Streetbeat News

Regulatory

JAGX

Napo Pharmaceuticals, part of Jaguar Health, Inc. (NASDAQ:JAGX), has announced that top line data from its Phase 3 OnTarget trial for crofelemer, a drug for preventing diarrhea in cancer patients, is forthcoming. The trial results are still blinded to the company and key personnel. The trial's abstract has been accepted for presentation at the San Antonio Breast Cancer Symposium in December 2023. Crofelemer is a plant-based drug approved under FDA botanical guidance, and the trial aims to address the unmet need for treatment of chemotherapy-induced overactive bowel (CIOB).

Portfolio Pulse from Benzinga Newsdesk

November 21, 2023 | 1:33 pm

ABVC

ABVC BioPharma has been granted a U.S. patent for PDC-1421, a treatment for ADHD. The patent application number is 17/120,965. This development could potentially enhance ABVC's intellectual property portfolio and provide a competitive edge in the ADHD treatment market.

Portfolio Pulse from Benzinga Newsdesk

November 21, 2023 | 1:32 pm

WAVD

WaveDancer, Inc. (NASDAQ:WAVD) has regained compliance with NASDAQ's listing requirements after previously failing to meet the minimum bid price and stockholders' equity standards. The company achieved compliance through a reverse stock split and by increasing its stockholders' equity above the required threshold. NASDAQ will monitor WaveDancer for one year, and the upcoming merger with Firefly Neuroscience, Inc. is expected to further impact compliance in Q1 2024.

Portfolio Pulse from Benzinga Newsdesk

November 21, 2023 | 1:24 pm

AVGO

NVDA

VMW

Broadcom Inc (AVGO) and VMware, Inc (VMW) have received all necessary regulatory approvals to close their merger deal, including from China. Despite this, both stocks traded lower in the premarket. The deal is expected to close on November 22, 2023. Broadcom has previously faced concerns over U.S. AI technology embargoes on China, which could affect a third of its revenue from China. Nvidia Corp (NVDA) was also mentioned in relation to U.S. plans to halt shipments of advanced AI chips to China.

Portfolio Pulse from Anusuya Lahiri

November 21, 2023 | 1:21 pm

ORTX

The US FDA has decided not to schedule an advisory committee meeting for Orchard Therapeutics' Biologics License Application for OTL-200, intended to treat Metachromatic Leukodystrophy, according to a recent SEC filing.

Portfolio Pulse from Benzinga Newsdesk

November 21, 2023 | 1:13 pm

INFN

Infinera (NASDAQ:INFN) has been awarded a California Competes grant valued at up to $14 million to expand and modernize its U.S.-based production of next-generation semiconductors. The grant, part of the CHIPS Act initiative, will support Infinera's domestic manufacturing of indium phosphide-based compound semiconductor and monolithic photonic integrated circuit technologies, enhancing America's economic and national security in semiconductor innovation and supply chain resilience.

Portfolio Pulse from Benzinga Newsdesk

November 21, 2023 | 1:07 pm

PLSE

Pulse Biosciences has submitted a 510(k) application to the US FDA for its CellFX nsPFA Percutaneous Electrode, a device that could potentially enhance the company's product offerings in the medical device market.

Portfolio Pulse from Benzinga Newsdesk

November 21, 2023 | 1:04 pm

SATL

Satellogic, a company specializing in high-resolution Earth observation data, has received a license from the National Oceanic and Atmospheric Administration (NOAA) to serve the US government market. This license allows Satellogic to expand its business with US government agencies, potentially increasing its revenue and market presence in the United States.

Portfolio Pulse from Benzinga Newsdesk

November 21, 2023 | 1:04 pm

LABP

Landos Biopharma has published the results of its NX-13 Phase 1b study in patients with ulcerative colitis in the Journal of Crohn's and Colitis. The study's findings are significant for the medical community and Landos Biopharma's development pipeline.

Portfolio Pulse from Benzinga Newsdesk

November 21, 2023 | 1:02 pm

SILO

Silo Pharma Inc (NASDAQ:SILO) has entered into an exclusive license agreement with Medspray Pharma BV for its soft mist nasal spray technology, which will be used for Silo's intranasal drug SPC-15, aimed at treating PTSD, anxiety, Alzheimer's, and anorexia. The technology promises better nasal deposition and reduced systemic absorption, enhancing patient safety and therapeutic delivery. SPC-15, a 5-HT4 receptor agonist, could benefit from the FDA's 505(b)(2) pathway if successful in trials. Silo Pharma is conducting preclinical studies with Columbia University.

Portfolio Pulse from Vandana Singh

November 21, 2023 | 1:00 pm