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PSNL

Personalis, Inc. (NASDAQ:PSNL) announced the validation of its NeXT Personal test, an ultra-sensitive assay for detecting minimal residual disease (MRD) and monitoring cancer treatment response. The test, which uses a personalized tumor-informed approach, demonstrated high analytical sensitivity and accuracy across nine cancer types in a study. Initial findings at the ESMO Congress showed its potential clinical benefit in early-stage lung cancer detection and outcome prediction.

Portfolio Pulse from Benzinga Newsdesk

March 26, 2024 | 1:05 pm

CELU

Celularity Inc. (NASDAQ:CELU) announced that its product Biovance 3L received a Healthcare Common Procedure Coding System (HCPCS) Q code approval from the U.S. Centers for Medicare & Medicaid Services (CMS), effective April 1, 2024. Biovance 3L is a tri-layer allograft derived from placental tissue for wound treatment. This approval is expected to drive growth and impact Celularity's performance positively.

Portfolio Pulse from Benzinga Newsdesk

March 26, 2024 | 1:02 pm

EGOX

Next.e.GO N.V. (NASDAQ:EGOX) shares plummeted premarket Tuesday after the company announced it received a delisting notification from Nasdaq due to its closing bid price falling below $0.10 for ten consecutive trading days and failing to meet the $1.00 minimum bid price requirement. The company has until June 10, 2024, to comply with the Minimum Bid Price Rule or face delisting. Shares were down 18.9% at $0.0413 in premarket trading.

Portfolio Pulse from Lekha Gupta

March 26, 2024 | 1:00 pm

MA

V

Visa has reached a settlement with U.S. merchants, agreeing to reduce rates and guarantee no rate increases for at least five years. This settlement resolves claims against Visa, Mastercard, and other defendants.

Portfolio Pulse from Benzinga Newsdesk

March 26, 2024 | 12:46 pm

GXAI

Gaxos.ai Inc. (NASDAQ:GXAI), a developer of artificial intelligence applications, has regained compliance with NASDAQ's minimum bid price requirement for continued listing on the NASDAQ Capital Market. This comes after the company's stock traded above the $1.00 minimum bid price for 10 consecutive trading days as of March 21, 2024, rectifying a previous deficiency notice received on July 10, 2023.

Portfolio Pulse from Happy Mohamed

March 26, 2024 | 12:35 pm

ENTX

Entera Bio Ltd. (NASDAQ:ENTX) announced the FDA's plan to rule within 10 months on using bone mineral density (BMD) as a surrogate endpoint for osteoporosis drug trials. This decision could benefit Entera's EB613, a first-in-class oral treatment for osteoporosis, currently in Phase 3, designed to meet the BMD thresholds proposed by the SABRE project. The approval of BMD as a surrogate endpoint could streamline the approval process for new osteoporosis treatments, addressing a significant treatment gap in a disease affecting over 200 million women globally.

Portfolio Pulse from Happy Mohamed

March 26, 2024 | 12:33 pm

YTEN

Yield10 Bioscience, Inc. (NASDAQ:YTEN) announced that its genome-edited E3902 Camelina has been cleared for planting in Canada by the Plant Biosafety Office of the Canadian Food Inspection Agency. This decision is based on the determination that E3902 is not a Plant with Novel Trait and is not subject to pre-market notification. E3902 Camelina, which has genome edits resulting in a 5% increase in oil production and a lighter seed coat color, has also received favorable regulatory determinations in the United States, Argentina, and Chile. Yield10 plans to continue its development and regulatory programs to provide new Camelina varieties to growers.

Portfolio Pulse from Benzinga Newsdesk

March 26, 2024 | 12:32 pm

INZY

Inozyme Pharma announced it will report topline data from its ongoing Phase 1/2 trials of INZ-701 for treating ABCC6 Deficiency and ENPP1 Deficiency on April 8, 2024. A conference call and webcast with key opinion leaders will be hosted on the same day.

Portfolio Pulse from Benzinga Newsdesk

March 26, 2024 | 12:31 pm

CERS

Cerus Corporation (NASDAQ:CERS) announced FDA approval for a 12-month shelf life for INTERCEPT Platelet Processing Sets, doubling the previous 6-month shelf life. This extension applies to all sizes of the sets in the U.S., effective immediately. The extension is expected to benefit supply chains and reduce product expiration risk. Cerus is also pursuing further extensions beyond 12 months.

Portfolio Pulse from Benzinga Newsdesk

March 26, 2024 | 12:31 pm

MESO

STOK

VKTX

Shares of Stoke Therapeutics, Viking Therapeutics, and Mesoblast saw significant increases after positive developments in their respective clinical trials and FDA communications. Stoke Therapeutics reported encouraging Phase 1/2a data for STK-001 in treating Dravet syndrome, leading to a 101% surge in its shares. Viking Therapeutics announced successful results from its Phase 1 trial of VK2735, resulting in a 21% increase in its stock price. Mesoblast shares jumped 49% after the FDA deemed its Phase 3 study data sufficient to support a Biologics License Application for remestemcel-L in treating pediatric patients with steroid-refractory acute graft versus host disease.

Portfolio Pulse from ryanfaloona@benzinga.com

March 26, 2024 | 12:26 pm