Streetbeat News

Regulatory

CERT

Certara, Inc. (NASDAQ:CERT), a global leader in biosimulation, has announced its 300th successful regulatory submission using its technology-enabled services and software. The submissions include those to initiate clinical trials and marketing applications. Certara's team of drug development and submission specialists have supported global submissions to various regulatory authorities including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada. In addition to regulatory submission services, Certara offers a software portfolio that aids in submission development.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 12:15 pm

LABP

Landos Biopharma will present new data on NX-13 from its Phase 1B trial in Ulcerative Colitis at the United European Gastroenterology Week 2023 Congress. The drug demonstrated rapid symptomatic relief and improvement in multiple biomarkers. The NEXUS Phase 2 Clinical Trial is ongoing with top-line readout expected in Q4 2024.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 12:14 pm

BALY

CZR

LVS

MGM

WYNN

MGM Resorts International's chances of winning two of the three full-scale casino licenses in New York City have reportedly become complicated due to an alleged bookmaking scandal in Las Vegas. The scandal involves the former head of the MGM Grand casino in Las Vegas, Scott Sibella, who was made to step down as president and operating chief of Resorts World. This could potentially benefit MGM's rivals in the casino race, including Bally's Corp, Caesars Entertainment Inc, Las Vegas Sands Corp, and Wynn Resorts Limited.

Portfolio Pulse from Shivani Kumaresan

September 19, 2023 | 12:13 pm

SCPH

scPharmaceuticals has received feedback from two FDA meetings regarding the development of an 80mg/1mL auto-injector. The company is planning to expand the FUROSCIX franchise to include this auto-injector as an additional delivery system for heart failure patients. The FDA has confirmed that no additional clinical data is required to pursue label expansion of FUROSCIX into chronic kidney disease (CKD).

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 12:13 pm

INAB

IN8bio has been granted new global patents that expand the use of its DeltEx Drug Resistant Immunotherapy (DRI) platform to include Chimeric Antigen Receptor T-cell (CAR-T) and checkpoint inhibitors (CPIs). This broadens IN8bio's foundational intellectual property for its DeltEx DRI platform. The company now holds 19 total granted U.S. and international patents, with numerous pending patent applications.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 12:07 pm

CRWD

ZS

Zscaler, Inc. (NASDAQ:ZS) has partnered with CrowdStrike and Imprivata to deliver a zero trust cybersecurity solution for healthcare organizations. The solution will provide visibility, threat protection, and traceability for end-to-end, multi-user, shared device access control. The integration aims to help healthcare organizations meet regulatory requirements, including HIPAA and HITECH, and protect against ransomware. The solution will be available to users of the Zscaler Zero Trust Exchange platform, Imprivata OneSign, and the CrowdStrike Falcon platform.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 12:05 pm

INDP

Indaptus Therapeutics, Inc. (NASDAQ:INDP) has announced the dosing of the first patient in the second cohort of its INDP-D101 trial, which is testing the single dose of Decoy20. This cohort dose is a reduction from the previous one, based on the significant pharmacodynamic effect seen with the first cohort. The company is encouraged by the initial results and plans to move Decoy20 to a multi-dosing regimen.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 12:04 pm

SRRK

Scholar Rock (NASDAQ:SRRK) has completed enrollment for the Phase 3 SAPPHIRE trial, which is evaluating the safety and efficacy of apitegromab in nonambulatory patients with Types 2 and 3 spinal muscular atrophy (SMA). The company also plans to present encore data from its Phase 2 TOPAZ trial extension period at the 2023 World Muscle Society (WMS) Annual Congress. Topline data from the Phase 3 trial is expected in Q4 2024.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 12:03 pm

CELZ

Creative Medical Technology has received FDA clearance to proceed with a Phase 1/2 trial of StemSpine using AlloStem. The study will enroll 30 individuals suffering from chronic lower back pain.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 12:02 pm

OBIO

The FDA has granted an Investigational Device Exemption to Orchestra Biomed for its BACKBEAT CNT therapy for hypertensive patients who are indicated for a dual-chamber cardiac pacemaker. This will allow the initiation of the BACKBEAT study.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 11:38 am