PK

Edgewise Therapeutics Reports Third Quarter 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Thursday, November 9, 2023
Biotechnology, Health, Pharmaceutical, Physical Therapy, Cardiology, LYNX, Research, FOX, DUNE, Ageing, Education, Biomarker, Muscular dystrophy, Muscular Dystrophy Association, NSAA, G&A, Myopathy, Glycogen storage disease type V, American Heart Association, WMS, R, Muscle contraction, Pharmacokinetics, Dystrophinopathy, Disorder, Glycogen, PK, Clinical trial, Duchenne muscular dystrophy, McArdle, Safety, HCM, Therapy, Patient, MESA, R9, Administration, Pharmaceutical industry, Edgewise, Duchenne, Becker

Edgewise Therapeutics, Inc. (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today reported financial results for the third quarter of 2023 and recent business highlights.

Key Points: 
  • Edgewise Therapeutics, Inc. (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today reported financial results for the third quarter of 2023 and recent business highlights.
  • “I’m thrilled with the progress we’ve made in 2023 across our skeletal and cardiovascular programs,” said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise.
  • Research and development (R&D) expenses were $23.8 million for the third quarter of 2023, compared to $19.6 million for the immediately preceding quarter.
  • General and Administrative (G&A) expenses were $5.7 million for the third quarter of 2023, compared to $5.8 million for the immediately preceding quarter.

Antibe Reports PK Results of First Clinical Study of Otenaproxesul’s New Formulation

Retrieved on: 
Thursday, November 9, 2023
Health, Other Science, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Hydrogen sulfide, Phase II, Plasma, OTCQX, PK, Pain, Inflammation, Patient, TSX, Chronic pain, Pharmaceutical industry

Antibe Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a clinical-stage biotechnology company leveraging its hydrogen sulfide platform to develop next-generation therapies targeting pain and inflammation, is pleased to announce the PK results of the pharmacokinetic/pharmacodynamic (“PK/PD”) study of otenaproxesul’s faster-absorbing formulation.

Key Points: 
  • Antibe Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a clinical-stage biotechnology company leveraging its hydrogen sulfide platform to develop next-generation therapies targeting pain and inflammation, is pleased to announce the PK results of the pharmacokinetic/pharmacodynamic (“PK/PD”) study of otenaproxesul’s faster-absorbing formulation.
  • The PK/PD study involved 36 healthy volunteers, randomized across three treatment arms: a single high dose and two five-day regimens of otenaproxesul.
  • As previously reported, all subjects completed the study with no clinically significant, drug-related adverse events and no increase in liver enzymes.
  • “We appreciate their support as we pursue otenaproxesul’s potential as a novel non-opioid and prepare for an exciting year ahead.”

Inozyme Pharma Reports Third Quarter 2023 Financial Results and Provides Business Highlights

Retrieved on: 
Tuesday, November 7, 2023
Generalized arterial calcification of infancy, Patient, Research, Research and development, Genomics, Clinical trial, PD, Calciphylaxis, Therapy, Biomarker, ESKD, G&A, American Society of Nephrology, Conference, Pros, Kidney disease, R, American Society for Bone and Mineral Research, Society, PXE, Columbia University School of General Studies, ENPP1, ASN, PK, Clinical Global Impression, Annual general meeting, GIC, Safety, ABCC6, Investment, Doctor of Philosophy, Administration, Nursing, Pharmaceutical industry

BOSTON, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (Nasdaq: INZY) (“Inozyme” or the “Company”), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today reported financial results for the third quarter ended September 30, 2023 and provided business highlights.

Key Points: 
  • Patient recruitment is underway, and the Company remains on track to report topline data in mid-2025.
  • Exploratory efficacy data reported suggested clinical benefit for ENPP1 Deficiency, including improvement in key biomarkers, patient-reported outcomes (PROs), and functional outcomes.
  • R&D Expenses were $13.3 million for the quarter ended September 30, 2023, compared to $12.2 million for the prior-year period.
  • Net loss was $16.6 million, or $0.29 loss per share, for the quarter ended September 30, 2023, compared to $16.4 million, or $0.38 loss per share, for the prior-year period.

Vigil Neuroscience Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, November 7, 2023
FDA, Research, Data analysis, Research and development, AD, IGNITE, Half-life, Genetic testing, Event, Food, European Commission, Publication, European Medicines Agency, Microglia, CSF1R, MAD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SAD, R, HCP, ANA, Approximation error, Civil service commission, Growth, Caregiver, PK, KOL, Medicine, EMA, TREM2, Patient, Administration, Investigational New Drug, Pharmaceutical industry, Cryptocurrency, IND, ALSP

WATERTOWN, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Vigil Neuroscience, Inc. (Nasdaq: VIGL), a clinical-stage biotechnology company committed to harnessing the power of microglia for the treatment of neurodegenerative diseases, today announced financial results for the third quarter ended September 30, 2023, and provided an update on recent progress.

Key Points: 
  • In September, we also proudly introduced our oral small molecule TREM2 agonist candidate, VG-3927, with the opening of our IND.
  • Cash Position: Cash, cash equivalents, and marketable securities were $133.6 million as of September 30, 2023, compared to $150.2 million as of June 30, 2023.
  • General and Administrative (G&A) Expenses: G&A expenses for the third quarter ended September 30, 2023, were $6.9 million, compared to $4.8 million for the same period in 2022.
  • Net Loss: Loss from operations for the third quarter ended September 30, 2023, were $20.5 million, compared to $17.5 million for the same period in 2022.

Autobahn Therapeutics Announces Positive Topline Results from Phase 1 Study of ABX-002, its Lead Oral Treatment for Major Depressive Disorder

Retrieved on: 
Tuesday, November 7, 2023
Health, Neurology, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Trial of the century, IND, PD, MDD, Food, DSM-IV codes, CNS, MAD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SAD, Development, Pharmacokinetics, Autobahn, PK, Biology, Safety, Vital signs, Therapy, TSH, Central nervous system, Pharmaceutical industry, Vaccine

ABX-002, a potent and selective thyroid hormone beta receptor (TRβ) agonist, is an orally administered small molecule being evaluated as a potential adjunctive treatment for people with major depressive disorder (MDD).

Key Points: 
  • ABX-002, a potent and selective thyroid hormone beta receptor (TRβ) agonist, is an orally administered small molecule being evaluated as a potential adjunctive treatment for people with major depressive disorder (MDD).
  • Results from the Phase 1 study:
    Across the range of doses tested, ABX-002 was safe and well-tolerated.
  • There were no serious adverse events and no premature discontinuations related to safety, with all 48 subjects completing the study.
  • “The positive data from this Phase 1 study represent a major milestone for ABX-002 and support its advancement into Phase 2 development,” said Kevin Finney, President and Chief Executive Officer of Autobahn Therapeutics.

87.5% ORR | Abbisko presented two clinical updates of Pimicotinib at the 2023 CTOS Annual Meeting

Retrieved on: 
Tuesday, November 7, 2023
PD, US, BTD, TGCT, Priority, Human, European Medicines Agency, IDMC, Male, Liver injury, Hip, BIRC, Ankle, PRO, Pain, IRC, Completeness, Part Two, Response evaluation criteria in solid tumors, QD, 1.1, MRI, Itch, AST, US FDA, CSF1, Motion, Rash, Neoplasm, Independent Review Committee, PK, ORR, Part, Safety, Therapy, ALT, Patient, LDH, ASCO, PDGFR, Contraindication, Nilotinib, III, DOR, Imatinib, Breakthrough therapy, Clinical trial, Hepatotoxicity, Knee, FDA, Dyslipidemia, CPK, RES, SD, RECIST, Pharmaceutical industry, Nursing

SHANGHAI, Nov. 6, 2023 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter) announced that two major clinical updates of its CSF-1R inhibitor pimicotinib（ABSK021）were presented at the 2023 Connective Tissue Oncology Society Annual Meeting, which is held in Ireland from November 1 to 4, 2023.

Key Points: 
  • SHANGHAI, Nov. 6, 2023 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter) announced that two major clinical updates of its CSF-1R inhibitor pimicotinib（ABSK021）were presented at the 2023 Connective Tissue Oncology Society Annual Meeting, which is held in Ireland from November 1 to 4, 2023.
  • The two clinical updates include reporting the design of the pivotal global multi-center phase III clinical trial and the further update of the phase Ib clinical trial of pimicotinib.
  • In 2023, the U.S. FDA conferred Breakthrough Therapy Designation and the European Medicines Agency granted Priority Medicine Designation upon Pimicotinib treatment of TGCT.
  • Here, we report the phase 1b safety and efficacy results of Pimicotinib in TGCT patients over a 1-year follow-up.

Portfolio Company Sorriso Pharmaceuticals Announces First Subject Dosed in Phase 1/1b Clinical Trial of SOR102

Retrieved on: 
Tuesday, November 7, 2023
United Kingdom, Biotechnology, Sorriso, Ulcerative colitis, Pharmacokinetics, PK, IBD, LSE, Safety, Patient, Pharmaceutical industry

LONDON, 1 November 2023: Arix Bioscience plc (“Arix” or the “Company”) (LSE: ARIX), a transatlantic venture capital company focused on investing in breakthrough biotechnology companies, notes that its Core Portfolio company, Sorriso Pharmaceuticals (“Sorriso”), has announced that the first subject has been dosed in the Company’s Phase 1/1b clinical program of SOR102.

Key Points: 
  • LONDON, 1 November 2023: Arix Bioscience plc (“Arix” or the “Company”) (LSE: ARIX), a transatlantic venture capital company focused on investing in breakthrough biotechnology companies, notes that its Core Portfolio company, Sorriso Pharmaceuticals (“Sorriso”), has announced that the first subject has been dosed in the Company’s Phase 1/1b clinical program of SOR102.
  • This Phase 1 trial is a randomized, double-blind study consisting of three parts.
  • Part 3 will evaluate safety, tolerability, PK, and clinical and biological activity of multiple oral doses of SOR102 in patients with mild to severe ulcerative colitis.
  • The trial is expected to enrol up to 60 adult participants at sites in the United Kingdom and Europe.

Aquestive Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, November 6, 2023
Anaphylaxis, FDA, Emergency, Sale, PDUFA, Food, Seizure, Clobazam, Lennox–Gastaut syndrome, EBITDA, Adrenaline, Net, Attention deficit hyperactivity disorder, Regulation of tobacco by the U.S. Food and Drug Administration, Research, Clutch (eggs), Offering, Pharmacokinetics, Senior, Diazepam, PK, New Drug Application, Allergy, NDA, Therapy, Note, Patient, ADHD, Pharmaceutical industry, Video game, Bookkeeping

“We continue to successfully execute on our 2023 key initiatives as demonstrated by our third quarter 2023 results,” said Daniel Barber, Chief Executive Officer of Aquestive.

Key Points: 
  • “We continue to successfully execute on our 2023 key initiatives as demonstrated by our third quarter 2023 results,” said Daniel Barber, Chief Executive Officer of Aquestive.
  • The Company is on track to commence its initial Phase 3 pivotal PK study for Anaphylm in the fourth quarter 2023.
  • Total reported revenues were $13.0 million in the third quarter 2023, compared to $11.5 million in the third quarter 2022.
  • Aquestive is updating its full-year 2023 financial guidance based on third quarter 2023 results and updated outlook for the remainder of 2023.

Medicenna Announces Promising Single-Agent Response and Durability of MDNA11 in the Phase 1/2 ABILITY Study During Dose Escalation at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC)

Retrieved on: 
Monday, November 6, 2023
Hypertelorism, PD, VLS, Trae tha Truth, BCC, MSI-H, MDNA, MCC, Poster, Pharmacodynamics, SITC, Immunotherapy, Radiation, SD, RDE, PK, DLT, Safety, Society, CSCC, PDAC, Patient, Combination therapy, Toxicity, TSX, LFT, Nevus, Medical imaging, Pharmaceutical industry, Vaccine

MDNA11 with uniquely differentiating ‘beta-enhanced not-alpha’ features, continues to be a potential best-in-class next-generation IL-2 super-agonist for treatment of advanced solid tumors.

Key Points: 
  • MDNA11 with uniquely differentiating ‘beta-enhanced not-alpha’ features, continues to be a potential best-in-class next-generation IL-2 super-agonist for treatment of advanced solid tumors.
  • Following return from a 7 week vacation, a single new lesion was observed and MDNA11 treatment was resumed.
  • Monotherapy expansion part of ABILITY-1 is enrolling patients with metastatic melanoma, non-melanoma skin cancers (CSCC, MCC, and BCC) and MSI-H/dMMR tumors.
  • A copy of the poster and a related slide deck have been posted to the “ Events and Presentations ” page of Medicenna’s website.

Aclaris Therapeutics Reports Third Quarter 2023 Financial Results and Provides a Corporate Update

Retrieved on: 
Monday, November 6, 2023
Janus, Research, Lilly, Eli Lilly and Company, AD, Plasma, Half-life, PD, Psoriatic arthritis, Washington University in St. Louis, Biomarker, JAK3, EPI, G&A, Health, Rheumatoid arthritis, MAD, JAK, R, RA, ITK, ACRS, Ulcerative colitis, Osteoporosis, Pharmacokinetics, Hidradenitis suppurativa, PK, Methotrexate, Pancreatic cancer, Safety, Atopic dermatitis, Collection, Chapter 11, Title 11, United States Code, Therapy, Patient, MK2, Pharmaceutical industry, Vaccine, Palladium, Cryptocurrency, Rare-earth element, Tobacco, Hydraulic machinery

WAYNE, Pa., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the third quarter of 2023 and provided a corporate update.

Key Points: 
  • Net loss was $29.3 million for the third quarter of 2023 compared to $20.0 million for the third quarter of 2022.
  • Total revenue was $9.3 million for the third quarter of 2023 compared to $19.0 million for the third quarter of 2022.
  • Research and development (R&D) expenses were $23.9 million for the quarter ended September 30, 2023 compared to $23.7 million for the prior year period.
  • General and administrative (G&A) expenses were $7.1 million for the quarter ended September 30, 2023 compared to $5.8 million for the corresponding prior year period.