GJB2

Sensorion Announces a €15 Million Financing, Extending Cash Runway Until the End of 2025

Retrieved on: 
Monday, April 8, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, Genetics, Clinical Trials, Other Health, SVB Securities, Stifel, EUR, GJB2, Euronext Growth, Patient, Code, Interim, Reserved, Sofinnova, Clinical trial, Commercial code, Person

The settlement-delivery of the Reserved Offering is expected to take place around April 11, 2024, subject to customary conditions.

Key Points: 
  • The settlement-delivery of the Reserved Offering is expected to take place around April 11, 2024, subject to customary conditions.
  • This builds on the earlier EUR 50 million financing announced in February 2024, adding up to a total of EUR 100 million raised in less than 9 months.
  • The capital increase enables the Company to finance its activities until the end of 2025.
  • Leerink Partners LLC (“Leerink Partners”) and Stifel Europe AG (“Stifel”) are acting as lead agents in connection with the Reserved Offering.

Sensorion Reports Full-Year 2023 Financial Results and Business Update

Retrieved on: 
Thursday, March 14, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Bioreactor, Malignancy, Cell, Chemistry, Patient, Orphan, Good manufacturing practice, Health care, CMC, G&A, Molecular biology, Quality of life, European Medicines Agency, Science, Clinical trial, Cisplatin, Therapy, Hertz, Neoplasm, CIO, Congress, Huber loss, Partnership, Ageing, EMA, Hearing loss, GMP, Cochlea, Biochemistry, Safety, Language, Perilymph, G7, Medication, Control, AAV, PTA, IHC, Pasteur Institute, CDMO, Communication, Genetics, Research, KOL, Ear, POC, FDA, Ototoxicity, GJB2, ABR, CTA, ANSM, Audiogram, Platinum, Investment company, Congenital hearing loss, Pathology, Presbycusis, Hearing, Pharmaceutical industry

Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent hearing loss disorders, today reports full-year 2023 financial results and business update.

Key Points: 
  • Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent hearing loss disorders, today reports full-year 2023 financial results and business update.
  • Nawal Ouzren, Chief Executive Officer of Sensorion, said: “Over the past months, Sensorion has successfully achieved all the major milestones on its roadmap.
  • In the first half of 2023, Sensorion achieved a major development milestone by completing the preclinical package, and successfully producing the GMP dual AAV SENS-501 clinical batches at 200L scale.
  • On April 6, 2023, Sensorion announced the candidate selection for GJB2-GT during its gene therapy focused R&D Day.

Sensorion Announces a €50.5 Million Financing With Participation From New and Existing US and European Healthcare Specialist Investors

Retrieved on: 
Friday, February 9, 2024
Health, Medical Devices, Genetics, Research, Science, Pharmaceutical, Biotechnology, Stifel, Sofinnova, Ototoxicity, Quality of life, GJB2, Huber loss, Euronext Growth, Code, Chair, SVB Securities, EUR, Pasteur Institute, Clinical trial, Patient, Reserved, Person, Commercial code, Audiology

The settlement-delivery of the Reserved Offering is expected to take place around February 13, 2024, subject to customary conditions.

Key Points: 
  • The settlement-delivery of the Reserved Offering is expected to take place around February 13, 2024, subject to customary conditions.
  • Nawal Ouzren, Chief Executive Officer of Sensorion, said: “We are delighted to announce today’s successful capital raise of EUR 50.5 million.
  • This strengthened shareholder base reinforces Sensorion’s ambition to advance its pipeline of innovative therapies intended to improve the quality of life of patients suffering from hearing disorders.
  • Leerink Partners LLC (“Leerink Partners”) and Stifel Europe AG (“Stifel”) are acting as lead agents in connection with the Reserved Offering.

Sensorion Announces Partnership With the Institut Pasteur to Accelerate Gene Therapy Programs Targeting Hearing Disorders Has Been Extended for Five Years

Retrieved on: 
Friday, January 5, 2024
Biotechnology, Health, Genetics, Pharmaceutical, Clinical Trials, Kavli Prize, Partnership, Pasteur Institute, Research, Congenital hearing loss, Hearing loss, Trial of the century, Deafness, GJB2, Huber loss, Physiology, Emeritus, Patient, Diagnosis, Safety, Pharmaceutical industry

The agreement has been amended to be extended up to December 31, 2028, to promote additional development gene therapy programs.

Key Points: 
  • The agreement has been amended to be extended up to December 31, 2028, to promote additional development gene therapy programs.
  • SENS-501, the most advanced program within the partnership that targets deafness caused by mutations in the gene coding for otoferlin, defined as a priority in 2019, has met its objectives.
  • The successful completion of the efficacy preclinical package in the frame of the collaboration between Sensorion and the Institut Pasteur advanced the program with the development of the OTOF-GT product (SENS-501) towards clinical stage.
  • Three indications, all linked to GJB2 mutations, are currently being evaluated: early presbycusis, progressive hearing loss during childhood, and congenital hearing loss.

Regeneron Completes Acquisition of Decibel Therapeutics, Adding Promising Gene Therapy Programs for Hearing Loss

Retrieved on: 
Monday, September 25, 2023
STRC, Centerview Partners, CVR, Doctor of Philosophy, Hearing loss, Eastern Time Zone, Congenital hearing loss, European Medicines Agency, Gene editing, Clinical trial, GAAP, AAV, Wilmer Cutler Pickering Hale and Dorr, Wachtell, Lipton, Rosen & Katz, Gene silencing, Biologics license application, GJB2, Acquisition, Patient, CVR Partners, Computershare, Biology, Medicines and Healthcare products Regulatory Agency, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, Regeneron Pharmaceuticals, Decibel

TARRYTOWN, N.Y., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it has successfully completed its acquisition of Decibel Therapeutics, Inc., strengthening the company’s gene therapy and auditory programs.

Key Points: 
  • TARRYTOWN, N.Y., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it has successfully completed its acquisition of Decibel Therapeutics, Inc., strengthening the company’s gene therapy and auditory programs.
  • The acquisition of Decibel builds on prior collaboration between the companies and includes three ongoing gene therapy programs targeting different forms of congenital, monogenic hearing loss.
  • Preclinical programs include AAV.103 for people with GJB2-related hearing loss and AAV.104 for people with stereocilin (STRC)-related hearing loss.
  • Following its acceptance of the tendered shares, Regeneron completed its acquisition of Decibel through a second step merger of Symphony Acquisition Sub, Inc., with and into Decibel.

Sensorion Reports 2023 First Half Results

Retrieved on: 
Wednesday, September 20, 2023
Biotechnology, Pharmaceutical, General Health, Health, Medical Devices, Genetics, Clinical Trials, Other Health, GMP, US Foods, Ear, PTA, European Medicines Agency, Huber loss, G&A, Malignancy, Patient, Institut Pasteur Korea, R, Cisplatin, POC, Pasteur Institute, Good manufacturing practice, Hearing loss, Congenital hearing loss, Cochlear Limited, IHC, Bioreactor, Perilymph, EMA, Platinum, Ototoxicity, HIV disease progression rates, Hearing, CIO, FDA, IND, Health care, Cochlea, Cell, AAV, GJB2, Presbycusis, Audiogram, Hertz, ANSM, KOL, Partnership, Neoplasm, Concept, Clinical trial, Quality of life, CTA, Medication, CDMO, Orphan, Pharmaceutical industry, Dentistry, Vaccine, Medical device, Cryptocurrency, Rare-earth element

In the first half of 2023, Sensorion achieved a major development milestone by completing the preclinical package, and successfully producing the GMP dual AAV OTOF-GT batches at 200L clinical scale.

Key Points: 
  • In the first half of 2023, Sensorion achieved a major development milestone by completing the preclinical package, and successfully producing the GMP dual AAV OTOF-GT batches at 200L clinical scale.
  • In April 2023, Sensorion announced the candidate selection for GJB2-GT during its R&D Day focusing on gene therapy.
  • The first patient was enrolled in December 2022 and Sensorion anticipates the publication of the preliminary results in H2 2023.
  • The annual accounts on June 30, 2023, drawn up according to IFRS standards and approved by the Board of Directors on September 18, 2023.

Decibel Therapeutics Reports Second Quarter 2023 Financial Results and Corporate Update

Retrieved on: 
Friday, August 11, 2023
European Medicines Agency, CVR, Ear, Hearing loss, Regeneron Pharmaceuticals, Congenital hearing loss, COMP, Cancer, STS, Brain, Research, Cisplatin, AAV, Sale, Committee, EMA, Development, State Administrative Expenses, GJB2, Acquisition, Ototoxicity, Patient, Administration, Hearing, Orphan, Genetic distance, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Food, Pharmaceutical industry, Decibel

BOSTON, Aug. 11, 2023 (GLOBE NEWSWIRE) -- Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, today reported financial results for the second quarter ended June 30, 2023 and provided a corporate update.

Key Points: 
  • In May 2023, Decibel announced the initiation of CHORD, a global Phase 1/2 dose escalation clinical trial of DB-OTO in pediatric patients.
  • Second Quarter 2023 Financial Results:
    Cash Position: As of June 30, 2023, cash, cash equivalents and available-for-sale securities were $78.3 million, compared to $104.6 million as of December 31, 2022.
  • Research and Development Expenses: Research and development expenses were $12.8 million for the second quarter of 2023, compared to $11.2 million for the same period in 2022.
  • General and Administrative Expenses: General and administrative expenses were $6.2 million for the second quarter of 2023, compared to $5.9 million for the same period in 2022.

Decibel Therapeutics to Present at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting

Retrieved on: 
Wednesday, May 10, 2023
American Society of Gene and Cell Therapy, GJB2, Gene, Society, Hearing loss, Hearing, Cell, Annual general meeting, Pharmaceutical industry, Antibiotics

BOSTON, May 10, 2023 (GLOBE NEWSWIRE) -- Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, today announced that it will present at the American Society of Gene and Cell Therapy (ASGCT) 25th Annual Meeting, being held in Los Angeles, California May 16 – 20th, 2023.

Key Points: 
  • BOSTON, May 10, 2023 (GLOBE NEWSWIRE) -- Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, today announced that it will present at the American Society of Gene and Cell Therapy (ASGCT) 25th Annual Meeting, being held in Los Angeles, California May 16 – 20th, 2023.
  • The Company will deliver podium presentations on its lead gene therapy product candidate, DB-OTO, a gene therapy designed to provide hearing to individuals with hearing loss caused by mutations of the otoferlin gene, and its AAV.103 product candidate, a gene therapy designed to restore hearing in individuals with hearing loss caused by mutations of the gap junction beta-2 (GJB2) gene.
  • Decibel will also present posters related to its preclinical pipeline and its platform.

Sensorion Announces Candidate Selection for GJB2 Gene Therapy Program

Retrieved on: 
Thursday, April 6, 2023
Biotechnology, Genetics, Health, Clinical Trials, Steps, Collège de France, US Foods, Genetic architecture, Opinion, Primate, Therapy, Ear, College, Hearing loss, Head, Deafness, Internet, CMC, European Medicines Agency, Natural history study, Huber loss, Cell, Patient, AAV, EDT, Human voice, Center for Research and Development in Health Sciences, AP-HP, Clinical trial, GJB2, Ototoxicity, Audiology, Hearing, CEST, Institut Pasteur Korea, Webcast, Research, POC, Laboratory, IND, Pasteur Institute, Food, Vaccine, Dentistry, Pharmaceutical industry, Nursing, Medical device

Géraldine Honnet, M.D., Chief Medical Officer of Sensorion, said: “We are very proud to have selected a candidate for our GJB2-GT program.

Key Points: 
  • Géraldine Honnet, M.D., Chief Medical Officer of Sensorion, said: “We are very proud to have selected a candidate for our GJB2-GT program.
  • “Sensorion believes gene therapy has the potential to transform lives and we are delighted to be moving this promising candidate forward towards clinical development.
  • Sensorion also plans to file a Clinical Trial Application for its OTOF-GT program, a dual-vector AAV gene therapy program for the treatment of children born with hearing loss caused by otoferlin deficiency this quarter.
  • Christine Petit
    GJB2-GT Program: Data to Drive Next Steps, Dr. Laurent Désiré
    GJB2-GT Program: Natural History Studies to Prepare Execution of Clinical Trials, Dr. Géraldine Honnet
    OTOF-GT Program: SENS-501, Sensorion’s Lead Gene Therapy Program, Dr. Laurent Désiré
    Enabling Reliable Gene Therapy Manufacturing and Analytical Control, Dr. Christine Le Bec

Decibel Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Corporate Update

Retrieved on: 
Tuesday, March 14, 2023
Research, Spanish Agency of Medicines and Medical Devices, Sale, Clinical trial, Genetic distance, Medication, Brain, AEMPS, Good laboratory practice, CTA, ARO, Cisplatin, State Administrative Expenses, AAV, Ear, Development, Administration, Medicines and Healthcare products Regulatory Agency, Patient, MHRA, Midwinter, FDA, GJB2, Regeneron Pharmaceuticals, Medical device, Health care, Hearing, Investigational New Drug, Therapy, IND, Congenital hearing loss, Pharmaceutical industry, Otorhinolaryngology, Decibel

BOSTON, March 14, 2023 (GLOBE NEWSWIRE) -- Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, today reported financial results for the fourth quarter and full year ended December 31, 2022 and provided a corporate update.

Key Points: 
  • BOSTON, March 14, 2023 (GLOBE NEWSWIRE) -- Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, today reported financial results for the fourth quarter and full year ended December 31, 2022 and provided a corporate update.
  • Board of Directors Update: In October 2022, Decibel announced the appointment of Kevin F. McLaughlin to its Board of Directors.
  • Fourth Quarter and Full Year 2022 Financial Results:
    Cash Position: As of December 31, 2022, cash, cash equivalents and available-for-sale securities were $104.6 million, compared to $162.3 million as of December 31, 2021.
  • General and administrative expenses were $23.6 million for the full year 2022, compared to $20.4 million for the full year 2021.