BioCompute Object

PepGen Reports Third Quarter 2023 Financial Results and Recent Corporate Developments

Retrieved on: 
Wednesday, November 8, 2023

BOSTON, Nov. 08, 2023 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today reported financial results for the third quarter ended September 30, 2023 and highlighted recent corporate developments.

Key Points: 
  • Orphan Drug Designation granted to PGN-EDODM1: In September 2023, the FDA granted Orphan Drug Designation to PGN-EDODM1 for the treatment of DM1.
  • PepGen expects to report initial results from this study in 2024.
  • Financial Results for the Three Months Ended September 30, 2023
    Cash and cash equivalents were $129.5 million as of September 30, 2023, which is anticipated to fund currently planned operations into 2025.
  • PepGen had approximately 23.8 million shares outstanding on September 30, 2023.

PepGen Inc. Announces Clinical Hold in the U.S. on IND Application to Initiate a Phase 1 Study of PGN-EDODM1 for Myotonic Dystrophy Type 1 (DM1)

Retrieved on: 
Tuesday, May 30, 2023

BOSTON, May 30, 2023 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that the Company received a clinical hold notice from the U.S. Food and Drug Administration (FDA) regarding their Investigational New Drug Application (IND) to initiate a Phase 1 study of PGN-EDODM1 in patients with Myotonic Dystrophy Type 1 (DM1).

Key Points: 
  • BOSTON, May 30, 2023 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that the Company received a clinical hold notice from the U.S. Food and Drug Administration (FDA) regarding their Investigational New Drug Application (IND) to initiate a Phase 1 study of PGN-EDODM1 in patients with Myotonic Dystrophy Type 1 (DM1).
  • The FDA indicated its intention to provide an official clinical hold letter to PepGen stating the reasons for the clinical hold within 30 days.
  • “We are disappointed to receive a clinical hold notice on our planned PGN-EDODM1 study in the U.S., and we will work closely with the FDA to lift the hold as quickly as possible,” said James McArthur, Ph.D., President and CEO of PepGen.
  • The clinical hold in the U.S. placed on PGN-EDODM1 does not impact the CONNECT1-EDO51 study which has been cleared to proceed in Canada.

Wellbeing Subsidiary KGK Science Receives Institutional Review Board Approval

Retrieved on: 
Tuesday, April 11, 2023

“KGK Science is thrilled to have received all of the regulatory approvals required to conduct this cutting-edge clinical trial.

Key Points: 
  • “KGK Science is thrilled to have received all of the regulatory approvals required to conduct this cutting-edge clinical trial.
  • We believe the first-ever Phase IIA clinical trial will be an impactful assessment of the potential of psilocybin in a disorder that truly affects the lives of many families and that has not yet been studies,” commented Najla Guthrie, CEO of Wellbeing and KGK.
  • The trial will be led by KGK Science and recruiting efforts are expected to begin this year.
  • “This approval further validates our high standards of ethical and clinical practice and is a significant clinical milestone for this study.”

Wellbeing Subsidiary KGK Science Receives Exemption Under Section 56 of the Controlled Drugs and Substances Act to Begin Psilocybin Clinical Trial

Retrieved on: 
Tuesday, February 14, 2023

“KGK Science is thrilled to have received all of the regulatory approvals required to conduct this cutting-edge clinical trial.

Key Points: 
  • “KGK Science is thrilled to have received all of the regulatory approvals required to conduct this cutting-edge clinical trial.
  • The results of the 10-person, open-label study will be used to support Nova Mentis’ drug development program under FDA Orphan Drug designation, which was received in late 2021.
  • The trial will be led by KGK Science and recruiting efforts are expected to begin in early 2023.
  • “Securing this latest regulatory approval from the Canadian government is a critical step in Nova Mentis’ research and drug development program and allows us to begin our groundbreaking clinical trial.

InvestmentPitch Media Video Discusses FSD Pharma’s Receipt of No Objection Letter from Health Canada for Clinical Trials for LUCID-21-302 for MS

Retrieved on: 
Thursday, February 9, 2023

The Letter of No Objection covers the company’s proposed Phase 1 clinical trial of LUCID-21-302 or Lucid-MS, a novel drug candidate for the treatment of Multiple Sclerosis and provides FSD Pharma with regulatory approval to move forward with the clinical trial in Canada.

Key Points: 
  • The Letter of No Objection covers the company’s proposed Phase 1 clinical trial of LUCID-21-302 or Lucid-MS, a novel drug candidate for the treatment of Multiple Sclerosis and provides FSD Pharma with regulatory approval to move forward with the clinical trial in Canada.
  • A Media Snippet accompanying this announcement is available by clicking on the image or link below:
    For more information, please view the InvestmentPitch Media video which provides additional information about this news and the company.
  • The video is available for viewing on “ InvestmentPitch ” and on “ YouTube ”.
  • If these links are not enabled, please visit www.InvestmentPitch.com and enter “FSD Pharma” in the search box.

Optimi Health, ATMA Journey Centers To Proceed With Phase I Natural Psilocybin and MDMA Clinical Trial Application to Health Canada

Retrieved on: 
Thursday, September 22, 2022

Optimi CEO, Bill Ciprick, says the goal of the clinical trial is to acquire data, including blood pressure, temperature, heart rate, and ECG readings, for Optimis proprietary formulation using natural EU-GMP psilocybin and MDMA.

Key Points: 
  • Optimi CEO, Bill Ciprick, says the goal of the clinical trial is to acquire data, including blood pressure, temperature, heart rate, and ECG readings, for Optimis proprietary formulation using natural EU-GMP psilocybin and MDMA.
  • Coming off the success of ATMAs recently completed Phase I psilocybin trial and a No Objection Letter to conduct its N-500 Phase II psilocybin clinical trial on frontline healthcare professionals, were excited to officially begin the process, he added.
  • ATMA is currently the only Canadian organization that has received approval from Health Canada to conduct a Phase I safety trial with psilocybin in healthy therapists, which it completed last month.
  • Optimis plan for commercialization involves the Company being an active leader in meeting therapist demand for natural EU-GMP psilocybin and MDMA.

Brickell Biotech Reports First Quarter 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, May 12, 2022

BOULDER, Colo., May 12, 2022 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. (“Brickell” or the “Company”) (Nasdaq: BBI), a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated prescription therapeutics for the treatment of autoimmune, inflammatory, and other debilitating diseases, today announced financial results for the first quarter ended March 31, 2022 and provided a corporate update.

Key Points: 
  • Research and development expenses were $6.0million for the first quarter of 2022, compared to $6.1million for the first quarter of 2021.
  • General and administrative expenses were $3.5million for the first quarter of 2022, compared to $3.0million for the first quarter of 2021.
  • Brickells net loss was $9.4million for the first quarter of 2022 compared to $9.0million for the first quarter of 2021.
  • Brickells management will host a conference call today at 4:30 p.m. EDT to discuss the financial results and recent corporate developments.

Sustainable Plastic Milestone: Revolution's Recycling Process Receives Groundbreaking Letter of No Objection (LNO) for Food Contact Applications

Retrieved on: 
Thursday, January 13, 2022

LITTLE ROCK, Ark., Jan. 13, 2022 /PRNewswire/ --The U.S. Food and Drug Administration (FDA) has issued a Letter of No Objection for Revolution's proprietary recycling method to produce post-consumer recycled, linear low-density polyethylene (PCR-LLDPE) for food contact applications.

Key Points: 
  • LITTLE ROCK, Ark., Jan. 13, 2022 /PRNewswire/ --The U.S. Food and Drug Administration (FDA) has issued a Letter of No Objection for Revolution's proprietary recycling method to produce post-consumer recycled, linear low-density polyethylene (PCR-LLDPE) for food contact applications.
  • The announcement of Revolution's FDA LNO represents a significant step forward in addressing the increasing global need for flexible film recycling and sustainable consumer packaging.
  • Increased demand for recycled content has driven the need for recyclers to meet the quality standards and food contact requirements set by consumer packaging applications.
  • Developing a method to meet food contact quality PCR represents the culmination of a long-term development project undertaken by the Revolution team.

Eledon Pharmaceuticals Reports Second Quarter 2021 Operating and Financial Results

Retrieved on: 
Thursday, August 12, 2021

IRVINE, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc., (“Eledon”) (NASDAQ: ELDN), a clinical stage biopharmaceutical company focused on developing targeted medicines for persons living with autoimmune disease, requiring an organ or cell-based transplant, or living with amyotrophic lateral sclerosis (ALS), today reported its second quarter 2021 operating and financial results.

Key Points: 
  • Enrollment in our ALS study is progressing well and we anticipate completing enrollment in the 4th quarter.
  • Presentation at the International Pancreas and Islet Transplantation World Congress annual meeting, which is being held virtually October 20-23, 2021.
  • Eledon will hold a conference call today, August 12, 2021, at 4:30 pm Eastern Time to discuss second quarter results.
  • Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors.

BioCompute and WHISE-Embleema Launch Framework for FDA Drug Submissions

Retrieved on: 
Tuesday, May 14, 2019

The United States Food and Drug Administration (FDA), together with the George Washington University, co-sponsored the 2019 BioCompute Workshop , entitled "BioCompute Objects: Tools for Communicating Next Generation Sequencing Data and Analysis."

Key Points: 
  • The United States Food and Drug Administration (FDA), together with the George Washington University, co-sponsored the 2019 BioCompute Workshop , entitled "BioCompute Objects: Tools for Communicating Next Generation Sequencing Data and Analysis."
  • This goal of this workshop is to engage more life sciences organizations to use BioCompute for NGS and other bioinformatics data analysis communications with the FDA.
  • A new Precision FDA-BioCompute Challenge will also be launched at the event to generate more BioCompute Objects (BCOs), and to integrate the BioCompute standard into more genome analysis tools.
  • WHISE compliance to FDA regulatory analytics follows from its reliance on a distributed network of HIVE deployment instances and BioCompute driven standardization architecture.