Day: September 10, 2022

(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...

– 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...

-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...

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...

– 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...

TCER® IMA402 is a next-generation, half-life extended TCR Bispecific targeting an HLA-A*02:01-presented peptide derived from PRAMEIn 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 profilePharmacokinetic characteristics of half-life extended IMA402 suggest potential for a favorable dosing regimen in patients with prolonged drug exposure at therapeutic levelsIMA402 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:...

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...

Results from two parallel trials show Cosentyx® (secukinumab) demonstrated superior efficacy vs placebo with statistically significant improvement in hidradenitis suppurativa (HS) signs and symptoms1Safety results were consistent with the well-established Cosentyx safety profileHS 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 life3,4Data 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 endBasel, September 10, 2022 — Novartis announced the results from two pivotal, Phase III studies (SUNSHINE and SUNRISE), in which Cosentyx® (secukinumab) demonstrated rapid and...

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...