Numerical

Incyte Presents New Late-Breaking Data from Phase 2 Study Evaluating Povorcitinib in Patients with Prurigo Nodularis

Retrieved on: 
Sunday, March 10, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Prurigo nodularis, Patient, AAD, JAK1, Numerical, American Academy, Safety

Incyte (Nasdaq:INCY) today announced results from a Phase 2 study evaluating the efficacy and safety of povorcitinib (INCB54707), an oral JAK1 inhibitor, in adult patients with prurigo nodularis (PN).

Key Points: 
  • Incyte (Nasdaq:INCY) today announced results from a Phase 2 study evaluating the efficacy and safety of povorcitinib (INCB54707), an oral JAK1 inhibitor, in adult patients with prurigo nodularis (PN).
  • Median times to itch NRS4 were 58, 35 and 17 days for patients who received 15, 45 and 75 mg of povorcitinib, respectively, and was not estimable for the placebo arm.
  • We are excited to be expanding research on povorcitinib into this new potential indication.”
    The secondary endpoints of the study were also met.
  • The most common treatment-emergent adverse events (TEAEs) among patients who received povorcitinib were headache (11.1%), fatigue (9.3%) and nasopharyngitis (7.4%).

CymaBay Reports Fourth Quarter and Year Ended December 31, 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, February 28, 2024
Alkaline phosphatase, Acquisition, Liver, Child, Therapy, EMA, Ursodeoxycholic acid, New Drug Application, Gilead Sciences, Education, IDEAL, FDA, Science, Quality of life, Food, Marketing, U.S. FDA, Breakthrough, ALP, Hospital, PBC, Phase 3, Cirrhosis, Hepatology, Seladelpar, Safety, ULN, European Medicines Agency, Numerical, Patient, MHRA, UDCA, Itch, NDA, NRS, Pharmaceutical industry

NEWARK, Calif., Feb. 28, 2024 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced corporate updates and financial results for the year and fourth quarter ended December 31, 2023.

Key Points: 
  • NEWARK, Calif., Feb. 28, 2024 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced corporate updates and financial results for the year and fourth quarter ended December 31, 2023.
  • “2023 was a seminal year for CymaBay with critical achievements in the development of our investigational therapeutic, seladelpar.
  • Net loss for the year ended December 31, 2023 and 2022 was $105.4 million and $106.0 million, or ($0.99) and ($1.21) per share, respectively.
  • Net loss for the three months ended December 31, 2023 was higher than the three months ended December 31, 2022 primarily due to higher operating expenses.

Pacira Announces Publication of Pivotal Study of EXPAREL as a Sciatic Nerve Block in the Popliteal Fossa for Patients After Bunionectomy

Retrieved on: 
Thursday, February 15, 2024
FDA, Foot, Bupivacaine, AUC, Hydrogen chloride, Safety, Numerical, Patient, Journal

TAMPA, Fla., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc., (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced the publication of its pivotal Phase 3 study supporting the efficacy and safety of EXPAREL® (bupivacaine liposome injectable suspension) as a single-dose sciatic nerve block in the popliteal fossa in patients undergoing bunionectomy. The results demonstrate that EXPAREL significantly improved pain control and reduced opioid consumption through 96 hours versus bupivacaine HCl. The data, which provided the basis for FDA approval for this indication was published in the Journal of Clinical Anesthesia.

Key Points: 
  • TAMPA, Fla., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc., (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced the publication of its pivotal Phase 3 study supporting the efficacy and safety of EXPAREL® (bupivacaine liposome injectable suspension) as a single-dose sciatic nerve block in the popliteal fossa in patients undergoing bunionectomy.
  • The results demonstrate that EXPAREL significantly improved pain control and reduced opioid consumption through 96 hours versus bupivacaine HCl.
  • The data, which provided the basis for FDA approval for this indication was published in the Journal of Clinical Anesthesia.
  • “The role of EXPAREL as a sciatic nerve block in the popliteal fossa, particularly for pain control following foot and ankle procedures, is pivotal as clinical goals toward outpatient migration continue to grow,” said Gary Schwartz, MD, FASA, Vice Chair of Pain and Anesthesiology at Maimonides Medical Center and lead author on the publication.

RAPT Therapeutics Announces Publication of Phase 1a/1b Clinical Trial of Zelnecirnon (RPT193) to Treat Atopic Dermatitis in Allergy

Retrieved on: 
Monday, November 27, 2023
Patient, Atopic dermatitis, Cytokine, Inflammation, Itch, Therapy, Asthma, NRS, Numerical, Safety, RAPT, Pharmaceutical industry

The Phase 1a portion of the trial was a standard single and multiple dose-escalation study in 72 healthy volunteers.

Key Points: 
  • The Phase 1a portion of the trial was a standard single and multiple dose-escalation study in 72 healthy volunteers.
  • The Phase 1b portion of the trial was a randomized, double-blind, placebo-controlled study examining zelnecirnon as monotherapy in 31 patients with moderate-to-severe atopic dermatitis (AD).
  • “We are pleased to have these exciting data published in the prestigious, peer-reviewed journal Allergy,” said Brian Wong, M.D., Ph.D., President and CEO of RAPT Therapeutics.
  • Based on the efficacy and safety data observed in the Phase 1b study, RAPT initiated a dose-ranging Phase 2b study in patients with moderate-to-severe AD and a Phase 2a study in asthma.

Press Release: TZIELD® Phase 3 data presented at ISPAD shows potential to slow the progression of Stage 3 type 1 diabetes in newly diagnosed children and adolescents; full data simultaneously published in The NEJM

Retrieved on: 
Wednesday, October 18, 2023
Medical Affairs Bureau, AUC, Ageing, Yale School of Medicine, Endocrinology, Conference, Diabetes, Acquisition, General Medicine Faculty of RostGMU (Rostov State Medical University), PROTECT, LSM, Numerical, Growth, Disease, Clinical trial, The New England Journal of Medicine, C-peptide, Sanofi, Safety, T1D, ISPAD, Patient, Pharmaceutical industry, Medical imaging, Management, Medicine

New data from TZIELD’s (teplizumab-mzwv) PROTECT Phase 3 trial were presented today at the 49th Annual ISPAD Conference, in Rotterdam, The Netherlands.

Key Points: 
  • New data from TZIELD’s (teplizumab-mzwv) PROTECT Phase 3 trial were presented today at the 49th Annual ISPAD Conference, in Rotterdam, The Netherlands.
  • The full data set has been simultaneously published in The New England Journal of Medicine .
  • This significant difference indicates the potential of TZIELD to slow the progression of Stage 3 type 1 diabetes in this population.
  • While the study’s key secondary endpoints did not meet statistical significance, numerical trends favoring TZIELD were seen in relevant clinical parameters.

Cara Therapeutics Announces Approval of KORSUVA® IV Injection Syringe in Japan for the Treatment of Pruritus in Hemodialysis Patients

Retrieved on: 
Monday, September 25, 2023
Numerical, Chronic kidney disease, Civil service commission, Marketing, Ministry of Health, Labour and Welfare, CSL Vifor, Patient, Itch, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, European Commission, Pharmaceutical industry, Health

STAMFORD, Conn., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced that its licensing partner Maruishi Pharmaceutical Co., Ltd. received manufacturing and marketing approval from Japan’s Ministry of Health, Labour and Welfare for KORSUVA® IV Injection Syringe for the treatment of pruritus in hemodialysis patients.

Key Points: 
  • STAMFORD, Conn., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced that its licensing partner Maruishi Pharmaceutical Co., Ltd. received manufacturing and marketing approval from Japan’s Ministry of Health, Labour and Welfare for KORSUVA® IV Injection Syringe for the treatment of pruritus in hemodialysis patients.
  • Cara earned a $1.5 million milestone payment upon approval, per the terms of the licensing agreement.
  • “We are pleased that our first-in-class therapy KORSUVA injection will be available to hemodialysis patients in Japan who are suffering from pruritus,” said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics.
  • KORSUVA is approved by the U.S. Food and Drug Administration for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis.

MoonLake Immunotherapeutics Reports Third Quarter 2022 Financial Results and Provides Recent Business Update

Retrieved on: 
Monday, November 14, 2022
Dermatology Life Quality Index, Clinical trial, MIRA, Abscess, Safety, Dermatology, Disease, Severity, Chemokine, Antibody, Prevalence, Investment, Health assessment, Moonlake, American College, Research, Inflammation, Pain, Adalimumab, Psoriasis Area and Severity Index, VHH, Patient, FDA, Rheumatology, Psoriasis, KDA, SLK, ARGO, Veni, vidi, vici, Skin, IRB, American College of Rheumatology, Temperature, Bimekizumab, Tissue, ACR, Numerical, Secukinumab, Pharmaceutical industry, Oyster, Medical imaging, Video game, HS, Ablynx, Psoriatic arthritis, Sanofi

Research and development expenses for the quarter ended September30, 2022, were $9.0 million, as compared to $11.4 million in the previous quarter.

Key Points: 
  • Research and development expenses for the quarter ended September30, 2022, were $9.0 million, as compared to $11.4 million in the previous quarter.
  • General and administrative expenses for the quarter ended September30, 2022, were $5.7 million, as compared to $6.3 million in the previous quarter.
  • Net loss for the quarter ended September30, 2022, was $14.7 million, compared to $17.4 million in the previous quarter.
  • MoonLake Immunotherapeutics AG, subsidiary of MoonLake Immunotherapeutics, was founded in 2021 and is headquartered in Zug, Switzerland.

Arjuna Natural: Rhuleave-K® Demonstrates Significant Pain Relief at Half the Dose

Retrieved on: 
Tuesday, October 18, 2022
NSF, ISO, Exertion, McGill, Aspirin, Head, Turmeric, Specialization, GMP, Neck, Person, Health, AKBA, Research, Arjuna, Pain management, Medicine, Injury, NRS, Certification, Trial of the century, Analgesic, Exercise, MD, Doctor of Philosophy, Pharmacokinetics, Pain, Lists of diseases, Journal, Headache, Frankincense, Numerical, PRS, Dietary supplement

KOCHI, India, Oct. 18, 2022 /PRNewswire/ -- Results of a third clinical study reveal that Arjuna Natural Pvt. Ltd.'s Rhuleave-K® is also effective in pain relief at a dosage 50% that of the previous two studies. The blend of pure extracts of frankincense (Boswellia serrata) and turmeric (Curcuma longa) already was recognized in the first studies as providing relief of acute musculoskeletal pain following exercise, demonstrating a strong cumulative pain relief effect at 1,000mg. In response to the impressive results of the current study, the researchers note that it was encouraging to find that Rhuleave-K® works well even at 500mg.

Key Points: 
  • New study demonstrates lower dose of botanical blend provides quick pain relief.
  • Ltd.'s Rhuleave-K is also effective in pain relief at a dosage 50% that of the previous two studies.
  • The primary outcome was the sum of pain intensity difference at 6 hours, as evaluated by the Numerical Rating Scale (NRS), and total pain relief (TOTPAR6) evaluated by categorical pain relief scale (PRS) every 30 minutes over 6 hours.
  • Results showed a significant decrease (62%) in pain intensity for Rhuleave-K, with total pain relief 84% better than with the placebo.

Virios Therapeutics Announces Top-Line Results from Phase 2b Study of IMC-1 in Fibromyalgia

Retrieved on: 
Monday, September 19, 2022
Research, Women, FDA, Clinical Trials, Biotechnology, Health, Consumer, Pharmaceutical, Science, Celecoxib, BHC, COVID-19, Sleep, Short bowel syndrome, American College, PASC, FDA, Center, ID, Week, Vaccination, Company, Fibromyalgia, Functional somatic syndrome, American College of Rheumatology, Therapy, Valaciclovir, Famciclovir, Patient, Attention, Chronic fatigue syndrome, CEO, Pain, Female, Numerical, Nasdaq, Omicron, Anxiety, Diagnosis, Center of excellence, Simplex, Fatigue, FM, Conditional sentence, Pharmaceutical industry, Medical device, Delta

The Virios Therapeutics team received unblinded data relating to the FORTRESS study on Friday, September 16, 2022.

Key Points: 
  • The Virios Therapeutics team received unblinded data relating to the FORTRESS study on Friday, September 16, 2022.
  • Virios Therapeutics will host a conference call and live webcast to discuss the FORTRESS study results today, Monday, September 19th, at 8:30 a.m. Eastern Time.
  • A live webcast and replay of the call will also be available on the Virios Therapeutics, Inc. website at www.virios.com .
  • Virios Therapeutics (Nasdaq: VIRI) is a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, such as fibromyalgia (FM).

VYNE Therapeutics Completes Enrollment in Phase 2a Trial of FMX114 for the Treatment of Mild-to-Moderate Atopic Dermatitis

Retrieved on: 
Friday, June 17, 2022
Janus, Skin, Population, Allergy, COVID-19, Numerical, Safety, Inflammation, Prescription, Shohei Okuno, ADSI, Itch, Temperature, 114, Itchy, Company, SDZ, Pharmacokinetics, Dermatitis, Erythema, U.S. Securities and Exchange Commission, Perspiration, Sphingosine, Disease, Limited, Atopic dermatitis, FMX, BET, Regulation, Quality of life, Fingolimod, Nasdaq, Patient, AD, Regulation Fair Disclosure, Cell, Therapy, GLOBE, Disclosure, Pharmaceutical industry, Vaccine

The Phase 2a segment of the FMX 114 study is designed to evaluate four weeks of FMX114 treatment in patients with AD compared to vehicle control.

Key Points: 
  • The Phase 2a segment of the FMX 114 study is designed to evaluate four weeks of FMX114 treatment in patients with AD compared to vehicle control.
  • We look forward to reporting the results of the Phase 2a segment of the study in approximately 6 to 8 weeks.
  • About The FMX114 2a study ( VY2021-01, ClinicalTrials.gov Identifier: NCT04927572 )
    The Phase 2a segment of the study is a randomized, double-blinded trial, designed to compare the safety and efficacy of FMX114 gel with vehicle gel.
  • As in the Phase 1b study, the enrollment criteria specifies that subjects must have two comparable target AD lesions for treatment upon entry.