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RNLX

Renalytix plc (NASDAQ:RNLX) shares are surging after the FDA granted De Novo marketing authorization for its KidneyIntelX.dkd prognostic test. The test, which uses an AI-enabled algorithm, assesses the risk of progressive kidney function decline in adults with diabetes and early-stage kidney disease. The company reported cash and cash equivalents of $33.0 million as of March 31, 2023, and recognized $0.7 million of revenue in Q3 FY22.

Portfolio Pulse from Vandana Singh

June 30, 2023 | 12:31 pm

BMRN

The FDA has approved BioMarin Pharmaceutical Inc's Roctavian gene therapy for adults with severe hemophilia A. This is the first approved gene therapy for severe hemophilia A in the U.S. BioMarin will continue to monitor the long-term effects of treatment with an extension study. Analysts from William Blair, Truist Securities, and Wedbush have given positive outlooks for BioMarin, with Truist Securities and Wedbush raising their price targets.

Portfolio Pulse from Vandana Singh

June 30, 2023 | 12:26 pm

PTCT

PTC Therapeutics' MIT-E trial of vatiquinone for mitochondrial disease-associated seizures failed to meet its primary goal. However, the study showed evidence of treatment effect in reducing seizure frequency. The company plans to discuss the results of the MOVE-FA trial of vatiquinone for Friedreich ataxia with regulatory authorities. William Blair maintains an Outperform rating on PTC Therapeutics, seeing its PKU program as undervalued. PTCT shares are trading lower by 2.98% at $40.00 premarket.

Portfolio Pulse from Vandana Singh

June 30, 2023 | 12:18 pm

ACCD

AUPH

BTTR

GNFT

IMBIL

RNLX

UNCY

WAVE

Renalytix Plc (RNLX) shares surged 48.7% in pre-market trading after receiving FDA De Novo marketing authorization for its KidneyIntelX.dkd prognostic test. Genfit S.A. (GNFT) shares gained 26.6% after positive results from Phase III ELATIVE® trial. Aurinia Pharmaceuticals Inc. (AUPH) shares rose 15.2% after the board announced exploration of strategic alternatives. Better Choice Company Inc. (BTTR) shares gained 15.2% after a $5 million investment from Alphia. Accolade, Inc. (ACCD) gained 12.2% after reporting better than expected Q1 earnings. iMedia Brands, Inc. (IMBIL) fell 18.1% in pre-market trading. Eco Wave Power Global AB (WAVE) fell 15.5% after announcing plans for a share repurchase program. Unicycive Therapeutics, Inc. (UNCY) fell 15.2% after an update on its marketing application.

Portfolio Pulse from Lisa Levin

June 30, 2023 | 12:12 pm

MDGL

Madrigal Pharmaceuticals has initiated a rolling submission of a New Drug Application (NDA) to the U.S. FDA for accelerated approval of resmetirom, a treatment for nonalcoholic steatohepatitis (NASH) with liver fibrosis. The company plans to complete the submission in July 2023. Resmetirom was granted Breakthrough Therapy designation in April 2023. Madrigal is currently conducting four Phase 3 clinical trials to demonstrate the safety and efficacy of resmetirom.

Portfolio Pulse from Happy Mohamed

June 30, 2023 | 12:11 pm

FXCOF

Foxconn Technology Co., Ltd. (OTC:FXCOF) has received approval from Vietnam to invest $246 million in two new projects in Quang Ninh, northern Vietnam. The projects, to be undertaken by Foxconn Singapore, will focus on manufacturing and assembling telecom and electric vehicle (EV) parts. Foxconn will spend $200 million on producing EV chargers and components, starting in January 2025, and $46 million to produce electronics and telecommunication components in October 2024. The company's total investments in Vietnam amount to about $3 billion.

Portfolio Pulse from Nabaparna Bhattacharya

June 30, 2023 | 12:07 pm

APLD

HPE

Applied Digital Corporation (APLD) has announced a collaboration with Hewlett Packard Enterprise (HPE) to deliver AI cloud services. HPE will provide its supercomputers to support large-scale AI through Applied Digital's AI cloud service. Applied Digital will use HPE Cray XD supercomputers to enhance its AI Cloud service and support critical workloads such as AI, machine learning, and HPC tasks. The partnership comes as Applied Digital continues to expand its capacity pipeline for its HPC data centers.

Portfolio Pulse from Happy Mohamed

June 30, 2023 | 12:04 pm

CHPT

HYMTF

TSLA

VWAGY

Volkswagen AG is in talks with Tesla, Inc to adopt its North American Charging Standard (NACS) technology. Volkswagen's charging network unit, Electrify America, has agreed to use the system. Other automakers and charging equipment makers, including Ford Motor Co, General Motors Co, and ChargePoint Holdings, Inc, have also signed up for Tesla's charging design. Volkswagen is considering implementing the NACS for its North American customers.

Portfolio Pulse from Anusuya Lahiri

June 30, 2023 | 12:03 pm

MSFT

Microsoft Corp (NASDAQ:MSFT) is rolling out its next big update for Windows 11, which includes the AI Copilot assistant. The Copilot feature integrates Bing Chat and ChatGPT functionality, making Windows the first desktop operating system to natively integrate AI. The AI assistant can perform tasks such as taking screenshots, summarizing webpages, and answering queries. Some features, like third-party plugin support, are currently missing but will be added in future updates.

Portfolio Pulse from Rounak Jain

June 30, 2023 | 11:40 am

GNFT

Genfit's shares are trading higher after the company and its partner Ipsen announced that the ELATIVE Phase 3 trial of elafibranor for primary biliary cholangitis met its primary endpoint.

Portfolio Pulse from Benzinga Newsdesk

June 30, 2023 | 10:34 am