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ReShape Lifesciences® Reports Year Ended December 31, 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, April 1, 2024

IRVINE, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- ReShape Lifesciences Inc. (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health-solutions company, today reported financial results for the fourth quarter and fiscal year ended December 31, 2023 and provided a corporate strategic update.

Key Points: 
  • Specifically, it received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent application 18/370,819.
  • December 2023: Engaged Maxim Group LLC, to act as the company’s exclusive financial advisor to help identify potential synergistic merger and acquisition partnerships.
  • December 2023: Received U.S. Food and Drug Administration (FDA) PMA supplement approval for its next-generation Lap-Band® 2.0 FLEX, designed to improve the patient experience.
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Biomea Fusion Highlights Initial Data from the First Two Type 1 Diabetes Patients Dosed with BMF-219

Retrieved on: 
Monday, April 1, 2024

REDWOOD CITY, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, today announced initial response data from the first two type 1 diabetes patients treated with BMF-219 in the ongoing Phase II study (COVALENT-112).

Key Points: 
  • “We are very excited to announce the initial response data from the first two type 1 diabetes patients enrolled in the COVALENT-112 study.
  • Both patients showed improvement in measures of beta-cell function after only 4 weeks of dosing with BMF-219.
  • The trial includes an open label portion for adults with type 1 diabetes up to 15 years since diagnosis.
  • It has been exciting to participate in this study and explore this new pathway for the benefit of our patients.

Biomea Fusion Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Highlights

Retrieved on: 
Monday, April 1, 2024

In 2023, initiated a Phase 2 study of BMF-219 in type 1 diabetes patients (COVALENT-112); initial readout anticipated in 2024.

Key Points: 
  • In 2023, initiated a Phase 2 study of BMF-219 in type 1 diabetes patients (COVALENT-112); initial readout anticipated in 2024.
  • Cash position of $177.2 million at the end of the fourth quarter of 2023.
  • REDWOOD CITY, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “the Company”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, reported fourth quarter and full year 2023 financial results and corporate highlights.
  • “2023 was a pivotal year for Biomea as we reported first positive data in type 2 diabetes and initiated our first clinical study in type 1 diabetes.

Teladoc Health Expands Obesity & Weight Management Capabilities

Retrieved on: 
Thursday, March 7, 2024

The multidisciplinary care model is designed by clinicians experienced in obesity medicine and delivered with a tailored approach to weight management.

Key Points: 
  • The multidisciplinary care model is designed by clinicians experienced in obesity medicine and delivered with a tailored approach to weight management.
  • Clients can provide their populations with comprehensive and integrated clinical care, that also addresses wellbeing, mental health and social drivers of health in a personalized manner,” said Dr. Vidya Raman-Tangella, Teladoc Health Chief Medical Officer.
  • The Comprehensive Weight Management solution is customized for health plans and employers to meet the needs of their populations and reduce the cost of care for obesity-related medical expenses by going beyond care coordination to deliver:
    An evidence-based, personally tailored approach inclusive of comprehensive support from providers experienced in obesity management, health coaching, medical nutrition therapy, and integrated, highly accessible mental health support.
  • More information on Teladoc Health’s obesity and weight management programs can be found here .

Biomea Fusion Presents Patient Cohorts in COVALENT-111 Displaying a Durable Placebo-Adjusted Mean Reduction of up to 1.4% in HbA1c While Off Therapy at Week-26, after BMF-219’s 28-Day Treatment Cycle, Supporting Improved Pancreatic Function

Retrieved on: 
Wednesday, March 6, 2024

REDWOOD CITY, Calif., March 06, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, today announced three poster presentations presenting long-term 26 week follow-up data from patients treated with BMF-219, enrolled in the escalation portion of the ongoing Phase II clinical study (COVALENT-111), at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) taking place in Florence, Italy from March 6-9, 2024. This clinical data from all dosing cohorts initiated to date as of February 12, 2024 from the Escalation Phase of COVALENT-111 will be featured during a Poster Discussion Presentation and two Poster Viewing Presentations at ATTD. Biomea will showcase the following three e-poster presentations:

Key Points: 
  • Please find a link here to our website where the poster presentations and discussion will be available.
  • A higher proportion of patients treated with 200mg QD achieved a clinically significant reduction in HbA1c compared to 100mg QD dosing.
  • A durable glycemic response (≥1.0% HbA1C reduction) was seen in 20% and 36% of patients in once daily 100 mg and 200 mg cohorts, respectively.
  • A PK study further assessing the optimal use of BMF-219 to ensure minimal variability of exposure is currently under way.

Sana Biotechnology Reports Fourth Quarter and Full Year 2023 Financial Results and Business Updates

Retrieved on: 
Thursday, February 29, 2024

The Investigational New Drug Application (IND) cleared in 4Q 2023, and Sana expects to share initial data in 2024.

Key Points: 
  • The Investigational New Drug Application (IND) cleared in 4Q 2023, and Sana expects to share initial data in 2024.
  • The Clinical Trial Application (CTA) cleared in 4Q 2023, and Sana expects initial data to be shared in the first half of 2024.
  • Non-GAAP research and development expense in 2023 excludes an expense related to the impairment of certain lab equipment and leasehold improvements, primarily due to the portfolio prioritization in the fourth quarter of 2023.
  • A discussion of non-GAAP measures, including a reconciliation of GAAP and non-GAAP measures, is presented below under “Non-GAAP Financial Measures.”

Northwell Health Researcher Shows Vitamin D Could Improve Insulin-producing Cells in Children With Type 1 Diabetes

Retrieved on: 
Tuesday, March 5, 2024

To help children and young people navigate type 1 diabetes, new research from Cohen Children’s Medical Center and The Feinstein Institutes for Medical Research at Northwell Health shows that taking vitamin D could help improve the function of insulin-producing cells.

Key Points: 
  • To help children and young people navigate type 1 diabetes, new research from Cohen Children’s Medical Center and The Feinstein Institutes for Medical Research at Northwell Health shows that taking vitamin D could help improve the function of insulin-producing cells.
  • View the full release here: https://www.businesswire.com/news/home/20240305266724/en/
    Dr. Benjamin Nwosu’s study shows that vitamin D could be an easier and more affordable option to help adolescents living with type 1 diabetes.
  • The research showed that by taking high-dose vitamin D, patients saw improvement in the function of insulin-producing cells which could extend the “honeymoon phase” of type 1 diabetes.
  • This research shows that by adding vitamin D, which is inexpensive and easy to obtain, one can make this phase of diabetes last longer.

Better Therapeutics Announces Acceptance of Late Breaking Abstract for Its AspyreRx Pivotal Trial 180 Day Outcomes and Participation at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD)

Retrieved on: 
Monday, March 4, 2024

Key highlights of Better Therapeutics’ participation at ATTD include:

Key Points: 
  • Key highlights of Better Therapeutics’ participation at ATTD include:
    The late-breaking abstract findings further validate the use of AspyreRx ™ as a safe and effective treatment for patients with type 2 diabetes (T2D).
  • Abstract Title: Randomized, Controlled Trial Of A Novel Digital Therapeutic In Patients With Type 2 Diabetes: BT-001 Pivotal Trial 180 Day Outcomes
    Abstracts will be published in the peer-reviewed Journal of Diabetes Technology & Therapeutics.
  • Additionally, Better Therapeutics will host a sponsored industry symposium on Saturday, March 09, 2024, at 8:30 a.m. local time (CET).
  • Attendees will have the opportunity to experience AspyreRx firsthand and learn more about its clinical benefits at the Better Therapeutics exhibition booth.

Biodexa CEO Issues Shareholder Letter Highlighting Progress in 2023 and Expected Milestones in 2024

Retrieved on: 
Monday, January 22, 2024

In December 2023, we completed an in-licensing of a new, potentially disease modifying, orally delivered clinical stage molecule for Type I diabetes, an unmet medical disease.

Key Points: 
  • In December 2023, we completed an in-licensing of a new, potentially disease modifying, orally delivered clinical stage molecule for Type I diabetes, an unmet medical disease.
  • Tolimidone is an activator of lyn kinase which has been shown to play a significant role in cell proliferation, differentiation, apoptosis, migration and metabolism.
  • We expect to report data from the in vivo LMD efficacy model by the end of the first quarter of 2024.
  • Certain statements in this shareholder letter may constitute “forward-looking statements” within the meaning of legislation in the United Kingdom and/or United States.

Incretin Mimetic Drugs Overtake Insulin in Total Prescriptions and Costs for Commercially Insured Patients

Retrieved on: 
Wednesday, January 10, 2024

An analysis by Cedar Gate Technologies found that incretin mimetic prescription medications (also known as GLP-1 agonists) have overtaken insulin in total prescriptions and cost among commercially insured patients.

Key Points: 
  • An analysis by Cedar Gate Technologies found that incretin mimetic prescription medications (also known as GLP-1 agonists) have overtaken insulin in total prescriptions and cost among commercially insured patients.
  • The data unveils a significant 36.1% increase in GLP-1 agonist prescriptions and a 43.4% surge in costs for these medications.
  • In contrast, insulin prescriptions experienced a 1.4% decrease during the same period, transitioning from the top-prescribed diabetes drug class in the preceding year to the second position on the list.
  • They accounted for $544 million and $487 million, respectively, in total costs in a single year for pharmacy claims included in Cedar Gate’s analysis.