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Regulatory

LEXX

Lexaria Bioscience Corp. (NASDAQ:LEXX) is evaluating its proprietary drug-delivery platform, DehydraTECH, for improved efficacy of GLP-1 drugs. The company began diabetes-related studies last year, which showed reduced blood-sugar levels and lowered body weight. Lexaria is planning to launch new human and animal studies to examine whether DehydraTECH processing can make GLP-1 drugs such as semaglutide even better.

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October 31, 2023 | 12:43 pm

APLM

Apollomics has announced two new cohorts in its global Phase 2 SPARTA study of Vebreltinib in non-small cell lung cancer and other solid tumors with MET dysregulation. The first cohort is evaluating the addition of vebreltinib to EGFR tyrosine kinase inhibitor for patients with EGFR-mutated NSCLC progressing on first line EGFR inhibitor therapy. The second cohort will evaluate vebreltinib monotherapy in histology-agnostic solid tumors with wild type MET gene that have high expression of c-MET and hepatocyte growth factor. A separate, ongoing Phase 1/2 trial is exploring the safety and efficacy of combining vebreltinib with frontline osimertinib in patients with EGFR-mutated NSCLC.

Portfolio Pulse from Benzinga Newsdesk

October 31, 2023 | 12:41 pm

ASND

Ascendis Pharma A/S (NASDAQ:ASND) plans to report its Q3 2023 financial results and provide a business update on November 7, 2023. The company also announced its intention to resubmit its NDA for TransCon PTH for adults with hypoparathyroidism to the FDA before mid-November 2023. A conference call and webcast will be hosted on the same day to discuss the financial results and operations.

Portfolio Pulse from Benzinga Newsdesk

October 31, 2023 | 12:39 pm

SIDU

Sidus Space (NASDAQ:SIDU) has successfully completed environmental testing of its AI-enhanced LizzieSat satellite, marking a critical milestone in preparation for the upcoming launch expected in the first quarter of 2024. The company has also obtained the necessary launch and operating license. The testing was completed by NTS Orlando.

Portfolio Pulse from Benzinga Newsdesk

October 31, 2023 | 12:36 pm

SPY

The Employment Cost Index for Q3 has come in at 1.1%, slightly above the estimated 1%.

Portfolio Pulse from Benzinga Newsdesk

October 31, 2023 | 12:30 pm

MBOT

Microbot Medical has revealed short term follow up outcomes from its pivotal pre-clinical study. The study used 6 LIBERTY Systems, each reaching 8 targets, with 100% usability and technical success. No adverse events or complications were observed. The company expects to receive the final report this quarter and plans to submit the Investigational Device Exemption (IDE) application to the FDA, pending the report and completion of the verification and validation process.

Portfolio Pulse from Benzinga Newsdesk

October 31, 2023 | 12:28 pm

FNV

The Panamanian government intends to hold a popular consultation on December 17 regarding Law 406, which recently approved the revised contract for the Cobre Panama mine. Franco-Nevada Corporation (FNV) has been in communication with its partner, First Quantum Minerals Ltd., who has contacted the government to understand the details of the consultation. Legal and logistic considerations and unconstitutionality challenges against Law 406 have been noted.

Portfolio Pulse from Benzinga Newsdesk

October 31, 2023 | 12:18 pm

PBLA

Panbela Therapeutics, Inc. (NASDAQ:PBLA) has announced the validation of its European patent for a novel process for the production of SBP-101 in the UK, Italy, Germany, France, and Spain. The patent, developed in collaboration with Syngene International Ltd., reduces the number of synthetic steps from seventeen to six. The patent is valid until 2039 and covers a shorter synthesis of SBP-101, which provides a scalable, efficient, and cost-effective manufacturing process.

Portfolio Pulse from Benzinga Newsdesk

October 31, 2023 | 12:17 pm

ADAP

Adaptimmune Therapeutics (NASDAQ:ADAP) has reported positive outcomes for patients with synovial sarcoma who received afami-cel in the SPEARHEAD-1 trial. The trial showed a 39% clinical response rate with a median duration of response of 12 months. The median overall survival was 17 months, compared to a historical median of less than 12 months for patients who received two or more prior lines of therapy. Adaptimmune is on track to make afami-cel its first commercial product, with the completion of the Biologics License Application (BLA) targeted for Q4 2023.

Portfolio Pulse from Benzinga Newsdesk

October 31, 2023 | 12:14 pm

ENVB

Enveric Biosciences (NASDAQ:ENVB) has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a patent application involving EB-373, a prodrug of psilocin being developed for the treatment of depression and anxiety disorders. The patent, titled 'C4-Carbonothioate-substituted Tryptamine Derivatives and Methods of Using,' includes claims for a family of novel prodrug derivatives of psilocin, including EB-373. The company has filed multiple patent applications for psilocin prodrugs and has submitted additional filings for companion Patent Cooperation Treaty and non-US national patent applications.

Portfolio Pulse from Benzinga Newsdesk

October 31, 2023 | 12:12 pm