Streetbeat News

Regulatory

ENSC

Ensysce Biosciences (NASDAQ:ENSC) has received approval from the Investigational Review Board for the PF614-201 protocol, a study designed to confirm the time of onset for pain relief by PF614. The study is a key step towards the full Phase 3 evaluation of PF614, a chemically modified opioid product. The company believes that PF614's features, including its bioequivalence to OxyContin and reduced abuse potential, will make it a game changer for the treatment of severe pain.

Portfolio Pulse from Happy Mohamed

August 08, 2023 | 12:35 pm

SPY

The USA has corrected its export figures to $247.50 billion, slightly higher than the previous figure of $247.10 billion.

Portfolio Pulse from Happy Mohamed

August 08, 2023 | 12:33 pm

JAGX

Jaguar Health's subsidiary, Napo Pharmaceuticals, has received activation from the FDA for its Investigational New Drug (IND) application for Crofelemer, a treatment for Microvillus Inclusion Disease.

Portfolio Pulse from Benzinga Newsdesk

August 08, 2023 | 12:32 pm

SPY

The US trade balance for June was reported at $(65.5B), slightly worse than the estimated $(65B).

Portfolio Pulse from Benzinga Newsdesk

August 08, 2023 | 12:30 pm

AIM

AIM ImmunoTech Inc. has completed enrollment for its Phase 2 study of Ampligen, a potential treatment for post-COVID conditions. The study has enrolled 80 subjects who will receive either Ampligen or a placebo for 12 weeks. The company expects to complete dosing by Q4 2023 and release topline data by Q1 2024. The rapid enrollment pace underscores the urgent need for a therapeutic option to treat Long COVID with chronic fatigue-like symptoms.

Portfolio Pulse from Happy Mohamed

August 08, 2023 | 12:28 pm

IXHL

Incannex Healthcare Ltd's subsidiary, Clarion Clinics Group, has begun accepting registrations of interest for its psychedelic-assisted therapy (PAT) treatments. The first clinic, located in Melbourne, is nearing completion and treatments are expected to commence following final approval of Authorised Psychiatrists by the Therapeutic Goods Administration (TGA). The treatments are aimed at the estimated 390,000 Australians suffering from post-traumatic stress disorder (PTSD) and 280,000 suffering from treatment-resistant depression (TRD).

Portfolio Pulse from Happy Mohamed

August 08, 2023 | 12:22 pm

NVO

Novo Nordisk A/S (NYSE:NVO) released the results from the SELECT cardiovascular outcomes trial, which showed a 20% reduction in major adverse cardiovascular events (MACEs) for people treated with semaglutide 2.4 mg compared to placebo. The trial enrolled 17,604 adults aged 45 years or older with overweight or obesity and established cardiovascular disease with no prior history of diabetes. Novo Nordisk expects to file for regulatory approvals of a label indication expansion for semaglutide 2.4 mg (Wegovy) in the U.S. and the EU in 2023.

Portfolio Pulse from Vandana Singh

August 08, 2023 | 12:20 pm

SPY

Federal Reserve's Harker has expressed optimism about the US economy, stating that he sees the country on the path to a 'soft landing'. He also mentioned the resumption of federal student loan repayments from October 1.

Portfolio Pulse from Benzinga Newsdesk

August 08, 2023 | 12:20 pm

SEAC

SeaChange International, Inc. (NASDAQ:SEAC) has announced its voluntary decision to deregister its common stock with the U.S. Securities and Exchange Commission (SEC) and delist from Nasdaq. The company expects the last trading day of its common stock on Nasdaq to be around August 28, 2023. The decision follows a strategic alternatives process initiated in December 2022, which explored potential transactions to maximize stockholder value. The company believes that delisting will save significant money, which can be used to execute its standalone plan and provide a benefit to the company's stockholders.

Portfolio Pulse from Happy Mohamed

August 08, 2023 | 12:20 pm

COCP

Cocrystal Pharma, Inc. (NASDAQ:COCP) has selected its novel oral protease inhibitor CDI-988 as a potential oral therapy for norovirus. The Phase 1 study of CDI-988 is approved by Australia Human Research Ethics Committees. Norovirus represents a significant unmet medical need with no approved treatments or vaccines. CDI-988 was specifically designed as a broad-spectrum antiviral inhibitor and has shown potent antiviral activity against a panel of pandemic GII.4 norovirus proteases.

Portfolio Pulse from Happy Mohamed

August 08, 2023 | 12:19 pm