Inflammation

EQS-News: Dermapharm Holding SE hits upper end of guidance range for adjusted EBITDA, primarily due to steadily growing international presence in branded business

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Mercredi, avril 10, 2024

Dermapharm Holding SE hits upper end of guidance range for adjusted EBITDA, primarily due to steadily growing international presence in branded business

Key Points: 
  • Dermapharm Holding SE hits upper end of guidance range for adjusted EBITDA, primarily due to steadily growing international presence in branded business
    The issuer is solely responsible for the content of this announcement.
  • » Adjusted consolidated EBITDA margin: 27.3%
    Grünwald, 14 March 2024 – Dermapharm Holding SE ("Dermapharm"), a rapidly growing manufacturer of branded pharmaceuticals and other healthcare products, today publishes its unaudited preliminary consolidated figures (IFRS) for financial year 2023.
  • Adjusted earnings before interest, taxes, depreciation and amortisation (EBITDA) declined by 13.8% to EUR 310.2 million (prior-year period: EUR 359.8 million).
  • We exceeded our guidance for consolidated revenue and reached the upper end of the forecast range for adjusted EBITDA.

Global Experts from SEPA Call for the Control of Gingivitis Rather than Waiting for Periodontitis to Develop

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Lundi, avril 8, 2024

SEPA: Limited knowledge among oral health teams of the recommendations and evidence currently available on oral antiseptics (that are clinically proven to be effective) reduces their implementation; therefore, more practical and simple advice is proposed.

Key Points: 
  • This was highlighted at an International Summit of Experts held at the Casa de las Encías in Madrid, Spain, the headquarters of the SEPA Foundation.
  • "Periodontal diseases are prevalent worldwide, affecting hundreds of millions of people," says the meeting coordinator, Dr. Paula Matesanz, vice president of SEPA.
  • As Dr. Iain Chapple summarizes, "It is time for a paradigm shift: we must control gingivitis and not wait until periodontitis develops."
  • J Clin Periodontol 2022 Jun:49 Suppl 24:4-71 (version adapted by SEPA available at https://portal.guiasalud.es/gpc/tratamiento-periodontitis-estadio-iv )
    * Chapple I, Time to take gum disease seriously.

Cardiol Therapeutics Announces Year-End 2023 Update on Operations

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Mardi, avril 2, 2024

"Cardiol Therapeutics made important progress in 2023 and early 2024 as we pursued our primary objective of providing new therapeutic options to patients with poorly served heart diseases," said David Elsley, President and Chief Executive Officer of Cardiol Therapeutics.

Key Points: 
  • "Cardiol Therapeutics made important progress in 2023 and early 2024 as we pursued our primary objective of providing new therapeutic options to patients with poorly served heart diseases," said David Elsley, President and Chief Executive Officer of Cardiol Therapeutics.
  • In January 2023, Cardiol announced the first patient had been enrolled in the Company's Phase II open-label pilot study ("MAvERIC-Pilot") investigating the tolerance, safety, and efficacy of CardiolRx™ in patients with recurrent pericarditis.
  • In November 2023, Cardiol announced that it had exceeded 50% of the patient enrollment target for the MAvERIC-Pilot study.
  • In January 2024, Cardiol announced that ARCHER had exceeded 50% patient enrollment and was progressing ahead of the original study timeline.

RAPT Therapeutics Announces Promising Results from Phase 2 Trial of Tivumecirnon in Combination with Anti-PD-1 Immunotherapy in CPI-Experienced Head and Neck Cancer Patients

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Mardi, avril 9, 2024

SOUTH SAN FRANCISCO, Calif., April 09, 2024 (GLOBE NEWSWIRE) --  RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, today announced safety and efficacy data from its ongoing Phase 2 trial of tivumecirnon in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab in the cohort of patients with advanced head and neck squamous cell carcinoma (HNSCC) whose disease progressed despite previous treatment with CPI therapy (CPI-experienced). The results were presented at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, CA.

Key Points: 
  • The results were presented at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, CA.
  • The AACR poster highlighted data from the 32-patient CPI-experienced HNSCC cohort in the trial evaluating tivumecirnon, an oral small molecule CCR4 antagonist designed to block the migration of regulatory T cells, in combination with pembrolizumab.
  • Patients in this cohort had heavily pretreated disease, with 69% of patients having received three or more (up to six) prior lines of treatment.
  • In the entire cohort, confirmed responses were observed in 5/32 patients (15.6%) regardless of PD-L1 or HPV status.

Nurix Therapeutics Reports First Clinical Evidence of CNS Activity of NX-5948, a Brain-Penetrant, Orally Available, BTK Degrader in Development for B Cell Malignancies

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Mardi, avril 9, 2024

SAN FRANCISCO, April 09, 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 the presentation of the first findings of clinical responses in the brain for NX-5948, an orally available, selective degrader of Bruton’s tyrosine kinase (BTK). The presentation included case studies for two patients, one with CLL with CNS involvement and the other with PCNSL, each demonstrating clinically meaningful responses. The presentation also provided evidence of measurable drug levels in the CNS of multiple patients in the ongoing Phase 1 trial who had CNS tumor involvement. These data were presented by Gwenn M. Hansen, Ph.D., chief scientific officer of Nurix, as part of the Major Symposium session Molecular Glues, PROTACs, and Next-Gen Degraders: Discovery and Early Preclinical Advances at the AACR 2024 Annual Meeting, which is being held from April 5-10, 2024, in San Diego, CA.

Key Points: 
  • The presentation included case studies for two patients, one with CLL with CNS involvement and the other with PCNSL, each demonstrating clinically meaningful responses.
  • The presentation also provided evidence of measurable drug levels in the CNS of multiple patients in the ongoing Phase 1 trial who had CNS tumor involvement.
  • “These data are the first demonstration of clinical activity in the brain of a targeted protein degrader, opening the door for new therapeutic strategies to treat leukemias and lymphomas with CNS involvement,” said Dr. Hansen.
  • “The CLL patient with CNS involvement showed an impressive durable response with NX-5948 as single agent therapy in this setting.

Nurix Therapeutics Announces Extension of Strategic Collaboration with Sanofi to Develop Novel Targeted Protein Degraders of STAT6

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Mardi, avril 9, 2024

SAN FRANCISCO, April 09, 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, announced today an extension of the ongoing research program with Sanofi for STAT6 (signal transducer and activator of transcription 6). STAT6 is a key drug target in type 2 inflammation.

Key Points: 
  • “STAT6 is a key transcription factor within the IL-4/IL-13 signaling pathways which act as drivers of inflammation in allergic conditions.
  • “Preclinical data from our STAT6 degraders show that targeted degradation of this key transcription factor provides a rapidly acting and potent blockade of signaling.
  • “We are very excited to pursue our collaboration with Sanofi, as it further demonstrates the productivity of our long-standing research program to develop a pipeline of breakthrough degraders to treat inflammation and autoimmunity.
  • Nurix’s disclosed pipeline in inflammation and autoimmunity now includes the STAT6 degrader with Sanofi, the IRAK4 degrader with Gilead, and Nurix’s proprietary BTK degrader, NX-5948.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Ventyx, and Anavex and Encourages Investors to Contact the Firm

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Mardi, avril 9, 2024

The Company's lead clinical product candidate is VTX958, a selective allosteric tyrosine kinase type 2 inhibitor for psoriasis, psoriatic arthritis, and Crohn's disease.

Key Points: 
  • The Company's lead clinical product candidate is VTX958, a selective allosteric tyrosine kinase type 2 inhibitor for psoriasis, psoriatic arthritis, and Crohn's disease.
  • In addition, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and prospects.
  • On November 6, 2023, during after-market hours, Ventyx issued a press release announcing results from the Phase 2 SERENITY Trial.
  • For more information on the Anavex class action go to: https://bespc.com/cases/AVXL

VTYX INVESTOR ALERT: Bronstein, Gewirtz & Grossman LLC Announces that Ventyx Biosciences, Inc. Investors with Substantial Losses Have Opportunity to Lead Class Action Lawsuit!

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Mardi, avril 9, 2024

Ventyx is a clinical-stage biopharmaceutical company that develops small molecule product candidates to address a range of inflammatory diseases.

Key Points: 
  • Ventyx is a clinical-stage biopharmaceutical company that develops small molecule product candidates to address a range of inflammatory diseases.
  • The Company’s lead clinical product candidate is VTX958, a selective allosteric tyrosine kinase type 2 inhibitor for psoriasis, psoriatic arthritis, and Crohn’s disease.
  • On November 6, 2023, during after-market hours, Ventyx issued a press release announcing results from the Phase 2 SERENITY Trial.
  • Bronstein, Gewirtz & Grossman, LLC is a nationally recognized firm that represents investors in securities fraud class actions and shareholder derivative suits.

Cue Biopharma Reports Fourth Quarter and Full Year 2023 Financial Results and Updated Business Highlights

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Lundi, avril 8, 2024

BOSTON, April 08, 2024 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively modulate disease-specific T cells, today reported fourth quarter and full year 2023 financial results.

Key Points: 
  • BOSTON, April 08, 2024 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively modulate disease-specific T cells, today reported fourth quarter and full year 2023 financial results.
  • The increase was due to revenue earned from our strategic collaboration agreement entered into with Ono Pharmaceutical in the first quarter of 2023.
  • As of December 31, 2023, the Company had approximately $48.5 million in cash, cash equivalents and marketable securities compared with $76.3 million as of December 31, 2022.
  • We expect our current cash, cash equivalents, and marketable securities to fund operations into the first quarter of 2025.

SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Ventyx Biosciences, Inc. of Class Action Lawsuit and Upcoming Deadlines – VTYX

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Lundi, avril 8, 2024

NEW YORK, April 08, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Ventyx Biosciences, Inc. (“Ventyx” or the “Company”) (NASDAQ: VTYX) and certain officers.

Key Points: 
  • NEW YORK, April 08, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Ventyx Biosciences, Inc. (“Ventyx” or the “Company”) (NASDAQ: VTYX) and certain officers.
  • To discuss this action, contact Danielle Peyton at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext.
  • Ventyx is a clinical-stage biopharmaceutical company that develops small-molecule product candidates to address a range of inflammatory diseases.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.