Streetbeat News

Regulatory

ZYXI

Zynex has received FDA clearance for its TensWave device, which is a significant milestone for the company. This approval could enhance Zynex's product offerings and potentially boost its market position.

Portfolio Pulse from Benzinga Newsdesk

September 03, 2024 | 1:17 pm

HAL

IEZ

PXJ

Halliburton's stock is falling due to a cyber attack that disrupted critical business applications. The company is assessing the breach's impact but expects no significant financial harm. However, risks like management distractions and regulatory scrutiny remain.

Portfolio Pulse from Nabaparna Bhattacharya

September 03, 2024 | 1:16 pm

LGVN

Longeveron has announced a Type C meeting with the FDA regarding the pathway to a Biological License Application (BLA) for Lomecel-B in treating Hypoplastic Left Heart Syndrome. The ongoing Phase 2b clinical trial, ELPIS II, is considered pivotal for potential full approval.

Portfolio Pulse from Benzinga Newsdesk

September 03, 2024 | 1:03 pm

GOOG

GOOGL

JPMorgan analyst Doug Anmuth warns that the DOJ trial against Alphabet Inc (Google) could negatively impact Google's earnings by up to 10%, with potential outcomes including opening up search distribution channels to competitors. The trial could lead to significant changes in Google's business model, affecting its core operations.

Portfolio Pulse from Surbhi Jain

September 03, 2024 | 12:56 pm

ANGO

AngioDynamics has received CE Mark approval for its Auryon System in Europe, which is a significant regulatory milestone that could enhance its market presence and sales in the European region.

Portfolio Pulse from Benzinga Newsdesk

September 03, 2024 | 12:37 pm

ARCT

Arcturus Therapeutics has received clearance for its Investigational New Drug (IND) application for ARCT-032, a treatment for cystic fibrosis. This development marks a significant step forward in the company's drug development pipeline.

Portfolio Pulse from Benzinga Newsdesk

September 03, 2024 | 12:35 pm

MOVE

Movano Health (Nasdaq: MOVE) is advancing to the final phase of the FDA review process for its EvieMED Ring, a wearable device with medical and wellness features. A recent meeting with the FDA resulted in a positive outcome, allowing the company to proceed with the review.

Portfolio Pulse from Benzinga Newsdesk

September 03, 2024 | 12:32 pm

DNLI

Denali Therapeutics announced the outcome of a recent FDA meeting and plans to file for accelerated approval of Tividenofusp Alfa for treating Hunter Syndrome.

Portfolio Pulse from Benzinga Newsdesk

September 03, 2024 | 12:28 pm

AUUD

PCVX

SHLS

Auddia, Shoals Technologies, and Vaxcyte shares are trading higher due to significant company developments. Auddia launched new interfaces for its app, Shoals Technologies won a legal ruling, and Vaxcyte advanced a vaccine candidate to Phase 3 trials.

Portfolio Pulse from Benzinga Newsdesk

September 03, 2024 | 12:27 pm

CRBU

Caribou Biosciences has received FDA Fast Track designations for its therapies CB-010 and CB-012, aimed at treating refractory SLE and relapsed or refractory AML, respectively. This designation is intended to expedite the development and review process.

Portfolio Pulse from Benzinga Newsdesk

September 03, 2024 | 12:25 pm