Expanded access

Prilenia Shares Preliminary Topline Results from Phase 3 PROOF-HD Clinical Trial in Huntington’s Disease and Data from Phase 2 HEALEY ALS Platform Trial of Pridopidine at the 75th American Academy of Neurology (AAN) Annual Meeting

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星期二, 四月 25, 2023
Health, Neurology, Clinical Trials, Research, Science, Biotechnology, CHDI, SWR, HSG, Patient, Disease, Regimen, Therapy, Clinical trial, TMS, Expanded access, NYU, Hope, TFC, HIV disease progression rates, Hospital, FDA, Massachusetts General Hospital, European Lead Factory, Conference, Safety, Cognition, New York University Grossman School of Medicine, Department of Neurology, Xuanwu hospital, GHI, DSM-IV codes, Master of Science, Functional, HD, Speech, AAN, Respiration, Quality of life, American Academy, Trial of the century, Harvard Medical School, Annual general meeting, Periodic breathing, Pharmaceutical industry, Medical imaging, ALS, Huntington's disease

These initial results, along with recently announced findings from the pridopidine arm of the HEALEY ALS Platform Trial, were presented today at the 75th American Academy of Neurology (AAN) Annual Meeting taking place in Boston, MA.

Key Points: 
  • These initial results, along with recently announced findings from the pridopidine arm of the HEALEY ALS Platform Trial, were presented today at the 75th American Academy of Neurology (AAN) Annual Meeting taking place in Boston, MA.
  • Effects on both of these measures were reduced by the use of concomitant medications.
  • Pridopidine was well-tolerated with no serious treatment-related adverse events, with a safety and tolerability profile similar to placebo and consistent with previous clinical studies.
  • “The Company is committed to advancing pridopidine in both HD and ALS, as well as additional indications.”

BioCorRx Provides Business Update for 2022

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星期一, 四月 3, 2023
Volunteering, PK, Private sector, Condition, NCT, Addiction, Expanded access, Initiative, Opioid use disorder, OTCQB, OUD, Veteran, Trial of the century, Plasma, Development, Clinical trial, Patient, Partnership to End Addiction, Cooperative, NIDA, Pain management, CFO, Security (finance), Substance abuse, FDA, Annual report, Factitious disorder, NIH, RFA, Safety, Pharmaceutical industry, Naltrexone, Drug overdose

ANAHEIM, CA, April 03, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire -- BioCorRx Inc. (OTCQB: BICX) (the “Company”), a developer and provider of innovative treatment programs for substance abuse and related disorders, today provided a business update for the year ended December 31, 2022 and reported on recent corporate developments.

Key Points: 
  • ANAHEIM, CA, April 03, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire -- BioCorRx Inc. (OTCQB: BICX) (the “Company”), a developer and provider of innovative treatment programs for substance abuse and related disorders, today provided a business update for the year ended December 31, 2022 and reported on recent corporate developments.
  • Lourdes Felix, CEO, CFO and Director of BioCorRx Inc., commented, “2022 was a transformative year for BioCorRx, as we made significant progress advancing the Phase I clinical trial of BICX104, an implantable biodegradable naltrexone pellet for the treatment of opioid use disorder (OUD).
  • BICX104 was well tolerated with no serious adverse events reported and achieved 84 days of therapeutic naltrexone plasma concentrations.
  • “We saw an increase in revenue in 2022 due to the increased number of patients treated at licensed clinics.

Cyclo Therapeutics Provides Business Update and Reports Full Year 2022 Financial Results

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星期一, 三月 20, 2023
Biotechnology, Genetics, Health, Clinical Trials, Society, Priority review, Expanded access, Cholesterol, SIMD, NPC1, CYTH, Organ dysfunction, Research, Cell, Dementia, Science, Death, Genetic disorder, Patient, HIV disease progression rates, Bank, Annual general meeting, NPC, Lysosome, AD, Therapy, Safety, Pharmaceutical industry, Nursing, EU

Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (“Cyclo Therapeutics” or the “Company”), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today reported its financial results for the full year 2022 and provided a business update.

Key Points: 
  • Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (“Cyclo Therapeutics” or the “Company”), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today reported its financial results for the full year 2022 and provided a business update.
  • Further we continue to have encouraging strategic discussions across the industry,” commented N. Scott Fine, CEO of Cyclo Therapeutics.
  • Cyclo Therapeutics received Orphan Drug Designation for Trappsol® Cyclo™ to treat NPC1 in both the U.S. and EU and Fast Track and Rare Pediatric Disease Designations in the U.S.
  • Enrolled patients will be randomized across three study arms: 500 mg/kg or 1000 mg/kg of Trappsol® Cyclo™ and placebo.

Tiziana Life Sciences Announces Publication in Proceedings of the National Academy of Sciences (PNAS) Illustrating the Immunological Basis of the Mechanism of Action for Intranasal Foralumab

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星期三, 三月 8, 2023
Pharmacist, Immune system, Brigham, Research, IND, BWH, Expanded access, Neurology, MS, Multiple sclerosis, National academy, Patient, EA, PNAS, Mall of America, Human, FDA, Vaccine, Pharmaceutical industry, COVID

The identification of a unique mechanism associated with nasal foralumab in humans was consistent across patients with COVID, multiple sclerosis and in healthy volunteers.

Key Points: 
  • The identification of a unique mechanism associated with nasal foralumab in humans was consistent across patients with COVID, multiple sclerosis and in healthy volunteers.
  • Furthermore, the unique immunomodulatory signature of intranasal foralumab makes it a promising therapeutic candidate for several rare Orphan pediatric neuroinflammatory diseases, which currently remain untreated.
  • The Company also notes Dr. Chitnis’s exciting desire to study intranasal foralumab in rare Orphan pediatric diseases.
  • Tiziana may pursue this unique and attractive opportunity when funding becomes available.”

Cyclo Therapeutics Provides Clinical Program Update and Highlights Recent Achievements

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星期三, 一月 11, 2023
Biotechnology, General Health, Health, Pharmaceutical, Clinical Trials, NPC1, Cell, Expanded access, CYTH, Brain, CSF, Therapy, Trial of the century, Society, Niemann–Pick disease, Death, MD, Lysosome, Commencement at Central Connecticut State University, AD, Cholesterol, Family, Conference, Diagnosis, Patient, Molecular genetics, 24S-Hydroxycholesterol, HIV disease progression rates, Research, Science, Serum, Organ dysfunction, Cerebrospinal fluid, Metabolism, Doctor of Philosophy, Genetic disorder, Neurodegeneration, Pharmaceutical industry, Medical device, Medical imaging, NPC

Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (“Cyclo Therapeutics” or the “Company”), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today provided updates for the Company’s Trappsol® Cyclo™ clinical program and provided a summary of key achievements in 2022, focused on our clinical portfolio of two neurodegenerative diseases with major unmet medical needs.

Key Points: 
  • Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (“Cyclo Therapeutics” or the “Company”), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today provided updates for the Company’s Trappsol® Cyclo™ clinical program and provided a summary of key achievements in 2022, focused on our clinical portfolio of two neurodegenerative diseases with major unmet medical needs.
  • We recently announced the commencement of patient enrollment and dosing in our early AD clinical study and are dedicated to building momentum for that program.
  • For more information about the Company’s Trappsol® Cyclo™ clinical program for the treatment of NPC1, visit www.ClinicalTrials.gov and reference identifiers NCT02939547 , NCT02912793 , NCT03893071 and NCT04860960 .
  • For more information about the Company’s Trappsol® Cyclo™ clinical program for the treatment of early AD and Expanded Access program, visit www.ClinicalTrials.gov and reference identifiers NCT05607615 and NCT03624842 , respectively.

Ascendis Pharma to Initiate TransCon™ PTH U.S. Expanded Access Program for Adult Patients with Hypoparathyroidism

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星期一, 十二月 5, 2022
Physician, Annual report, EAP, Hypoparathyroidism, Priority review, FDA, Safety, Science, PDUFA, PTH, Research, Investment, Expanded access, COVID-19, Patient, Southern Transcon, Pharmaceutical industry, Fine chemical, Princeton University

COPENHAGEN, Denmark, Dec. 05, 2022 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has allowed the Company to initiate an expanded access program (EAP) for its investigational parathyroid hormone replacement therapy, TransCon PTH (palopegteriparatide), for adult patients with hypoparathyroidism. To qualify, patients must live in the U.S., have PTH treatment experience, and have medical needs that cannot be addressed by commercial products or clinical trials. Requests for access to TransCon PTH under the U.S. EAP must be made by the treating physician.

Key Points: 
  • “We are pleased to work with the FDA to expand access to TransCon PTH for eligible patients and look forward to sharing more details about this program soon,” said Edward Trott, M.D., Vice President, Global Medical Affairs at Ascendis Pharma.
  • “Recognizing the hypopara community’s urgent need, we remain committed to making TransCon PTH, if approved, more broadly available as quickly as possible.”
    TransCon PTH is an investigational prodrug in development for adult patients with hypoparathyroidism.
  • The safety and efficacy of TransCon PTH have not been established and TransCon PTH is not currently approved by the FDA.
  • Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo and TransCon are trademarks owned by the Ascendis Pharma Group.

Stevens Nation Responds to FDA's Refusal to File Letter, NurOwn Recipients Call for Advisory Committee Meeting

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星期二, 十一月 22, 2022
Authorization, Muscle weakness, CDER, Brainstorm, Therapy, Camping, Atrophy, Eating, Refusal, FDA, Amyotrophic lateral sclerosis, Pulmonology, EAPS, Spinal cord, University of California, Irvine, Expanded access, RTF, UC, Advisory Committee, CDC, Patient, Phase, Aerospace, Walking, Motor neuron, Neurology, Brain, Life expectancy, Letter, Food, Exercise, Disease, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, EAP, Pharmaceutical industry, Medical device, Renewable energy, ALS

WASHINGTON, Nov. 21, 2022 /PRNewswire/ -- Brainstorm Cell Therapeutics is seeking FDA approval of its mesenchymal stem cell therapy called NurOwn for the treatment of ALS. In response to the FDA's Refusal to File letter, and as people who participated in the NurOwn trials and its Expanded Access program ("EAP"), we support Brainstorm's efforts to seek an Advisory Committee ("AdCom") meeting.

Key Points: 
  • In response to the FDA's Refusal to File letter, and as people who participated in the NurOwn trials and its Expanded Access program ("EAP"), we support Brainstorm's efforts to seek an Advisory Committee ("AdCom") meeting.
  • We must insist that the FDA allow testimony about the "clinically meaningful" changes that occurred when we received NurOwn.
  • However, the Phase III trial did meet a pre-specified secondary endpoint in a subgroup of patients with less advanced ALS.
  • The best people to attest to how NurOwn made them "feel and function" are the people who received NurOwn.

Kintara Therapeutics Presents Three Posters at the 2022 Society for Neuro-Oncology Annual Meeting

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星期五, 十一月 18, 2022
SAN, Cancer, RELA, Bevacizumab, Neck, National Cancer Institute, Bladder cancer, Report, Glioblastoma, Expanded access, Therapy, Marketing, Research, NCI, Sun Yat-sen University Cancer Center, Annual report, Sumathi Best Television Current Reporting Award, Patient, Annual general meeting, Global Coalition Against Pneumonia, COVID-19, Sun, GBM, Head, MD Anderson Cancer Center, Central nervous system, SNO, Ovary, Disease, NSCLC, Pakistan Society of Neuro-Oncology, Pharmaceutical industry, Radiation therapy, CMBC

SAN DIEGO, Nov. 18, 2022 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced data from three posters that are being presented at the 2022 Society for Neuro-Oncology (SNO) Annual Meeting.

Key Points: 
  • SAN DIEGO, Nov. 18, 2022 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced data from three posters that are being presented at the 2022 Society for Neuro-Oncology (SNO) Annual Meeting.
  • The 2022 SNO Annual Meeting is being held from November 16 through November 20, 2022 in Tampa, Florida.
  • These two patients, a 32-year-old woman and a 49-year-old man, have remained alive 53 months and 35 months, respectively, as of the October 2022 poster cut-off date.
  • Located in San Diego, California, Kintara is dedicated to the development of novel cancer therapies for patients with unmet medical needs.

Cyclo Therapeutics Reports Third Quarter 2022 Financial Results and Highlights Recent Achievements

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星期五, 十一月 11, 2022
Biotechnology, Genetics, Health, Clinical Trials, CEO, U.S. Securities and Exchange Commission, Research, AD, Company, CYTH, Society, Protocol, Risk, Disease, Metabolism, Therapy, Security (finance), Molecular genetics, Patient, Expanded access, Form 10-K, Conference, Science, Niemann–Pick disease, NPC, Nasdaq, Pharmaceutical industry

Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (Cyclo Therapeutics or the Company), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today reported its financial results for the third quarter of 2022 and highlighted recent achievements.

Key Points: 
  • Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (Cyclo Therapeutics or the Company), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today reported its financial results for the third quarter of 2022 and highlighted recent achievements.
  • The dedication of our team and clinical sites is a testament to the potential of Trappsol Cyclo and the urgent need for an innovative treatment option.
  • Net loss for the quarter ended September 30, 2022 was approximately $4.2 million.
  • Cyclo Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with disease.

Tilray Brands Acquires Montauk Brewing Company

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星期一, 十一月 7, 2022
Expansion, Sweetwater, EBITDA, Securities Exchange Act of 1934, Finance, Accretion (finance), Marketing, Annual report, Acquisition, SEC, Beer, NEW, Company, GLOBE, CEO, Securities Act of 1933, TSX, Green flash, Forward-looking statement, Whole Foods Market, CPG, Expanded access, Patient, EDGAR, Growth, Adjustment, Stop & Shop, Goal, Investment, SweetWater Brewing Company, Fastest, Montauk, Nasdaq, Shareholder, Target, NASDAQ, Diageo, Achievement, Communication, Management, Coffee, Retail, Alpine, Costco, Metro New York, Tilray

NEW YORK, Nov. 07, 2022 (GLOBE NEWSWIRE) -- Tilray Brands, Inc. ( “Tilray Brands” or the “Company”) (NASDAQ | TSX: TLRY), today announced the acquisition of Montauk Brewing Company (“Montauk Brewing”), the #1 craft brewer in Metro New York. Montauk Brewing is well-known for its beloved product portfolio, premium price point, and distribution across over 6,400 points of distribution, including top national retailers such as Target, Whole Foods, Trader Joe’s, Stop & Shop, King Kullen, Walmart, 7-Eleven, Costco, BJ’s, and Speedway. The acquisition is expected to be accretive to the Company’s adjusted EBITDA.

Key Points: 
  • Brand Portfolio
    Veteran Industry Executive Ty H. Gilmore Appointed President of Tilray Brands U.S. Beer Business
    NEW YORK, Nov. 07, 2022 (GLOBE NEWSWIRE) -- Tilray Brands, Inc. ( Tilray Brands or the Company) (NASDAQ | TSX: TLRY), today announced the acquisition of Montauk Brewing Company (Montauk Brewing), the #1 craft brewer in Metro New York.
  • Montauk Brewing joins Tilrays growing U.S. beverage-alcohol segment, which already includes SweetWater Brewing Company, the 10th largest craft brewer in the nation with distribution across more than 40 states, the Alpine and Green Flash iconic Southern California brands, and its leading lifestyle bourbon and spirits brand,Breckenridge Distillery.
  • Opportunity for Accelerated Growth of Montauk Brewing Company: Montauk Brewing has enormous potential to expand its customer base and grow throughout the U.S. as a true national brand.
  • Tilray Brands intends to leverage SweetWaters existing nationwide infrastructure to accelerate Montauk Brewings distribution network and revenue growth.