Tyrosine kinase inhibitor

Biora Therapeutics Announces New Patent for its NaviCap™ Targeted Oral Delivery Platform

Retrieved on: 
Tuesday, December 19, 2023
Janus, Disease, Tyrosine kinase inhibitor, Dicarboxylic acid, Antibody, Inflammatory bowel disease, B cell, Gastrointestinal disease, Patent, Integrin, Gastrointestinal tract, SAN, Therapy, JAK, GI, IP, Device, Janus kinase, Peptide, United States patent law, Chemokine, Ulcerative colitis, Pharmaceutical industry

SAN DIEGO, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc .

Key Points: 
  • SAN DIEGO, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc .
  • (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced that it received an Issue Notification from the U.S. Patent and Trademark Office for a patent related to the treatment of gastrointestinal (GI) disorders through targeted delivery of JAK inhibitors for its NaviCap™ targeted oral delivery platform under development.
  • 17/313,339, entitled “Treatment of a Disease of the Gastrointestinal Tract with a JAK Inhibitor and Devices,” will issue as US Patent No.
  • The patent covers many JAK inhibitors, including those that are approved or in development for a range of indications.

Inhibikase Therapeutics Reports Third Quarter Financial Results and Highlights Recent Period Activity

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Tuesday, November 14, 2023
Imatinib, Safety, D, Parkinson's disease, Therapy, International, IND, PD, Clinical trial, Patient, Research, European, Multiple system atrophy, MSA, FDA, Tyrosine kinase inhibitor, Federal, Orphan, ABL, Pharmaceutical industry

“We are very pleased with the progress of the last quarter,” noted Dr. Milton H. Werner, President and Chief Executive Officer of Inhibikase.

Key Points: 
  • “We are very pleased with the progress of the last quarter,” noted Dr. Milton H. Werner, President and Chief Executive Officer of Inhibikase.
  • Twenty-four participants have been enrolled, 7 prospective participants are in screening and 15 potential participants are going through informed consents.
  • The 201 Trial patient portal ( www.the201trial.com ) has been visited by more than 20,000 unique people since launch in September, 2023.
  • The Company expects that existing cash and cash equivalents will be sufficient to fund operations into the fourth quarter of 2024.

Elanco Animal Health Reports Fourth Quarter and Full Year 2022 Results

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Tuesday, February 21, 2023
Health, Consumer, Agriculture, Pets, Natural Resources, Veterinary, EBITDA, JAK, Cattle, North American Pet Health Insurance Association, ERP, Dog, Diabetes, Methane, GAAP, Farm Animal, Pressure, Research, Travel, FDA, Dermatology, Growth, Advertising, Tax, CER, Tyrosine kinase inhibitor, U.S. FDA, Sale, Bayer, Selection, Cat, Pig, Vaccine, Poultry, EPA, Pharmaceutical industry, Video game, Elanco

Asset impairment, restructuring, and other special charges were $32 million in the fourth quarter of 2022, compared to $110 million in the fourth quarter of 2021.

Key Points: 
  • Asset impairment, restructuring, and other special charges were $32 million in the fourth quarter of 2022, compared to $110 million in the fourth quarter of 2021.
  • Reported net interest expense was $62 million in the fourth quarter of 2022, a 13% increase as compared to the fourth quarter of 2021.
  • The adjusted effective tax rate was negative 22.0% in the fourth quarter of 2022 as compared to 19.2% in the fourth quarter of 2021.
  • Adjusted EBITDA was $174 million in the fourth quarter of 2022, a decrease of 19% compared to the fourth quarter of 2021.

AB Science receives Notice of Deficiency (NOD) from Health Canada for masitinib in the treatment of amyotrophic lateral sclerosis (ALS)

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Tuesday, December 13, 2022
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AB Science SA (Euronext - FR0010557264 - AB) today announced that it has received a Notice of Deficiency (“NOD”) for its masitinib New Drug Submission in the treatment of amyotrophic lateral sclerosis.

Key Points: 
  • AB Science SA (Euronext - FR0010557264 - AB) today announced that it has received a Notice of Deficiency (“NOD”) for its masitinib New Drug Submission in the treatment of amyotrophic lateral sclerosis.
  • This NOD means that Health Canada has requested the provision of additional information related to masitinib New Drug Submission.
  • The Response to a Notice of Deficiency is to be submitted within 90 calendar days from the date the NOD was sent.
  • AB Science will liaise with Health Canada to address the deficiencies, with the intention to resume the process within the allocated timeframe.

AB Science receives U.S. Food and Drug Administration (FDA) authorization to initiate confirmatory Phase 3 clinical study with masitinib in the treatment of Alzheimer’s Disease

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Monday, November 21, 2022
Marketing, ADAS, Inflammation, ANSM, Cell, Cognition, ADAS-Cog, Donanemab, Amyotrophic lateral sclerosis, B cell, AMF, Incidence, III, Degenerative disease, Patient, Cholinesterase, Veterinary medicine, Medicine, MMSE, ALS, Alzheimer's disease, Organic, Mini–Mental State Examination, Scientific Committee on Antarctic Research, AB, University, AD, Disease, Multiple sclerosis, Research, Science, Memantine, Safety, PKI, Reno 1868 FC, Communication, Euronext Paris, Macrophage, Tyrosine kinase inhibitor, European Medicines Agency, Microglia, Central nervous system, AE, INT, Mast cell, Memory, Survival, Pharmaceutical industry, Dietary supplement, Vaccine, Copper, Neurodegeneration

The primary endpoint of study AB21004 will be to evaluate the effect of masitinib on absolute change from baseline in ADCS-ADL score and in ADAS-Cog-11.

Key Points: 
  • The primary endpoint of study AB21004 will be to evaluate the effect of masitinib on absolute change from baseline in ADCS-ADL score and in ADAS-Cog-11.
  • Furthermore, masitinib is an orally administered tyrosine kinase whereas the aforementioned anti-amyloid antibody drugs are administered via injection.
  • The trial (AB21004) aims to confirm the outcomes observed in the previous masitinib phase 2B/3 study (AB09004) supporting the efficacy and safety of masitinib.
  • Study AB09004 was the first successful phase 2B/3 randomized trial in mild-to-moderate Alzheimers disease of a drug targeting innate immune cells of the neuroimmune system.

Fresh Tracks Therapeutics Reports Third Quarter 2022 Financial Results and Provides Corporate Update

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Thursday, November 10, 2022
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BOULDER, Colo., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Fresh Tracks Therapeutics, Inc. (the “Company” or “Fresh Tracks”) (Nasdaq: FRTX), a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated prescription therapeutics for the treatment of autoimmune, inflammatory, and other debilitating diseases, today announced financial results for the third quarter ended September 30, 2022 and provided a corporate update.

Key Points: 
  • To better align with our new strategic vision and plans, we recently rebranded the Company to Fresh Tracks Therapeutics, commented Robert Brown, Chief Executive Officer of Fresh Tracks.
  • In the second quarter of 2022, Fresh Tracks entered into an asset purchase agreement (APA) with Botanix SB Inc. (Botanix).
  • Fresh Tracks management will host a conference call today at 4:30 p.m. EDT to discuss the financial results and recent corporate developments.
  • Fresh Tracks Therapeutics is a clinical-stage pharmaceutical company striving to transform patient lives through the development of innovative and differentiated prescription therapeutics.

AB Science receives first agencies authorizations to initiate confirmatory Phase 3 clinical study with masitinib in the treatment of Alzheimer’s disease

Retrieved on: 
Monday, October 10, 2022
Medicine, Mini–Mental State Examination, Euronext Paris, Scientific Committee on Antarctic Research, Science, INT, ADAS, Lists of diseases, Sorbonne University, AMF, Population, Donanemab, ALS, Company, MMSE, Marketing, Neurology, Veterinary medicine, Incidence, Communication, Central nervous system, Macrophage, B cell, Research, Cell, Mast cell, Memantine, Degenerative disease, Microglia, PKI, Alzheimer's disease, Ageing, AD, Survival, Inflammation, Vacuum, Memory, Cholinesterase, Disease, Multiple sclerosis, ADAS-Cog, Cognition, Patient, Amyotrophic lateral sclerosis, III, MD, Safety, AE, AB, Tyrosine kinase inhibitor, Pharmaceutical industry, Medical imaging, Vaccine, Dietary supplement, Copper, Neurodegeneration

The objective of study AB21004 is to confirm treatment effect with masitinib 4.5 mg/kg/day as an adjunct to cholinesterase inhibitor and/or memantine in patients with mild-to-moderate Alzheimer's disease.

Key Points: 
  • The objective of study AB21004 is to confirm treatment effect with masitinib 4.5 mg/kg/day as an adjunct to cholinesterase inhibitor and/or memantine in patients with mild-to-moderate Alzheimer's disease.
  • Professor Bruno Dubois, MD, principal investigator of the study and Professor of Neurology at Sorbonne University, France commented, We are very excited to initiate this confirmatory phase III study with masitinib in Alzheimers disease.
  • There is a vacuum of treatment options for patients with mild or moderate Alzheimers disease.
  • The results from first phase 2B/3 study, AB09004, were very encouraging, especially considering this is a difficult to treat patient population.

AB Science - Positive recommendation of the Data and Safety Monitoring Board to continue the Phase 2 study evaluating the antiviral activity of masitinib in Covid-19

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Wednesday, September 14, 2022
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AB Science SA (Euronext - FR0010557264 - AB) today announced continuation of the Phase 2 study evaluating the antiviral activity of masitinib in patients who have a confirmed diagnosis of COVID-19, following the recommendation of the Data and Safety Monitoring Board (DSMB).

Key Points: 
  • AB Science SA (Euronext - FR0010557264 - AB) today announced continuation of the Phase 2 study evaluating the antiviral activity of masitinib in patients who have a confirmed diagnosis of COVID-19, following the recommendation of the Data and Safety Monitoring Board (DSMB).
  • The DSMB indicated that there was no safety concern and recommended continuation of the study without restrictions.
  • AB Science currently has two on-going phase 2 clinical studies in COVID-19:
    Study AB21002, evaluating the antiviral activity of masitinib in patients with symptomatic mild to moderate COVID-19.
  • Study AB20001, evaluating the safety and efficacy of masitinib plus isoquercetin in hospitalized patients with moderate or severe COVID-19.

Brickell Biotech Reports Second Quarter 2022 Financial Results and Provides Corporate Update

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Thursday, August 11, 2022
U.S. Securities and Exchange Commission, Exercise, GLOBE, TSA, Clinical trial, Research, Patient, SAD, TTK, Food, NDA, Inflammation, Autoimmunity, Policy, Sale, Humanitarian use licenses, LRRK2, Safety, Conference, Pharmacokinetics, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Intellectual property, Tyrosine kinase inhibitor, MAD, Compliance, ASX, BBI, APA, COVID-19, Acquisition, Next, Down syndrome, AD, Investor, Time, Degenerative disease, DYRK1A, File, Botanix Pharmaceuticals, Company, Therapy, Stimulator of interferon genes, Atopic dermatitis, Lists of diseases, Insurance, Private Securities Litigation Reform Act, EDT, Human, CLK, Pharmaceutical industry, Video game, Nasdaq, Brickell

BOULDER, Colo., Aug. 11, 2022 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. (“Brickell” or the “Company”) (Nasdaq: BBI), a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated prescription therapeutics for the treatment of autoimmune, inflammatory, and other debilitating diseases, today announced financial results for the second quarter ended June 30, 2022 and provided a corporate update.

Key Points: 
  • BOULDER, Colo., Aug. 11, 2022 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. (Brickell or the Company) (Nasdaq: BBI), a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated prescription therapeutics for the treatment of autoimmune, inflammatory, and other debilitating diseases, today announced financial results for the second quarter ended June30, 2022 and provided a corporate update.
  • Revenue was $4.3million for the second quarter of 2022, compared to $0.2million for the second quarter of 2021.
  • General and administrative expenses were $3.9million for the second quarter of 2022, compared to $2.9million for the second quarter of 2021.
  • Brickells net loss was $1.1million for the second quarter of 2022 compared to $11.1million for the second quarter of 2021.

AB Science today announced publication of results from its positive study of masitinib in severe asthma uncontrolled by oral corticosteroids in the peer-reviewed Journal of Asthma and Allergy

Retrieved on: 
Tuesday, June 7, 2022
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Results from this phase 3 study showed that corticosteroid-dependent severe asthma patients treated with masitinib at 6.0 mg/kg/d had a lower risk of severe asthma exacerbations compared with those in a placebo-control group that did not receive masitinib.

Key Points: 
  • Results from this phase 3 study showed that corticosteroid-dependent severe asthma patients treated with masitinib at 6.0 mg/kg/d had a lower risk of severe asthma exacerbations compared with those in a placebo-control group that did not receive masitinib.
  • Phase 3 study (AB07105) evaluating oral masitinib at 6 mg/kg/d versus placebo in severe asthma uncontrolled by oral corticosteroids (OCS) met its primary endpoint.
  • Masitinib significantly decreased the rate of severe asthma exacerbations in patients with severe asthma uncontrolled by OCS.
  • 13 months)
    Masitinib has a unique positioning in severe asthma, in terms of administration (oral administration), mechanism of action, targeted population, and broader eosinophil level.