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ADIL

Adial Pharmaceuticals has received positive feedback from US and EU regulators regarding the development of AD04, a treatment for Alcohol Use Disorder (AUD). The regulators acknowledged the importance of ongoing research in the AUD therapeutic area and confirmed the primary US endpoint based on Percentage of No Heavy Drinking Days. Adial plans to focus its efforts on the US, as the US standards should translate to acceptance in other international markets. The company expects to register AD04 with the FDA in Q3 of 2025, with the trials costing approximately $25 million in total.

Portfolio Pulse from Happy Mohamed

July 11, 2023 | 12:43 pm

PLTR

Shares of Palantir Technologies Inc (NYSE:PLTR) have risen nearly 90% over the last three months, with the rally accelerating after the company reported better-than-expected quarterly results and guided for continued profitability in each quarter of 2023. The company has seen strong demand for its new AI platform, and its shares are up more than 150% year-to-date. Palantir held its first ever AIPCon in June, where CEO Alex Karp highlighted the unprecedented demand for its AI products.

Portfolio Pulse from Adam Eckert

July 11, 2023 | 12:38 pm

BTTX

CING

DFLI

Cingulate Therapeutics (CING) announced positive results from Phase 3 trial of CTx-1301 for ADHD, causing its stock to surge by 81.5%. Dragonfly Energy (DFLI) partnered with the world's largest teardrop manufacturer to provide full lithium power systems, leading to a 45.8% increase in its stock. Better Therapeutics (BTTX) saw a 24.5% rise in its shares after the FDA approved its AspyreRx prescription-only digital therapeutic treatment for type 2 diabetes.

Portfolio Pulse from Benzinga Newsdesk

July 11, 2023 | 12:38 pm

CING

Cingulate Therapeutics announced positive top-line results from its Phase 3 adult efficacy and safety trial of CTx-1301 for ADHD, leading to a rise in its share prices.

Portfolio Pulse from Benzinga Newsdesk

July 11, 2023 | 12:37 pm

SLRX

Salarius Pharmaceuticals has received FDA clearance for its Investigational New Drug Application for SP-3164. The company will begin a Phase 1 clinical trial in patients with relapsed/refractory Non-Hodgkin Lymphoma. The trial will assess the safety and preliminary efficacy of SP-3164, with patient dosing expected to begin in 2H 2023.

Portfolio Pulse from Benzinga Newsdesk

July 11, 2023 | 12:35 pm

SSKN

STRATA Skin Sciences, Inc. (NASDAQ:SSKN) announced that the Journal of Clinical and Aesthetic Dermatology published a review and an expert perspectives article on its TheraClearX system for the treatment of mild-to-moderate acne. The review highlighted the system's mechanism of action, key features, and clinical outcomes. The expert perspectives article emphasized the device's safety, efficacy, and visible improvement in patients after beginning treatment.

Portfolio Pulse from Happy Mohamed

July 11, 2023 | 12:34 pm

DERM

Journey Medical Corporation has announced that its Phase 3 trials evaluating DFD-29 for the treatment of Papulopustular Rosacea in adults have achieved co-primary and all secondary endpoints.

Portfolio Pulse from Benzinga Newsdesk

July 11, 2023 | 12:33 pm

PCVX

Vaxcyte has advanced to the second stage of its ongoing Phase 2 study evaluating VAX-24 for the prevention of invasive pneumococcal disease in infants. The initiation of Stage 2 was approved by the Independent Data Safety Monitoring Board following a review of Stage 1 safety and tolerability data. The Stage 2 portion of the VAX-24 infant study will include Prevnar 20® (PCV20) as a study comparator. The company expects to announce topline data from the primary immunization series by 2025, followed by topline data from the booster dose approximately nine months later.

Portfolio Pulse from Benzinga Newsdesk

July 11, 2023 | 12:33 pm

PDSB

PDS Biotechnology Corporation (NASDAQ:PDSB) has strengthened its intellectual property portfolio with a new patent allowed in Canada for the combination of Versamune and PDS0301. The patent provides broad protection for treatments utilizing Versamune-based therapies, including PDS0101, in combination with PDS0301 as a potential treatment for cancer. This expands PDS Biotech's market coverage and adds to its worldwide patent portfolio. The company's proprietary combination of Versamune-based PDS0101 and PDS0301 with an immune checkpoint inhibitor resulted in 21 months median overall survival in advanced HPV-positive cancer patients who had failed all prior treatments.

Portfolio Pulse from Happy Mohamed

July 11, 2023 | 12:33 pm

DCFC

Tritium DCFC Limited (NASDAQ:DCFC) has been selected to provide all fast chargers for the first phase of Hawai'i's National Electric Vehicle Infrastructure (NEVI) Formula Program. This makes Tritium the first manufacturer to secure a fast charger order through NEVI program funding. The Federal Highway Administration approved Hawai'i's Electric Vehicle Infrastructure Deployment Plan in September 2022, granting the state access to $2.6 million of NEVI funding in FY2022. The state is expected to receive a total of $17.6 million in funding throughout the duration of the NEVI Formula Program.

Portfolio Pulse from Happy Mohamed

July 11, 2023 | 12:31 pm