Streetbeat News

Regulatory

ARWR

Arrowhead Pharmaceuticals presented interim data from its Phase 2 Gateway study of ARO-ANG3 for homozygous familial hypercholesterolemia, showing 44-48% mean reductions in LDL-C. The company is planning a Phase 3 study and intends to meet with regulatory authorities in H2 2023.

Portfolio Pulse from Benzinga Newsdesk

May 23, 2023 | 11:37 am

GLUE

Monte Rosa Therapeutics is advancing its second development candidate, MRT-6160, for the treatment of autoimmune diseases. The company plans to file an Investigational New Drug (IND) application for MRT-6160 in the first half of 2024.

Portfolio Pulse from Benzinga Newsdesk

May 23, 2023 | 11:34 am

WVE

Wave Life Sciences' shares have been halted due to pending news.

Portfolio Pulse from Benzinga Newsdesk

May 23, 2023 | 11:27 am

EBS

INVVY

IZQVF

The FDA has approved Indivior's Opvee nasal spray for emergency treatment of opioid overdose in adults and pediatric patients aged 12 years and older. Indivior acquired the product from Opiant Pharmaceuticals and expects annual net revenue of $150 million to $250 million from Opvee.

Portfolio Pulse from Vandana Singh

May 23, 2023 | 11:16 am

RGNX

REGENXBIO has secured FDA Regenerative Medicine Advanced Therapy (RMAT) designation for its RGX-121 gene therapy for Hunter Syndrome. The RMAT designation aims to expedite drug development and review processes for promising new treatments.

Portfolio Pulse from Benzinga Newsdesk

May 23, 2023 | 11:06 am

RCKT

The FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to Rocket Pharmaceuticals' RP-L301, an investigational gene therapy for Pyruvate Kinase Deficiency, a rare blood disorder characterized by severe anemia and excessive red blood cell breakdown.

Portfolio Pulse from Benzinga Newsdesk

May 23, 2023 | 11:03 am

UEC

Uranium Energy Corp (NYSE:UEC) has selected SLR Consulting and Wood to conduct an S-K 1300 Initial Assessment Economic Study for its 100% owned Roughrider Project in Saskatchewan, Canada. CanNorth will conduct environmental baseline work for the project.

Portfolio Pulse from Benzinga Newsdesk

May 23, 2023 | 10:57 am

SPY

VGK

Former Russian President Medvedev warns that the more destructive weapons Kyiv receives, the closer the possibility of a nuclear apocalypse becomes.

Portfolio Pulse from Charles Gross

May 23, 2023 | 10:33 am

BYDDY

TM

TSLA

VWAGY

China has overtaken Japan as the world's largest car exporter, with a 58% surge in Q1 exports to 1.07 million vehicles. The growth is attributed to the rising popularity of electric vehicles and the void left by automakers withdrawing from the Russian market.

Portfolio Pulse from Anan Ashraf

May 23, 2023 | 10:24 am

AFMD

Affimed N.V. (NASDAQ:AFMD) has received FDA clearance for its IND application to initiate a Phase 2 clinical trial for the combination of AFM13 and Artiva Biotherapeutics' AB-101. The trial, AFM13-203 (LuminICE-203), will evaluate the safety and efficacy of the combination therapy in patients with r/r cHL and CD30-positive PTCL. The study is set to begin in Q3 2023, with data from the safety run-in phase expected in H1 2024.

Portfolio Pulse from Benzinga Newsdesk

May 23, 2023 | 10:17 am