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Regulatory

STIM

Neuronetics, Inc. (NASDAQ:STIM) announced healthcare policy updates from Magellan, BlueCross BlueShield (BCBS) of Kansas City, and Dean Health Plan that increase access to the company's NeuroStar Advanced Therapy. The changes reduce the number of prior antidepressant medication failures required for coverage of transcranial magnetic stimulation (TMS) therapy for major depressive disorder (MDD). The updates from BCBS Kansas City and Dean Health Plan are effective immediately, while the Magellan update will take effect on November 18, 2023.

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November 09, 2023 | 1:39 pm

OWLT

Owlet, Inc. (NYSE:OWLT) has received De Novo clearance from the U.S. Food and Drug Administration for its Dream Sock, the first over-the-counter medical pulse oximetry solution for infants. The FDA-cleared Dream Sock will monitor and display infants' health readings, including pulse rate and oxygen saturation level, and will alert caregivers if readings fall outside of preset ranges. The company plans to make these features available to all existing and new Dream Sock users upon launch. The clearance follows the company's previous FDA clearance of BabySat, a prescription monitoring system.

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November 09, 2023 | 1:37 pm

PCVX

Vaxcyte, Inc. (NASDAQ:PCVX) has initiated a Phase 1/2 clinical study for VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD) in adults. The study will enroll approximately 1,000 adults aged 50 and older, with topline data expected in the second half of 2024. VAX-31 is designed to provide coverage for approximately 95% of IPD circulating in the U.S. adult population.

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November 09, 2023 | 1:32 pm

BBIO

BridgeBio Pharma is set to present additional data from its Phase 3 ATTRibute-CM study on patients with Transthyretin Amyloid Cardiomyopathy at the American Heart Association Scientific Sessions in 2023.

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November 09, 2023 | 1:28 pm

PDSB

PDS Biotech has announced updated survival data from a Phase 2 clinical trial of PDS0101-based triple combination therapy in advanced HPV16-positive cancer patients. The data shows a 75% survival rate at 36 months for ICI naive patients and a 72% 12-month survival rate for ICI resistant patients. The company's CEO, Frank Bedu-Addo, expressed optimism about the results and the potential for a registrational clinical trial of PDS0101 and PDS0301 in combination with a commercial ICI.

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November 09, 2023 | 1:27 pm

DXR

Daxor Corporation (NASDAQ:DXR), a global leader in blood volume measurement technology, has been granted a new patent for a system that provides remote blood volume monitoring. The patent covers various methods, including wearable devices like smartwatches. The technology will help optimize ongoing care based on the patient's evolving blood volume status. This addition to Daxor's intellectual property portfolio is part of the company's strategy to fuel future product development.

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November 09, 2023 | 1:20 pm

ESTA

Establishment Labs Holdings Inc. (NASDAQ:ESTA) has received approval from China's National Medical Products Administration for its Motiva Implants. This marks the company's entry into the second largest global market for breast aesthetics. The approval is the first for breast implant technology in China in over a decade. The company expects Chinese plastic surgeons to adopt their technology as their first choice.

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November 09, 2023 | 1:16 pm

PHIO

Phio Pharmaceuticals has announced the enrollment of the first US patient in a Phase 1B clinical trial for intratumoral PH-762 Anti-PD-1 therapy for the treatment of skin carcinomas. This marks a significant step in the company's clinical development program.

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November 09, 2023 | 12:33 pm

IKNA

Ikena Oncology has shared initial data from the ongoing dose escalation portion of its Phase 1 trial of IK-930. The data shows signs of clinical activity and tumor shrinkage in multiple patients with difficult-to-treat Epithelioid Hemangioendothelioma.

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November 09, 2023 | 12:31 pm

KO

The Coca-Cola Company has expressed disagreement with the supplemental opinion issued by the US Tax Court on November 8, related to the case of The Coca-Cola Company & Subsidiaries Vs. Commissioner of Internal Revenue.

Portfolio Pulse from Benzinga Newsdesk

November 09, 2023 | 12:02 pm