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Regulatory

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.

Portfolio Pulse from Benzinga Newsdesk

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.

Portfolio Pulse from Benzinga Newsdesk

November 02, 2023 | 1:11 pm

KYMR

Kymera Therapeutics (NASDAQ:KYMR) announced new clinical data from the Phase 1 trial of STAT3 degrader KT-333, highlighting safety, pharmacokinetics, pharmacodynamics, and clinical responses. The data will be presented at the ASH 65th Annual Meeting and Exposition in December 2023. The abstract reported Phase 1 data from 21 patients, with one partial response reported after two cycles in a CTCL patient and stable disease reported after two cycles in three solid tumor patients. No dose limiting toxicities or serious adverse events were reported.

Portfolio Pulse from Benzinga Newsdesk

November 02, 2023 | 1:10 pm

SCLX

Scilex Holding Company (NASDAQ:SCLX) has announced a positive Type C meeting with the U.S. Food and Drug Administration (FDA), reaching an agreement on the path forward to advance the clinical development of SP-102 and on the requirements to file a New Drug Application (NDA). Scilex plans to commence an open-label multi-center safety and efficacy trial in the first half of 2024, with completion of enrollment projected to occur in 2025. If approved, SP-102 would be the first corticosteroid with an indication for epidural administration in the U.S.

Portfolio Pulse from Benzinga Newsdesk

November 02, 2023 | 1:10 pm

TSM

Taiwan Semiconductor Manufacturing Company (TSMC) is reassessing its upcoming fab projects in Kaohsiung, Taichung, and Longtan. The company also plans to delay the establishment of its advanced packaging fab at the Tongluo campus of Taiwan's Hsinchu Science Park.

Portfolio Pulse from Benzinga Newsdesk

November 02, 2023 | 1:07 pm

NTRA

Natera, Inc. (NASDAQ:NTRA) announced the publication of initial results from RenaCARE, a study assessing the impact of genetic testing within the chronic kidney disease (CKD) population. The study found that 20.8% of CKD patients had a positive genetic finding, with 48.8% of these patients receiving a new or reclassified diagnosis and 34% receiving information on disease subtype. The results also showed that 90.7% of positive patients had a change in management, including 32.9% with a change in treatment plan.

Portfolio Pulse from Benzinga Newsdesk

November 02, 2023 | 12:57 pm

OCG

Oriental Culture Holding LTD. (OCG) has regained compliance with Nasdaq's minimum bid price requirement. The company's common stock has been $1.00 per share or greater for 10 consecutive trading days, from October 18, 2023 to October 31, 2023.

Portfolio Pulse from Benzinga Newsdesk

November 02, 2023 | 12:56 pm

ARTL

Artelo Biosciences, Inc. (NASDAQ:ARTL) will present preclinical data on ART26.12 and ART12.11, potential treatments for anxiety and depression, at Neuroscience 2023. The company plans to file an IND application with the FDA in the first half of 2024 to develop ART26.12 for the treatment of neuropathic pain. ART26.12 has shown positive effects in animal models of painful neuropathies, including chemotherapy-induced peripheral neuropathy and diabetic neuropathy.

Portfolio Pulse from Benzinga Newsdesk

November 02, 2023 | 12:54 pm