Streetbeat News

Regulatory

GH

Guardant Health has received EU IVDR certification for its Guardant360 CDx blood test, which is a significant milestone for the company.

Portfolio Pulse from Benzinga Newsdesk

May 21, 2024 | 12:11 pm

LIPO

Lipella Pharmaceuticals has received FDA Type-C meeting guidance for its LP-10 (Liposomal Tacrolimus) clinical program and plans to advance its lead product candidate to Phase 2b. The trial will evaluate LP-10 as a treatment for hemorrhagic cystitis in approximately 36 patients in the second half of 2024.

Portfolio Pulse from Benzinga Newsdesk

May 21, 2024 | 12:05 pm

DRRX

DURECT Corporation has received FDA Breakthrough Therapy Designation for its drug Larsucosterol, aimed at treating alcohol-associated hepatitis.

Portfolio Pulse from Benzinga Newsdesk

May 21, 2024 | 12:03 pm

GL

Globe Life has received a preliminary, informal inquiry from the SEC's Fort Worth Regional Office regarding recent short seller reports. The company intends to fully cooperate and does not believe it will result in a material loss.

Portfolio Pulse from Benzinga Newsdesk

May 21, 2024 | 11:56 am

BMY

HALO

Halozyme announced that Bristol Myers Squibb received an updated FDA action date of December 29, 2024, for the Biologics License Application for subcutaneous nivolumab co-formulated with Halozyme's ENHANZE. The application is based on Phase 3 trial results showing noninferior pharmacokinetics, efficacy, and safety compared to the intravenous formulation.

Portfolio Pulse from Benzinga Newsdesk

May 21, 2024 | 11:55 am

COIN

MARA

RIOT

Crypto-related stocks, including Marathon Digital Holdings, Riot Platforms, and Coinbase, are trading higher as Ethereum gains 22% amid rising odds of ETF approval. Analysts have increased the likelihood of a spot ETH ETF approval from 25% to 75%, leading to a market rally.

Portfolio Pulse from Pooja Rajkumari

May 21, 2024 | 11:48 am

CTXR

Trading halt status for CTXR was updated at 7:25:00 AM ET. The news and resumption times have been provided.

Portfolio Pulse from Benzinga Newsdesk

May 21, 2024 | 11:25 am

SABS

SAB Biotherapeutics has received FDA clearance for its IND application to proceed with a Phase 1 trial for SAB-142, a treatment for Type 1 Diabetes.

Portfolio Pulse from Benzinga Newsdesk

May 21, 2024 | 11:16 am

AZO

IWM

LOW

M

NVDA

PANW

QQQ

SPY

TOL

URBN

VSAT

ZM

Wall Street is expected to open mostly flat as traders await Nvidia's earnings and several Fed speeches. Bitcoin surged above $71K on Ethereum ETF approval speculation. Key stocks in focus include Nvidia, Palo Alto Networks, Zoom Video Communications, Lowe's, AutoZone, Macy's, Toll Brothers, Viasat, and Urban Outfitters.

Portfolio Pulse from Shanthi Rexaline

May 21, 2024 | 11:14 am

CLSD

Clearside Biomedical has announced the publication of consensus guidelines for drug delivery via suprachoroidal space (SCS) injection in the peer-reviewed journal RETINA. An expert panel of ophthalmologists developed these guidelines, which support SCS injection as a safe and effective method for delivering retinal and choroidal therapeutics.

Portfolio Pulse from Benzinga Newsdesk

May 21, 2024 | 11:13 am