanifibranor in NASH after the implementation of the revised study design in early 2023, with 913 patients randomized to date.
  • An adverse event of elevated aminotransferases has been reported in a patient enrolled in the trial following a scheduled visit.

Investigator-initiated Phase 1/2 Clinical Trial Using Salarius Pharmaceuticals’ Seclidemstat in Combination with Azacitidine to Treat Hematologic Cancers Resumes Patient Enrollment

Retrieved on: 
Wednesday, January 3, 2024
DCR, LSD1, SUSAR, Database, Canaccord Genuity, Food, Survival, Learning, Cyclophosphamide, Chronic myelomonocytic leukemia, Probability, Bone marrow, FDA, TC, Progression-free survival, Myelodysplastic syndrome, CMML, MD, MDS, Clinical trial, Monroe Dunaway Anderson, University, Azacitidine, Effectiveness, MD Anderson Cancer Center, Sarcoma, Patient, Ewing sarcoma, Pharmaceutical industry

While these efforts are ongoing, the Company continues to support the continuation of its clinical programs, as appropriate.

Key Points: 
  • While these efforts are ongoing, the Company continues to support the continuation of its clinical programs, as appropriate.
  • In October 2022, the FDA placed the MDACC investigator-initiated trial under a partial clinical hold following a suspected unexpected serious adverse reaction (SUSAR) in the FET-rearranged arm of Salarius’ Phase 1/2 trial with seclidemstat in sarcomas.
  • In addition to the MDACC investigator-initiated clinical trial, seclidemstat has been studied in a company-sponsored Phase 1/2 clinical trial evaluating its use in combination with TC for the treatment of relapsed/refractory Ewing sarcoma.
  • The Company-sponsored Ewing sarcoma clinical trial focuses on seclidemstat in combination with TC as a treatment for relapsed and refractory Ewing sarcoma.

Chinook Therapeutics Announces Voluntary Pause in Dosing of CHK-336 in Ongoing Phase 1 Clinical Trial in Healthy Volunteers

Retrieved on: 
Tuesday, April 11, 2023
Clinical trial, Consultant, Excipient, SAE, Kidney, MAD, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SUSAR, Food, Safety, Pharmaceutical industry, Vaccine, Chinook

Dosing was halted per trial protocol when the event occurred, followed by a voluntary pausing of the trial by Chinook to enable further investigation.

Key Points: 
  • Dosing was halted per trial protocol when the event occurred, followed by a voluntary pausing of the trial by Chinook to enable further investigation.
  • The event has been reported to the U.S. Food and Drug Administration (FDA) through a Suspected Unexpected Severe Adverse Reaction (SUSAR) report.
  • The SAE had a rapid onset and rapid recovery; follow-up of the subject is ongoing.
  • Next steps will be determined once Chinook and the trial’s Safety Monitoring Committee have reviewed all safety data.

Magenta Therapeutics Voluntarily Pauses the MGTA-117 Phase 1/2 Dose-Escalation Clinical Trial to Investigate Drug Safety

Retrieved on: 
Wednesday, January 25, 2023
AML, Patient safety, Cardiac arrest, Food, SAE, Myelodysplastic syndrome, Cohort, MDS, Magenta, Clinical trial, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, Adverse effect, SUSAR, Death, Therapy, Pharmaceutical industry

CAMBRIDGE, Mass., Jan. 25, 2023 (GLOBE NEWSWIRE) -- Magenta Therapeutics (Nasdaq: MGTA) today announced that the latest participant dosed at the Cohort 3 level (0.08 mg/kg) in the ongoing MGTA-117 Phase 1/2 Dose-Escalation Clinical Trial in relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) experienced a Grade 5 Serious Adverse Event (SAE) (respiratory failure and cardiac arrest resulting in death) deemed to be possibly related to MGTA-117.

Key Points: 
  • CAMBRIDGE, Mass., Jan. 25, 2023 (GLOBE NEWSWIRE) -- Magenta Therapeutics (Nasdaq: MGTA) today announced that the latest participant dosed at the Cohort 3 level (0.08 mg/kg) in the ongoing MGTA-117 Phase 1/2 Dose-Escalation Clinical Trial in relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) experienced a Grade 5 Serious Adverse Event (SAE) (respiratory failure and cardiac arrest resulting in death) deemed to be possibly related to MGTA-117.
  • The known information has been reported to the U.S. Food and Drug Administration (FDA) as a Suspected Unexpected Serious Adverse Reaction (SUSAR).
  • After consultation with the trial’s safety Cohort Review Committee and with the highest regard for patient safety, Magenta has voluntarily paused dosing in the clinical trial and is working to evaluate the totality of available data and determine next steps for the development of MGTA-117.

Magenta Therapeutics Provides Update for MGTA-117 Phase 1/2 Dose Escalation Clinical Trial

Retrieved on: 
Tuesday, December 20, 2022
Clinical trial, SUSAR, Bilirubin, Bone marrow, Blood, Alkaline phosphatase, Food, Therapy, Lung, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, DLT, Myelodysplastic syndrome, Magenta, ALT, Society, FDA, AML, Adverse effect, Infrared spectroscopy correlation table, Hematology, Observation, MDS, SAE, AST, Cohort, Pharmaceutical industry

CAMBRIDGE, Mass., Dec. 20, 2022 (GLOBE NEWSWIRE) -- Magenta Therapeutics (Nasdaq: MGTA) today announces that, per the clinical trial protocol for the MGTA-117 Phase 1/2 Dose Escalation Clinical Trial in relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), it has stopped dosing participants at the Cohort 4 dosing level (0.13 mg/kg) and plans to dose additional participants at the Cohort 3 dosing level (0.08 mg/kg).

Key Points: 
  • Three participants have been dosed in Cohort 4, and dose-limiting toxicities (DLTs) were observed in the second and third dosed participants.
  • Magenta reported the clinical data and other information applicable to the first observed DLT to the U.S. Food and Drug Administration (FDA) today.
  • In accordance with the clinical trial protocol and following the recommendation of the trial’s safety Cohort Review Committee on December 19, 2022, Magenta plans to continue enrollment at the Cohort 3 dose level.
  • The Company continues to believe that the benefit/risk profile at the Cohort 3 dose level is acceptable to continue enrolling participants in this trial.

Investigators Present Clinical Data on Salarius Pharmaceuticals’ Seclidemstat in Patients with MDS and CMML at the 2022 American Society of Hematology Annual Meeting

Retrieved on: 
Tuesday, December 13, 2022
Life, CMML, Cancer prevention, Azacitidine, Sarcoma, Clinical trial, Annual report, Effectiveness, Hematological Cancer Research Investment and Education Act, Salinicola salarius, Cancer Prevention and Research Institute of Texas, Food, MDS, FDA, Poster, Safety, Cancer, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Exposition, Trial of the century, ASH, MD Anderson Cancer Center, SUSAR, Ewing's sarcoma, Drug development, Survival, Research, Society, Research institute, LSD1, Index (publishing), Biology, University, Patient, Pharmaceutical industry, IND

HOUSTON, Dec. 13, 2022 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX), a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment options, today announced that investigators in the Department of Leukemia at the University of Texas MD Anderson Cancer Center presented clinical data on seclidemstat in patients with MDS and CMML at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition underway in New Orleans and virtually.

Key Points: 
  • of the Department of Leukemia and is available in the Investors Events and Presentations section of Salarius’ website here .
  • As of October 2022, nine patients were enrolled with a median follow-up time of 3.9 months.
  • Typically, overall survival is four to six months for patients after failing therapy with hypomethylating agents.
  • The Phase 1 dose-escalation portion of this study will evaluate up to six dose levels of seclidemstat.

Salarius Pharmaceuticals Presents SP-3164 Data Demonstrating Activity in Preclinical Lymphoma Models at the American Society of Hematology Annual Meeting

Retrieved on: 
Tuesday, December 13, 2022
Life, Cancer prevention, Sarcoma, Clinical trial, Annual report, Effectiveness, Hematological Cancer Research Investment and Education Act, Cancer Prevention and Research Institute of Texas, Letter, Food, FDA, Poster, Safety, Cancer, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Exposition, Trial of the century, ASH, Lenalidomide, Deuterium, SUSAR, Drug discovery, Ewing's sarcoma, Drug development, Research, Society, NHL, Research institute, Biology, Patient, MD Anderson Cancer Center, Rituximab, Vaccine, Pharmaceutical industry, Salinicola salarius, IND, DLBCL

HOUSTON, Dec. 13, 2022 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX), a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment options, announces that yesterday Daniela Santiesteban, Ph.D., Salarius’ director of targeted protein degradation development, presented positive SP-3164 preclinical data at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition underway in New Orleans and virtually.

Key Points: 
  • Avadomide is an extensively studied clinical compound that has demonstrated encouraging single-agent and combination-therapy efficacy in non-Hodgkin’s lymphomas (NHL) and other hematologic malignancies.
  • This, along with the data presented at ASH showing compelling SP-3164 activity in lymphoma models, supports SP-3164’s potential in NHL for the clinical trial planned for 2023.
  • Salarius may not actually achieve the plans, carry out the intentions or meet the expectations or objectives disclosed in the forward-looking statements.
  • Salarius disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made.

Salarius Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Business Update

Retrieved on: 
Thursday, November 10, 2022
GLOBE, Exhibition, Review, Private Securities Litigation Reform Act, Hematological Cancer Research Investment and Education Act, Azacitidine, Ministry of Education (Malaysia), MD Anderson Cancer Center, Food, Nasdaq, Sarcoma, Research, Myelodysplastic syndrome, Biology, Society, Lymphatic system, COVID-19, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Cancer, Research institute, SEC, Annual report, SUSAR, U.S. Securities and Exchange Commission, Food and Drug Administration, Drug development, Clinical trial, University, Patient, CEO, Drug discovery, Acquisition, Chronic myelomonocytic leukemia, Ewing's sarcoma, ASH, Monroe Dunaway Anderson, FDA, Investor, Trial of the century, Cryptocurrency, Pharmaceutical industry, Aquaculture, IND, Salinicola salarius

HOUSTON, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment options, today reported financial results for the three and nine months ended September 30, 2022 and provided a business update.

Key Points: 
  • HOUSTON, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment options, today reported financial results for the three and nine months ended September 30, 2022 and provided a business update.
  • The increase in net loss was due to higher operating expenses, including development spending on SP-3164, which was acquired in January 2022.
  • As of September 30, 2022, Salarius had cash, cash equivalents and restricted cash of $16.8 million, compared with $29.2 million as of December 31, 2021.
  • Salarius Pharmaceuticals, Inc.is a clinical-stage biopharmaceutical company developing therapies for patients with cancer in need of new treatment options.