ULN

Spruce Biosciences Reports Full Year 2023 Financial Results and Provides Corporate Updates

Retrieved on: 
Wednesday, March 13, 2024
Biotechnology, Pharmaceutical, Health, Research, A4, GC, Congenital adrenal hyperplasia, Administration, PCOS, P-value, GCS, Patient, Cash, Șaeș, Spruce, Outline, CAH, Clinical trial, Safety, Hyperandrogenism, Polycystic ovary syndrome, ULN, Research and development, Food, FDA, Pharmaceutical industry

(Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need, today reported financial results for the year ended December 31, 2023 and provided corporate updates.

Key Points: 
  • (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need, today reported financial results for the year ended December 31, 2023 and provided corporate updates.
  • “We are grateful to all the patients, families, study team and investigators who supported the CAHmelia-203 clinical trial,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer, Spruce Biosciences.
  • Non-cash stock-based compensation expense for the year ended December 31, 2023 was $4.6 million compared to $3.6 million in 2022.
  • Net Loss: Net loss for the year ended December 31, 2023 was $47.9 million compared to $46.2 million in 2022.

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.

Kira Pharmaceuticals Presents Positive Results of KP104 Phase 2 Study in Complement-Naïve Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) at the 2023 ASH Annual Meeting

Retrieved on: 
Thursday, December 14, 2023
Safety, Interim, ASH, Cohort, Headache, PD, PNH, Patient, ULN, IgA nephropathy, Week, Microangiopathy, Pharmacokinetics, Immunoglobulin A, COVID19, Common, Society, RBC, LDH, Medical device, Pharmaceutical industry, Fine chemical, Vaccine

The interim results support the advancement of KP104 to Phase 3 studies as an optimal and safe treatment for PNH patients to address currently unmet medical needs.

Key Points: 
  • The interim results support the advancement of KP104 to Phase 3 studies as an optimal and safe treatment for PNH patients to address currently unmet medical needs.
  • The presentation has also been selected to be featured in the 2024 Highlights of ASH.
  • Kira Pharmaceuticals is committed to advancing KP104 as an innovative therapy for patients with PNH and other complement-mediated diseases.
  • Title: KP104, a bifunctional C5 antibody/factor H fusion protein, effectively controls both intravascular and extravascular hemolysis: interim results from a phase 2 study in complement inhibitor-naïve PNH patients

CymaBay Reports Second Quarter and Six Months Ended June 30, 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, August 10, 2023
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NEWARK, Calif., Aug. 10, 2023 (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, announced today corporate updates and financial results for the second quarter ended June 30, 2023.

Key Points: 
  • ET
    NEWARK, Calif., Aug. 10, 2023 (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, announced today corporate updates and financial results for the second quarter ended June 30, 2023.
  • Research and development expenses for the three months ended June 30, 2023, and 2022 were $19.5 million and $17.9 million, respectively.
  • Research and development expenses for the six months ended June 30, 2023 were $38.1 million and $36.3 million, respectively.
  • Net loss for the six months ended June 30, 2023 was $29.6 million and $54.9 million, or ($0.30) and ($0.62), respectively.

American Regent® Launches Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound)

Retrieved on: 
Tuesday, May 2, 2023
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MELVILLE, N.Y., May 2, 2023 /PRNewswire/ -- American Regent, Inc.® is pleased to announce the launch of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound), which is an alternative to Abraxane®.

Key Points: 
  • Do not administer Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) to patients with baseline absolute neutrophil counts (ANC) of less than 1,500 cells/mm3.
  • In the case of severe neutropenia (
  • Permanently discontinue treatment with Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) and gemcitabine upon making a diagnosis of pneumonitis.
  • Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) has different dosage and administration instructions from other paclitaxel products.

Exelixis Provides Update on Phase 3 CONTACT-01 Trial Evaluating Cabozantinib in Combination with Atezolizumab in Patients with Metastatic Non-Small Cell Lung Cancer Previously Treated with Immunotherapy and Chemotherapy

Retrieved on: 
Thursday, December 8, 2022
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Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.

Key Points: 
  • Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.
    CABOMETYX in combination with atezolizumab is not indicated as a treatment for NSCLC.
  • The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC, HCC, and DTC studies.
  • Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients.
  • Discontinue CABOMETYX in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic events that require medical intervention.

Enrollment Completed in Phase 3 PATHFNDR-1 Study Evaluating Oral Paltusotine for the Treatment of Acromegaly

Retrieved on: 
Thursday, October 13, 2022
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PATHFNDR-1 is one of two ongoing, placebo-controlled Phase 3 studies evaluating the safety and efficacy of once-daily oral paltusotine in acromegaly patients.

Key Points: 
  • PATHFNDR-1 is one of two ongoing, placebo-controlled Phase 3 studies evaluating the safety and efficacy of once-daily oral paltusotine in acromegaly patients.
  • The Phase 3 PATHFNDR-2 studys enrollment is ongoing and topline results are expected in the fourth quarter of 2023.
  • We would like to thank study participants and clinical research professionals for their interest and contributions to the PATHFNDR-1 study.
  • In Phase 2 studies, paltusotine maintained IGF-1 levels in acromegaly patients who switched from injectable depot medications to once-daily oral paltusotine.

Recordati Rare Diseases Announce Publication of Long-term Outcomes From the Extension to the Phase III LINC 3 Study of Isturisa® (Osilodrostat) in Patients With Cushing’s Disease in the European Journal of Endocrinology

Retrieved on: 
Wednesday, August 31, 2022
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Median duration of exposure to Isturisa from core study baseline to end of the extension was 130 weeks (range 1245).

Key Points: 
  • Median duration of exposure to Isturisa from core study baseline to end of the extension was 130 weeks (range 1245).
  • Recordati Rare Diseases is committed to improving the lives of patients with this rare, debilitating and life-threatening condition.
  • Long-term outcomes of osilodrostat in Cushings disease: LINC 3 study extension The European Journal of Endocrinology 2022.
  • Efficacy and safety of osilodrostat in patients with Cushing's disease (LINC 3): a multicentre phase III study with a double-blind, randomised withdrawal phase.

Gilead Sciences Signs New Joint Procurement Agreement with the European Commission for Veklury® (Remdesivir)

Retrieved on: 
Tuesday, July 19, 2022
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Veklury (remdesivir) is a nucleotide analog invented by Gilead, building on more than a decade of the companys antiviral research.

Key Points: 
  • Veklury (remdesivir) is a nucleotide analog invented by Gilead, building on more than a decade of the companys antiviral research.
  • As new SARS-CoV-2 variants of concern emerge around the world, Gilead continuously evaluates the effectiveness of Veklury against viral variants.
  • Veklury, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.
  • For more information about Gilead, please visit the companys website at www.gilead.com , follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

BridgeBio Pharma Announces Positive Phase 1 Data and Phase 2/3 Trial Design for BBP-711, a Potentially Best-In-Class GO Inhibitor for Primary Hyperoxaluria Type 1 (PH1) and Recurrent Kidney Stone Formers

Retrieved on: 
Monday, June 27, 2022
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PALO ALTO, Calif., June 27, 2022 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced positive Phase 1 data for BBP-711 in healthy volunteers, supporting the development of the investigational therapy for patients with primary hyperoxaluria type 1 (PH1) and recurrent kidney stone formers. The data were shared in a feature oral presentation at European Society for Pediatric Nephrology (ESPN) 2022, taking place in Ljubljana, Slovenia.

Key Points: 
  • BBP-711 is an orally-administered small molecule inhibitor of glycolate oxidase (GO) that is being developed to treat conditions of excess oxalate.
  • Overproduction of oxalate in hyperoxaluria, including PH1 and recurrent kidney stone formers with elevated oxalate, can lead to kidney stone formation, nephrocalcinosis and renal impairment.
  • These data are encouraging for patients with PH1 as BBP-711 could become a novel oral therapy to prevent hyperoxaluria and its long-term consequences.
  • Moreover, BridgeBio operates in a very competitive and rapidly changing environment in which new risks emerge from time to time.