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Regulatory

VCYT

Veracyte, Inc. (NASDAQ:VCYT) has published a study demonstrating the effectiveness of its Decipher Prostate Genomic Classifier in guiding personalized treatment for prostate cancer. The study used data from the National Cancer Institute's SEER database and showed that the Decipher test can accurately predict the likelihood of a patient's cancer metastasizing within the next five years. This information can help physicians recommend tailored treatment plans.

Portfolio Pulse from Happy Mohamed

August 01, 2023 | 12:59 pm

SCPH

scPharmaceuticals Inc. (NASDAQ:SCPH) has received positive feedback from the FDA regarding the potential expansion of the FUROSCIX® indication for use in NYHA Class IV heart failure patients. The company plans to file for Class IV indication expansion by the end of this year. Additionally, the company announced the issuance of U.S. patents covering concentrated formulations of furosemide, enabling the development of additional furosemide formulations for subcutaneous administration.

Portfolio Pulse from Happy Mohamed

August 01, 2023 | 12:50 pm

COEP

Coeptis Therapeutics has filed an FDA 513(g) submission for a CD38 in vitro companion diagnostic. This is a significant step in the development and potential approval of the diagnostic tool.

Portfolio Pulse from Benzinga Newsdesk

August 01, 2023 | 12:49 pm

TYRA

Tyra Biosciences, Inc. (NASDAQ:TYRA) has received FDA Orphan Drug Designation for its lead precision medicine program, TYRA-300, for the treatment of achondroplasia. The company also announced the appointment of Michael Bober, M.D. Ph.D., as Vice President, Clinical Development and Medical Affairs, to lead the skeletal dysplasia program. TYRA-300 is currently being evaluated in a Phase 1/2 clinical study and the company plans to submit an IND for a Phase 2 clinical study in pediatric achondroplasia in 2024.

Portfolio Pulse from Happy Mohamed

August 01, 2023 | 12:47 pm

BABA

NVDA

Alibaba Group Holding Limited's stock is trading lower due to a contraction in China's official manufacturing purchasing managers' index (PMI) for a fourth month. The company is also undergoing a corporate restructuring and has invested in agriculture-related technology. Alibaba and its Chinese peers are vulnerable to potential U.S. sanctions on the semiconductor industry. U.S. chipmaker Nvidia Corp, known for its AI chips, has a sizable exposure to China.

Portfolio Pulse from Anusuya Lahiri

August 01, 2023 | 12:47 pm

KTTA

Pasithea Therapeutics Corp. (NASDAQ:KTTA) has published a study in the Proceedings of the National Academy of Sciences that shows an increase in α5 integrin expression in ALS human and mouse brain tissue. The study also shows that targeting α5 integrin results in improved survival and motor function. The company's lead α5/β1 integrin drug candidate is expected to be selected in H2 2023.

Portfolio Pulse from Happy Mohamed

August 01, 2023 | 12:35 pm

MEDIF

TSX:LABS

MediPharm Labs Corp. has made its first delivery of cannabis clinical trial materials to the US for use in an NIH funded clinical trial. The company has also completed the US FDA drug API manufacturer inspection at its Ontario facility. MediPharm is now a registered foreign drug manufacturing site with the US FDA and believes it is the only Canadian Pharmaceutical company with this registration. This allows MediPharm to further market cannabidiol API to pharmaceutical companies for new novel drugs, generic drugs, and clinical trial materials.

Portfolio Pulse from Vuk Zdinjak

August 01, 2023 | 12:34 pm

META

VGK

Meta Platforms is reportedly proposing to seek user consent before showing behavioral ads in the European Union, according to sources. This move is seen as a response to the EU's strict data privacy laws.

Portfolio Pulse from Charles Gross

August 01, 2023 | 11:59 am

TSLA

The US government has opened an investigation into 280,000 new Tesla vehicles over potential loss of steering control and power steering. This could potentially lead to recalls and damage Tesla's reputation.

Portfolio Pulse from Charles Gross

August 01, 2023 | 11:55 am

ALT

Altimmune has enrolled the first subject in the Phase 2B IMPACT trial evaluating the efficacy and safety of Pemvidutide in subjects with non-alcoholic steatohepatitis. Topline results are expected in Q1 2025.

Portfolio Pulse from Benzinga Newsdesk

August 01, 2023 | 11:51 am