Streetbeat News

Regulatory

ARQT

The FDA has accepted Arcutis Biotherapeutics' supplemental New Drug Application for Roflumilast Cream 0.15% to treat atopic dermatitis in adults and children aged 6 and above. This acceptance indicates a regulatory milestone for Arcutis, potentially expanding the use of Roflumilast Cream beyond its current indications.

Portfolio Pulse from Benzinga Newsdesk

November 29, 2023 | 1:04 pm

KTTA

Pasithea Therapeutics Corp. (NASDAQ:KTTA) has received positive feedback from the FDA on its clinical development plan for PAS-004, a treatment for CNS disorders. The FDA recommended starting dosing in patients rather than healthy volunteers. PAS-004 has orphan drug designation for NF1 treatment since November 2020.

Portfolio Pulse from Benzinga Newsdesk

November 29, 2023 | 1:00 pm

EGRX

Eagle Pharmaceuticals (EGRX) has been notified by Nasdaq about a deficiency due to not filing its quarterly report (Form 10-Q) on time. This could potentially lead to delisting if the issue is not resolved.

Portfolio Pulse from Benzinga Newsdesk

November 29, 2023 | 12:36 pm

VVOS

Vivos Therapeutics, Inc. has received FDA 510(k) clearance for its CARE oral appliances, designed to treat severe obstructive sleep apnea in adults. This includes the DNA, mRNA, and mmRNA oral appliances, marking a significant milestone for the company in the medical device and technology sector.

Portfolio Pulse from Benzinga Newsdesk

November 29, 2023 | 12:32 pm

HROW

Harrow Health, Inc. has successfully completed the transfer of the New Drug Application (NDA) for Triesence, a synthetic corticosteroid used to treat various ocular inflammatory conditions, to its own portfolio.

Portfolio Pulse from Benzinga Newsdesk

November 29, 2023 | 12:14 pm

QURE

The FDA has approved uniQure's Investigational New Drug (IND) application for AMT-191, a gene therapy for Fabry Disease. This clearance allows uniQure to proceed with clinical trials, potentially leading to a new treatment option for patients with this genetic disorder.

Portfolio Pulse from Benzinga Newsdesk

November 29, 2023 | 12:13 pm

BCDA

BioCardia, Inc. has announced that following a recent consultation with Japan's Pharmaceuticals and Medical Devices Agency (PMDA), the PMDA indicated that data from outside Japan may be sufficient for the approval of BioCardia's CardiAMP autologous cell therapy. This development suggests that BioCardia may not need to conduct additional clinical trials within Japan, potentially accelerating the approval process for CardiAMP in the Japanese market.

Portfolio Pulse from Benzinga Newsdesk

November 29, 2023 | 12:10 pm

GLD

SPY

U.S. stock markets closed higher on Tuesday, with consumer discretionary shares leading gains and healthcare sector losses. The Conference Board's consumer confidence index rose, and home prices increased. Asia markets showed mixed performance, with Japan's Nikkei 225 and China's Shanghai Composite down, while Australia's S&P/ASX 200 gained. European markets were mostly up, with the STOXX 600, Germany's DAX, and France's CAC seeing gains, but the UK's FTSE 100 traded lower. Commodities saw crude oil prices rise and gold cross $2,000. U.S. futures were up in early trading, and the U.S. Dollar Index strengthened slightly.

Portfolio Pulse from Akanksha Bakshi

November 29, 2023 | 12:08 pm

BCRX

BioCryst Pharmaceuticals has announced that its drug ORLADEYO (berotralstat) has been approved by Argentina's National Administration of Drugs, Foods, and Medical Devices (ANMAT). This approval allows for the treatment of hereditary angioedema (HAE) in patients in Argentina.

Portfolio Pulse from Benzinga Newsdesk

November 29, 2023 | 12:06 pm

GBTC

MSTR

Andrew Tate compared Michael Saylor's responsible business practices at MicroStrategy with Sam Bankman-Fried's fraudulent activities at FTX. Tate highlighted Saylor's net-benefit approach to business, contrasting it with Bankman-Fried's 0-benefit strategy, which led to his conviction on fraud charges. Tate also discussed the potential SEC approval of a Bitcoin ETF, mentioning several contenders for the ETF including Grayscale, Ark/21 Shares, Bitwise, BlackRock, VanEck, WisdomTree, Valkyrie, Invesco Galaxy, and Fidelity Wise Origin.

Portfolio Pulse from Mehab Qureshi

November 29, 2023 | 12:04 pm