Streetbeat News

Regulatory

SUPN

M8 Pharmaceuticals has entered into an exclusive licensing agreement with Supernus Pharmaceuticals (NASDAQ:SUPN) to seek regulatory approval and commercialize Qelbree, a non-stimulant ADHD medication, in Latin America. Qelbree is approved in the US for treating ADHD in adults and children aged 6 and older. This partnership aligns with Acino's mission to expand access to innovative medicines in Latin America and strengthens its position in the CNS therapeutic area. Supernus has chosen M8 as a partner for Qelbree's regulatory approval and commercialization in Mexico and Brazil, highlighting the company's commitment to addressing ADHD treatment challenges globally.

Portfolio Pulse from Benzinga Newsdesk

May 07, 2024 | 2:03 pm

AGRI

DIS

GSUN

MTC

NUVO

NUWE

U.S. stocks traded higher with the Dow Jones gaining over 50 points. Walt Disney Co reported better-than-expected Q2 earnings with a slight revenue miss. Nuwellis, MMTec, and Golden Sun Health Technology shares surged, while AgriFORCE, GreenPower Motor, and Holdco Nuvo Group shares fell. European and Asian markets showed mixed results, with notable economic updates from the Eurozone and Asia Pacific regions.

Portfolio Pulse from Avi Kapoor

May 07, 2024 | 1:51 pm

LLY

Eli Lilly announced that the FDA will hold an in-person meeting of the Peripheral & Central Nervous System Drugs Advisory Committee on June 10 to discuss Donanemab, as reported by Reuters.

Portfolio Pulse from Benzinga Newsdesk

May 07, 2024 | 1:42 pm

APO

BLCR

PARA

SONY

WBIL

Sony Group Corp (NYSE:SONY) and Apollo Global Management Inc (NYSE:APO) have jointly bid $26 billion for Paramount Global (NASDAQ:PARA), causing Sony's shares to drop significantly. The deal raises concerns about Sony's financial capacity and the strategic fit, given it exceeds Sony's cash reserves and involves a substantial premium. The acquisition could face regulatory scrutiny, especially regarding the CBS channel. Meanwhile, Sony is focusing on its Bravia line to compete in the streaming market, where Netflix Inc (NASDAQ:NFLX) and Walt Disney Co (NYSE:DIS) are major players. PARA stock has lost 22% in the last 12 months, while SONY gained 3%. Investors can gain exposure to SONY through WBI BullBear Quality 3000 ETF (NYSE:WBIL) and BlackRock Large Cap Core ETF (NASDAQ:BLCR).

Portfolio Pulse from Anusuya Lahiri

May 07, 2024 | 1:25 pm

MULN

Mullen Automotive, Inc. (NASDAQ: MULN) announces its subsidiary, Bollinger Motors, has partnered with Amerit Fleet Solutions to provide mobile service and maintenance for Bollinger's commercial EV fleet customers. The agreement covers EV service and warranty support for the Bollinger B4 and future vehicles in key states. Amerit will offer maintenance and repair services outside Bollinger's authorized dealer service areas, enhancing nationwide coverage and fleet efficiency. This partnership follows Bollinger Motors' recent strategic moves, including partnerships for battery supply and vehicle assembly, expansion of its dealer network, and qualification for federal clean vehicle tax credits.

Portfolio Pulse from Benzinga Newsdesk

May 07, 2024 | 1:20 pm

ACB

CGC

MSOS

TLRY

The DEA's move to reclassify cannabis from Schedule I to Schedule III could significantly benefit the cannabis industry, potentially unlocking $1.1 billion in cash flow improvements due to the removal of IRS 280E tax burdens. This reclassification is expected to strengthen balance sheets and increase financial flexibility for multi-state operators (MSOs). The industry anticipates further regulatory and legislative actions, such as the SAFE Banking Act, which could ease financial operations. The stock market's response has been tempered, but liquidity remains a challenge, with major trading volumes in NASDAQ-listed Canadian LPs and the MSOS ETF. The final ruling could be effective by mid-December.

Portfolio Pulse from Nicolás Jose Rodriguez

May 07, 2024 | 1:15 pm

MBRX

Moleculin Biotech, Inc. (MBRX) announced positive interim data for Annamycin in its AML clinical development program, showing increased complete remission rates. The data supports advancing to a Phase 2 trial aimed at New Drug Approval. A virtual AML Clinical Day is scheduled to discuss these results.

Portfolio Pulse from Benzinga Newsdesk

May 07, 2024 | 1:02 pm

MSFT

Microsoft Corporation (NASDAQ:MSFT) is facing scrutiny from a Spanish startup group, which has filed a complaint with the Spanish antitrust regulator over Microsoft's cloud practices. The complaint alleges Microsoft uses its dominant position to force Azure cloud adoption, setting up barriers that limit startups' ability to compete. This comes amid broader investigations into Microsoft's practices by EU and UK regulators, and follows a similar complaint by CISPE, which includes Amazon.com, against Microsoft.

Portfolio Pulse from Benzinga Neuro

May 07, 2024 | 1:01 pm

ICCM

An independent study in Japan showed 0% breast cancer local recurrence 5 years after treatment with IceCure's ProSense, demonstrating its potential as a standard treatment for early-stage breast cancer. The study, published in Breast Cancer journal, highlighted excellent cosmetic outcomes, high patient satisfaction, and improved quality of life post-cryoablation. IceCure's distribution partner in Japan, Terumo Corporation, plans to submit a regulatory clearance application for ProSense in H2 2024. IceCure expects to receive a total of $13.2 million from Terumo for exclusive distribution rights in Japan.

Portfolio Pulse from Benzinga Newsdesk

May 07, 2024 | 12:45 pm

BIOX

Bioceres Crop Solutions Corp. (NASDAQ:BIOX) announced the approval of three new bio-insecticidal/bio-nematicidal solutions by Brazil's Ministry of Agriculture and Livestock. These solutions, derived from inactivated cells of the company's proprietary Burkholderia platform, mark a significant regulatory milestone in Brazil, the world's leading bio-control market. This approval enables the commercialization of these products in Brazil, potentially opening the door for future product launches. Bioceres' bio-control solutions are commercialized under the Rizobacter brand and other third-party brands in Brazil. The company's CEO, Federico Trucco, highlighted the approval as a key milestone for growth in Brazil and noted the global relevance of this market to the company.

Portfolio Pulse from Benzinga Newsdesk

May 07, 2024 | 12:43 pm