Streetbeat News

Regulatory

SEEL

Seelos Therapeutics' CEO Raj Mehra released a letter to stockholders discussing the company's recent reverse stock split and public offering, compliance with Nasdaq's minimum bid price requirement, and updates on their lead programs SLS-002 and SLS-005. SLS-002 was selected for a DOD-funded trial for PTSD treatment, retaining commercial rights. SLS-005 showed potential in a Phase IIb/III study for Spinocerebellar Ataxia. The company is seeking partnerships and has two proposals for the upcoming Special Meeting of Stockholders on January 10, 2024, including increasing authorized shares to 400 million and issuing more shares to Lind Partners under a convertible note.

Portfolio Pulse from Benzinga Newsdesk

December 22, 2023 | 1:03 pm

SRPT

Sarepta Therapeutics has submitted an efficacy supplement to the FDA to expand the label for ELEVIDYS to include Duchenne Muscular Dystrophy patients without restrictions on age or ambulatory status. This could potentially increase the patient population eligible for treatment with ELEVIDYS.

Portfolio Pulse from Benzinga Newsdesk

December 22, 2023 | 1:02 pm

NVO

The FDA and Novo Nordisk have warned of counterfeit Ozempic in the U.S. market. Thousands of units of the diabetes drug have been seized, with confirmed counterfeit components including needles, pen labels, and packaging. The FDA has identified a specific lot and serial number to avoid and is investigating five non-serious adverse events related to the counterfeit product. High demand for Ozempic and Wegovy has led to supply restrictions and the emergence of knockoffs. Novo Nordisk's stock (NVO) fell slightly in premarket trading.

Portfolio Pulse from Vandana Singh

December 22, 2023 | 12:52 pm

AZN

IONS

The FDA has approved AstraZeneca and Ionis Pharmaceuticals' Wainua (eplontersen) for the treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Wainua is unique as it can be self-administered via an auto-injector. The approval is based on positive results from the NEURO-TTRansform Phase 3 trial. The companies plan to commercialize Wainua in the U.S. and seek approval in other regions. Analysts estimate peak sales could reach $3.5 to $7 billion with expanded approval. IONS shares rose 7% and AZN shares increased 0.47% in premarket trading.

Portfolio Pulse from Vandana Singh

December 22, 2023 | 12:49 pm

HOOK

Hookipa Pharma has filed a prospectus related to the proposed resale of 15 million shares of common stock by a selling stockholder. The filing is on Form S-3, which is used by companies to register securities with the SEC.

Portfolio Pulse from Charles Gross

December 22, 2023 | 12:37 pm

NVDA

Nvidia Corp (NASDAQ:NVDA) stock is trading lower due to the U.S. Department of Commerce's announcement of a new survey to analyze the U.S. semiconductor supply chain and national defense industrial base, with a focus on legacy chips and security risks related to China. Nvidia is already affected by the U.S. embargo on semiconductor and AI technology exports to China. The survey, mandated by the NDAA for FY 2021, aims to strengthen the supply chain and address national security concerns. NVDA shares dropped 0.47% in premarket trading.

Portfolio Pulse from Anusuya Lahiri

December 22, 2023 | 12:34 pm

CMI

Cummins Inc. has reached an agreement in principle to settle regulatory proceedings concerning its emissions certification and compliance process for pick-up truck applications. The settlement indicates that Cummins may have faced issues with regulatory compliance in the past, which it is now moving to resolve. This could have implications for investor confidence and the company's financial liabilities.

Portfolio Pulse from Benzinga Newsdesk

December 22, 2023 | 12:33 pm

CDTX

Cidara Therapeutics announced that its drug Rezzayo (Rezafungin Acetate) has been approved by the European Union for the treatment of invasive candidiasis in adults. This marks the first new treatment option for this condition in over 15 years. Following the approval by the European Medicines Agency (EMA), Cidara is set to receive a milestone payment of approximately $11.14 million from Mundipharma.

Portfolio Pulse from Benzinga Newsdesk

December 22, 2023 | 12:32 pm

AAPL

Beeper, a chat app developer, is facing constant disruptions from Apple Inc. (NASDAQ:AAPL), leading to a strategic shift. Beeper Mini, which aimed to bridge iMessage between iPhone and Android users, has been affected by Apple's interference, causing reputational damage for Beeper. As a response, Beeper is making its iMessage connection software open-source and focusing on long-term goals. This follows a series of service disruptions and calls for an antitrust investigation into Apple's actions against Beeper Mini.

Portfolio Pulse from Benzinga Neuro

December 22, 2023 | 11:55 am

BCH-USD

Anthony Scaramucci, founder of SkyBridge Capital, predicts that a Bitcoin Cash (BCH) ETF could be approved by the SEC next week, suggesting the timing could be used to 'bury the news'. Bitcoin Cash is a cryptocurrency that forked from Bitcoin in 2017. Several firms, including BlackRock, Grayscale, Fidelity Investments, WisdomTree Inc., Ark Invest, and 21Shares, have filed for a spot Bitcoin ETF, but none have been approved. SkyBridge Capital's cryptocurrency investments, including Bitcoin, Ethereum, and Solana, have seen significant gains.

Portfolio Pulse from Mehab Qureshi

December 22, 2023 | 11:39 am