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Regulatory

PTPI

Petros Pharmaceuticals, Inc. (NASDAQ:PTPI) has announced the successful launch of an AI tool developed in collaboration with a major software provider, aimed at optimizing self-screening for STENDRA (avanafil), an erectile dysfunction medication in development for OTC status. The AI tool is part of a Human Factors study designed to assess the safety and effectiveness of the web app used for patient self-screening, in line with FDA guidance. The company believes this AI integration will address FDA requests and help achieve significant clinical milestones for STENDRA.

Portfolio Pulse from Benzinga Newsdesk

March 19, 2024 | 1:04 pm

BTCUSD

The Government Pension Investment Fund (GPIF) of Japan, the world's largest pension fund, is exploring Bitcoin (BTC) as a diversification asset amid its significant value rally. GPIF is researching various 'illiquidity assets' including Bitcoin, forests, and farmland. This interest aligns with Bitcoin reaching new all-time highs, following a year of over 130% value increase, partly due to the launch of Bitcoin ETFs in the U.S. The move reflects a shift in institutional attitudes towards cryptocurrency, despite its volatility.

Portfolio Pulse from Benzinga Neuro

March 19, 2024 | 12:44 pm

ICCM

IceCure Medical announced positive topline results from its ICE3 cryoablation breast cancer study, with 96.39% of patients showing no local recurrence. The company plans to submit the full dataset to the FDA in April for marketing authorization of ProSense® for early-stage breast cancer treatment. This study is the largest of its kind in the U.S. for early-stage low-risk malignant breast tumors, with no significant device-related adverse events reported.

Portfolio Pulse from Benzinga Newsdesk

March 19, 2024 | 12:34 pm

NNDM

Nano Dimension announced that a patent has been granted to its DeepCube Technology for model training and optimization on decentralized networks. This innovation is crucial for the commercialization of the company's industrial AI solution.

Portfolio Pulse from Benzinga Newsdesk

March 19, 2024 | 12:33 pm

ATOS

Atossa Therapeutics announced a positive five-year update on its FDA-approved Expanded Access Program for a US breast cancer patient using (Z)-Endoxifen. The patient remains cancer-free with no significant safety or tolerability issues reported.

Portfolio Pulse from Benzinga Newsdesk

March 19, 2024 | 12:32 pm

SPY

The Building Permits (MoM) for February saw an increase of 1.9%, indicating a potential uptick in construction activity and possibly reflecting a positive outlook for the real estate and construction sectors.

Portfolio Pulse from Benzinga Newsdesk

March 19, 2024 | 12:31 pm

SPY

Building permits in February increased to 1.518 million, surpassing both the estimated 1.500 million and the previous month's 1.489 million.

Portfolio Pulse from Benzinga Newsdesk

March 19, 2024 | 12:31 pm

CYBR

CyberArk (NASDAQ:CYBR), an identity security company, announced that its SaaS offerings, CyberArk Endpoint Privilege Manager and CyberArk Workforce Identity, have achieved FedRAMP High authorization. This status enables CyberArk to support federal agencies and public sector organizations in securing access to applications, protecting distributed workforces, and accelerating cloud innovation based on Zero Trust principles. The authorization aligns with the government's Cloud Smart strategies and Zero Trust compliance, emphasizing CyberArk's commitment to enhancing public sector cybersecurity.

Portfolio Pulse from Happy Mohamed

March 19, 2024 | 12:28 pm

ERIC

Ericsson (NASDAQ:ERIC) has launched Ericsson Federal Technologies Group (EFTG) to drive 5G digital transformation for U.S. federal agencies, emphasizing national security and economic benefits. EFTG, led by Christopher Ling, aims to leverage Ericsson's 5G technology and Made in the USA equipment to meet U.S. Government requirements. The initiative underscores Ericsson's commitment to U.S. connectivity, security, and technological leadership.

Portfolio Pulse from Benzinga Newsdesk

March 19, 2024 | 12:21 pm

SEEL

Seelos Therapeutics, Inc. (NASDAQ:SEEL) provided an update on its Phase 2/3 HEALEY ALS Platform trial for SLS-005 in ALS treatment. The study didn't meet primary and secondary endpoints but showed a potential efficacy signal in a pre-specified subgroup. SLS-005 demonstrated a 22% improvement in ALSFRS-R slope and a 25% slowing in SVC decline in this subgroup. Seelos plans to request an FDA meeting for next steps and continue partner discussions. SLS-005 was well-tolerated, with an imbalance in deaths deemed unrelated to the drug.

Portfolio Pulse from Benzinga Newsdesk

March 19, 2024 | 12:20 pm