Streetbeat News

Regulatory

SPY

The USA PCE price index for April came in at 0.3%, matching both the estimate and the prior month's figure.

Portfolio Pulse from Benzinga Newsdesk

May 31, 2024 | 12:30 pm

NVS

Novartis' Scemblix (asciminib) has shown superior efficacy and a favorable safety profile compared to standard-of-care TKIs in a Phase III trial for newly diagnosed CML patients. The trial met both primary endpoints, demonstrating higher MMR rates and fewer adverse events. Scemblix has been granted US FDA Breakthrough Therapy Designation and is under review.

Portfolio Pulse from Benzinga Newsdesk

May 31, 2024 | 12:20 pm

ITRM

Iterum Therapeutics shares are trading higher after the FDA acknowledged receipt of the company's resubmission of its New Drug Application for oral sulopenem.

Portfolio Pulse from Benzinga Newsdesk

May 31, 2024 | 12:16 pm

MAXN

Maxeon Solar Technologies has regained compliance with Nasdaq Listing Rule 5250(c)(1) after filing its 2023 Annual Report. The company had previously received a notice of non-compliance due to a delayed filing.

Portfolio Pulse from Benzinga Newsdesk

May 31, 2024 | 12:10 pm

LIPO

Lipella Pharmaceuticals has completed the site initiation visit for its Phase 2a trial of LP-310, a treatment for Oral Lichen Planus. Clinical testing is expected to begin in mid-2024.

Portfolio Pulse from Benzinga Newsdesk

May 31, 2024 | 12:04 pm

ITRM

Iterum Therapeutics has received FDA acceptance for its resubmission of a New Drug Application (NDA) for oral sulopenem, aimed at treating uncomplicated urinary tract infections.

Portfolio Pulse from Benzinga Newsdesk

May 31, 2024 | 12:03 pm

FBTC

GBTC

Bitcoin spot ETFs have seen a $48.706 million inflow on May 30, marking the thirteenth consecutive day of positive net inflows. The Grayscale Bitcoin Trust (GBTC) reported no outflows, while the Fidelity Wise Origin Bitcoin Fund (FBTC) saw a $119 million inflow. Ethereum spot ETF trading is progressing, with the SEC requesting draft S-1 filings from issuers.

Portfolio Pulse from Murtuza Merchant

May 31, 2024 | 11:40 am

SPRC

SciSparc has been granted a patent by the European Patent Office for 'Compositions And Methods Of Potentiating Antimicrobials,' adding to a similar patent previously granted by the United States Patent and Trademark Office. This strengthens the company's intellectual property portfolio and competitive position in the global pharmaceutical market.

Portfolio Pulse from Benzinga Newsdesk

May 31, 2024 | 11:21 am

IVVD

Invivyd has disclosed a general alignment with the U.S. FDA on a repeatable and expedient emergency use authorization pathway for the prevention and treatment of symptomatic COVID-19. This pathway involves a master, registrational clinical trial protocol to streamline the evaluation of new monoclonal antibodies (mAbs). Invivyd plans to rapidly move towards a registrational clinical trial of VYD2311.

Portfolio Pulse from Benzinga Newsdesk

May 31, 2024 | 11:14 am

PFE

The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for Pfizer's Fidanacogene Elaparvovec, a one-time gene therapy for severe Hemophilia B in adult patients.

Portfolio Pulse from Benzinga Newsdesk

May 31, 2024 | 11:12 am