Histology

EQS-News: Immunic, Inc. Reports Year End 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, March 13, 2024

The highly encouraging results demonstrated clear separation from placebo in serum neurofilament light chain (NfL) levels in patients with progressive multiple sclerosis (PMS).

Key Points: 
  • The highly encouraging results demonstrated clear separation from placebo in serum neurofilament light chain (NfL) levels in patients with progressive multiple sclerosis (PMS).
  • The results demonstrated meaningful improvements over placebo in four key dimensions of celiac disease pathophysiology: histology, disease symptoms, biomarkers and nutrient absorption.
  • Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial in access.
  • An archived replay of the webcast will be available approximately one hour after completion on Immunic’s website at: ir.imux.com/events-and-presentations .

Microbix Unveils Test Controls for Head and Neck Cancer

Retrieved on: 
Monday, March 11, 2024

While HPV is best known for causing cancers of the cervix in women, this virus family also causes cancer in other bodily tissues.

Key Points: 
  • While HPV is best known for causing cancers of the cervix in women, this virus family also causes cancer in other bodily tissues.
  • Such further types of HPV-driven cancer include those of the “Head and Neck,” collectively tumours inside and behind the nose, throughout the mouth (including the tongue, gums, and palate), all sections of the throat, and the voice box.
  • Unfortunately, a lack of standardized and reproducible reference samples makes it challenging to control the recommended test workflows for diagnosing such cancers.
  • These standardized and reproducible tissue-oriented test controls will then be added to Microbix’s catalogue of QAPs, expanding its activities into support of oncology workflows alongside its wide range of infectious disease test controls.

Akero Therapeutics Announces Publication of Phase 2b SYMMETRY Cohort D Study in Clinical Gastroenterology and Hepatology

Retrieved on: 
Thursday, March 7, 2024

SOUTH SAN FRANCISCO, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease, today announced publication of results in Clinical Gastroenterology and Hepatology from an expansion cohort (Cohort D, N=31) of the Phase 2b SYMMETRY study.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease, today announced publication of results in Clinical Gastroenterology and Hepatology from an expansion cohort (Cohort D, N=31) of the Phase 2b SYMMETRY study.
  • Tolerability of EFX on top of GLP-1RA (N=21 patients) was generally comparable to GLP-1RA alone (placebo, N=10).
  • The most frequent adverse events for EFX-treated patients were grade 1 or 2 gastrointestinal events (diarrhea, nausea, and increased appetite).
  • Patients treated with EFX plus GLP-1RA showed a similar mean weight loss from baseline relative to patients treated with GLP-1RA alone.

Akero Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, February 29, 2024

SYNCHRONY Histology is evaluating the safety and efficacy of 28 and 50mg doses of efruxifermin (EFX) in patients with biopsy confirmed pre-cirrhotic MASH (F2-F3).

Key Points: 
  • SYNCHRONY Histology is evaluating the safety and efficacy of 28 and 50mg doses of efruxifermin (EFX) in patients with biopsy confirmed pre-cirrhotic MASH (F2-F3).
  • Additional patients will be enrolled and followed for long-term clinical outcomes to support an application for full marketing approval.
  • In the fourth quarter of 2023, Akero reported results for the week 36 analysis of the Phase 2b SYMMETRY study in patients with cirrhosis due to MASH.
  • Akero's cash, cash equivalents, short-term and long-term marketable securities for the year ended December 31, 2023 were $569.3 million.

Sensei Biotherapeutics Reports Full Year 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Wednesday, February 28, 2024

BOSTON, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, today reported financial results for the full year 2023, and provided corporate updates.

Key Points: 
  • “2023 saw the entry of our differentiated anti-VISTA antibody, SNS-101, into clinical development,” said John Celebi, President and Chief Executive Officer.
  • Recent updates include:
    A total of 33 patients have been treated with SNS-101 +/- Libtayo in the dose escalation phase of this study.
  • On October 23, 2023 , Sensei presented a trial-in-progress poster from the Phase 1/2 clinical trial for SNS-101 at the European Society for Medical Oncology Congress (ESMO) 2023.
  • On November 1, 2023, Sensei announced the appointment of Stephanie Krebs, MS, MBA, as Chief Business Officer.

Medical Journal: Image-Guided Superficial Radiation Therapy Is Superior to Superficial Radiation Therapy Without Guidance

Retrieved on: 
Tuesday, February 20, 2024

BURR RIDGE, Ill., Feb. 20, 2024 /PRNewswire/ -- SkinCure Oncology, the world leader in providing a comprehensive model for the delivery of Image-Guided Superficial Radiation Therapy (Image-Guided SRT or IGSRT) for the treatment of nonmelanoma skin cancer, presented to dermatology patients as the GentleCure™ experience, announced the publication of research, "Image guidance improves freedom from recurrence in superficial radiation therapy for non-melanoma skin cancer," in Advances in Radiation Oncology, a peer-reviewed journal from the American Society for Radiation Oncology (ASTRO).

Key Points: 
  • It shows definitively that the new technology is superior, and represents a seminal moment in the care of skin cancer patients using radiation.
  • This study is the first to rigorously compare SRT to IGSRT, and it covers all the data that exists on IGSRT.
  • Superficial radiation therapy was developed over 100 years ago ( here ) and was the standard therapy for nonmelanoma skin cancer until Mohs micrographic surgery emerged in the 1930's ( here ).
  • IGSRT and the GentleCure experience will be showcased at the upcoming American Academy of Dermatology annual meeting in San Diego, at booth 3555.

Anika Highlights Its Recently Launched Integrity™ Implant System and RevoMotion™ Reverse Shoulder Arthroplasty System Along with Other Key Regenerative Products During the 2024 AAOS Annual Meeting

Retrieved on: 
Tuesday, February 13, 2024

BEDFORD, Mass., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global joint preservation company, today announced it is highlighting recently-launched products in high growth segments of joint preservation and restoration from its Regenerative Solutions, Sports Medicine and Arthrosurface Joint Solutions businesses during the 2024 American Academy of Orthopedic Surgeons (AAOS) Annual Meeting on February 13-15 in San Francisco, CA. Throughout the event, Anika will feature its differentiated shoulder portfolio including the recently launched Integrity Implant System for rotator cuff repair, RevoMotion Reverse Shoulder Arthroplasty (RSA) System with newly launched AIMTM (Anika Implant Management) surgical planning software, X-Twist Fixation System with biocomposite suture anchor, OVOMotion® with Inlay Glenoid Total Shoulder Arthroplasty (TSA) System, and many more of its early intervention orthopedic solutions, in booth #5145.

Key Points: 
  • “Anika is excited to highlight our recently launched Integrity Implant System, our newest regenerative hyaluronic acid (HA)-based scaffold for rotator cuff repair, and our X-Twist Fixation System with biocomposite suture anchor.
  • We have also enhanced our shoulder arthroplasty offerings with the launch of AIM, Anika Implant Management, for 3-D preoperative planning which is now available with both the RevoMotion Reverse Shoulder and OVOMotion Total Shoulder arthroplasty systems.
  • The RevoMotion Reverse Shoulder Arthroplasty System, with the industry’s smallest diameter threaded baseplate, offers surgeons and patients the ability to restore motion and preserve bone.
  • Several new Sports Medicine products will also be available in early 2024, including the ProPass™ Suture Passer, and other new shoulder instrumentation.

David Bruning Named Chief Executive Officer of StageBio

Retrieved on: 
Monday, February 12, 2024

JACKSON, Va., Feb. 12, 2024 /PRNewswire/ -- StageBio, a leading provider of GLP-compliant histology, pathology, image analysis and archiving services for both preclinical and clinical research, is pleased to announce the appointment of David Bruning as Chief Executive Officer.

Key Points: 
  • JACKSON, Va., Feb. 12, 2024 /PRNewswire/ -- StageBio, a leading provider of GLP-compliant histology, pathology, image analysis and archiving services for both preclinical and clinical research, is pleased to announce the appointment of David Bruning as Chief Executive Officer.
  • Having served on the StageBio Board of Directors for the past five years in addition to previously being a longstanding customer of StageBio, Mr. Bruning possesses a deep understanding of the company, its strategic priorities and the evolving needs of its customers.
  • On his appointment as CEO, Mr. Bruning comments, "I'm grateful for the opportunity to lead StageBio in its next phase of growth.
  • David's understanding of the business and its customers, coupled with his industry expertise, positions him for success in driving continuous growth for StageBio in 2024 and beyond."

StatLab Medical Products Announces New Facility Opening

Retrieved on: 
Monday, February 12, 2024

StatLab Medical Products (StatLab), a leading global developer and manufacturer of medical diagnostic equipment and supplies, announces the commencement of injection molding manufacturing at a new, state-of the-art histology consumable manufacturing facility in Arlington, Texas.

Key Points: 
  • StatLab Medical Products (StatLab), a leading global developer and manufacturer of medical diagnostic equipment and supplies, announces the commencement of injection molding manufacturing at a new, state-of the-art histology consumable manufacturing facility in Arlington, Texas.
  • This represents a new era of innovation and transformational opportunity for StatLab with a new essential manufacturing capability for histology solutions now actively operating in the United States.
  • View the full release here: https://www.businesswire.com/news/home/20240212393712/en/
    The new StatLab histology consumable manufacturing facility, where injection molding is operational, producing histology cassettes—a critical component of the histology workflow in laboratories.
  • A short reception and facility tours will follow through 2PM.

Dupixent® (dupilumab) FDA Approved as First and Only Treatment Indicated for Children Aged 1 Year and Older with Eosinophilic Esophagitis (EoE)

Retrieved on: 
Thursday, January 25, 2024

TARRYTOWN, N.Y. and PARIS, Jan. 25, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of pediatric patients aged 1 to 11 years, weighing at least 15 kg, with eosinophilic esophagitis (EoE). Dupixent is now the first and only medicine approved in the U.S. specifically indicated to treat these patients. This approval expands the initial FDA approval for EoE in May 2022 for patients aged 12 years and older, weighing at least 40 kg. The FDA evaluated Dupixent for this expanded indication under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions.

Key Points: 
  • Dupixent is now the first and only medicine approved in the U.S. specifically indicated to treat these patients.
  • This approval expands the initial FDA approval for EoE in May 2022 for patients aged 12 years and older, weighing at least 40 kg.
  • Approximately 21,000 children under the age of 12 in the U.S. are currently being treated for EoE with unapproved therapies.
  • “With this approval, Dupixent becomes the first and only treatment option for EoE patients aged 1 and older, weighing at least 15 kg.