Streetbeat News

Regulatory

RCKT

Rocket Pharmaceuticals has reached an agreement with the FDA on the design of a pivotal Phase 2 trial for RP-A501 in Danon Disease. The company anticipates filing the Clinical Trial Application (CTA)/Investigational Medicinal Product Dossier (IMPD) for RP-A501 in the third quarter of this year to initiate EU study activities. Rocket has also secured an ICD-10 code from CMS for LAMP2 deficiency in Danon Disease.

Portfolio Pulse from Benzinga Newsdesk

September 12, 2023 | 8:02 pm

AAPL

Apple Inc.'s shares are trading lower following a report suggesting Huawei is increasing its Mate 60 series smartphone shipment target by 20%. This comes after China's ban on the use of Apple devices for official use and the introduction of Huawei's Mate 60 and Mate 60 Pro smartphones. Apple also showcased the iPhone 15 at its Wonderlust event.

Portfolio Pulse from Ryan Gustafson

September 12, 2023 | 7:50 pm

COIN

Coinbase Global Inc (NASDAQ: COIN) is investing in Truflation, a provider of verifiable economic data, as part of its support for Web3 and Blockchain technologies. Coinbase is also advocating for standardized crypto regulations at the upcoming G20 summit.

Portfolio Pulse from Khyathi Dalal

September 12, 2023 | 7:40 pm

CURLF

The New York State Office of Cannabis Management (OCM) is expanding its licensing program for recreational marijuana, starting October 4. Businesses can apply for multiple cannabis-related licenses via the New York Business Express platform. The OCM has provisions for Social and Economic Equity applicants, who receive 50% off application and licensing fees. However, the entry of industry giants like Curaleaf Holdings Inc (OTCQX:CURLF) could threaten smaller businesses. The OCM board has also approved a cannabis research license application.

Portfolio Pulse from Joana Scopel

September 12, 2023 | 7:36 pm

SPY

Commerce Secretary Gina Raimondo is expected to meet with U.S. business CEOs on Thursday, according to sources. The specifics of the meeting are not disclosed.

Portfolio Pulse from Benzinga Newsdesk

September 12, 2023 | 7:33 pm

TEVA

Teva Pharmaceutical Industries Ltd (NYSE:TEVA), the primary producer of Adderall, faced shortages last year due to a lack of factory workers. The shortage led customers to seek other options, depleting supplies from competitor companies. Despite calls from the U.S. government to increase production, major players, including Teva, have announced no plans to enhance their output. The U.S. Drug Enforcement Administration imposes limits on ADHD medication production, which some producers argue prevent them from fully addressing demand.

Portfolio Pulse from Vandana Singh

September 12, 2023 | 6:53 pm

CVS

WBA

The FDA has issued warning letters to eight companies, including CVS Health Corp and Walgreens Boots Alliance Inc, for manufacturing or marketing unapproved ophthalmic drug products. The products are illegally marketed to treat conditions such as conjunctivitis, cataracts, glaucoma, and others. The FDA is concerned that these products pose a heightened risk of harm to users. The companies have been asked to respond within 15 days and state how they will correct the violations.

Portfolio Pulse from Vandana Singh

September 12, 2023 | 6:46 pm

BMY

GERN

Goldman Sachs has upgraded Geron Corporation (GERN) to Buy from Neutral, with a price target of $4. The FDA has assigned a standard review and a PDUFA action date of June 16, 2024, for Geron's New Drug Application for imetelstat. The FDA plans to hold an advisory committee meeting. The recent approval of Bristol-Myers Squibb & Co's Reblozyl does not negate the opportunity for imetelstat. The recent pullback in GERN shares has presented a buying opportunity.

Portfolio Pulse from Vandana Singh

September 12, 2023 | 6:43 pm

AAPL

AMZN

GOOG

The U.S. Justice Department has accused Alphabet Inc's Google of maintaining a monopoly by allegedly paying over $10 billion annually to secure its position as the default search engine on web browsers and mobile devices. The government alleges that Google's actions stifle competition and hamper innovation in the online search market. Google reportedly paid Apple between $4 billion - $7 billion to maintain its default position on Safari and over $1 billion to wireless carriers to secure its status as the default on Android smartphones. If the Justice Department prevails, it may seek remedies in the second phase, potentially separating Alphabet's search business from other products.

Portfolio Pulse from Anusuya Lahiri

September 12, 2023 | 6:04 pm

ETHUSD

Solidus Labs has identified $2 billion worth of wash trades on Ethereum-based decentralized exchanges (DEXs) since 2020. The firm analyzed around 30,000 DEX liquidity pools and found that 67% were tainted by wash traders. These activities accounted for 16% of the total trading volume in these manipulated pools. Solidus Labs' CEO, Asaf Meir, stated that market manipulation remains a significant challenge within the crypto industry.

Portfolio Pulse from Murtuza Merchant

September 12, 2023 | 6:02 pm