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Day: December 9, 2023

Biomea Fusion Announces Near Doubling the Percentage of Patients with Durable HbA1c Reduction in the 200 mg Dose Cohorts

BMF-219 is an investigational novel covalent menin inhibitor developed to regenerate insulin-producing beta cells with the aim to cure diabetesAt Week 26, 22 weeks after the last dose of BMF-219, the 200 mg cohorts increased the percentage of patients to approximately 40% with durable HbA1c reduction of 1% or more as compared to the 100 mg cohorts which reported earlier as 20%. To date, the dose escalation portion has shown after only 4 weeks of dosing with BMF-219 that patients across all dosing cohorts have consistently experienced generally meaningful HbA1c reductions and no serious adverse events or study discontinuations.REDWOOD CITY, Calif., Dec. 09, 2023 (GLOBE NEWSWIRE) — Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small...

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FibroGen Presents Data from Phase 3 MATTERHORN Trial of Roxadustat in Patients with Anemia of Lower Risk Transfusion-Dependent Myelodysplastic Syndromes at American Society of Hematology Annual Meeting

A post hoc analysis of patients with higher transfusion burden at baseline showed a larger percentage of patients achieved transfusion independence ≥ 56 days with roxadustat vs. placebo (36.1% vs 11.5%; p=0.047ǂ). Dr. Moshe Mittelman’s presentation was selected for the “2024 Highlights of ASH” SAN FRANCISCO, Dec. 09, 2023 (GLOBE NEWSWIRE) — FibroGen, Inc. (NASDAQ: FGEN) announced today the presentation of efficacy and safety data from MATTERHORN, a Phase 3 clinical study of roxadustat for the treatment of anemia in patients with lower risk transfusion-dependent myelodysplastic syndromes (MDS) at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition being held in San Diego, California December 9 – 12, 2023. The oral presentation was selected for the “2024 Highlights of ASH”. “We are excited to have our...

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Cogent Biosciences Announces Positive Initial Data from Phase 2 SUMMIT Trial Evaluating Bezuclastinib in Patients with Nonadvanced Systemic Mastocytosis (NonAdvSM)

Rapid and ongoing improvement in patient symptoms, with 57% median best improvement on MC-QoL and 78% of patients reporting ≥1 point improvement on PGIS by week 20 100% of bezuclastinib treated patients achieved at least 50% improvement across all relevant biomarker measures, including serum tryptase, KIT D816V VAF, and mast cell burden; Placebo patients, after cross-over to bezuclastinib, also demonstrated rapid symptomatic improvement, with 75% median best improvement on MC-QoL, and 67% of patients reporting ≥1 point improvement on PGIS Bezuclastinib safety and tolerability profile supports potential for chronic dosing with no related serious adverse events and no bleeding or cognitive events Cogent to host investor webcast on Monday, December 11 at 8:00 a.m. ET WALTHAM, Mass. and BOULDER, Colo., Dec. 09, 2023 (GLOBE NEWSWIRE) —...

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New data reinforce the benefit of early preventative treatment with Roche’s Hemlibra for babies with severe haemophilia A

Phase III HAVEN 7 primary data presented at ASH 2023 provide additional confidence in the favourable efficacy and safety profile of subcutaneous Hemlibra given soon after birth 1 At nearly two years median follow-up in the descriptive, single-arm study, no babies experienced spontaneous bleeds requiring treatment, and all treated bleeds were as a result of trauma 1 Safety results were consistent with previous studies of Hemlibra, with no new safety signals observed 1 The HAVEN 7 study was developed in collaboration with the haemophilia A community, to generate additional evidence for the prophylactic treatment of infants with haemophilia ABasel, 09 December 2023 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the primary analysis of the Phase III HAVEN 7 study reinforced the efficacy and safety of Hemlibra® (emicizumab)...

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Bulletin from Annual General Meeting in SkiStar AB

At SkiStar AB (publ)’s annual general meeting, held in Sälen on 9 December 2023, the following decisions were made.A dividend of SEK 2.60 per share was adopted. Record day 12 December 2023. Lena Apler, Fredrik Paulsson, Gunilla Rudebjer, Anders Sundström, Anders Svensson and Vegard Søraunet were re-elected to the board and Carina Åkerström was elected as new board member. Anders Sundström was re-elected chairman of the board. Board fees, including committee fees, were raised to a total of SEK 2,890,000 (2022: SEK 2,810,000). The fees shall be distributed as follows: SEK 670,000 (650,000) to the chairman of the board and SEK 310,000 (300,000) each to the other non-executive directors. Audit committee members will receive total fees of SEK 240,000 (unchanged), distributed as follows: SEK 120,000 to the committee chairman and SEK 60,000...

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Adaptive Biotechnologies Announces New Data Highlighting the Clinical Relevance of MRD Testing with clonoSEQ® in Patients with Blood Cancers at the 65th ASH Annual Meeting

Treatment adapted studies show the potential for MRD assessment to guide the personalization of blood cancer care New data demonstrates MRD assessed from blood in multiple myeloma may be an indicator of early responseSEATTLE, Dec. 09, 2023 (GLOBE NEWSWIRE) — Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today announced new data demonstrating the expanding use of Adaptive’s next-generation sequencing (NGS)-based clonoSEQ® test in assessing minimal residual disease (MRD) in blood cancer patient care and in clinical trials. The data are being presented in more than 30 abstracts at the 65th Annual Meeting of the American Society of Hematology (ASH), December 9-12...

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Borregaard ASA: Operational issues and lower biovanillin demand in the 4th quarter

During the 4th quarter of 2023, operational issues have affected production at the Sarpsborg site, reducing the result mainly in BioMaterials. Following the annual maintenance stop in October, the production volumes, quality, and ability to utilise internal bioenergy have been temporarily reduced. This is due to various failures in production equipment after maintenance, as well as prolonged commissioning of new equipment. The operational issues have now been addressed, and no carry-over effects are expected into the 1st quarter of 2024. The result in BioSolutions will be negatively impacted by lower sales volume of biovanillin in the 4th quarter. This is mainly due to lower demand for biovanillin, which is increasingly affected by a significant expansion in the global supply of synthetic vanillin and ethyl vanillin. In total, the negative...

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Completion of the Third Tranche of Stellantis Share Buyback Program and Weekly Report (December 1-7, 2023)

Completion of the Third Tranche of Stellantis Share Buyback Program and Weekly Report (December 1-7, 2023) AMSTERDAM, December 8, 2023 – Stellantis N.V. (“Stellantis” or the “Company”) announced today that its Third Tranche of the Share Buyback Program announced on September 11, 2023, covering up to €500 million to be executed in the open market during the period between September 11, 2023 and December 11, 2023, has been completed. Since September 11, 2023 up to and including December 7, 2023, the Company has purchased a total of 28,180,299 common shares for a total consideration of €499,999,796. During the period between December 1 up to and including December 7, 2023 the Company has repurchased the following common shares:Date Number of Shares Repurchased Average Market Purchase Price in € per share Repurchased Volume in €...

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Alaska Energy Metals Announces Flow-Through Financing; Acquisition Update and IR Developments

Highlights:Alaska Energy Metals Corporation announces intention to conduct a non-brokered flow-through private placement The TSX Venture Exchange has issued a bulletin publishing its acceptance of the Angliers-Belleterre acquisitionVANCOUVER, British Columbia, Dec. 08, 2023 (GLOBE NEWSWIRE) — Alaska Energy Metals Corporation (TSX-V: AEMC, OTCQB: AKEMF) (“AEMC” or the “Company”) is pleased to announce that, subject to TSX Venture Exchange acceptance, it plans to conduct a non-brokered private placement of flow-through common shares at a price of $0.50 per share to raise gross proceeds of $1,000,000. The net proceeds will be used for exploration activities on the Angliers project. Finder’s fees will be payable in connection with this financing. The TSXV has published its bulletin providing final approval for the acquisition of...

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KBW Announces Index Rebalancing for Fourth-Quarter 2023

NEW YORK, Dec. 08, 2023 (GLOBE NEWSWIRE) — Keefe, Bruyette & Woods, Inc., a leading specialist investment bank to the financial services and fintech sectors, and a wholly owned subsidiary of Stifel Financial Corp. (NYSE: SF), announces the upcoming index rebalancing for the fourth quarter of 2023. This quarter, there are constituent changes within four of our indexes: the KBW Nasdaq Financial Sector Dividend Yield Index (Index Ticker: KDX, ETF Ticker: KBWD), KBW Nasdaq Financial Technology Index (Index Ticker: KFTX, ETF Ticker: FTEK.LN), KBW Nasdaq Global Bank Index (Index Ticker: GBKX), and KBW Nasdaq Premium Yield Equity REIT Index (Index Ticker: KYX, ETF Ticker: KBWY). There are a number of changes to the two modified-dividend-yield-weighted indexes—KDX and KYX—to adjust annually for relevant dividend yields and ensure...

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