Streetbeat News

Regulatory

SUPN

Supernus Pharmaceuticals' stock is trading lower following the FDA's issuance of a Complete Response Letter regarding the company's New Drug Application for SPN-830.

Portfolio Pulse from Benzinga Newsdesk

April 08, 2024 | 12:20 pm

INMB

INmune Bio Inc. (NASDAQ:INMB) presented data on INB03, a novel immunotherapy for high-risk breast cancer, at AACR 2024. INB03 targets soluble TNF to modulate immune checkpoints, enhancing therapeutic outcomes in HER2+ and triple-negative breast cancer (TNBC). Studies showed INB03, in combination with anti-HER2 and anti-PD1 therapies, reduced tumor growth and metastasis by altering immune cell behavior and decreasing immune checkpoint proteins. The company seeks partners to advance clinical development and expand its patent portfolio for INB03 in oncology.

Portfolio Pulse from Benzinga Newsdesk

April 08, 2024 | 12:16 pm

FCEL

XOM

FuelCell Energy, Inc. (FCEL) and ExxonMobil Technology and Engineering Company (EMTEC) have updated and extended their joint development agreement to accelerate access to carbonate fuel cell technology for carbon capture. This technology, which captures CO2 emissions while generating electricity and hydrogen, could lower the cost and barriers to carbon capture adoption. A pilot project is set to start in early 2026 at Esso Nederland BV's Rotterdam Manufacturing Complex. The agreement allows FuelCell Energy to market its carbon capture technology, enhanced by joint innovations, aiming to accelerate commercial delivery.

Portfolio Pulse from Benzinga Newsdesk

April 08, 2024 | 12:07 pm

AAPL

NVDA

SMH

SOXX

TSM

Taiwan Semiconductor Manufacturing Co (TSMC) is significantly expanding its U.S. investment to over $65 billion, supported by a $6.6 billion federal grant, to produce advanced 2-nanometer chips. This includes building a third chip manufacturing facility in Phoenix, Arizona, by 2030, marking the largest foreign direct investment in U.S. history for a greenfield project. TSMC also aims for 60% local procurement for its first chip manufacturing facility in Japan by 2030. Despite a severe earthquake in Taiwan, TSMC maintains its annual revenue growth forecast. TSMC stock has gained 59% in the last 12 months, and investors can also gain exposure through VanEck Semiconductor ETF (SMH) and iShares Semiconductor ETF (SOXX).

Portfolio Pulse from Anusuya Lahiri

April 08, 2024 | 12:06 pm

SUPN

Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN) received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for SPN-830, an investigational apomorphine infusion device for Parkinson's disease. The CRL indicates the application is not ready for approval due to issues related to product quality and the master file for the infusion device. Supernus plans to address these issues and resubmit the NDA. No clinical safety or efficacy issues were identified.

Portfolio Pulse from Benzinga Newsdesk

April 08, 2024 | 12:06 pm

AUUD

AUUDW

Auddia Inc. announced the issuance of U.S. Patent 11,935,520 for its core AI technology used in the faidr app, which delivers ad-free AM/FM radio. This patent supports Auddia's AI for Audio platform and marks a significant milestone in securing its proprietary technology. Additionally, Auddia has advanced its provisional patent application for AI improvements in large language models (LLMs) to a non-provisional application, aiming to enhance LLM prompts and create new GPTs with industry-specific expertise.

Portfolio Pulse from Benzinga Newsdesk

April 08, 2024 | 12:04 pm

BIOR

Biora Therapeutics, Inc. (NASDAQ:BIOR) announced the issuance of a new patent by the USPTO for its BioJet platform, which enables oral, systemic delivery of biotherapeutics through liquid jet delivery to the small intestine. The patent covers key parameters for this technology, which has shown promising preclinical results, including systemic bioavailability comparable to subcutaneous injections. Biora's BioJet platform could revolutionize the oral delivery of large molecule drugs, with the company holding a strong patent position in this area.

Portfolio Pulse from Benzinga Newsdesk

April 08, 2024 | 12:02 pm

AMD

BABA

INTC

NVDA

ONLN

PGJ

Alibaba Group Holding Ltd (NYSE:BABA) announced significant price reductions for its cloud services, extending discounts internationally. This follows a price cut in China that sparked a pricing battle with JD.com Inc (NASDAQ:JD). The U.S. has further restricted China's access to advanced AI processors, impacting companies like Alibaba. Despite challenges, Alibaba seeks alternatives and plans to enhance its cloud business. Intel Corp (NASDAQ:INTC) supplied chips to Huawei, countering U.S. sanctions, while Advanced Micro Devices Inc (NASDAQ:AMD) and Nvidia Corp (NASDAQ:NVDA) are also mentioned in the context of U.S. export controls. Alibaba's stock is available through Invesco Golden Dragon China ETF (NASDAQ:PGJ) and ProShares Online Retail ETF (NYSE:ONLN).

Portfolio Pulse from Anusuya Lahiri

April 08, 2024 | 11:55 am

OCGN

Ocugen's stock price increased following the announcement of the U.S. FDA's clearance for an IND amendment, allowing the company to initiate a Phase 3 clinical trial of OCU400.

Portfolio Pulse from Benzinga Newsdesk

April 08, 2024 | 11:47 am

BNO

USO

Iraq plans to resume oil exports to Turkey via the Kirkuk-Ceyhan pipeline, inactive for a decade, with a potential export capacity of 350,000 barrels per day. This development comes amid stalled negotiations with the Kurdistan Regional Government and could significantly impact regional oil exports and the global oil market, which is already facing tight supply and rising demand.

Portfolio Pulse from Benzinga Neuro

April 08, 2024 | 11:34 am