DSMC

BridgeBio Pharma Presents Updated Encouraging Clinical and Biomarker Data from its BBP-812 Canavan Disease Gene Therapy Program at the 2023 American Society of Gene and Cell Therapy (ASGCT) Annual Meeting

Retrieved on: 
Monday, May 22, 2023

“Canavan disease is a rapidly progressive, rare neurological disease that affects children from birth and has no treatment options beyond supportive care.

Key Points: 
  • “Canavan disease is a rapidly progressive, rare neurological disease that affects children from birth and has no treatment options beyond supportive care.
  • The changes in key biomarkers, brain myelination and – critically – clinical function observed in children receiving BBP-812 in our study are compelling, and as we continue to advance our program we are hopeful that we will see outcomes that make a meaningful difference in the lives of children with Canavan disease and their families,” said Genevieve Laforet, M.D., Ph.D., vice president of clinical development at Aspa Therapeutics, the BridgeBio affiliate that is developing BBP-812 for Canavan disease.
  • “We are beyond grateful to the children and their families who are participating in CANaspire as well as the study investigators, who together are making it possible to explore the potential of BBP-812 as a therapy for Canavan disease.
  • Across individual participants, percent decreases in NAA from baseline ranged between 70% and 95% in cerebrospinal fluid (CSF), 29% and 88% in urine, and 8% and 75% in brain (by magnetic resonance spectroscopy)
    All participants in the CANaspire trial had urine NAA levels consistent with typical Canavan disease prior to receiving BBP-812.

Airway Therapeutics Completes Dose Escalation in Phase 1b Trial of Zelpultide Alfa (AT-100) for Very Preterm Infants at Risk for Bronchopulmonary Dysplasia

Retrieved on: 
Tuesday, April 11, 2023

The Phase 1b trial is being conducted in the U.S. and Spain.

Key Points: 
  • The Phase 1b trial is being conducted in the U.S. and Spain.
  • Airway has established a subsidiary, Airway Spain SL, to lead the Phase 1b trial and subsequent clinical trials across the E.U.
  • “The DSMC confirmed the excellent safety profile of zelpultide alfa following completion of the third cohort of infants who received the highest dose.
  • The Phase 1b trial is a randomized, blinded, air-sham controlled study to establish the safety and tolerability of zelpultide alfa.

Theriva Biologics Reports Third Quarter 2022 Operational Highlights and Financial Results

Retrieved on: 
Thursday, November 10, 2022

ET

Key Points: 
  • ET
    ROCKVILLE, Md., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Theriva Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today reported financial results for the quarter ended September 30, 2022, and provided a corporate update.
  • We are encouraged by our clinical results demonstrating the therapeutic potential of Therivas oncology-focused platform, said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics.
  • In October 2022, the Company rebranded as Theriva Biologics and began trading on NYSE American under the new ticker symbol TOVX.
  • ET to review the third quarter 2022 operational highlights and financial results.

United Therapeutics Corporation Reports Third Quarter 2022 Financial Results

Retrieved on: 
Wednesday, November 2, 2022

Income tax expense for the three months ended September 30, 2022 and 2021 was $73.2 million and $41.7 million, respectively.

Key Points: 
  • Income tax expense for the three months ended September 30, 2022 and 2021 was $73.2 million and $41.7 million, respectively.
  • Our first commercial shipments to specialty pharmacies occurred in June 2022 and the first patients started Tyvaso DPI therapy shortly thereafter.
  • We will host a webcast to discuss our third quarter 2022 financial results on Wednesday, November 2, 2022, at 9:00 a.m. Eastern Time.
  • ORENITRAM, REMODULIN, REMUNITY, TYVASO, TYVASO DPI, and UNITUXIN are registered trademarks of United Therapeutics Corporation and/or its subsidiaries.

Distillate Capital Continues to Build Its Innovative Value-Focused Lineup With the Launch of DSMC: The Distillate Small/Mid Cash Flow ETF

Retrieved on: 
Thursday, October 6, 2022

Were excited to be bringing DSMC to the marketplace and to continue talking with advisors and investors about modern ways to approach value investing through the lens of free cash flow.

Key Points: 
  • Were excited to be bringing DSMC to the marketplace and to continue talking with advisors and investors about modern ways to approach value investing through the lens of free cash flow.
  • The impact this trend has had on traditional measures of value cannot be understated, added Jay Beidler, Co-Founder of Distillate.
  • Free Cash Flow refers to the cash generated by a business after accounting for capital investments required to maintain or grow the business.
  • The fund Distillate Small/Mid Cash Flow ETF(DSMC) is distributed by Quasar Distributors, LLC.

Castle Automotive Group Completes 2 Massive Acquisitions: Naperville Chrysler Jeep Dodge Ram & Gary Lang Auto Group (Kia, Subaru, Chevrolet, Cadillac, Buick, GMC, Mitsubishi)

Retrieved on: 
Friday, September 30, 2022

OAK BROOK, Ill., Sept. 30, 2022 (GLOBE NEWSWIRE) -- Castle Automotive Group (CAG), a growing automotive retailer with corporate headquarters in Oakbrook Terrace, IL, has completed two transactions this year with the acquisition of Naperville Chrysler Dodge Jeep Ram and Gary Lang Auto Group in McHenry.

Key Points: 
  • OAK BROOK, Ill., Sept. 30, 2022 (GLOBE NEWSWIRE) -- Castle Automotive Group (CAG), a growing automotive retailer with corporate headquarters in Oakbrook Terrace, IL, has completed two transactions this year with the acquisition of Naperville Chrysler Dodge Jeep Ram and Gary Lang Auto Group in McHenry.
  • "First of all, I would like to say thank you and congratulations to Ed Burke, President of Naperville CDJR and Gary Lang, President of Gary Lang Auto Group.
  • -Joe Castle, CEO of Castle Automotive Group
    Stellantis N.V. is a multinational automotive manufacturing corporation formed in 2021.
  • Castle Automotive Group (CAG) currently owns 10 locations throughout Illinois and Northwest Indiana representing Domestic, Asian, and Germain brands.

Synthetic Biologics Announces Positive Outcome of Data and Safety Monitoring Committee (DSMC) Review in Phase 1b/2a Clinical Trial of SYN-004 (ribaxamase) in Allogeneic Hematopoietic Cell Transplant Recipients

Retrieved on: 
Tuesday, September 27, 2022

ROCKVILLE, Md., Sept. 27, 2022 (GLOBE NEWSWIRE) -- Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, today announced a positive outcome from the Data and Safety Monitoring Committee (DSMC) review of results from the first Cohort of its Phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease (aGVHD).

Key Points: 
  • A total of 13 SAEs were reported among 10 patients, with the most common SAE being infections and infestations including sepsis.
  • None of the three ECL positive plasma samples were found to contain active SYN-004 using a functional enzyme activity assay.
  • The ongoing randomized, double-blinded, placebo-controlled Phase 1b/2a clinical trial is being conducted at Washington University School of Medicine in St. Louis.
  • A previously completed placebo-controlled Phase 2b clinical trial of 412 patients demonstrated SYN-004 protected the gut microbiome from antibiotic-mediated dysbiosis.

VBL Therapeutics Receives FDA Fast Track Designation for Ofra-Vec for the Treatment of Platinum-Resistant Ovarian Cancer

Retrieved on: 
Tuesday, April 26, 2022

We are pleased to receive FDA Fast Track designation for ofra-vec in platinum-resistant ovarian cancer.

Key Points: 
  • We are pleased to receive FDA Fast Track designation for ofra-vec in platinum-resistant ovarian cancer.
  • The lead clinical program for ofra-vec is the OVAL Phase 3 registration-enabling trial in recurrent platinum-resistant ovarian cancer patients.
  • Ofra-vec has received orphan designations for the treatment of ovarian cancer and for the treatment of glioma by the European Commission.
  • The FDA granted ofra-vec orphan designation for the treatment of malignant glioma and fast track designation for the treatment of rGBM and the treatment of platinum-resistant ovarian cancer.

Achieve Life Sciences Announces Phase 3 ORCA-2 Trial of Cytisinicline in Smoking Cessation Clears Final Review by Data Safety Monitoring Committee (DSMC)

Retrieved on: 
Monday, November 22, 2021

SEATTLE, Wash and VANCOUVER, British Columbia, Nov. 22, 2021 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced the completion of the fifth and final Data Safety Monitoring Committee (DSMC) review for its Phase 3 ORCA-2 smoking cessation trial of cytisinicline.

Key Points: 
  • SEATTLE, Wash and VANCOUVER, British Columbia, Nov. 22, 2021 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced the completion of the fifth and final Data Safety Monitoring Committee (DSMC) review for its Phase 3 ORCA-2 smoking cessation trial of cytisinicline.
  • The DSMC concluded that there are no concerns regarding the Phase 3 study conduct and the safety and adverse event profile remains favorable.
  • The ORCA-2 trial is designed to evaluate the smoking cessation effectiveness, safety, and tolerability of 3 mg cytisinicline taken three times daily (TID) for either 6 or 12 weeks, compared with placebo.
  • Subjects in the trial have completed study treatment and continue to receive standard behavioral support while completing follow-up assessments through 24 weeks post randomization.

VBL Therapeutics Reports Third Quarter 2021 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, November 15, 2021

TEL AVIV, Israel and NEW YORK, Nov. 15, 2021 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT), a clinical stage biotechnology company developing first-in-class therapeutics for difficult-to-treat malignant solid tumors and immune or inflammatory indications, today announced financial results for the third quarter ended September 30, 2021, and provided a corporate update.

Key Points: 
  • We continue to execute on our development and strategic objectives which we believe positions 2022 as a potentially transformational year for VBL, said Dror Harats, M.D., Chief Executive Officer of VBL.
  • We also expect to initiate a first-in-human trial with VB-601, our monocyte targeting program, in the second half of 2022.
  • At September 30, 2021, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits of $50.8 million.
  • Revenues for the quarter ended September 30, 2021, were $0.2 million, as compared to $0.2 million in the comparable period in 2020.