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Regulatory

MYGN

Myriad Genetics has announced that its MyRisk Hereditary Cancer Test with RiskScore now includes breast density, personal/family clinical history, and a polygenic risk score. This is expected to provide a more comprehensive breast cancer risk assessment and help detect cancer in its early stages. The Federal Drug Administration recently updated mammography regulations requiring facilities to notify patients about their breast density by September 2024.

Portfolio Pulse from Happy Mohamed

July 24, 2023 | 12:23 pm

BDX

Becton, Dickinson and Company (BDX) shares are trading higher after the company received FDA510(k) clearance for the updated BD Alaris Infusion System. Raymond James upgraded the stock from Market Perform to Outperform with a $305 price target.

Portfolio Pulse from Benzinga Newsdesk

July 24, 2023 | 12:23 pm

TLIS

Talis Biomedical Corporation (NASDAQ:TLIS) has regained compliance with the Nasdaq minimum bid price requirement of at least $1.00 per share. This follows the company's 1-for-15 reverse stock split approved by stockholders on June 9, 2023, and effected on July 5, 2023.

Portfolio Pulse from Happy Mohamed

July 24, 2023 | 12:23 pm

VRCA

The FDA has approved Verrica Pharmaceuticals' Ycanth, a topical solution for molluscum contagiosum, a skin disease impacting 6 million people in the US. The drug is expected to be available by September 2023. Despite the approval, Verrica's shares fell by 20.60% in premarket trading.

Portfolio Pulse from Vandana Singh

July 24, 2023 | 12:19 pm

PBLA

Panbela Therapeutics, Inc. (NASDAQ:PBLA) has opened enrollment in the UK and Germany for its ASPIRE global clinical trial in the first-line treatment of metastatic pancreatic cancer. The company plans to have all sites open for enrollment within the next couple of months, and then towards the interim data analysis in early 2024. There are approximately 95 sites planned for throughout the United States, Europe, Australia, and South Korea.

Portfolio Pulse from Happy Mohamed

July 24, 2023 | 12:18 pm

KROS

The FDA has approved Keros Therapeutics' Investigational New Drug Application, allowing the company to conduct a Phase 2 trial of KER-012 in combination with background therapy in patients with Pulmonary Arterial Hypertension.

Portfolio Pulse from Benzinga Newsdesk

July 24, 2023 | 12:16 pm

ICCM

IceCure Medical Ltd. (NASDAQ:ICCM) has received approval from Health Canada for its ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing. The approval strengthens the company's market potential in North America. IceCure's CEO, Eyal Shamir, stated that the approval will create synergies in the broader North American market and the company plans to expand its activities into Canada.

Portfolio Pulse from Happy Mohamed

July 24, 2023 | 12:10 pm

BDX

Becton, Dickinson And Co has received FDA 510(k) clearance for its Alaris Infusion System, leading to a rise in its share prices.

Portfolio Pulse from Benzinga Newsdesk

July 24, 2023 | 12:10 pm

LCTX

Lineage Cell Therapeutics and Cancer Research UK have reported topline Phase 1 study results for VAC2 in the treatment of advanced non-small cell lung cancer.

Portfolio Pulse from Benzinga Newsdesk

July 24, 2023 | 12:10 pm

FEXD

Fintech Ecosystem Development Corp. (NASDAQ:FEXD) has announced a fourth extension of the deadline to complete its initial business combination to August 21, 2023. The company's sponsor, Revofast LLC, has deposited $110,000 into the company's trust account in connection with this extension.

Portfolio Pulse from Happy Mohamed

July 24, 2023 | 12:10 pm