Streetbeat News

Regulatory

EKSO

Ekso Bionics has been granted U.S. Patent #11679056 for an advanced gait control system and methods enabling continuous walking motion of a powered exoskeleton device.

Portfolio Pulse from Charles Gross

June 20, 2023 | 12:13 pm

SONN

Sonnet BioTherapeutics has received regulatory approval to initiate a clinical trial of SON-1010 combined with atezolizumab in Australia.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2023 | 12:08 pm

AKBA

Akebia Therapeutics (NASDAQ: AKBA) has received Swissmedic marketing authorization for Vafseo (vadadustat), a treatment for anemia associated with chronic kidney disease in adults on dialysis. The approval is based on data from a comprehensive development program, and the drug is now approved in 34 countries.

Portfolio Pulse from Happy Mohamed

June 20, 2023 | 12:05 pm

SPRY

The FDA has extended the target action date for ARA Pharmaceuticals' New Drug Application for Neffy (intranasal epinephrine) for allergic reactions, including anaphylaxis, to September 19.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2023 | 12:05 pm

ARDS

Aridis Pharmaceuticals announced that its AR-301 program has been deemed eligible for consideration under the FDA Limited Population Pathway for Antibacterial and Antifungal Drugs.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2023 | 12:04 pm

ICVX

Icosavax has initiated a Phase 2 trial for its IVX-A12 vaccine candidate against RSV and hMPV in older adults. The company previously reported positive interim Phase 1 results in May 2023.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2023 | 12:04 pm

ACLX

The FDA has placed a clinical hold on Arcellx's multiple myeloma phase 2 trial, causing the company's shares to trade lower.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2023 | 11:59 am

CYN

CYNGN has been granted U.S. Patent #11679726 for vehicle sensor systems, which could potentially enhance the company's position in the autonomous vehicle technology market.

Portfolio Pulse from Charles Gross

June 20, 2023 | 11:52 am

ADBE

Adobe Inc faces an extended EU antitrust investigation for its $20 billion acquisition of rival Figma. The European regulators are concerned about less innovation and higher prices. The UK and the US Department of Justice are also probing the deal.

Portfolio Pulse from Anusuya Lahiri

June 20, 2023 | 11:43 am

PGEN

The FDA has granted Breakthrough Therapy Designation for Precigen's PRGN-2012 Adenoverse Immunotherapy for Recurrent Respiratory Papillomatosis, potentially accelerating the development and review process.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2023 | 11:32 am