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Flexion Therapeutics To Start Testing FX301 For Post-Op Pain In Patients After Musculoskeletal Surgery
Monday, March 1, 2021 - 12:58pm | 212The FDA signed off Flexion Therapeutics Inc's (NASDAQ: FLXN) Phase 1b proof of concept trial evaluating FX301 administered as a popliteal fossa block (a commonly used nerve block in the foot and ankle-related surgeries) in patients undergoing bunionectomy. FX301 combines...
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Atossa Therapeutics' COVID-19 Nasal Spray Safe In Early-Stage Study
Thursday, February 25, 2021 - 11:15am | 180Atossa Therapeutics Inc (NASDAQ: ATOS) announces final results from its Phase 1 study evaluating AT-301 administered by nasal spray. AT-301 is being developed for at-home use for patients recently diagnosed with COVID-19. The treatment was considered to be safe and well-...
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Decibel Therapeutics' Hearing Loss Gene Therapy Shows Potential In Preclinical Studies
Wednesday, February 24, 2021 - 1:52pm | 256Decibel Therapeutics Inc (NASDAQ: DBTX) presented preclinical data of its gene therapy candidate, DB-OTO, for hearing loss due to mutation of the otoferlin gene. Decibel presented the data at the Annual MidWinter Meeting of the Association for Research in Otolaryngology. DB-OTO...
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Intra-Cellular Therapies Discloses New Drug Candidate For Dementia Related Episodes
Wednesday, February 24, 2021 - 10:42am | 289Intra-Cellular Therapies Inc (NASDAQ: ITCI) expands its pipeline with a new molecular entity, ITI-1284, a sublingually delivered deuterated form of lumateperone. ITI-1284 has been developed in collaboration with Catalent Inc (NYSE: CTLT), using its...
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Benitec Biopharma's Gene Therapy For Rare Muscle Disorder Shows Encouraging Action In Animal Studies
Wednesday, February 24, 2021 - 9:26am | 354Benitec Biopharma Inc (NASDAQ: BNTC) reports an interim analysis of the BB-301 Pilot Dosing study conducted in large animal subjects. BB-301 a genetic medicine directly injected into the pharyngeal muscles. It employs the proprietary platform, which allows for a "Silence...
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Frequency Therapeutics' FX-322 Data Published In Peer-Reviewed Journal
Tuesday, February 23, 2021 - 7:12am | 261Frequency Therapeutics Inc (NASDAQ: FREQ) has announced the publication of its lead candidate FX-322 Phase 1/2 study results in Otology & Neurotology. The data was initially announced in April 2019. The data showed hearing improvements in adults with acquired sensorineural...
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Insmed's Inhaled Treprostinil Palmitil Is Safe; Healthy Volunteers Study Show
Friday, February 19, 2021 - 8:37am | 326Insmed Incorporated (NASDAQ: INSM) has announced topline results from the Phase 1 study evaluating treprostinil palmitil inhalation powder (TPIP) in healthy volunteers. The company plans to present complete data from this study at an upcoming medical meeting. The study's...
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Inhibikase Initiates Early-Stage Study Of Parkinson's Candidate
Wednesday, February 17, 2021 - 12:48pm | 230Inhibikase Therapeutics Inc (NASDAQ: IKT) has dosed the first patients in its Phase 1 trial of IkT-148009, an Abelson Tyrosine Kinase (c-Abl) inhibitor, for the treatment of Parkinson's disease. This randomized Phase 1 study in healthy volunteers will assess the safety,...
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Selecta Biosciences/Asklepios Start Early-Stage Study To Assess ImmTOR In Gene Therapy
Wednesday, February 17, 2021 - 9:55am | 195Selecta Biosciences Inc (NASDAQ: SELB) and Asklepios BioPharmaceutical, a subsidiary of Bayer AG (OTCMKTS: BAYRY), have initiated a Phase 1 dose-escalation trial evaluating SEL-399, an adeno-associated viral serotype 8 (AAV8) empty vector capsid (EMC-101) without...
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IMU-838 Data In COVID-19 Study Fails To Cheer Immunic Investors; Stock Tanks
Wednesday, February 17, 2021 - 8:49am | 408Immunic Inc (NASDAQ: IMUX) completes the main analysis of Phase 1 CALVID-1 trial evaluating its lead asset, IMU-838. It is a selective oral DHODH inhibitor used in hospitalized patients with moderate COVID-19. Though the data from 204 patients showed evidence of...
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Diffusion Pharma Climbs After Completing Early-Stage TSC Study In COVID-19 Patients
Tuesday, February 16, 2021 - 9:18am | 286Diffusion Pharmaceuticals Inc (NASDAQ: DFFN) announces topline data from Phase 1b trial evaluating trans sodium crocetinate ("TSC") in hospitalized COVID-19 patients with confirmed hypoxemia, the most common cause of tissue hypoxia (deprived of adequate oxygen supply...
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Exelixis' Cabozantinib Shows Overall Objective Response Rates of 38% In Genitourinary Tumor Settings
Tuesday, February 16, 2021 - 9:06am | 323Exelixis Inc (NASDAQ: EXEL) announces final data from Phase 1 trial sponsored and conducted by the U.S. National Cancer Institute (NCI), including seven expansion cohorts, evaluating cabozantinib in combination with either Bristol-Myers Squibb Co's (NYSE: BMY)...
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Denali's Enzyme Replacement Therapy Shows Encouraging Biomarker Effects In Early-Stage Hunter Syndrome Study
Friday, February 12, 2021 - 8:54am | 403Denali Therapeutics Inc (NASDAQ: DNLI) has announced additional interim results from its ongoing Phase 1/2 study evaluating ETV:IDS (DNL310) as a potential brain-penetrant enzyme replacement therapy for Hunter syndrome (MPS II). MPS II is a rare neurodegenerative...
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Dicerna Starts Dosing With Nedosiran In Primary Hyperoxaluria Early-Stage Study
Thursday, February 11, 2021 - 12:19pm | 262Dicerna Pharmaceuticals Inc (NASDAQ: DRNA) initiates patient dosing in Phase 1 PHYOX 4 trial evaluating its lead candidate, nedosiran, to treat primary hyperoxaluria, a rare condition characterized by the recurrent kidney and bladder stones. The condition often...
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ESSA Pharma's Interim EPI-7386 Data Shows Continuous Antigen Decline In Early-Stage Prostate Cancer Study
Thursday, February 11, 2021 - 10:38am | 332ESSA Pharma Inc (NASDAQ: EPIX) has announced initial data from Phase 1 trial evaluating the company's lead candidate, EPI-7386, to treat patients with metastatic castration-resistant prostate cancer. Data were at the 2021 American Society of Clinical Oncology...