Myasthenia gravis

AI-Based Analysis of Dynamic Digital Radiography Data Gives Researchers Greater Insight into Lung Function and Pulmonary Disorders

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木曜日, 5月 23, 2024

This AI-powered technique provides a reliable alternative to pulmonary function tests (PFTs), which have limited assessment capabilities and can be difficult for some patients with pulmonary disorders to complete.

Key Points: 
  • This AI-powered technique provides a reliable alternative to pulmonary function tests (PFTs), which have limited assessment capabilities and can be difficult for some patients with pulmonary disorders to complete.
  • Researchers at the Icahn School of Medicine at Mount Sinai ("Icahn Mount Sinai") used Dynamic Digital Radiography (DDR) data, an X-ray imaging technology developed by Konica Minolta, to create their AI-powered technique that analyzes lung function.
  • PFTs and chest radiography are both typically utilized for the evaluation of pulmonary disorders and respiratory function; however, these tools offer a static assessment.
  • “DDR is a much easier method to capture lung function and it provides more clinical data than PFT alone.

Cartesian Therapeutics Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Descartes-08 for the Treatment of Myasthenia Gravis

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水曜日, 5月 22, 2024

GAITHERSBURG, Md., May 22, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Regenerative Medicine Advanced Therapy (“RMAT”) designation for Descartes-08 for the treatment of myasthenia gravis (“MG”).

Key Points: 
  • GAITHERSBURG, Md., May 22, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Regenerative Medicine Advanced Therapy (“RMAT”) designation for Descartes-08 for the treatment of myasthenia gravis (“MG”).
  • “We look forward to working closely with the FDA to efficiently advance the development of Descartes-08 for this underserved population.
  • Descartes-08 was previously granted Orphan Drug Designation by the FDA for the treatment of MG.
  • In January 2024, Cartesian announced positive twelve-month follow-up data from its Phase 2a study of Descartes-08 in patients with generalized MG.

COUR Pharmaceuticals Appoints Paul M. Peloso, MD, as Chief Medical Officer

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火曜日, 5月 21, 2024

Prior to joining COUR, Dr. Peloso served as Chief Medical Officer for ACELYRIN, Inc., a biopharma company focused on providing life-changing new treatment options for patients by employing a strategy of identifying, acquiring and accelerating development and commercialization of promising drug candidates.

Key Points: 
  • Prior to joining COUR, Dr. Peloso served as Chief Medical Officer for ACELYRIN, Inc., a biopharma company focused on providing life-changing new treatment options for patients by employing a strategy of identifying, acquiring and accelerating development and commercialization of promising drug candidates.
  • While at ACELYRIN, Dr. Peloso was responsible for global clinical development of the company’s pipeline of products, with an initial focus in immunology.
  • Prior to this role, Dr. Peloso served as group medical director for both AbbVie and Merck, where he leveraged his extensive experience in biologics, small molecules, and medical devices.
  • “We are delighted to welcome Dr. Peloso during this time of significant growth at COUR,” said John J. Puisis, founder, president, and chief executive officer of COUR.

Fc and Glycoengineered Antibodies Research 2024-2035: Close to 250 Trials are Evaluating Fc and Glycoengineered Antibodies to Treat Myriad of Disease Indications - ResearchAndMarkets.com

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木曜日, 5月 23, 2024

The new research study consists of industry trends, detailed Fc and glycoengineered antibodies market analysis, key market insights, market impact analysis, market forecast and opportunity analysis.

Key Points: 
  • The new research study consists of industry trends, detailed Fc and glycoengineered antibodies market analysis, key market insights, market impact analysis, market forecast and opportunity analysis.
  • Currently, several drug developers, along with technology providers in this domain, are actively developing various Fc and glycoengineered antibodies.
  • Around 250 clinical trials have been registered across different geographical regions in order to evaluate various Fc and glycoengineered antibodies.
  • This market report includes an easily searchable excel database of all the companies that have the capability to offer Fc and glycoengineered antibodies.

Upneeq® Wins 2024 Shape Skin Award, “Best for Lift”, in the Professional Treatment Category

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金曜日, 5月 17, 2024

RVL Pharmaceuticals announced today that its prescription eye drop, Upneeq® (oxymetazoline hydrochloride ophthalmic solution), 0.1% has been selected as a 2024 Shape Skin Award winner by Shape Magazine, named “Best for Lift” in the professional category.

Key Points: 
  • RVL Pharmaceuticals announced today that its prescription eye drop, Upneeq® (oxymetazoline hydrochloride ophthalmic solution), 0.1% has been selected as a 2024 Shape Skin Award winner by Shape Magazine, named “Best for Lift” in the professional category.
  • The product was also named as a "Best Professional Grade'' treatment by editors in 2022 and received a 2023 Shape Beauty Award for “Best In-Office" treatments.
  • 37 winners were ultimately chosen, and judges awarded Upneeq for its subtle but noticeable lift for droopy eyelids.
  • “Shape is an empowering and trusted voice in health and beauty with a committed community to quality self-care.

OmniAb Reports First Quarter 2024 Financial Results and Business Highlights

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木曜日, 5月 9, 2024

OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three months ended March 31, 2024, and provided operating and partner program updates.

Key Points: 
  • OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three months ended March 31, 2024, and provided operating and partner program updates.
  • “The OmniAb team continued to make great progress this past quarter in advancing and expanding our portfolio and partnership base.
  • General and administrative expense was $8.3 million for the first quarter of 2024, compared with $8.2 million for the same period in 2023.
  • As of March 31, 2024, OmniAb had cash, cash equivalents and short-term investments of $69.0 million.

Dianthus Therapeutics Highlights Recent Business Achievements and Reports Q1 Financial Results

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木曜日, 5月 9, 2024

NEW YORK and WALTHAM, Mass., May 09, 2024 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics to treat severe autoimmune diseases, today reported financial results for the first quarter ending March 31, 2024, and provided an update on recent business achievements.

Key Points: 
  • “The first quarter of 2024 was highlighted by the initiation of our Phase 2 MaGic trial of DNTH103 for patients with gMG.
  • Initial top-line results from this trial are anticipated to be available in the second half of 2025.
  • Dianthus successfully completed a private investment in public equity (“PIPE”) financing in January 2024 that resulted in gross proceeds of approximately $230 million.
  • Additional Information - For additional information on the Company’s financial results for the quarter ended March 31, 2024, please refer to the Form 10-Q filed with the SEC.

Century Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Updates

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木曜日, 5月 9, 2024

Century’s core Allo-Evasion™ edits are designed to overcome the three major pathways of host versus graft rejection: CD8+ T cells, CD4+ T cells and NK cells.

Key Points: 
  • Century’s core Allo-Evasion™ edits are designed to overcome the three major pathways of host versus graft rejection: CD8+ T cells, CD4+ T cells and NK cells.
  • In April 2024, the Company announced plans to expand clinical development of CNTY-101 into additional autoimmune disease indications beyond SLE.
  • In the second half of 2024, Century intends to submit additional regulatory filings for CNTY-101 in autoimmune disease indications with limited current treatment options and high unmet need.
  • Century plans to share additional data from its Phase 1 ELiPSE-1 trial in R/R non-Hodgkin lymphoma (NHL) at the upcoming ASCO Annual Meeting, being held May 31-June 4, 2024, in Chicago, IL.

Myasthenia Gravis Foundation of America (MGFA) Kicks off Annual National MG Patient Conference With Program Announcements

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月曜日, 4月 29, 2024

TAMPA BAY, Fla., April 29, 2024 /PRNewswire/ -- More than 400 members of the myasthenia gravis (MG) rare disease community will come together this week at the MGFA National Patient Conference for support and a better understanding of how to manage their disease while learning about the latest in treatments and clinical studies.  

Key Points: 
  • Myasthenia Gravis Foundation of America (MGFA™) , the largest, leading patient advocacy organization solely dedicated to the myasthenia gravis community kicked off its annual conference today with a volunteer awards dinner and new program announcements.
  • The conference features patient stories and individuals diagnosed with myasthenia gravis as well as presentations and discussions from patients, caregivers, researchers, MG expert clinicians, and pharmaceutical and industry partners.
  • Bringing together MG patients and other members of the community to learn from and support each other is so powerful," said Samantha Masterson, president and CEO of the Myasthenia Gravis Foundation of America.
  • MGFA Global MG patient Registry – The MGFA Global MG Patient Registry gives the MG community a loud voice in ensuring that research studies and clinical trials are built to evaluate the most promising MG research.

Century Therapeutics Strengthens Position in Autoimmune Disease with Strategic Pipeline Expansion Supported by $60 Million Private Placement and Acquisition of Clade Therapeutics

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木曜日, 4月 11, 2024

PHILADELPHIA, April 11, 2024 (GLOBE NEWSWIRE) -- Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune and inflammatory diseases, today announced plans to expand clinical development for its lead program, CNTY-101, a CD19-targeting iNK cell therapy, into additional autoimmune disease indications. CNTY-101 is currently being evaluated in a clinical trial in B-cell malignancies (ELiPSE-1) as well as a planned clinical trial in systemic lupus erythematosus (SLE) (CALiPSO-1), which is on track to be initiated in the first half of 2024. Century plans to pursue additional autoimmune disease indication regulatory filings in 2024. Century’s increased research and development activities in autoimmune diseases are further supported by a $60 million private placement of its common stock to certain institutional investors. Concurrently, Century announced pipeline and platform enhancements through the acquisition of Clade Therapeutics, Inc. (“Clade”), a privately-held biotech company focused on discovering and delivering engineerable, off-the-shelf, scalable, and consistent stem cell-based medicines, with a focus on iPSC-derived αβ T cells. The acquisition brings additional iPSC-focused pipeline programs and technology to Century spanning across cancer and autoimmune diseases.

Key Points: 
  • Century plans to pursue additional autoimmune disease indication regulatory filings in 2024.
  • Century’s increased research and development activities in autoimmune diseases are further supported by a $60 million private placement of its common stock to certain institutional investors.
  • The acquisition brings additional iPSC-focused pipeline programs and technology to Century spanning across cancer and autoimmune diseases.
  • With support from a distinguished group of investors, coupled with the acquisition of Clade, we are poised for continued success,” said Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century.