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BDX

The FDA has approved Becton Dickinson's (BDX) BD Alaris Infusion System with 510(k) clearance, allowing the company to return to full commercial operations. The clearance covers updated hardware features and a new software version with enhanced cybersecurity. The company expects to begin shipping devices and recognizing revenue in FY24 and does not expect any material incremental revenue contribution for the remainder of FY23. BDX shares are up 6.48% in premarket trading.

Portfolio Pulse from Vandana Singh

July 24, 2023 | 12:28 pm

SNDX

Syndax Pharma announced positive topline results of its trial of Axatilimab in chronic graft-versus-host disease, leading to a rise in its share prices.

Portfolio Pulse from Benzinga Newsdesk

July 24, 2023 | 12:26 pm

KOD

REGN

Kodiak Sciences Inc's shares are falling after the company announced topline results from three Phase 3 studies of tarcocimab tedromer, a novel antibody biopolymer conjugate, for neovascular age-related macular degeneration (AMD) and diabetic macular edema. The DAYLIGHT study met the primary endpoint of non-inferior visual acuity gains for tarcocimab dosed monthly compared to Regeneron Pharmaceutical Inc's Eylea. However, the GLEAM and GLIMMER studies did not meet their primary efficacy endpoints. An unexpected increase in cataracts was observed over time in the tarcocimab arms of both GLEAM and GLIMMER. Kodiak has decided to discontinue further development of tarcocimab.

Portfolio Pulse from Vandana Singh

July 24, 2023 | 12:25 pm

ENPH

Enphase Energy, Inc. (NASDAQ:ENPH) and LGCY Power have announced a partnership to expand solar, battery, and EV charger product deployments across the United States. LGCY Power, one of the fastest growing residential solar installers in the US, will expand deployments of Enphase Energy Systems powered by IQ8 Microinverters and IQ Batteries, as well as Enphase electric vehicle (EV) chargers. LGCY Power also plans to utilize Solargraf, Enphase's cloud-based design and proposal software platform.

Portfolio Pulse from Happy Mohamed

July 24, 2023 | 12:24 pm

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

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

LH

Labcorp (NYSE:LH) has announced the availability of menopause testing through its Labcorp OnDemand digital health platform. The Menopause Test and Menopause Support Program aim to provide women with insights to guide their healthcare decisions. The test is part of a suite of more than 50 curated tests available to consumers, which can be collected at over 2,000 Labcorp patient service centers nationwide, including over 400 Labcorp at Walgreens locations.

Portfolio Pulse from Happy Mohamed

July 24, 2023 | 12:16 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

RMED

Ra Medical Systems, Inc. (NYSE/American:RMED) has reported an increase in clinical adoption of its VIVO system, a three-dimensional non-invasive mapping system, by hospitals. The company's electrophysiology division, Catheter Precision, LLC, recently expanded its sales and clinical support team in the US. Several hospitals are currently reviewing VIVO, and approvals are expected in the coming months.

Portfolio Pulse from Happy Mohamed

July 24, 2023 | 12:14 pm