Trial of the century

Latest data of InnoCare's ICP-332 for the Treatment of Atopic Dermatitis Presented at LBA Session of 2024 AAD

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수요일, 3월 13, 2024

75 eligible AD patients were randomized into three groups: once daily oral ICP-332 80 mg, once daily oral 120 mg, and placebo respectively.

Key Points: 
  • 75 eligible AD patients were randomized into three groups: once daily oral ICP-332 80 mg, once daily oral 120 mg, and placebo respectively.
  • ICP-332 demonstrated a rapid response, with the NRS score from baseline in the two treatment groups showing statistically significant improvement on day 2.
  • With the improvement of pruritus, the quality of life of subjects in the two treatment groups was significantly elevated.
  • The 2024 AAD Annual Meeting is held from March 8 to 12 in San Diego, California, USA.

Crearene AG and Alzchem Group AG: Successful addition of creatine to dialysis patient treatments

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수요일, 3월 13, 2024

Crearene AG and Alzchem Group AG: Successful addition of creatine to dialysis patient treatments

Key Points: 
  • Crearene AG and Alzchem Group AG: Successful addition of creatine to dialysis patient treatments
    As part of their cooperation, Alzchem Group AG and Crearene AG announced in October 2023 that a clinical study on the use of creatine in dialysis treatments had been launched.
  • The aim is to demonstrate the technical feasibility, patient safety and dose finding of creatine-based dialysis treatment solutions.
  • Using specially purified creatine from the Alzchem Group, a University Medical Center Groningen team, led by Prof. Dr. Stephan J.L.
  • Based on the promising initial results, Alzchem Group AG and Crearene AG have extended their collaboration to develop creatine-based treatment solutions for medical applications until the end of 2025.

Affluent Medical announces successful first-in-human implantation of its artificial sphincter Artus for the treatment of stress urinary incontinence.

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수요일, 3월 13, 2024

Affluent Medical announces successful first-in-human implantation of its artificial sphincter Artus for the treatment of stress urinary incontinence.

Key Points: 
  • Affluent Medical announces successful first-in-human implantation of its artificial sphincter Artus for the treatment of stress urinary incontinence.
  • This first implantation of the artificial urinary sphincter Artus was successfully performed by Prof. Roman Zachoval, MD, PhD, head of the Department of Urology at Thomayer University Hospital in Prague, Czech Republic, on a 68-year-old male with severe urinary incontinence.
  • “Artus is easy to prepare and implant due to its innovative design compared to the previous generation of urinary sphincters.
  • Artus is an implantable artificial urinary sphincter developed for the treatment of moderate to severe urinary incontinence in both men and women.

Olema Oncology Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Corporate Update

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월요일, 3월 11, 2024

“In 2023 we demonstrated the unique opportunity ahead for palazestrant to make a meaningful impact on improving treatment options for women with ER+/HER2- breast cancer.

Key Points: 
  • “In 2023 we demonstrated the unique opportunity ahead for palazestrant to make a meaningful impact on improving treatment options for women with ER+/HER2- breast cancer.
  • Presented palazestrant monotherapy Phase 2 clinical results at the European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain, as an oral presentation demonstrating compelling activity in both wild-type and ESR1-mutant tumor types.
  • Non-GAAP G&A expenses were $3.1 million and $13.3 million for the quarter and year ended December 31, 2023, respectively, excluding $1.4 million and $5.5 million non-cash stock-based compensation expense respectively.
  • A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

CytomX Therapeutics Reports 2023 Financial Results and Provides Business Update

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월요일, 3월 11, 2024

SOUTH SAN FRANCISCO, Calif., March 11, 2024 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, today reported full year 2023 financial results and provided a business update.

Key Points: 
  • Throughout 2023, CytomX made substantial progress across all research partnerships including the commencement of programs under its new alliances with Regeneron and Moderna.
  • In 2023, CytomX remained focused on controlling costs and efficiently allocating capital towards its lead pipeline programs.
  • General and administrative expenses in the fourth quarter of 2023 were $7.8 million compared to $10.1 million in the corresponding period in 2022.
  • CytomX management will host a conference call and simultaneous webcast today at 5 p.m. EDT (2 p.m. PDT) to discuss the financial results and provide a business update.

Unveiling Complexion Renewal Oil: A Revolutionary Skincare Innovation

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월요일, 3월 11, 2024

DAVIE, Fla., March 11, 2024 (GLOBE NEWSWIRE) -- CosMedical Technologies, a leader in skincare innovation and forerunner in the custom branded skincare industry, proudly unveils its latest breakthrough: Complexion Renewal Oil.

Key Points: 
  • DAVIE, Fla., March 11, 2024 (GLOBE NEWSWIRE) -- CosMedical Technologies, a leader in skincare innovation and forerunner in the custom branded skincare industry, proudly unveils its latest breakthrough: Complexion Renewal Oil.
  • "With its unique formulation and sustainable ingredients, Complexion Renewal Oil is poised to be a great addition to our skincare partners’ line of custom branded products."
  • Harnessing the power of innovative actives such as Rock Samphire, Micro-resurfacing Acid Blend, and Phyto-7 Oil Complex, Complexion Renewal Oil offers unparalleled efficacy.
  • For more information about Complexion Renewal Oil and CosMedical Technologies’ other groundbreaking products, please contact CosMedical Technologies® at 800-275-3627 or [email protected]

Assertio Reports Fourth Quarter and Full Year 2023 Financial Results

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월요일, 3월 11, 2024

LAKE FOREST, Il., March 11, 2024 (GLOBE NEWSWIRE) --  Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a pharmaceutical company with comprehensive commercial capabilities offering differentiated products to patients, today reported financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • Rolvedon net product sales were $11.0 million in the fourth quarter, the first full quarter following the acquisition of Spectrum.
  • Gross margin3 in the fourth quarter was 70%, decreased from 88% in the prior year fourth quarter.
  • Assertio announced its initial 2024 operating guidance as follows:
    For the quarter ended December 31, 2023, cash and cash equivalents totaled $73.4 million.
  • Assertio’s management will host a conference call to discuss its fourth quarter and full year 2023 financial results today:

Nurix Therapeutics Announces U.S. FDA Lifts Partial Clinical Hold on NX-2127 Phase 1 Trial

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월요일, 3월 11, 2024

SAN FRANCISCO, March 11, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the U.S.

Key Points: 
  • SAN FRANCISCO, March 11, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the U.S.
  • Phase 1a/1b study evaluating NX-2127 in adults with relapsed/refractory B-cell malignancies.
  • The partial clinical hold on the study was announced by Nurix on November 1, 2023, following the company’s communication to the FDA of its intention to transition to an improved manufacturing process.
  • “We are pleased with the timely resolution of the partial clinical hold, which allows us to reinitiate enrollment in the NX-2127 Phase 1 study utilizing drug product from our new manufacturing process,” said Paula G. O’Connor, M.D., executive vice president and head of clinical development at Nurix.

Replay’s cell therapy product company Syena announces first patient dosed in Phase 1/2 study of TCR-NK cell therapy for multiple myeloma

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월요일, 3월 11, 2024

Syena has an exclusive licensing agreement for MD Anderson’s TCR-NK technology platform.

Key Points: 
  • Syena has an exclusive licensing agreement for MD Anderson’s TCR-NK technology platform.
  • This first-in-class engineered cell therapy comprises cord blood-derived natural killer cells that express an affinity-enhanced TCR targeted against the NY-ESO-1 antigen.
  • The Phase 1/2 clinical study will assess the safety and efficacy of NY-ESO-1 TCR/IL-15 NK in patients with relapsed or refractory multiple myeloma.
  • NY-ESO-1 is highly expressed in poor-prognosis multiple myeloma, making this a suitable indication for demonstrating proof of concept for Syena’s TCR-NK technology platform.

Samsung Bioepis Presents Two Abstracts for Its Immunology Portfolio at the 2024 American Academy of Dermatology (AAD) Annual Meeting

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토요일, 3월 9, 2024

“We are excited to present new clinical data for our immunology portfolio at AAD Annual Meeting.

Key Points: 
  • “We are excited to present new clinical data for our immunology portfolio at AAD Annual Meeting.
  • The high-concentration (40 mg/0.4 mL) formulation of prefilled syringe and prefilled autoinjector of HADLIMA was approved in August 2022.
  • The study showed that efficacy, safety, and immunogenicity between the three arms were comparable up to Week 52.
  • Details of the Samsung Bioepis’ abstracts are as follows:
    Clinical Similarity of SB17 (Proposed Ustekinumab Biosimilar) to Reference Ustekinumab in Patients with Moderate to Severe Plaque Psoriasis: Randomized, Double-blind, Phase III, 52-Week Results