Exophthalmos

ACELYRIN, INC. Reports Full Year 2023 Financial Results and Recent Highlights

Retrieved on: 
Thursday, March 28, 2024
Research, IL-17A, Strategic planning, Cell, Exophthalmos, Disease, Infection, Fungus, Risk, Inflammation, SLRN, Patient, Psoriatic arthritis, Acquisition, Doctor of Philosophy, MD, Quality of life, CAS, Senior, IPR, Eye, NeoGenomics, Graves' ophthalmopathy, Suicidal ideation, Behavior, Hidradenitis suppurativa, QW, Drug development, LOS, Corporate communication, Abscess, Diplopia, Pharmaceutical industry

LOS ANGELES, March 28, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today reported financial results for the full year ended December 31, 2023 and highlighted recent corporate updates and upcoming milestones.

Key Points: 
  • R&D Expenses: Research and development expenses were $355.9 million for the full year ended December 31, 2023, as compared to $55.6 million for 2022.
  • G&A Expenses: General and administrative expenses were $66.2 million for the full year ended December 31, 2023, as compared to $13.5 million for 2022.
  • Net Loss: Net loss for the full year ended December 31, 2023 was $381.6 million, compared to $64.8 million for 2022.
  • In December 2023, the Company announced the appointment of Lynn Tetrault to its Board of Directors.

Kriya Provides Update on Pipeline Progress Ahead of Company Presentation at 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Monday, January 8, 2024
Continuity, Diabetes, Entrepreneurship, Risk, C3, Non-alcoholic fatty liver disease, Epilepsy, FDA, CR2, Anticonvulsant, Inflammation, Neuron, Geographic atrophy, Conference, Paratriathlon, Pain, European, Disease, Cmax, Glycated hemoglobin, Trigeminal neuralgia, FGF21, Steatosis, Therapy, Computational biology, Exophthalmos, TED, Diplopia, Varenicline, Smoking, Injection, AAV, CNS, DSM-IV codes, Patient, Graves' ophthalmopathy, Medicine, Seizure, Glucokinase, Neurology, CR1, NASH, Insulin, Brain, GMP, Trigeminal nerve, Ophthalmology, Pathology, Fibrosis, Pharmaceutical industry

PALO ALTO, Calif. and RESEARCH TRIANGLE PARK, N.C., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Kriya Therapeutics, Inc., ("Kriya") a biopharmaceutical company developing gene therapies for common diseases affecting millions of people around the world, today provided an update on its pipeline of gene therapies for prevalent conditions including geographic atrophy, thyroid eye disease, diabetes, NASH, trigeminal neuralgia and epilepsy. Kriya is advancing the first of its gene therapy product candidates into the clinic in 2024 and expects up to five programs in the clinic by the end of 2025.

Key Points: 
  • Kriya’s pipeline includes gene therapies across three major therapeutic areas: ophthalmology, metabolic disease and neurology.
  • Its programs share the following features: direct-to-tissue delivery, validated biology, de-risked clinical and regulatory paths and large commercial markets.
  • Dr. Ramaswamy will share further information on Kriya’s portfolio during his presentation at the J.P. Morgan 42nd Annual Healthcare Conference on Tuesday, January 9th at 9:00 AM PT in San Francisco, California.
  • A significant proportion of patients suffer from refractory epilepsy, many of whom are candidates for invasive neurosurgery.

Tourmaline Bio Announces Expected Upcoming Key Milestones for the Clinical Development of TOUR006, a Long-Acting Subcutaneous Inhibitor of IL-6 with Best-in-Class Potential, in Thyroid Eye Disease (TED) and Atherosclerotic Cardiovascular Disease (ASCVD)

Retrieved on: 
Monday, January 8, 2024
TED, Quality of life, Entrepreneurship, TRML, C-reactive protein, Diplopia, Membrane protein, Moyamoya disease, FDA, Alignment, Inflammation, Injection, Spirited, Half-life, MD, Pharmacokinetics, IL-6, Biomarker, Patient, Safety, Cardiovascular disease, CRP, CAS, Exophthalmos, Pharmaceutical industry

NEW YORK, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Tourmaline Bio, Inc. (Tourmaline) (NASDAQ: TRML), a late-stage clinical biotechnology company developing transformative medicines to dramatically improve the lives of patients with life-altering immune and inflammatory diseases, announced today that:

Key Points: 
  • This second pivotal trial will replace the previously planned TED basket trial and does not impact Tourmaline’s expected cash runway through 2026.
  • This trial is targeted to commence in the first half of 2024, with topline data expected in the first half of 2025.
  • Pending success, the results from the Phase 2 trial are expected to position Tourmaline to be ready in 2025 to commence a pivotal Phase 3 trial in cardiovascular disease.
  • To date, TOUR006 has been studied in 448 participants, including patients with autoimmune disorders, across six clinical trials.

Kriya Announces Gene Therapy Program for Thyroid Eye Disease

Retrieved on: 
Friday, January 5, 2024
TED, Quality of life, Entrepreneurship, Conference, Geographic atrophy, Diplopia, Teprotumumab, Fibroblast, FDA, Paratriathlon, European, Disease, Graves' ophthalmopathy, Eye, Therapy, Inflammation, Adipocyte, PALO, AAV, Ophthalmology, Cell, Exophthalmos

PALO ALTO, Calif. and RESEARCH TRIANGLE PARK, N.C., Jan. 05, 2024 (GLOBE NEWSWIRE) -- Kriya Therapeutics, Inc., (Kriya) a biopharmaceutical company developing gene therapies for common diseases affecting millions of people around the world, today announced its gene therapy program for thyroid eye disease (TED), a debilitating autoimmune condition resulting in proptosis and diplopia, medical terms describing bulging of the eyes and double vision respectively, due to inflammation of the muscles and fat tissue behind the eye. TED affects approximately one million people in the United States and the European Union.

Key Points: 
  • TED affects approximately one million people in the United States and the European Union.
  • Kriya is developing KRIYA-586, a one-time, adeno-associated virus (AAV) gene therapy that drives durable expression of a monoclonal antibody that blocks IGF-1 receptors.
  • IGF-1R blockade has been established as a clinically validated mechanism of action, as evidenced by teprotumumab, the first and only FDA-approved therapy for TED.
  • "We believe that an in-office, focally administered gene therapy for TED would meaningfully improve the quality of life of people with TED, with the potential to durably address the disease following one-time injection,” said Shankar Ramaswamy, M.D., Co-Founder and CEO of Kriya.

BriaCell Images Confirm Robust Anti-Tumor Activity in Patient with “Eye-Bulging” Metastatic Breast Cancer

Retrieved on: 
Thursday, January 4, 2024
MRI, Neoplasm, Breast cancer, Woman, BCT, Eye, Therapy, CNS, TSX, Patient, Central nervous system, Magnetic resonance imaging, Exophthalmos, Medical imaging

The patient had metastatic breast cancer behind her eye, causing proptosis (eye-bulging) and significant pain that were both markedly reduced with BriaCell’s treatment.

Key Points: 
  • The patient had metastatic breast cancer behind her eye, causing proptosis (eye-bulging) and significant pain that were both markedly reduced with BriaCell’s treatment.
  • We observed significant tumor reduction along with significant eye pain reduction after only 3 cycles of treatment with the Bria-IMT™ combination regimen.
  • The Bria-IMT™ regimen has been very well tolerated and the patient remains on treatment,” stated Dr. William V. Williams, BriaCell’s President and CEO.
  • The Bria-IMT™ combination regimen is currently undergoing a pivotal Phase 3 study in advanced breast cancer.

BriaCell Records New Responder with Remarkable Improvement of “Eye-Bulging” Metastatic Tumor

Retrieved on: 
Thursday, November 30, 2023
Survival, HER2, Breast cancer, BCT, Disease, Brain, Cancer, Eye, Therapy, Skull, University, Sternum, Neoplasm, Observation, Spine, Face, TSX, Patient, Central nervous system, Pelvis, Exophthalmos, Pharmaceutical industry

After only 3 cycles, patient experienced a remarkable improvement of eye-bulging “proptosis” caused by orbital metastatic breast cancer tumor behind the eye.

Key Points: 
  • After only 3 cycles, patient experienced a remarkable improvement of eye-bulging “proptosis” caused by orbital metastatic breast cancer tumor behind the eye.
  • BriaCell’s clinical team reported a patient with extensive metastatic breast cancer who had failed all available therapies.
  • “We were excited to offer her the latest treatments and thrilled to share in her success and joy.”
    The noted responder, a post-menopausal metastatic breast cancer patient (the “Remarkable Responder”), experienced a remarkable improvement of proptosis caused by breast cancer tumors behind the eye, resulting in significant pain reduction in the ocular region.
  • BriaCell had previously reported a similar case of a remarkable response with 100% resolution of an eye-bulging orbital tumor ( release here ).

Global Graves' Disease Drug Pipeline Research Report 2023: Comprehensive Insights About 8+ Companies and 10+ Pipeline Drugs - ResearchAndMarkets.com

Retrieved on: 
Thursday, November 9, 2023
Health, Pharmaceutical, CAS, Neonatal Fc receptor, Therapy, Grave, II, Exophthalmos, Linsitinib, Graves' ophthalmopathy, News, Discovery, Graves' disease, Viridian, Disease, Clinical trial, TED, Mergers and acquisitions, Diplopia, Immunoglobulin G, Recycling, NDA, Autoimmunity, Patient, Pharmaceutical industry, Vaccine, Phase

The "Graves' Disease - Pipeline Insight, 2023" report offers comprehensive insights into the Graves' Disease pipeline landscape, encompassing information on more than 8 companies and over 10 pipeline drugs.

Key Points: 
  • The "Graves' Disease - Pipeline Insight, 2023" report offers comprehensive insights into the Graves' Disease pipeline landscape, encompassing information on more than 8 companies and over 10 pipeline drugs.
  • The report delivers a thorough understanding of the current scenario and growth prospects within the Graves' Disease indication.
  • It furnishes an extensive overview of the Graves' Disease pipeline landscape, including information on the disease itself and treatment guidelines.
  • The assessment section of the report includes a comprehensive commercial assessment of Graves' Disease, as well as a clinical evaluation of the pipeline products currently in development.

Thrive Health IV Centers Expand in Key Markets and Open Research Clinics

Retrieved on: 
Tuesday, September 5, 2023
Exophthalmos, Partnership, Graves' ophthalmopathy, Clinical trial, Woman, Research, Approximation error, Doctor of Philosophy, Science, Grave, Patient, University of California, San Francisco Fetal Treatment Center, FACS, Thyroid disease, FDA, Health, Hyperthyroidism, Autoimmunity, TED, Medical device, Pharmaceutical industry, MD

BEVERLY HILLS, Calif., Sept. 5, 2023 /PRNewswire-PRWeb/ -- Thrive Health IV, founded by renowned board certified oculoplastic surgeon, Raymond Douglas, MD, PhD, announced today the opening of three new dedicated treatment centers of excellence in Miami, Florida, Des Moines, Iowa and Chicago, Illinois for Thyroid Eye Disease [TED] and other rare ophthalmic conditions.

Key Points: 
  • Thrive Health IV leverages cutting edge science and exceptional concierge care in the growing category of medical biologics and new disease modalities.
  • Thrive Health IV is also launching a new research division and operating clinical trials at all sites, propelling Thrive Health IV to the forefront of all potential therapies for auto-immune thyroid related eye disease and other rare ophthalmic conditions.
  • Additional Thrive Health IV locations with research and clinical trial operations are set to open in two new states in three additional markets as a next phase before 2024.
  • Thrive Health IV centers of excellence, also offers ongoing patient care management that includes monitoring blood sugar and complimentary audiology testing.

TEPEZZA® (teprotumumab) Approved in Brazil for the Treatment of Active Thyroid Eye Disease (TED)

Retrieved on: 
Monday, June 26, 2023
Science, Biotechnology, Research, Pharmaceutical, Optical, Health, FDA, Clinical Trials, Exophthalmos, ANVISA, OPTIC, Diplopia, Medicine, Patient, Autoimmune disease, CAS, Brazilian Health Regulatory Agency, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, TED

Horizon Therapeutics plc (Nasdaq: HZNP) today announced the Brazilian Health Regulatory Agency (ANVISA) has approved TEPEZZA for the treatment of active TED.

Key Points: 
  • Horizon Therapeutics plc (Nasdaq: HZNP) today announced the Brazilian Health Regulatory Agency (ANVISA) has approved TEPEZZA for the treatment of active TED.
  • TEPEZZA is the first and only medicine approved for active TED in Brazil, filling a significant unmet need for those who are living with this progressive autoimmune disease that can threaten vision.
  • The first trial in Japan (OPTIC-J) is evaluating TEPEZZA for the treatment of TED patients with disease duration of nine months or less and high clinical activity score (CAS), which is a measure of disease activity.
  • The second is evaluating TEPEZZA for the treatment of adults with disease duration of two to ten years and low CAS.

Horizon Therapeutics plc Announces Positive Topline Data from Phase 3 Clinical Trial (OPTIC-J) in Japan Evaluating TEPEZZA® (teprotumumab-trbw) for the Treatment of Active Thyroid Eye Disease (TED)

Retrieved on: 
Thursday, June 22, 2023
Health, Clinical Trials, Research, Science, Pharmaceutical, Optical, Biotechnology, Exophthalmos, Steroid, CAS, Cover My Eyes (Pain and Heaven), Diplopia, Patient, Red, Week, Graves' ophthalmopathy, Disease, TED, Pharmaceutical industry

Horizon Therapeutics plc (Nasdaq: HZNP) today announced positive topline results from its randomized, double-masked, placebo-controlled Phase 3 clinical trial evaluating TEPEZZA for the treatment of TED in Japanese patients with higher levels of disease activity, as measured by clinical activity score (CAS).

Key Points: 
  • Horizon Therapeutics plc (Nasdaq: HZNP) today announced positive topline results from its randomized, double-masked, placebo-controlled Phase 3 clinical trial evaluating TEPEZZA for the treatment of TED in Japanese patients with higher levels of disease activity, as measured by clinical activity score (CAS).
  • At Week 24, 89% of patients treated with TEPEZZA had a clinically meaningful improvement in proptosis (≥2 mm) compared with placebo (11%) (p
  • Additional data from the trial will be presented at a medical congress and published in a peer-reviewed medical journal.
  • The trial methodology is based on the OPTIC Phase 3 trial conducted in the United States and Europe.