Day: September 10, 2022

Kitron ASA - New share capital registered

Kitron ASA – New share capital registered

(2022-09-10) Reference is made to the stock exchange announcement from Kitron ASA on 30 August 2022 regarding issuance of 676,664 new shares under the Company’s share incentive program. The share capital increase in connection with the share incentive program has been registered in the Norwegian Register of Business Enterprises today. Registered share capital in Kitron ASA following the registration is NOK 19,769,105.30 divided on 197,691,053 shares, each with a par value of NOK 0.10. Each share gives one vote at the company’s general meeting. Kitron is a leading Scandinavian electronics manufacturing services company for the Connectivity, Electrification, Industry, Medical devices and Defence/Aerospace sectors. The group is located in Norway, Sweden, Denmark, Lithuania, Germany, Poland, the Czech Republic, China and the United...

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SpringWorks Therapeutics Announces Data from Phase 3 DeFi Trial Evaluating Nirogacestat in Adult Patients with Progressing Desmoid Tumors at the European Society for Medical Oncology (ESMO) Congress 2022

SpringWorks Therapeutics Announces Data from Phase 3 DeFi Trial Evaluating Nirogacestat in Adult Patients with Progressing Desmoid Tumors at the European Society for Medical Oncology (ESMO) Congress 2022

– Nirogacestat Treatment Resulted in Rapid, Sustained and Statistically Significant Improvements in Primary and All Key Secondary Efficacy Endpoints – – NDA Submission to the U.S. FDA Planned for Second Half of 2022; Application to be Submitted for Review Under the FDA’s Real-Time Oncology Review Program (RTOR) – – Company to Host Virtual Investor Event on Sunday, September 11 at 10:00 a.m. ET (4:00 p.m. CEST) – STAMFORD, Conn., Sept. 10, 2022 (GLOBE NEWSWIRE) — SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, announced that data from the Phase 3 DeFi trial of nirogacestat, an investigational oral gamma secretase inhibitor, in adult patients with progressing desmoid tumors, are being presented...

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Apexigen Presents New Data from a Phase 2 Trial Evaluating its CD40 Antibody, Sotigalimab, in Combination with Neoadjuvant Chemoradiation in Patients with Resectable Esophageal and Gastroesophageal Junction Cancers at ESMO Congress 2022

Apexigen Presents New Data from a Phase 2 Trial Evaluating its CD40 Antibody, Sotigalimab, in Combination with Neoadjuvant Chemoradiation in Patients with Resectable Esophageal and Gastroesophageal Junction Cancers at ESMO Congress 2022

-Sotigalimab in combination with neoadjuvant chemoradiation induced higher pathologic complete response rates, an important predictor of survival, in patients with both adenocarcinoma and squamous cell carcinoma- SAN CARLOS, Calif., Sept. 10, 2022 (GLOBE NEWSWIRE) — Apexigen, Inc. (NASDAQ: APGN) a clinical-stage company focused on developing innovative antibody-based therapeutics for the treatment of cancer with a focus on immuno-oncology, today announced the presentation of new data from a Phase 2 multicenter clinical trial evaluating sotigalimab (sotiga), Apexigen’s agonist antibody targeting CD40, in combination with neoadjuvant chemoradiation for patients with resectable esophageal and gastroesophageal junction (GEJ) cancers. Encouraging pathologic complete response (pCR) rates were observed in patients with both adenocarcinoma...

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Cabaletta Bio Presents New Interim Data from the DesCAARTes™ Phase 1 Trial at the 31st EADV Congress

Cabaletta Bio Presents New Interim Data from the DesCAARTes™ Phase 1 Trial at the 31st EADV Congress

PHILADELPHIA, Sept. 10, 2022 (GLOBE NEWSWIRE) — Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on the discovery and development of targeted cell therapies for patients with autoimmune diseases, today presented updated clinical and translational data through 6 months of follow-up in cohorts A1 through A4 as well as 28-day safety data and DSG3-CAART persistence data through day 29 for cohorts A1 through A5 from the DesCAARTes™ trial at the 31st European Academy of Dermatology and Venereology (EADV) Congress, which is being held in Milan, Italy from September 7-10, 2022. “The new data continue to support the favorable safety profile of DSG3-CAART, with no dose-limiting toxicities, and one grade 1 cytokine release syndrome through cohort A5, at a dose of up to 7.5 billion DSG3-CAART cells. No clear...

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Adagene Presents Interim Monotherapy Data at ESMO 2022 Showing Compelling Safety, Anti-Tumor Activity and Pharmacokinetics of Masked, Anti-CTLA-4 SAFEbody® ADG126 in Patients with Advanced Tumors

Adagene Presents Interim Monotherapy Data at ESMO 2022 Showing Compelling Safety, Anti-Tumor Activity and Pharmacokinetics of Masked, Anti-CTLA-4 SAFEbody® ADG126 in Patients with Advanced Tumors

– Best-in-class profile demonstrated with repeat dosing across dose levels – – Antitumor activity observed in cold tumors with steady accumulation of activated ADG126 – – On track in 2022 to report results of ADG126 dose escalation in combination with anti-PD-1 therapy, establishing dose regimen for phase 2a dose expansion cohorts – SAN DIEGO and SUZHOU, China, Sept. 10, 2022 (GLOBE NEWSWIRE) — Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced the publication of data showing the best-in-class potential of ADG126, a masked, anti-CTLA-4 SAFEbody®. Interim results from the Phase 1 portion of an ongoing Phase 1b/2 trial of ADG126 are being presented at the European Society for Medical Oncology (ESMO) Congress 2022 in...

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Immatics Presents Comprehensive Preclinical Data Set for TCR Bispecific Candidate IMA402 Targeting PRAME at European Society for Medical Oncology (ESMO) Congress 2022

Immatics Presents Comprehensive Preclinical Data Set for TCR Bispecific Candidate IMA402 Targeting PRAME at European Society for Medical Oncology (ESMO) Congress 2022

TCER® IMA402 is a next-generation, half-life extended TCR Bispecific targeting an HLA-A*02:01-presented peptide derived from PRAME In preclinical studies, IMA402 demonstrated enhanced anti-tumor activity in vivo and reduced T cell engager-associated toxicities as part of overall favorable in vitro safety profile Pharmacokinetic characteristics of half-life extended IMA402 suggest potential for a favorable dosing regimen in patients with prolonged drug exposure at therapeutic levels IMA402 is part of Immatics’ strategy to leverage the full clinical potential of targeting PRAME, one of the most promising targets for TCR-based therapies  Phase 1/2 clinical trial on track to start in 2023; submission of the CTA/IND1 application is planned for 2Q 2023   Tuebingen, Germany and Houston, Texas, September 10, 2022 – Immatics N.V. (NASDAQ:...

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POINT Biopharma Provides Updated Efficacy and Safety Data from the Lead-In Cohort of the Phase 3 SPLASH Trial in mCRPC at ESMO Congress 2022

POINT Biopharma Provides Updated Efficacy and Safety Data from the Lead-In Cohort of the Phase 3 SPLASH Trial in mCRPC at ESMO Congress 2022

Newly published poster on the single-arm 27-patient safety and dosimetry lead-in provides key updates including: A median rPFS time of 11.5 months A best radiographic objective response (CR, PR) was achieved in 60% of the 10 participants with evaluable disease at baseline PNT2002 was well tolerated with no treatment-related deaths INDIANAPOLIS, Sept. 10, 2022 (GLOBE NEWSWIRE) — POINT Biopharma Global Inc. (NASDAQ: PNT) (the “Company” or “POINT”), a company accelerating the discovery, development and global access to life-changing radiopharmaceuticals, today published a poster at ESMO Congress 2022 containing updated efficacy and safety data from the 27-patient safety and dosimetry lead-in cohort for the Company’s phase 3 SPLASH trial (NCT04647526) evaluating PNT2002 for the treatment of metastatic castration-resistant prostate...

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Novartis Cosentyx® shows clinically meaningful symptom improvements in patients with hidradenitis suppurativa in pivotal Phase III trials

Novartis Cosentyx® shows clinically meaningful symptom improvements in patients with hidradenitis suppurativa in pivotal Phase III trials

Results from two parallel trials show Cosentyx® (secukinumab) demonstrated superior efficacy vs placebo with statistically significant improvement in hidradenitis suppurativa (HS) signs and symptoms1 Safety results were consistent with the well-established Cosentyx safety profile HS is a chronic, inflammatory skin condition affecting up to one in 100 people worldwide2, resulting in painful, potentially disfiguring lesions, which leaves feelings of stigmatization and can severely impact quality of life3,4 Data from SUNSHINE and SUNRISE trials were submitted as part of regulatory applications to health authorities in Europe; plan to submit in the US by year end Basel, September 10, 2022 — Novartis announced the results from two pivotal, Phase III studies (SUNSHINE and SUNRISE), in which Cosentyx® (secukinumab) demonstrated rapid and...

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Ultragenyx and Mereo BioPharma to Present Setrusumab Data Update at ASBMR

Ultragenyx and Mereo BioPharma to Present Setrusumab Data Update at ASBMR

NOVATO, Calif. and MOUNTAIN VIEW, Calif. and LONDON, Sept. 09, 2022 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), (“Ultragenyx”), a biopharmaceutical company focused on the development and commercialization of novel products for serious rare and ultra-rare genetic diseases and Mereo BioPharma Group plc (NASDAQ: MREO), (“Mereo”), a clinical-stage biopharmaceutical company focused on rare diseases and oncology, today announced that additional data from Mereo’s Phase 2b ASTEROID study related to setrusumab (UX143) and information on the Phase 2/3 Orbit study will be presented at the American Society for Bone and Mineral Research 2022 Annual Meeting (ASBMR) being held September 9-12, 2022, in Austin, Texas. Setrusumab is a monoclonal antibody in development for the treatment of Osteogenesis Imperfecta (OI), a rare...

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