Streetbeat News

Regulatory

GERN

Geron Corporation (NASDAQ: GERN) has announced the publication of abstracts from the IMerge Phase 3 clinical trial evaluating its investigational telomerase inhibitor imetelstat in patients with lower risk myelodysplastic syndromes (MDS). The data shows consistently higher transfusion independence (TI) response rates than placebo across different risk groups. Imetelstat is currently under regulatory review by the FDA and EMA for the treatment of transfusion-dependent anemia in adult patients with lower risk MDS.

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November 02, 2023 | 1:17 pm

RLYB

Rallybio has announced that its FNAIT Natural History Study abstract has been accepted for presentation at the 65th American Society of Hematology Annual Meeting.

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November 02, 2023 | 1:16 pm

IONM

Assure Holdings Corp. (NASDAQ:IONM), a provider of intraoperative neuromonitoring and remote neurology services, has been granted an extension by Nasdaq to regain compliance with the stockholders' equity continued listing requirement. The company has until January 22, 2024, to complete key steps of its compliance plan and must demonstrate compliance upon filing its periodic report for the quarter ended March 31, 2024. Failure to comply may result in delisting.

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November 02, 2023 | 1:14 pm

AUTL

Autolus Therapeutics plc (NASDAQ:AUTL) will present clinical data updates at the American Society of Hematology Annual Meeting 2023. The presentations will include updates on the ongoing FELIX Phase Ib/II study and MCARTY Phase I Study, as well as data demonstrating the robustness of obe-cel's manufacturing process. The company expects to file a BLA later this year.

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November 02, 2023 | 1:13 pm

ORIC

ORIC Pharmaceuticals, Inc. (NASDAQ:ORIC) announced a poster presentation on the initial Phase 1b clinical data for ORIC-533 in patients with relapsed/refractory multiple myeloma at the 65th American Society of Hematology Annual Meeting. The study included a heavily pretreated patient population and ORIC-533 was well tolerated with no dose limiting toxicities. Preliminary evidence of enhanced CD8+ T-cell activation was seen at the highest dose levels tested and early evidence of single agent clinical activity was observed.

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November 02, 2023 | 1:12 pm

CNTA

Centessa Pharmaceuticals will present additional 52-weeks of continuous treatment data from the third year of an ongoing Phase 2a study of SerpinPC for the treatment of Hemophilia at the ASH Annual Meeting.

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November 02, 2023 | 1:12 pm

LXRX

Lexicon Pharmaceuticals (NASDAQ:LXRX) announced that five data presentations related to INPEFA® (sotagliflozin) will be delivered during the American Heart Association Scientific Sessions 2023. The presentations will highlight the early clinical benefit of INPEFA for heart failure and atherosclerotic events, and the cost-effectiveness metrics associated with the use of INPEFA. The FDA recently approved INPEFA for the treatment of heart failure.

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November 02, 2023 | 1:12 pm

IRON

Disc Medicine, Inc. (NASDAQ:IRON) has announced the completion of enrollment for phase 2 BEACON and AURORA studies of bitopertin in erythropoietic protoporphyria (EPP). The company will present preliminary data from these studies and from phase 1b study of DISC-0974 in myelofibrosis (MF) patients with anemia at the 65th American Society of Hematology (ASH) Annual Meeting. The company will also host a conference call on December 11th to discuss these updates.

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November 02, 2023 | 1:11 pm

ALPN

Alpine Immune Sciences has presented initial clinical data on Povetacicept in autoimmune glomerulonephritis at the American Society of Nephrology Kidney Week 2023. The low-dose Povetacicept was well tolerated and reduced UPCR by over 50% in IgA nephropathy. The company is now planning to begin a pivotal phase 3 IgAN study in the second half of 2024.

Portfolio Pulse from Benzinga Newsdesk

November 02, 2023 | 1:11 pm

APTO

Aptose Biosciences Inc. (NASDAQ:APTO) announced that clinical data for its drug tuspetinib has been selected for oral presentation at the 65th American Society of Hematology (ASH) Annual Meeting in December 2023. The data will be presented by Naval Daver from the University of Texas MD Anderson Cancer Center and will include updates from Aptose's ongoing APTIVATE trial of tuspetinib in patients with acute myeloid leukemia.

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November 02, 2023 | 1:11 pm