Nationwide Children's Hospital

Humacyte Fourth Quarter and Year End 2023 Financial Results and Business Update

Retrieved on: 
Friday, March 22, 2024
Diagnosis, Research, U.S. FDA, Peripheral artery disease, Infection, Patent, Buddha's hand, Evaluation, PAD, Journal, Sale, University, Doctor of Philosophy, Efficacy, Priority review, Regenerative medicine, Clinical trial, Trial of the century, Vascular surgery, HAV, Hospital, Injury, Nationwide Children's Hospital, HUMA, FACS, Amputation, Food, FDA, Defense, BLA, PDUFA, Pharmaceutical industry

DURHAM, N.C., March 22, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced financial results for the fourth quarter and year ended December 31, 2023 and highlighted recent corporate accomplishments in advancing the investigational Human Acellular Vessel (HAV) closer to planned U.S. market launch.

Key Points: 
  • There was no revenue for either the fourth quarter of 2023 or the fourth quarter of 2022, and there was no revenue for the year ended December 31, 2023.
  • Research and development expenses were $20.2 million for the fourth quarter of 2023, compared to $15.0 million for the fourth quarter of 2022, and were $76.6 million for the year ended December 31, 2023, compared to $63.3 million for the year ended December 31, 2022.
  • General and administrative expenses were $6.0 million for the fourth quarter of 2023, compared to $5.8 million for the fourth quarter of 2022, and were $23.5 million for the year ended December 31, 2023, compared to $22.9 million for the year ended December 31, 2022.
  • The 2023 increases in net loss resulted from the non-cash remeasurement of the contingent earnout liability, and operating expense increases, described above.

Global Leaders in Cancer Research and Biotech Join The Mark Foundation for Cancer Research's Scientific Advisory and Industry Advisory Committees

Retrieved on: 
Tuesday, April 2, 2024
Molecule, Medicine, Cancer Research UK, FRS, Weill Cornell Medicine, Francis Crick Institute, B cell, Patient, Investment, Children's National Hospital, Therapy, Research, Biotechnology, Genentech, Dana–Farber Cancer Institute, Committee, Trial of the century, University, University College Hospital, Metastasis, Multiple sclerosis, Drug discovery, MBBS, Chairperson, MD, University College London, Senior, FRCP, University of California, Berkeley, Hospital, Nationwide Children's Hospital, Marker beacon, Diagnosis, Lung cancer, Ludwig Cancer Research, University of Pennsylvania, Doctor of Philosophy, BTK, GV (company), Celera Corporation, Pharmaceutical industry

NEW YORK, April 2, 2024 /PRNewswire/ -- The Mark Foundation for Cancer Research, a leading nonprofit dedicated to advancing research that transforms the prevention, diagnosis, and treatment of cancer, proudly announces the appointment of new members to its Scientific Advisory and Industry Advisory Committees.

Key Points: 
  • The committee assists the foundation in reviewing its scientific goals and grant applications, as well as providing strategic advice and support for its research programs and investments.
  • "The outstanding researchers on our advisory committees provide invaluable guidance and insight to help steer its programs toward success and impact."
  • "The Mark Foundation's funding of high-risk, high-impact research is essential in the quest to achieve real breakthroughs in cancer research," said Johanna Joyce, PhD.
  • "I am honored to join the Scientific Advisory Committee, to support the next generations of scientists and projects that will revolutionize treatments for patients."

MAIA Biotechnology and Nationwide Children’s Hospital Announce Presentation of THIO’s Potency in Pediatric Brain Tumors at American Association of Cancer Research Annual Meeting

Retrieved on: 
Wednesday, March 6, 2024
Children, Biotechnology, Health, Pharmaceutical, Oncology, Research, Family, Hospitals, Consumer, Science, Clinical Trials, Cancer, Central nervous system, Radiation, Immune system, MAIA, Ohio State University, Cell proliferation, Nationwide Children's Hospital, Nationwide, Hospital, Brain, AACR, Survival rate, Prognosis, CNS, Associate, Survival, Immunotherapy, DIPG

The research was conducted in collaboration with Nationwide Children's Hospital and led by Dr. Drissi.

Key Points: 
  • The research was conducted in collaboration with Nationwide Children's Hospital and led by Dr. Drissi.
  • The study explored the combination of THIO and ionizing radiation (IR) treatments to induce direct anticancer effects and stimulate anti-tumor immunity in diffuse intrinsic pontine glioma (DIPG).
  • DIPG, a very difficult-to-treat and high-risk childhood cancer, is a central nervous system (CNS) tumor that forms in the brainstem.
  • Scientists from Nationwide Children’s Hospital and MAIA have shown that THIO synergistically sensitizes DIPG cells to ionizing radiation (IR), significantly decreasing cell proliferation.

Sarepta Therapeutics Announces Fourth Quarter and Full-Year 2023 Financial Results and Recent Corporate Developments

Retrieved on: 
Wednesday, February 28, 2024
Health, Genetics, Research, Pharmaceutical, Science, Biotechnology, SRPT, Hart–Scott–Rodino Antitrust Improvements Act, Investment, Interest, Sarepta Therapeutics, Part, Sale, University, Trial of the century, Ageing, BLA, GAAP, Therapy, BioMarin Pharmaceutical, Income tax, PMR, Depreciation, Magnesium deficiency, Nationwide Children's Hospital, Hospital, Safety, Patent, Clinical trial, Biologics license application, Mutation, Priority review, Acquisition, PIN, Dystrophin, FDA, Food, DMD, Duchenne muscular dystrophy, U.S. FDA, Agency, Patient, PRV, PMO, Pharmaceutical industry

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported financial results for the fourth quarter and full-year 2023.

Key Points: 
  • Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported financial results for the fourth quarter and full-year 2023.
  • Beginning in the fourth quarter of 2023, amortization of in-licensed rights (formerly included within depreciation and amortization expense) and income tax (benefit) expense are no longer excluded from the non-GAAP results.
  • Non-GAAP financial results for the fourth quarter and full-year 2022 have been updated to reflect this change for comparability.
  • All relevant non-GAAP measures are reconciled from their respective GAAP measures in the attached table “Reconciliation of GAAP Financial Measures to Non-GAAP Financial Measures.”

Limb-Girdle Muscular Dystrophy Leaders Advance Collaborative Dialogue to Accelerate Drug Development to Address the Urgent Unmet Need in Limb-Girdle Muscular Dystrophy

Retrieved on: 
Tuesday, February 27, 2024
LGMD, Nationwide Children's Hospital, Analysis Group, OND, FDA, Clinical trial, Food, Drug development, Sarepta Therapeutics, Virginia Commonwealth University, Hospital, Treatment, Senior advisor, Documentation, University, CDER, Therapy, Keynote, Patient, Science, Limb–girdle muscular dystrophy

The meeting focused on six LGMD subtypes: 2A/R1, 2B/R2, 2C/R5, 2D/R3, 2E/R4, and 2I/R9.

Key Points: 
  • The meeting focused on six LGMD subtypes: 2A/R1, 2B/R2, 2C/R5, 2D/R3, 2E/R4, and 2I/R9.
  • We are thrilled that the workshop advanced a collaborative dialogue and brought people together from every facet of the drug development process to drive progress for patients.
  • This was truly a monumental event for the LGMD community and a model for others to follow in the future."
  • In-depth documentation of the workshop's findings and next steps is in progress and will be shared when available.

APhA announces 2024 Remington Honor Medal recipient

Retrieved on: 
Wednesday, January 10, 2024
Pediatrics, Patient, Emeritus, Research, Multimedia, Internal medicine, American Pharmacists Association, National academy, Doctor of Pharmacy, OSU, Pharmacist, Society, Nahata, Book, Hospital, Nationwide Children's Hospital, Ohio State University, College, British campaign medals, Nursing

WASHINGTON, Jan. 10, 2024 /PRNewswire/ -- The American Pharmacists Association (APhA) began announcing the selection of the 2024 APhA Awards and Honors Program recipients today.

Key Points: 
  • WASHINGTON, Jan. 10, 2024 /PRNewswire/ -- The American Pharmacists Association (APhA) began announcing the selection of the 2024 APhA Awards and Honors Program recipients today.
  • Recipients will be officially recognized during the APhA Annual Meeting & Exposition in Orlando, FL, March 22–25, 2024.
  • It serves as the preeminent award for the profession of pharmacy and is the highest honor bestowed by APhA.
  • Milap C. Nahata, PharmD, MS, of Powell, OH, was selected as the recipient of the 2024 Remington Honor Medal.

Children's Miracle Network Hospitals® Announces 11 New National Champions Advocating for Pediatric Healthcare

Retrieved on: 
Tuesday, January 2, 2024
Long, PVL, Walking, Nyla, Children's Specialized Hospital, Family, Hospital, Children's Hospital, Occupational therapy, Arrhythmia, Research, State, PTLS, Hope, Bed rest, NICU, Health, Organic, Eye, Infant, Nationwide Children's Hospital, Cancer, Cerebral palsy, Syndrome, Love, Fertilisation, Doctor of Philosophy, Long QT syndrome, Genetic testing, Children's Miracle Network Hospitals, Safety, Prediabetes, DSM-IV codes, National championship, Life, Health insurance

SALT LAKE CITY, Jan. 2, 2024 /PRNewswire-PRWeb/ -- Children's Miracle Network Hospitals proudly introduces its newest cohort of National Champions, a group of extraordinary ambassadors dedicated to raising awareness about the critical need for charitable donations to support pediatric healthcare. These inspirational children and their families hail from diverse backgrounds and represent various member hospitals across the U.S. Each Champion's unique journey exemplifies the profound impact of donations on their lives, underscoring the urgent need to support Children's Miracle Network Hospitals.

Key Points: 
  • Adeline - Duke Children's Hospital (Age: 8)
    "The stories of our National Champions emphasize the transformative impact of charitable donations on pediatric healthcare," said Aimee Daily, Ph.D., President & CEO, Children's Miracle Network Hospitals.
  • Children's Miracle Network Hospitals, the largest fundraising network for children's hospitals in the U.S. and Canada, partners with leading pediatric healthcare providers to give kids a world of possibilities.
  • "The stories of our National Champions emphasize the transformative impact of charitable donations on pediatric healthcare," said Aimee Daily, Ph.D., President & CEO, Children's Miracle Network Hospitals.
  • National Champions are a group of ambassadors for Children's Miracle Network Hospitals located throughout the U.S. As National Champions, they're key to informing the public that children's hospitals are charities in need of donations.

Humacyte Third Quarter 2023 Financial Results and Business Update

Retrieved on: 
Thursday, November 9, 2023
Sale, Trauma, Patient, Nationwide Children's Hospital, Research, Conference, Infection, Military personnel, Human, Food, Conference call, Journal, Clinical professor, HUMA, Moyamoya disease, Trial of the century, Extremities, BLA, PAD, Buddha's hand, Amputation, Injury, Saphenous, Chin Na, Patent, Gunshot, Polytetrafluoroethylene, Clinical trial, Peripheral artery disease, Chronic limb threatening ischemia, HAV, Dialysis, FDA, Success, File, Survival, Mayo Clinic, Accident, Hospital, Pharmaceutical industry, Medical device, Tetralogy of Fallot

DURHAM, N.C., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced financial results for the third quarter ended September 30, 2023 and highlighted recent corporate accomplishments advancing the investigational, universally implantable Human Acellular Vessel (HAV) closer to planned U.S. market launch.

Key Points: 
  • In addition, we recently published preclinical results of our small caliber HAV in a juvenile heart disease model.
  • Planned BLA Filing this Quarter – Humacyte plans to file a BLA for the HAV for the treatment of vascular trauma with the FDA during the current quarter.
  • There was no revenue for the third quarter of 2023 and nine months ended September 30, 2023.
  • The decrease in other net expense for the third quarter of 2023 compared to 2022 resulted primarily from an increase in interest income due to rate increases.

Share Your Story Foundation Launches New Line of Pajamas for Children Going Through Cancer Treatment

Retrieved on: 
Wednesday, December 13, 2023
Courage, Ewing sarcoma, Hope, Pajamas, Share, Patient, Nationwide Children's Hospital, System, Cancer, Housing, Herberger, Hershberger, Life, Hospital, Mobile phone

COLUMBUS, Ohio, Dec. 13, 2023 /PRNewswire/ -- Share Your Story Foundation – a non-profit organization that meets the practical needs of families affected by cancer – is launching the first-ever line of pajamas tailored to the unique needs of pediatric cancer patients. The pajamas have strategically placed adaptable closures which provide convenient access to ports and picc lines, buttery-soft fabrics and print designs that offer messages of hope and courage.

Key Points: 
  • The small collection is called hallegrace, in honor of Halle Temple, the young lady who inspired their design.
  • From the age of six, Halle faced Ewing sarcoma, a rare bone cancer, three times before passing away in May 2020.
  • Through it all, Halle was on a mission to make the lives of other cancer patients more comfortable, and it was through this dream that the Share Your Story Foundation was born.
  • To date, Share Your Story Foundation has focused on housing families for free that are going through long-term cancer treatment at Nationwide Children's Hospital and The James.

Limb-Girdle Muscular Dystrophy Scientific Leaders - Together With the FDA - Will Come Together for a Drug Development Workshop on February 8, 2024

Retrieved on: 
Wednesday, December 13, 2023
Food, OND, Therapy, Hospital, CBER, Patient, Nationwide Children's Hospital, Virginia Commonwealth University, FDA, CDER, Caregiver, Limb–girdle muscular dystrophy, University, Muscular dystrophy, Drug development, Pharmaceutical industry, Medical device, LGMD, Research

ROCKVILLE, Md., Dec. 13, 2023 /PRNewswire/ -- On February 8, 2024, The Speak Foundation, a patient-led 501(c)(3) organization for Limb-Girdle Muscular Dystrophy (LGMD), will be convening a multi-stakeholder LGMD Scientific Drug Development Workshop in Rockville, Maryland.

Key Points: 
  • ROCKVILLE, Md., Dec. 13, 2023 /PRNewswire/ -- On February 8, 2024, The Speak Foundation, a patient-led 501(c)(3) organization for Limb-Girdle Muscular Dystrophy (LGMD), will be convening a multi-stakeholder LGMD Scientific Drug Development Workshop in Rockville, Maryland.
  • The workshop will continue to drive the momentum for the sense of urgency needed by the patient community to accelerate LGMD drug development.
  • "This workshop is a continuing step to work with the FDA and LGMD scientific leaders on pushing critical drug development forward.
  • The LGMD Scientific Workshop will be a focused discussion with clinicians, scientific researchers, drug developers, regulators, patients and patient advocates on the characteristics of LGMD that drive drug development programs.