Streetbeat News

Regulatory

BLTE

Belite Bio has announced its submission to the National Medical Products Administration (NMPA) for the Phase 3 clinical trial of Tinlarebant in China. The drug is aimed at treating gouty arthritis (GA).

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October 17, 2023 | 8:24 pm

FSNB

The New York Stock Exchange (NYSE) has announced that it will begin delisting proceedings against Fusion Acquisition Corp. II.

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October 17, 2023 | 8:16 pm

VKTX

Viking Therapeutics (NASDAQ:VKTX) has presented new data from its Phase 1 clinical trial of VK2735, a dual GLP-1/GIP receptor agonist, at ObesityWeek 2023. The data shows that 28 days of treatment with VK2735 resulted in significant reductions in liver fat content and plasma lipid levels. The treatment also resulted in weight loss of up to 7.8% from baseline. The company believes these results suggest potential benefits for patients with obesity, non-alcoholic fatty liver disease (NAFLD), and non-alcoholic steatohepatitis (NASH).

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October 17, 2023 | 8:08 pm

NPCE

NeuroPace has announced enhancements to its RNS System, designed to streamline care. The upgraded nSight Platform improves clinicians' ability to track, review, and evaluate patient data. The 'Simple Set Programming' feature enables direct programming set transfer to the RNS Tablet. The FDA has approved a smaller, portable, and simpler tablet remote monitor with wireless connectivity.

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October 17, 2023 | 8:07 pm

KURA

Kura Oncology has announced results from a study of Tipifarnib in patients with HRAS mutant HNSCC, showing meaningful antitumor activity. The data supports the rapid advancement of KO-2806 into combinations with targeted therapies in large solid tumor indications. The results will be presented at the 2023 ESMO Congress.

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October 17, 2023 | 8:06 pm

YMAB

Y-mAbs Therapeutics has announced that the U.S. FDA has cleared its Investigational New Drug (IND) application for CD38-SADA. This clearance allows the company to proceed with clinical trials.

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October 17, 2023 | 8:05 pm

BGNE

BeiGene announced that its Phase 3 RATIONALE 315 trial met primary endpoints for tislelizumab plus chemotherapy in patients with resectable non-small cell lung cancer. The data showed 56.2% of patients achieved major pathological response, versus 15.0% with neoadjuvant chemotherapy alone. Also, 40.7% of patients achieved the key secondary endpoint of pathological complete response, compared to 5.7% with neoadjuvant chemotherapy alone.

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October 17, 2023 | 8:05 pm

LXRX

Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) highlighted two studies demonstrating the positive financial impact of INPEFA (sotagliflozin), recently approved by the FDA for heart failure treatment. The studies, presented at the Academy of Managed Care Pharmacy Nexus 2023 National Meeting, showed that while INPEFA increased pharmacy costs, it reduced medical costs due to lower readmission rates and fewer emergency department visits. The studies also concluded that INPEFA is a cost-effective treatment for heart failure among patients with type 2 diabetes.

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October 17, 2023 | 8:03 pm

BMY

Bristol Myers Squibb (NYSE:BMY) announced three-year follow-up results from the Phase 3 CheckMate -816 trial, demonstrating sustained event-free survival and promising overall survival trends with three cycles of Opdivo in combination with platinum-based chemotherapy for the neoadjuvant treatment of patients with resectable non-small cell lung cancer. The results showed a greater reduction in the risk of disease recurrence, progression or death than chemotherapy alone, regardless of PD-L1 expression levels. The results will be presented at the European Society for Medical Oncology Congress 2023.

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October 17, 2023 | 7:51 pm

BMY

Bristol Myers Squibb (NYSE:BMY) announced results from the Phase 3 CheckMate -901 trial, where Opdivo in combination with cisplatin-based chemotherapy demonstrated significant improvements in overall survival and progression-free survival for patients with unresectable or metastatic urothelial carcinoma. The treatment reduced the risk of death by 22% and showed a tolerable safety profile. The data will be presented at the European Society for Medical Oncology Congress 2023.

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October 17, 2023 | 7:49 pm