BLA

EQS-News: Heidelberg Pharma Announces Royalty Financing Agreement with HealthCare Royalty for up to USD 115 million

Retrieved on: 
Wednesday, March 13, 2024

Ladenburg, Germany, 4 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech Company developing innovative Antibody Drug Conjugates (ADCs), and HealthCare Royalty (HCRx) today announced that they have signed a royalty financing agreement.

Key Points: 
  • Ladenburg, Germany, 4 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech Company developing innovative Antibody Drug Conjugates (ADCs), and HealthCare Royalty (HCRx) today announced that they have signed a royalty financing agreement.
  • Key terms of the agreement between Heidelberg Pharma and HCRx:
    Following the receipt by HCRx of a maximum cumulative amount, royalty payments will revert to Heidelberg Pharma and HCRx will receive a low single digit royalty tail percentage thereafter
    Prof. Dr. Andreas Pahl, Chief Executive Officer at Heidelberg Pharma, commented: “We are delighted to partner with HealthCare Royalty.
  • This agreement will provide us with a non-dilutive financing based on expected royalty payments from the worldwide sales of ZircaixTM.
  • Heidelberg Pharma will hold a conference call on 25 March 2024 with the publication of the Annual Report.

Larimar Therapeutics Announces the Dosing of the First Patient in Long-term Open Label Extension Study for Nomlabofusp in Patients with Friedreich’s Ataxia

Retrieved on: 
Monday, March 11, 2024

Nomlabofusp (CTI-1601) is a novel protein replacement therapy designed to address the root cause of Friedreich's ataxia (FA) by delivering frataxin to mitochondria.

Key Points: 
  • Nomlabofusp (CTI-1601) is a novel protein replacement therapy designed to address the root cause of Friedreich's ataxia (FA) by delivering frataxin to mitochondria.
  • “We are pleased to dose the first patient in our OLE study, further advancing the nomlabofusp clinical program and building on the successful completion of our Phase 2 dose escalation study.
  • Based on our Phase 1 and Phase 2 findings, we expect to continue daily dosing throughout the study,” said Carole Ben-Maimon, MD, President, and Chief Executive Officer of Larimar.
  • Initial data from the OLE study is expected in Q4 2024.

United States Food & Drug Administration (FDA) Supports Accelerated Approval Pathway for Rexlemestrocel-L in End-Stage Heart Failure Patients with a Left Ventricular Assist Device (LVAD)

Retrieved on: 
Sunday, March 10, 2024

“We are very pleased with FDA’s feedback that the presented results from our pivotal study of rexlemestrocel-L in end-stage HFrEF patients with LVADs may support an accelerated approval,” said Mesoblast CEO Dr. Silviu Itescu.

Key Points: 
  • “We are very pleased with FDA’s feedback that the presented results from our pivotal study of rexlemestrocel-L in end-stage HFrEF patients with LVADs may support an accelerated approval,” said Mesoblast CEO Dr. Silviu Itescu.
  • “We intend to request a pre-Biologics License Application (BLA) meeting to discuss data presentation, timing and FDA expectations for an accelerated approval filing.”
    Every year in the United States over 100,000 patients progress to end-stage HFrEF.
  • In contrast, in ischemic patients treated with rexlemestrocel-L, IL-6 levels returned to normal by 2 months and remained low through 12 months.
  • Mesoblast intends to request a pre-BLA meeting with FDA to discuss data presentation, timing and FDA expectations for an accelerated approval filing in end-stage ischemic HFrEF patients with LVAD implantation.

Samsung Bioepis Presents Two Abstracts for Its Immunology Portfolio at the 2024 American Academy of Dermatology (AAD) Annual Meeting

Retrieved on: 
Saturday, March 9, 2024

“We are excited to present new clinical data for our immunology portfolio at AAD Annual Meeting.

Key Points: 
  • “We are excited to present new clinical data for our immunology portfolio at AAD Annual Meeting.
  • The high-concentration (40 mg/0.4 mL) formulation of prefilled syringe and prefilled autoinjector of HADLIMA was approved in August 2022.
  • The study showed that efficacy, safety, and immunogenicity between the three arms were comparable up to Week 52.
  • Details of the Samsung Bioepis’ abstracts are as follows:
    Clinical Similarity of SB17 (Proposed Ustekinumab Biosimilar) to Reference Ustekinumab in Patients with Moderate to Severe Plaque Psoriasis: Randomized, Double-blind, Phase III, 52-Week Results

Immuron Announces Positive Results Support Travelan® progress to Phase 3 Clinical Trials in the US

Retrieved on: 
Thursday, March 7, 2024

MELBOURNE, Australia, March 07, 2024 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce the interim topline results confirming that a single daily dose of Travelan® is effective in prevention of moderate to severe diarrhea following challenge with enterotoxigenic Escherichia coli (ETEC).

Key Points: 
  • This interim analysis summarizes the data for a total of 60 subjects who have completed the inpatient challenge component of this current clinical study.
  • Last patients last visits are anticipated to commence in April this year and final clinical study report will be completed in H2 2024.
  • To learn more about Phase 2 study design, read: U.S. Food and Drug Administration Step 3: Clinical Research
    IMM-124E (Travelan®) will be the first product developed with Immuron’s platform technology to proceed into Phase 3 clinical trials.
  • Immuron is in the process of exploring non-dilutive funding opportunities for these Phase 3 clinical trials.

DBV Technologies Reports Full Year 2023 Financial Results and Business Update

Retrieved on: 
Thursday, March 7, 2024

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company focused on treatment options for food allergies and other immunologic conditions with significant unmet medical need, today reported financial results for the full year 2023.

Key Points: 
  • DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company focused on treatment options for food allergies and other immunologic conditions with significant unmet medical need, today reported financial results for the full year 2023.
  • Published EPITOPE results in the New England Journal of Medicine with an accompanying editorial, entitled, Good News for Toddlers with Peanut Allergy.
  • ET to discuss full year 2023 financial results and provide a business update.
  • The conference call may be accessed by dialing:
    A webcast of the call will also be available under "Events" in the Investors section of the DBV Technologies website: https://dbv-technologies.com/investor-overview/events .

Zymeworks Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Wednesday, March 6, 2024

Financial Results for the Year Ended December 31, 2023

Key Points: 
  • Financial Results for the Year Ended December 31, 2023
    Revenue was $76.0 million in 2023 compared to $412.5 million in 2022.
  • Higher interest income in 2023 was due to income earned on higher cash resources and at higher rates of return in 2023.
  • “We are happy to report a continued reduction of our operating cash burn and operating losses during 2023 compared to 2022,” said Chris Astle, Ph.D., Senior Vice President and Chief Financial Officer of Zymeworks.
  • Reconciliations between historical GAAP and non-GAAP information are contained at the end of this press release following the accompanying financial data.

Capricor Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, February 29, 2024

Further, Capricor will receive a meaningful mid-range double-digit revenue share of product revenue under the terms of this Agreement.

Key Points: 
  • Further, Capricor will receive a meaningful mid-range double-digit revenue share of product revenue under the terms of this Agreement.
  • Next steps for Cohort A: plan to report top-line data in the fourth quarter of 2024.
  • Revenues for the fourth quarter of 2023 were approximately $12.1 million compared with approximately $1.0 million for the fourth quarter of 2022.
  • Operating expenses: Total operating expenses for the fourth quarter of 2023 were approximately $13.2 million compared with approximately $9.0 million for the fourth quarter of 2022.

PRISM MarketView Highlights Work of Emerging Companies on Rare Disease Day

Retrieved on: 
Thursday, February 29, 2024

All areas of medicine, and all organs and body systems, are impacted by rare diseases, including rare neurological and neuromuscular diseases, metabolic, skin and bone diseases, and chromosomal disorders.

Key Points: 
  • All areas of medicine, and all organs and body systems, are impacted by rare diseases, including rare neurological and neuromuscular diseases, metabolic, skin and bone diseases, and chromosomal disorders.
  • Today on Rare Disease Day, PRISM MarketView highlights emerging companies working to deliver life changing treatments for those living with rare diseases.
  • RDEB is a severe rare disease characterized by extremely fragile, and extensive blistering and wounds.
  • Capricor is a biotechnology company dedicated to advancing transformative cell and exosome-based therapeutics to redefine the treatment landscape for rare diseases.

Mesoblast Reports Financial Results and Operational Update for Half-Year Ended December 31, 2023

Retrieved on: 
Wednesday, February 28, 2024

NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an operational update and reported financial results for the period ended December 31, 2023.

Key Points: 
  • NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an operational update and reported financial results for the period ended December 31, 2023.
  • Reduction in net cash usage for operating activities:
    For the three months ended December 31, 2023, net cash usage was US$12.3 million, a 25% reduction versus the comparative quarter in FY2023.
  • For the six months ended December 31, 2023, net cash usage was US$26.6 million, a 14% reduction versus the comparative period in FY2023.
  • Manufacturing reduced by 47% for the six months ended December 31, 2023, from US$12.8 million to US$6.7 million.