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DCTH

Delcath Systems, Inc. (NASDAQ:DCTH) announced the publication of positive results from the Phase 3 FOCUS study of HEPZATO KIT for treating unresectable metastatic Uveal Melanoma (mUM), showing a significantly higher overall response rate compared to historical controls. The FDA approved HEPZATO KIT based on these results. The study's findings, which include a 73.6% disease control rate and a 7.7% complete response rate, were published in the Annals of Surgical Oncology. Safety profiles were comparable to existing treatments, with no treatment-related deaths reported.

Portfolio Pulse from Benzinga Newsdesk

May 06, 2024 | 1:03 pm

HSDT

Helius Medical Technologies announced that the Centers for Medicare & Medicaid Services (CMS) has released its preliminary Medicare payment determinations for the PoNS Controller and Mouthpiece, indicating a positive step towards reimbursement for these devices.

Portfolio Pulse from Benzinga Newsdesk

May 06, 2024 | 1:02 pm

SIMO

Silicon Motion Technology (NASDAQ:SIMO) has received diverse analyst ratings, with 11 analysts offering perspectives ranging from bullish to bearish in the last three months. The average 12-month price target for SIMO is $90.18, up from $82.33, with targets ranging from $85.00 to $110.00. Analyst actions include ratings adjustments and price target changes, reflecting a positive outlook on the company's performance. Silicon Motion operates in the semiconductor industry, focusing on NAND flash controllers and SSD solutions, and has shown a revenue growth rate of 0.81% as of December 31, 2023, with a strong net margin of 10.42% and an ROE of 2.8%.

Portfolio Pulse from Benzinga Insights

May 06, 2024 | 1:00 pm

EYPT

EyePoint Pharmaceuticals Inc. (NASDAQ:EYPT) reported that its Phase 2 PAVIA trial of Duravyu for non-proliferative diabetic retinopathy did not meet the primary endpoint, despite showing a biologic effect and favorable safety profile. The company plans to review the full 12-month data for future direction. Shares plummeted 29.9% to $13.84 in premarket trading.

Portfolio Pulse from Vandana Singh

May 06, 2024 | 1:00 pm

BYDDF

F

GM

TSLA

Chinese EVs face a significant barrier entering the U.S. market due to a 27.5% import tariff, impacting their competitiveness against U.S. automakers like Ford, General Motors, and Tesla. Despite their popularity globally, these tariffs, alongside concerns over national security and environmental advocacy, limit their market penetration in the U.S. Meanwhile, U.S. companies are developing more affordable EV models, with Tesla planning a lower-priced EV launch next year. The Biden administration is balancing affordable EV promotion with American job protection, maintaining or potentially increasing tariffs.

Portfolio Pulse from Benzinga Neuro

May 06, 2024 | 12:58 pm

AMD

AOTG

NVDA

AMD is gearing up for AI leadership by expanding its product portfolio and quadrupling its R&D investment to $5.9 billion in 2023 from $1.5 billion in 2019. The company plans significant announcements at Computex, highlighting its strong AI software stack and the benefits of its acquisition of Xilinx. Despite concerns over gaming segment weakness and competition from Nvidia, AMD sees strong demand in AI and data center GPUs. AMD stock has risen over 58% in the last 12 months, with exposure available through AOT Growth And Innovation ETF.

Portfolio Pulse from Anusuya Lahiri

May 06, 2024 | 12:51 pm

ASNS

Actelis Networks, Inc. (NASDAQ:ASNS) has completed a new order for the City of Bakersfield, CA, providing a hybrid-fiber solution to modernize the city's traffic management system. This follows a recent $2.3 million order from the Washington D.C. Department of Transportation. Actelis' technology will support Bakersfield's street safety initiatives by enabling fiber-grade network connectivity for real-time communication between the traffic operations center and traffic controllers at intersections. The solution leverages existing copper infrastructure while offering a path to future fiber upgrades, representing a cost-effective, long-term investment for the city.

Portfolio Pulse from Benzinga Newsdesk

May 06, 2024 | 12:50 pm

AAPL

HNHPF

Hon Hai Precision Industry Co. (Foxconn), Apple Inc.'s largest iPhone manufacturer, reported a 19% increase in April revenue to $15.8 billion, marking its best April revenue ever. This surge is attributed to stronger iPhone demand and the launch of Apple's new MacBook Air. Despite Apple facing challenges in the Chinese market and a global 16% drop in iPhone sales in Q1 2024, Hon Hai's record revenue suggests a potential positive turn for Apple's iPhone sales. Apple shares were slightly down in premarket trading.

Portfolio Pulse from Rounak Jain

May 06, 2024 | 12:46 pm

EYPT

FRPT

TCBP

EyePoint Pharmaceuticals' shares plummeted by 42% after its Phase 2 PAVIA trial of DURAVYU failed to meet the primary endpoint. Conversely, XBP Europe Holdings saw a 108% surge in shares following a $40 million contract win for a transformation project. Freshpet's shares increased by 15% due to strong Q1 financial results.

Portfolio Pulse from ryanfaloona@benzinga.com

May 06, 2024 | 12:44 pm

LYRA

Lyra Therapeutics shares dropped following the announcement that its ENLIGHTEN 1 trial failed to meet its primary endpoint.

Portfolio Pulse from Benzinga Newsdesk

May 06, 2024 | 12:42 pm