Streetbeat News

Regulatory

ARGX

argenx SE announced that the European Commission approved its product VYVGART (efgartigimod alfa) for subcutaneous use as an add-on treatment for generalized myasthenia gravis in adults. This approval follows the previous sanction for intravenous use and extends the product's availability in the EU and additional European countries. argenx will collaborate with health authorities to ensure patient access in these regions.

Portfolio Pulse from Benzinga Newsdesk

November 16, 2023 | 12:41 pm

CYBN

Cybin announced it will release Phase 2 topline safety and efficacy data for its CYB003 drug in treating Major Depressive Disorder on November 30, 2023. Additionally, Cybin will host an R&D briefing on the same day.

Portfolio Pulse from Benzinga Newsdesk

November 16, 2023 | 12:34 pm

SRDX

Surmodics announced that Dr. Peter A. Schneider will present 36-month data from its Transcend clinical trial at the 50th Annual Veith Symposium in New York. This presentation could provide insights into the long-term efficacy and safety of Surmodics' medical devices.

Portfolio Pulse from Benzinga Newsdesk

November 16, 2023 | 12:31 pm

ATHE

Alterity Therapeutics has presented new data on its lead drug candidate, ATH434, at the Society for Neuroscience. The data could potentially impact the company's stock as it reflects progress in the drug's development.

Portfolio Pulse from Benzinga Newsdesk

November 16, 2023 | 12:26 pm

RDY

Dr. Reddy's Laboratories has launched Nerivio, an FDA-approved wearable device for drug-free migraine management, in India. This could expand the company's product portfolio and potentially increase its market share in the therapeutic device segment.

Portfolio Pulse from Benzinga Newsdesk

November 16, 2023 | 12:21 pm

BABA

FXI

SPY

Alibaba has expressed concerns that the newly expanded U.S. export control rules could have a material and adverse effect on its Cloud Intelligence Group. The company also warned that the rules might generally restrict businesses from upgrading their technological capabilities.

Portfolio Pulse from Charles Gross

November 16, 2023 | 12:15 pm

ADMA

ADMA Biologics has received FDA approval for its tenth plasma collection facility, ADMA BioCenters, located in Laurel, Maryland. The facility began operations and started collecting source plasma in the first half of 2023.

Portfolio Pulse from Benzinga Newsdesk

November 16, 2023 | 12:05 pm

AZN

BMY

MRK

RHHBY

The FDA has approved Bristol Myers Squibb's Augtyro for treating ROS1-positive non-small cell lung cancer. Acquired through a $4.1 billion deal with Turning Point Therapeutics, Augtyro demonstrated a 79% objective response rate in TKI-naïve patients. It enters a competitive market with existing treatments from Roche, Merck, and AstraZeneca. Augtyro will be available in the U.S. in mid-December 2023, and BMY shares closed at $51.57.

Portfolio Pulse from Vandana Singh

November 16, 2023 | 11:48 am

BABA

Alibaba's subsidiary Freshippo has postponed its plans for an IPO due to current market conditions. The company is taking time to evaluate the market before proceeding with the public offering.

Portfolio Pulse from Charles Gross

November 16, 2023 | 11:48 am

SWTX

SpringWorks Therapeutics announced positive topline results from the Phase 2b ReNeu trial of Mirdametinib for NF1-PN, showing a 52% response rate in pediatric patients and 41% in adults. The treatment led to significant improvements in patient-reported outcomes and was well tolerated with low rates of severe adverse events. Additional data will be presented at a medical conference, and an NDA submission to the U.S. FDA is planned for the first half of 2024. The company will host a conference call to discuss these results.

Portfolio Pulse from Benzinga Newsdesk

November 16, 2023 | 11:33 am