Day: October 22, 2023

Cobre Panamá Mining Concession Contract Enacted Into Law in Panamá

(In United States dollars, except where noted otherwise) TORONTO, Oct. 22, 2023 (GLOBE NEWSWIRE) — First Quantum Minerals Ltd. (“First Quantum” or “the Company”) (TSX: FM) announced today that Law 406, which approves the refreshed mining concession contract (“Concession Contract”) for the Cobre Panamá mine, was published in the Official Gazette of Panamá on October 20, 2023. On October 20, 2023, the National Assembly in Panamá approved Bill 1100, being the proposal for approval of the Concession Contract for the Cobre Panamá mine, in the third debate of the plenary session with a vote of 47 in favour out of a total of 55 votes registered. On the same day, President Laurentino Cortizo sanctioned Bill 1100 into Law 406 and this was subsequently published in the Official Gazette. The enactment of Law 406 marks the final step in revising...

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Press Release: Dupixent® (dupilumab) Phase 3 Results show sustained efficacy for up to one year in children 1 to 11 years of age with eosinophilic esophagitis (EoE)

Dupixent® (dupilumab) Phase 3 Results show sustained efficacy for up to one year in children 1 to 11 years of age with eosinophilic esophagitis (EoE) Late-breaking presentation at ACG 2023 showed histologic and endoscopic improvements were maintained with no new safety signals to week 52 with higher dose Dupixent in these children Data reinforce the role of type 2 inflammation in EoE and the importance of targeting both IL-4 and IL-13 pathways sBLA for Dupixent to treat children aged 1 to 11 years with EoE is under Priority Review in the U.S.; if approved, Dupixent would be the first and only FDA-approved treatment for these children with EoE Paris and Tarrytown, N.Y. October 22, 2023. Positive results from a Phase 3 trial demonstrated the efficacy and safety profile of Dupixent® (dupilumab) for up to one year (52 weeks) in children...

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Dupixent® (dupilumab) Phase 3 Results Show Sustained Efficacy for Up to One Year in Children 1 to 11 Years of Age with Eosinophilic Esophagitis (EoE)

Late-breaking presentation at ACG 2023 showed histologic and endoscopic improvements were maintained with no new safety signals to week 52 with higher dose Dupixent in these children Data reinforce the role of type 2 inflammation in EoE and the importance of targeting both IL-4 and IL-13 pathways sBLA for Dupixent to treat children aged 1 to 11 years with EoE is under Priority Review in the U.S.; if approved, Dupixent would be the first and only FDA-approved treatment for these children with EoE PARIS and TARRYTOWN, N.Y., Oct. 22, 2023 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that positive results from a Phase 3 trial evaluating the investigational use of Dupixent® (dupilumab) showed consistent efficacy and safety for up to one year (52 weeks) in children aged 1 to 11 years with...

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Agillic joins partner Immeo in supporting the ‘Knæk Cancer’ (fight cancer) fundraising campaign

Cancer affects one out of every three people in Denmark before the age of 75, making cancer something that touches most, if not every Dane. Whether as a patient, next of kin, friend, or colleague, we all know someone. Every year, Kræften Bekæmpelse (The Danish Cancer Society) partners with TV2 for a national ‘Knæk Cancer’ fundraising campaign. For the past several years, Agillic partner Immeo has been supporting the campaign by organising a one-day tennis tournament as a fundraiser, bringing clients, partners, and friends together to contribute. Ivan Beltoft, Partner at Immeo, explains:“We have chosen to combine fun with sport and fundraising. We are very happy with the great support from our colleagues and clients who showed up with families and participated in our tennis tournament. We are very proud of this year’s collection and that...

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TIVDAK® (tisotumab vedotin-tftv) Significantly Prolonged Overall Survival in Patients with Recurrent or Metastatic Cervical Cancer Compared with Chemotherapy in Global Phase 3 innovaTV 301 Trial

Media Release TIVDAK demonstrated statistically significant overall survival, progression-free survival and objective response rate compared to chemotherapy in late-breaking results presented at ESMO 2023 congress Results from innovaTV 301 intended to serve as pivotal confirmatory trial for U.S. accelerated approval and to support global regulatory applications COPENHAGEN, Denmark, and BOTHELL, Wash.; October 22, 2023 – Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) announced additional results today from the Phase 3 innovaTV 301 randomized global trial, which showed treatment with TIVDAK demonstrated a statistically significant and clinically meaningful 30 percent reduction in the risk of death in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy, compared with chemotherapy...

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Potential of Arvinas’ PROTAC® AR Degraders Reinforced by 11.1 months rPFS with Bavdegalutamide and Updated Positive Interim Data from Second Generation ARV-766 in mCRPC

– Data presented at the European Society for Medical Oncology from the Phase 1/2 trial with bavdegalutamide showed 11.1 months radiographic progression free survival in mCRPC patients with tumors harboring AR 878/875 mutations – – Interim data from the Phase 1/2 trial of Arvinas’ second PROTAC AR degrader, ARV-766, showed robust efficacy in a broader mCRPC patient population with a tolerability profile well-suited to both early- and late-line settings – – Company to prioritize the initiation of a Phase 3 trial with ARV-766 in mCRPC – – Arvinas will host conference call to discuss results on Sunday, October 22 at 3:00 p.m. CEST / 9:00 a.m. ET – NEW HAVEN, Conn., Oct. 22, 2023 (GLOBE NEWSWIRE) — Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation,...

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HOOKIPA Pharma Presents Additional Preliminary Phase 2 Data on HB-200 in Combination with Pembrolizumab as First-Line Treatment in Patients with HPV16+ Head and Neck Cancers at European Society for Medical Oncology Congress 2023

42 percent objective response rate (ORR) was observed among 19 evaluable patients with recurrent/metastatic head and neck cancer in the first-line setting—doubling historical ORR reported with pembrolizumab alone1 Strong immunogenicity and activation of antigen-specific CD8+ T cells observed Data reinforce HOOKIPA’s commitment to start a randomized trial of HB-200 in combination with pembrolizumab as 1st-line treatment of recurrent/metastatic HPV16+ head and neck cancer in 2024 Data presented at the European Society for Medical Oncology Congress 2023 NEW YORK and VIENNA, Austria, Oct. 22, 2023 (GLOBE NEWSWIRE) — HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today presented updated data from its ongoing Phase 2 trial of...

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Sutro Biopharma Announces Presentation of Data for Luveltamab Tazevibulin (luvelta) from the Phase 1 Dose-Expansion Study in Endometrial Cancers at ESMO 2023

– Luvelta demonstrated encouraging preliminary anti-tumor activity (29% response rate) in late-stage patients with recurrent/relapsed endometrial cancer with tumor proportion score (TPS) >25% FolRα expression – – Safety profile was consistent with prior data in patients with platinum-resistant ovarian cancer – SOUTH SAN FRANCISCO, Calif., Oct. 22, 2023 (GLOBE NEWSWIRE) — Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced initial results from a Phase 1 dose-expansion study of luveltamab tazevibulin (luvelta), a novel Folate receptor alpha (FolRα)-targeting ADC, in patients with endometrial cancer, in a mini oral presentation at the 2023 European Society For Medical Oncology (ESMO)...

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Revolution Medicines Presents Promising Clinical Activity and Safety Data from Phase 1/1b Trial of RMC-6236

Investor Webcast to be held Sunday, October 22 at 12:30 p.m. Eastern Time REDWOOD CITY, Calif., Oct. 22, 2023 (GLOBE NEWSWIRE) — Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, today announced promising anti-tumor and safety data for RMC-6236, its RASMULTI(ON) Inhibitor, in patients with previously treated non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) across several dose levels and KRASG12X genotypes, including common KRAS-mutant genotypes G12D and G12V. These initial results were presented during a Proffered Paper session at the European Society for Medical Oncology (ESMO) Congress in Madrid, October 20-24, 2023. “Today’s presentation marks an important milestone in the clinical development of RMC-6236, an unprecedented,...

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Olema Oncology Announces Positive Phase 2 Monotherapy Clinical Study Results for Palazestrant

Across all 86 heavily pretreated patients, the median PFS was 4.6 months with a CBR of 40%; in patients with ESR1 mutations at baseline, the median PFS was 5.6 months with a CBR of 52% In an analysis of 49 second- and third-line patients, the median PFS was 7.2 months with a CBR of 48%; the median PFS was 7.3 months with a CBR of 59% in patients with ESR1 mutations Results support continued development of palazestrant in the OPERA-01 monotherapy Phase 3 pivotal trial Olema will host an investor conference call at 8:00 a.m. ET on Monday, October 23, 2023 SAN FRANCISCO, Oct. 22, 2023 (GLOBE NEWSWIRE) — Olema Pharmaceuticals, Inc. (“Olema”, “Olema Oncology”, or the “Company”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers,...

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