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ALGN

Align Technology has received clearance from the U.S. FDA for its Invisalign Palatal Expander System, making it commercially available in the U.S. This product provides a removable alternative to traditional palatal expanders and can be used in conjunction with Invisalign First aligners for comprehensive early intervention orthodontic treatment.

Portfolio Pulse from Benzinga Newsdesk

December 18, 2023 | 2:31 pm

BMRA

Biomerica Inc (NASDAQ:BMRA) has received FDA 510(k) clearance for its Hp Detect Stool Antigen ELISA test, which is used to detect H. pylori bacteria, a major cause of gastric cancer. This approval is significant as H. pylori affects about 35% of the U.S. population and is linked to over 80% of gastric cancers. The news has led to a 57.58% increase in BMRA's stock price in premarket trading.

Portfolio Pulse from Vandana Singh

December 18, 2023 | 2:24 pm

ADN

Advent Technologies has signed a €1.8 million frame contract with Volta Energy to supply methanol-powered fuel cell units. Deliveries are scheduled to start in January 2024 and continue throughout the year to meet the customer's timeline.

Portfolio Pulse from Benzinga Newsdesk

December 18, 2023 | 2:17 pm

FTDR

Frontdoor, Inc. (NASDAQ:FTDR) has announced the promotion of Kathy Collins to SVP & Chief Revenue Officer and Evan Iverson to SVP & Chief Operations Officer, effective January 1, 2024. These newly created positions aim to enhance the growth and customer experience of the American Home Shield and Frontdoor brands. Collins will oversee revenue-generating activities without backfilling her previous role as Chief Brand Officer. Iverson will manage operational functions and continue his work on contractor engagement without a separate backfill for his previous role.

Portfolio Pulse from Happy Mohamed

December 18, 2023 | 2:15 pm

CRWD

CrowdStrike (NASDAQ:CRWD) and Optiv have surpassed $1 billion in sales of the CrowdStrike Falcon platform through their partnership. This milestone highlights the success of their collaboration in modernizing cybersecurity across various industries. CrowdStrike's Falcon platform, combined with Optiv's partner program, has driven growth and reduced risk for customers. CrowdStrike also achieved over $1 billion in AWS Marketplace sales and was recognized as a growth leader in a Canalys report, with a 39.1% growth rate in channel sales.

Portfolio Pulse from Happy Mohamed

December 18, 2023 | 2:12 pm

LNTH

Lantheus Holdings, Inc. (LNTH) shares dropped following the announcement of topline results from the phase 3 SPLASH study for metastatic castration-resistant prostate cancer, conducted in collaboration with POINT Biopharma.

Portfolio Pulse from Benzinga Newsdesk

December 18, 2023 | 2:09 pm

SYY

Sysco Corporation (NYSE:SYY) and iFoodDS have initiated a proof-of-concept project to develop solutions for compliance with the FDA's FSMA 204 Food Traceability Rule. The project aims to create a flexible, scalable, and interoperable traceability system that will benefit Sysco's extensive supplier network and customers by ensuring a safer and more transparent food supply chain. Sysco is committed to finding compliance solutions that can be widely implemented, while iFoodDS brings expertise in scalable traceability platforms.

Portfolio Pulse from Happy Mohamed

December 18, 2023 | 2:05 pm

GPCR

Structure Therapeutics' stock price has declined following the announcement of a development program update for their drug GSBR-1290.

Portfolio Pulse from Benzinga Newsdesk

December 18, 2023 | 2:04 pm

CYCC

CYCCP

Cyclacel Pharmaceuticals reported promising Phase 1 data for fadraciclib, showing efficacy against tumors with CDKN2A, CDKN2B, and MTAP deletions. A patient with squamous NSCLC achieved significant tumor shrinkage. Retrospective analysis revealed similar deletions in patients who responded to fadraciclib. The Phase 2 study will further evaluate its efficacy. Cyclacel also reported progress in their plogosertib study, with observed anticancer activity. The company is exploring the potential of fadraciclib and plogosertib as monotherapies for various cancers.

Portfolio Pulse from Happy Mohamed

December 18, 2023 | 2:04 pm

SNES

SenesTech, Inc. has entered into an exclusive distribution agreement with Fruit Tree Limited for its Evolve Soft Bait product in Hong Kong and Macau. The agreement includes an initial order for the product, which is designed for rodent control.

Portfolio Pulse from Benzinga Newsdesk

December 18, 2023 | 2:01 pm