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Orphan Disease Articles & Analysis

31 news found

Biotech Stock News Bite - Longeveron Inc. (NASDAQ: LGVN) Stock Soars on Clinical Pipeline and 2024 Key Priorities and Goals

Biotech Stock News Bite - Longeveron Inc. (NASDAQ: LGVN) Stock Soars on Clinical Pipeline and 2024 Key Priorities and Goals

We believe that by using the same cells that promote tissue repair, organ maintenance, and immune system function, we can develop safe and effective therapies for some of the most difficult diseases and conditions. In 2024, we are focusing our efforts on two of our most promising programs: Hypoplastic Left Heart Syndrome (HLHS); and Alzheimer's Disease. ...

ByInvestorideas.com


BIO Investor Forum Company Snapshot: InvivoSciences

BIO Investor Forum Company Snapshot: InvivoSciences

Application of induced pluripotent technology allows to fabricate tissues in diseased states, e.g., hereditary cardiac diseases, cardiac fibrosis, cancer and orphan diseases. ...

ByInvivoSciences, Inc. (IVS)


Teva and MODAG Announce Licensing Collaboration for Neurodegenerative Disease Drug Candidate

Teva and MODAG Announce Licensing Collaboration for Neurodegenerative Disease Drug Candidate

“With Teva’s strong foundation in neuroscience and our in-house expertise in neurology and psychiatry, this licensing and collaboration agreement adds a promising new compound to our early-stage pipeline as a possible orphan disease treatment for the growing patient population living with multiple system atrophy, as well as a potential option for ...

ByMODAG GmbH


Eagle Pharmaceuticals Provides Business Update and Guidance for 2023

Eagle Pharmaceuticals Provides Business Update and Guidance for 2023

Commercial and Pipeline Update Product portfolio Acute Care Hospital: RYANODEX®, vasopressin, Barhemsys®, Byfavo® Oncology: BENDEKA, BELRAPZO, PEMFEXY11, TREAKISYM Japan12 75-person commercial team covers all products excluding BENDEKA and TREAKISYM Company projects growth in earnings while still supporting R&D Cash flow from legacy products expected to continue to ...

ByEagle Pharmaceuticals, Inc.


LISCure`s Phase 2 Drug Candidate Granted Orphan Drug Designation (ODD) from US FDA

LISCure`s Phase 2 Drug Candidate Granted Orphan Drug Designation (ODD) from US FDA

LB-P8 is, to the best of company's knowledge, the first drug to be granted orphan drug designation in the field of microbiome-based treatment for metabolic diseases. ...

ByLISCure Biosciences Inc.


Orphan Drug Designations by the U.S. FDA are meant to support the development of drug candidates that could potentially bring substantial therapeutic benefits

Orphan Drug Designations by the U.S. FDA are meant to support the development of drug candidates that could potentially bring substantial therapeutic benefits

At present, no PD-L1/4-1BB bispecific antibody has been approved for the treatment of pancreatic cancer worldwide. Orphan Drugs, also known as Rare Disease Drugs, refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions. Orphan Drug Designations by the U.S. FDA are ...

ByAntengene Corporation Limited


Aesther Healthcare Acquisition Corp. Has Entered Into an Agreement and Plan of Merger with Ocean Biomedical, Inc., a Next-Generation Biopharma Company, to List on NASDAQ

Aesther Healthcare Acquisition Corp. Has Entered Into an Agreement and Plan of Merger with Ocean Biomedical, Inc., a Next-Generation Biopharma Company, to List on NASDAQ

It is being used to target multiple fibrotic diseases, including Idiopathic Pulmonary Fibrosis (IPF), and Hermansky-Pudlak Syndrome, a rare ‘orphan disease’ with no known treatment. ...

ByOcean Biomedical


InMed Announces Update on Phase 2 Clinical Trial Investigating INM-755 Cannabinol Cream for Epidermolysis Bullosa

InMed Announces Update on Phase 2 Clinical Trial Investigating INM-755 Cannabinol Cream for Epidermolysis Bullosa

Epidermolysis bullosa, or EB, is a group of rare genetic skin diseases characterized by fragile skin that can lead to extensive blistering and wounding. It affects skin and mucous membranes, particularly of the gastrointestinal tract, genitourinary and respiratory systems. It is a debilitating disease affecting a small number of people, thus earning it an ...

ByInMed Pharmaceuticals Inc.


Capricor Therapeutics Reports First Quarter 2022 Financial Results and Provides Corporate Update

Capricor Therapeutics Reports First Quarter 2022 Financial Results and Provides Corporate Update

ET Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of a broad spectrum of diseases, announced today its financial results for the first quarter ended March 31, 2022 and provided a corporate update. ...

ByCapricor Therapeutics, Inc.


Emmaus Life Sciences Announces Launch of Full-Service Telehealth Solution

Emmaus Life Sciences Announces Launch of Full-Service Telehealth Solution

The company is also engaged in the discovery and development of innovative treatments and therapies for certain rare and orphan diseases as well as those affecting larger populations, such as diverticulosis. ...

ByEmmaus Medical, Inc


Capricor Therapeutics to Participate in the Cantor Fitzgerald Rare Orphan Disease Summit

Capricor Therapeutics to Participate in the Cantor Fitzgerald Rare Orphan Disease Summit

Capricor Therapeutics (NASDAQ: CAPR) a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of a broad spectrum of diseases, announced today that Dr. Linda Marbán, CEO of Capricor, will participate in a panel discussion at the virtual Cantor Fitzgerald Rare Orphan ...

ByCapricor Therapeutics, Inc.


Capricor Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update

Capricor Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update

ET- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of a broad spectrum of diseases, announced today its financial results for the fourth quarter and full year 2021 and provided a corporate update. ...

ByCapricor Therapeutics, Inc.


AVM Biotechnology Expands C-Suite in Anticipation of 2023 Commercialization Efforts

AVM Biotechnology Expands C-Suite in Anticipation of 2023 Commercialization Efforts

He has spent most of his career in the hospital, orphan disease and oncology areas of the pharmaceutical and biotech industry cofounding Vidara Therapeutics and working for companies such as Pharmacia, Dendreon and Horizon Therapeutics. ...

ByAVM Biotechnology


Ocugen, Inc. Announces U.S. FDA Acceptance of Investigational New Drug Application to Initiate a Phase 1/2 Clinical Trial for Gene Therapy Candidate OCU400 to Treat Inherited Retinal Degeneration

Ocugen, Inc. Announces U.S. FDA Acceptance of Investigational New Drug Application to Initiate a Phase 1/2 Clinical Trial for Gene Therapy Candidate OCU400 to Treat Inherited Retinal Degeneration

OCU400 was granted four orphan drug disease designations from the FDA for treating four different gene mutation-associated retinal degenerative diseases between 2019 and 2020. The European Medicines Agency (EMA) granted Ocugen broad orphan medicinal product designation in 2021 for OCU400 for the treatment of both retinitis ...

ByOcugen, Inc.


INOVIO Collaborates with GuardRX and Geneva University Hospitals for Heterologous Booster Clinical Trial of its Ebola DNA Vaccine Candidate, INO-4201

INOVIO Collaborates with GuardRX and Geneva University Hospitals for Heterologous Booster Clinical Trial of its Ebola DNA Vaccine Candidate, INO-4201

INOVIO (NASDAQ: INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases, today announced that several volunteers have been dosed with its DNA-based, intradermal Ebola vaccine candidate, INO-4201, as part of a randomized, ...

ByINOVIO Pharmaceuticals


Emmaus Life Sciences Announces Partnership with UpScript to Provide Telehealth Solutions to Sickle Cell Disease Patients

Emmaus Life Sciences Announces Partnership with UpScript to Provide Telehealth Solutions to Sickle Cell Disease Patients

(UpScript), to offer telehealth solutions to sickle cell disease patients, expanding access to Endari, Emmaus’ prescription L-glutamine oral powder for the treatment of sickle cell disease. ...

ByEmmaus Medical, Inc


LAVA Therapeutics Receives FDA Orphan Drug Designation for LAVA-051 for the Treatment of Chronic Lymphocytic Leukemia

LAVA Therapeutics Receives FDA Orphan Drug Designation for LAVA-051 for the Treatment of Chronic Lymphocytic Leukemia

Data from the Phase 1 dose escalation phase of the study are expected in the first half of 2022 with top line clinical data from the Phase 2a expansion cohorts expected in the second half of 2022. About Orphan Drug Designation The term orphan drug refers to pharmaceutical products developed for the prevention, diagnosis and treatment of rare ...

ByLAVA Therapeutics N.V.


AB2 Bio expands Phase 3 trial of Tadekinig alfa in monogenic HLH

AB2 Bio expands Phase 3 trial of Tadekinig alfa in monogenic HLH

AB2 Bio Ltd, a Swiss advanced clinical-stage biotech company, specialized in developing innovative therapies for the treatment of severe systemic autoinflammatory diseases including rare diseases with high unmet medical needs, announces the expansion of its Phase 3 trial of Tadekinig alfa in the orphan disease IL-18 driven ...

ByAB2 Bio Ltd.


Lung Therapeutics Announces Appointment of Sharon Morriss, PhD, as Senior Vice President of Clinical Development

Lung Therapeutics Announces Appointment of Sharon Morriss, PhD, as Senior Vice President of Clinical Development

Lung Therapeutics, Inc., a clinical stage biopharmaceutical company developing novel therapeutics for orphan, pulmonary diseases and conditions, today announced the appointment of Sharon Morriss, PhD, as Senior Vice President of Clinical Development. ...

ByLung Therapeutics, Inc.


Lung Therapeutics Announces Appointment of Cory M. Hogaboam, Ph.D., as Chief Scientific Officer

Lung Therapeutics Announces Appointment of Cory M. Hogaboam, Ph.D., as Chief Scientific Officer

Lung Therapeutics, Inc., a clinical stage biopharmaceutical company developing novel therapeutics for orphan, pulmonary diseases and conditions, today announced the appointment of Cory M. ...

ByLung Therapeutics, Inc.

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