Streetbeat News

Regulatory

TMBR

Timber Pharmaceuticals announced interim pharmacokinetic analyses from the Phase 3 ASCEND study, indicating minimal systemic absorption of isotretinoin in patients with congenital ichthyosis treated with TMB-001. The full results will be presented at the Society for Pediatric Dermatology's Annual Meeting.

Portfolio Pulse from Happy Mohamed

June 20, 2023 | 12:20 pm

UBS

UBS Group AG may face hundreds of millions of dollars in penalties over Credit Suisse's mishandling of Archegos Capital after Swiss, U.S., and U.K. regulators completed their investigations. The Federal Reserve's fine may be up to $300 million, while the Prudential Regulation Authority's penalty might be up to £100 million.

Portfolio Pulse from Akanksha Bakshi

June 20, 2023 | 12:19 pm

ACLX

GILD

TSVT

The FDA has placed a clinical hold on Arcellx Inc's (NASDAQ:ACLX) iMMagine-1 Phase 2 clinical program for CART-ddBCMA, a drug for relapsed or refractory multiple myeloma, following a recent patient death. Arcellx is working with the FDA to amend the protocol. Kite, a Gilead Sciences Inc (NASDAQ:GILD) company, announced a collaboration with Arcellx in December 2022 to co-develop and co-commercialize CART-ddBCMA.

Portfolio Pulse from Vandana Singh

June 20, 2023 | 12:19 pm

WKSP

Worksport Ltd. is applying for ISO 9000 certification for its 220,000 sq. ft. Western N.Y. manufacturing facility. The company expects to deliver its light truck tonneau covers and later manufacture its SOLIS solar tonneau covers, designed to work with its improved hot swap battery system.

Portfolio Pulse from Happy Mohamed

June 20, 2023 | 12:18 pm

LXRX

Lexicon Pharmaceuticals will present clinical study results for LX9211, a non-opioid treatment for diabetic peripheral neuropathic pain, and INPEFA, a recently approved drug for heart failure, at the American Diabetes Association's 83rd Scientific Sessions.

Portfolio Pulse from Happy Mohamed

June 20, 2023 | 12:17 pm

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