Streetbeat News

Regulatory

SPY

The PCE Price Index for May has been corrected to 3.8% YoY, lower than the previously reported 4.6%.

Portfolio Pulse from Bill Haddad

June 30, 2023 | 12:32 pm

SPY

The USA Core PCE Price Index for May came in at 0.3%, in line with estimates, but lower than the previous month's 0.4%.

Portfolio Pulse from Happy Mohamed

June 30, 2023 | 12:31 pm

SPY

The PCE Price Index for May has been reported at 4.6%, which is in line with the expectations.

Portfolio Pulse from Bill Haddad

June 30, 2023 | 12:31 pm

RNLX

Renalytix plc (NASDAQ:RNLX) shares are surging after the FDA granted De Novo marketing authorization for its KidneyIntelX.dkd prognostic test. The test, which uses an AI-enabled algorithm, assesses the risk of progressive kidney function decline in adults with diabetes and early-stage kidney disease. The company reported cash and cash equivalents of $33.0 million as of March 31, 2023, and recognized $0.7 million of revenue in Q3 FY22.

Portfolio Pulse from Vandana Singh

June 30, 2023 | 12:31 pm

SPY

The USA Core PCE Price Index for May came in at 4.6%, slightly below the estimated 4.7% and the prior figure of 4.7%.

Portfolio Pulse from Happy Mohamed

June 30, 2023 | 12:30 pm

BMRN

The FDA has approved BioMarin Pharmaceutical Inc's Roctavian gene therapy for adults with severe hemophilia A. This is the first approved gene therapy for severe hemophilia A in the U.S. BioMarin will continue to monitor the long-term effects of treatment with an extension study. Analysts from William Blair, Truist Securities, and Wedbush have given positive outlooks for BioMarin, with Truist Securities and Wedbush raising their price targets.

Portfolio Pulse from Vandana Singh

June 30, 2023 | 12:26 pm

ACCD

AUPH

BTTR

GNFT

IMBIL

RNLX

UNCY

WAVE

Renalytix Plc (RNLX) shares surged 48.7% in pre-market trading after receiving FDA De Novo marketing authorization for its KidneyIntelX.dkd prognostic test. Genfit S.A. (GNFT) shares gained 26.6% after positive results from Phase III ELATIVE® trial. Aurinia Pharmaceuticals Inc. (AUPH) shares rose 15.2% after the board announced exploration of strategic alternatives. Better Choice Company Inc. (BTTR) shares gained 15.2% after a $5 million investment from Alphia. Accolade, Inc. (ACCD) gained 12.2% after reporting better than expected Q1 earnings. iMedia Brands, Inc. (IMBIL) fell 18.1% in pre-market trading. Eco Wave Power Global AB (WAVE) fell 15.5% after announcing plans for a share repurchase program. Unicycive Therapeutics, Inc. (UNCY) fell 15.2% after an update on its marketing application.

Portfolio Pulse from Lisa Levin

June 30, 2023 | 12:12 pm

MDGL

Madrigal Pharmaceuticals has initiated a rolling submission of a New Drug Application (NDA) to the U.S. FDA for accelerated approval of resmetirom, a treatment for nonalcoholic steatohepatitis (NASH) with liver fibrosis. The company plans to complete the submission in July 2023. Resmetirom was granted Breakthrough Therapy designation in April 2023. Madrigal is currently conducting four Phase 3 clinical trials to demonstrate the safety and efficacy of resmetirom.

Portfolio Pulse from Happy Mohamed

June 30, 2023 | 12:11 pm

AMZN

Amazon has hired several former Federal Trade Commission (FTC) officials in preparation for an antitrust battle with the regulator. The company is facing charges of forcing third-party sellers to use its logistics network. The FTC has already filed three lawsuits against Amazon and may bring an antitrust suit to break up the company. Some speculate that the FTC may force Amazon to spin off its Amazon Web Services unit, divest its logistics business, or unwind significant acquisitions like MGM and Whole Foods.

Portfolio Pulse from Anusuya Lahiri

June 30, 2023 | 12:07 pm

SPY

VGK

Ukrainian President Zelenskiy has ordered top military commanders to strengthen the country's northern military direction following an aborted mutiny by the Wagner group in Russia.

Portfolio Pulse from Charles Gross

June 30, 2023 | 11:43 am