$AGIO: Promising potential for anemia treatment.
$ALZN: FDA approves Alzamend Neuro's lithium study.
$CYBN: Cybin's depression study findings, plans. Briefing.
$INAB: IN8bio's INB-200 boosts survival in glioblastoma.
$AZN: FDA approves FoundationOne CDx for breast cancer.
$SAVA Cassava Sciences finishes recruiting patients for crucial Phase 3 study on Alzheimer's, testing oral Simufilam as a potential treatment.
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$OCGN Ocugen, Inc. Receives Positive Scientific Advice from European Medicines Agency regarding Approval Process for OCU400 Gene Therapy for Retinitis Pigmentosa.
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$OCGN Ocugen completes dosing of subjects with Geographic Atrophy in Phase 1/2 ArMaDa trial of OCU410 gene therapy modifier.
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$OCGN Preliminary trial results for Ocu400, a modifier gene therapy for retinitis pigmentosa and Leber Congenital Amaurosis, show promise.
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$OCGN Ocugen, Inc. begins Phase 3 trial for OCU400, the first gene therapy for retinitis pigmentosa with broad indication.
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Pharma/Biotech Highlights:
$AGNPF: Algernon may spin off Ifenprodil development.
$VRNA: Verona Pharma seeks FDA approval.
$IMMP: Immutep receives patent for cancer treatment.
$ACIU: FDA quickens development of Alzheimer's treatment.
$OCGN Approval granted for Cohort 3 and Phase 2 enrollment in OCU410 ArMaDa study for Geographic Atrophy by Data and Safety Monitoring Board.
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$ESPR Esperion unveils significant new CLEAR Outcomes data at ACC.24, emphasizing NEXLETOL's value for various populations, including women, Hispanics, and obese patients.
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$OCGN Ocugen, Inc. finishes giving doses to subjects with geographic atrophy in high-dose group of Phase 1/2 ArMaDa trial for OCU410 gene therapy.
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$CYBN Cybin receives new US patent for CYB003, supporting its breakthrough therapy program for Major Depressive Disorder.
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$RVVTF Revive Therapeutics announces data safety monitoring board meeting date for Phase 3 clinical study of Bucillamine in the treatment of COVID-19.
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$OCGN Ocugen announces positive data and initiation of enrollment in medium dose for OCU410ST in GARDian study for Stargardt Disease.
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$CYBN Cybin to unveil Phase 2 results of CYB003's safety and efficacy in treating Major Depressive Disorder, along with an R&D briefing on Nov 30, 2023.
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$AGNPF Algernon Pharmaceuticals hires Maxim Group to investigate potential spin-off of its Ifenprodil Phase 2 chronic cough drug development program.
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$OCGN Ocugen, Inc. gets FDA clearance for IND Amendment to start OCU400 Phase 3 trial first gene therapy in Phase 3 for broad retinitis pigmentosa indication.
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$IPHA Innate Pharma to unveil latest interim phase 2 efficacy results of Lacutamab in Mycosis Fungoides at the prestigious International Conference on Malignant Lymphoma.
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$JAGX Jaguar Health has applied for Orphan Drug Designation from the FDA for Crofelemer, aiming to treat diarrhea caused by cholera.
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$OCGN Ocugen, Inc. completes dosing in subjects with geographic atrophy secondary to dAMD in high-dose cohort of OCU410 Phase 1/2 ArMaDa clinical trial—an innovative gene therapy.
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$ABUS Imdusiran in combination with Short Course Interferon successfully achieves sustained undetectable HBsAg levels, a critical step towards HBV Functional Cure.
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FDA announces Orphan Drug Designation for elamipretide by Stealth Bio to treat patients with Duchenne muscular dystrophy (DMD).
$MITO is up more than 60% on the news 📈
#orphandrug
#DMD
#stocks
$RVVTF Revive Therapeutics partners with Defence Research and Development Canada to assess Bucillamine for nerve agent impact.
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$OCGN Ocugen completes dosing for high dose cohort of Phase 1/2 GARDian trial for OCU410ST, a gene therapy for Stargardt Disease.
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$ARDX Ardelyx presents encouraging data on symptom response in IBS-C patients treated with IBSRELA® (tenapanor) and holds an IBS-C Product Theater at ACG 2023.
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$SGMO Sangamo Therapeutics gets FDA support for accelerated approval and EMA Prime eligibility of ST-920 in Fabry Disease.
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$TGTX Data for BRIUMVI® show 92% of patients with relapsing MS were free from disability progression after 5 years of treatment.
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$ADAP Adaptimmune will share data from mid-point analysis of IGNYTE-ESO trial at ASCO, showing support for Lete-cel and advancing sarcoma portfolio.
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$MNMD up 45% today 🚀 as 20-year-old university student that made a $110 million profit with a one-month bet on Bed Bath & Beyond stock – also mentions Mind Medicine
Mind Medicine also with positive updates on their pipeline this summer:
$RVVTF Revive Therapeutics and Attwill Medical Solutions team up for clinical and commercial development of an innovative lyophilized version of Bucillamine.
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$BRTX BioRestorative Therapies will showcase early clinical data on BRTX-100 at the Orthopaedic Research Society (ORS) 2024 Annual Meeting.
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$BNGO Bionano reports that optical genome mapping found 1250+ structural variants, including 56 gene fusions, in pediatric leukemia not detected by whole genome sequencing.
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$ARDX Ardelyx's Tenapanor takes a step towards addressing hyperphosphatemia as China accepts the new drug application. Promising news for patients in need!
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$OCGN Ocugen initiates enrollment in Phase 1/2 ArMaDa study for Geographic Atrophy, following positive data and safety monitoring board review for OCU410 modifier gene therapy.
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$MREO, RARE Ultragenyx and Mereo BioPharma report Phase 2 results from Orbit Study showing lasting decrease in fracture rates with Setrusumab (UX143) for Osteogenesis Imperfecta patients.
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$CGTX Patients with mild Alzheimer's disease who received continuous Simufilam treatment for 24 months showed no decline in cognition scores.
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Alkeus announces $150M Series B financing to fast-track registration for gildeuretinol (ALK-001) in Stargardt Disease treatment.
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$MDGL FDA approves Madrigal Pharmaceuticals' Rezdiffra™ (resmetirom) for treating Noncirrhotic Nonalcoholic Steatohepatitis (NASH) with moderate to advanced liver fibrosis.
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Beam Therapeutics hopes to 'transition to a clinical-stage company' with initiation of a P1 trial for their Sickle Cell Disease cell therapy 🧬 beam-101 in 2022
$BEAM is up 18% the past month 📈
Mind Medicine finally gets a day not in the red as the FDA 🇺🇸 cleared its Investigational New Drug (IND) application which will allow the company to proceed with a Phase 2 trial of MM-120 for treatment of Generalized Anxiety Disorder (GAD) 🧠.
$MNMD is up almost 17% today 📈.
Sorrento Therapeutics up ~13% today 📈 as they announced last week that their preclinical COVID-19 oral 💊 anti-viral sti-1558 effectively inhibited Omicron virus entry. A needed boost, since $SRNE has been down >50% over the last 3 months 📉.
#COVID19
#antiviral
$JAGX New research at Boston Children's Hospital demonstrates the possible use of Jaguar Health's Crofelemer in treating MVID, a rare disease in children. Harvard Medical School was involved in the study.
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Editas Medicine is up 37% in the past month 🔼
Earlier this week, $EDIT announced it had successfully dosed its first patient with their Sickle Cell Disease Gene Therapy EDIT301 🧬 in a P1 trial $CRISPR
#stocks
#biotech
#genetherapy
$VINC Vincerx Pharma reports strong clinical effectiveness of Enitociclib combined with Venetoclax and Prednisone in treating Lymphoma.
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$HOTH: Hoth testing HT-001 on critically ill patients after FDA approval.
$HALO $ARGX: Japan approves VYVDURA to treat Myasthenia Gravis.
$PMVP: PMV Pharma advances trial and secures funding.
$GHRS: GH Research secures patent for Mebufotenin.
$ARDX Ardelyx to provide updates on XPHOZAH (tenapanor) for Hyperphosphatemia at Kidney Week 2023, Nov 1-5 in Philadelphia, PA.
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$BDTX Black Diamond Therapeutics shares new data on EGFR mutations in NSCLC at AACR 2024, highlights potential for BDTX-1535.
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Cantargia shares Phase 2 Clinical Data for Nadunolimab in Pancreatic Cancer at ESMO Gastrointestinal Cancer Congress 2024.
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$KPTI Karyopharm's Selinexor granted FDA Fast Track designation for Myelofibrosis treatment, showing promising potential
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$TNXP Tonix Pharmaceuticals has announced that its single-dose Mpox vaccine TNX-801 meets WHO's new Target Product Profile for Mpox vaccines in global health emergencies.
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FDA accepts Mirati Therapeutics new drug application (NDA) for their Lung Cancer Treatment adagrasib. $MRTX is down 20% the past week 📉.
#oncology
#FDA
$RVVTF Revive Therapeutics updates assessment of Bucillamine for nerve agent exposure with Defence Research and Development Canada.
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$GILD Gilead and Arcus reveal positive results of Domvanalimab-based treatment for Upper GI Cancers, suggesting promising clinical activity in initial therapy.
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Pharma/Biotech Highlights:
$RVVTF: Revive shares progress on Bucillamine improvements.
$PHAR: Pharming tests leniolisib on young children.
$IMUX: Immunic secures US patent for Vidofludimus.
$BCRX: New Spanish treatment for hereditary angioedema.
$LXRX Brand Institute collaborates with Lexicon Pharmaceuticals to develop brand name for FDA-approved INPEFA™ (sotagliflozin)
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Amylyx Pharma announces the FDA has scheduled a meeting with them to discuss clinical data & potential approval of their ALS drug AMX-0035. $AMLX is up 13% today 📈.
#ALS
#FDA
NLS Pharmaceuticals announces positive results from their Phase 2 trial of Quilience 💊 to treat patients with Narcolepsy. $NLSP is down 24% today 📉 despite the results.
#narcolepsy
#stocks
#pharma
Kazia discloses non-binding letter of intent to grant rights for developing and commercializing Paxalisib beyond oncology.
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Virios Therapeutics $VIRI crashes 70% 📉 as company announces their lead product IMC1 💊 failed to meet its Main Endpoint in a P2 Fibromyalgia study.
#biotech
#fail
#stocks