Streetbeat News

Regulatory

OWLT

Owlet, Inc. (NYSE:OWLT) has announced that the New York Stock Exchange (NYSE) has accepted its business plan to regain compliance with the continued listing standards. The company was previously not in compliance due to its average global market capitalization and stockholders' equity being less than $50 million. The NYSE has given Owlet an 18-month cure period to regain conformity. A 1-for-14 reverse stock split of the Common Stock became effective on July 7, 2023, which the company expects will help it regain compliance with the $1.00 minimum average closing price requirement of the NYSE.

Portfolio Pulse from Happy Mohamed

July 11, 2023 | 12:47 pm

ADCT

ADC Therapeutics SA has voluntarily paused enrollment of new patients in the Phase 2 LOTIS-9 trial evaluating Zynlonta and rituximab in patients with untreated diffuse large B-cell lymphoma. This decision comes after a review of data from the 40 patients enrolled in the trial, which indicated potentially excessive respiratory-related events. The company does not expect to report additional data from the trial by the end of the year. ADCT shares are down 15.60% at $2.00 during the premarket session.

Portfolio Pulse from Vandana Singh

July 11, 2023 | 12:47 pm

CVM

CEL-SCI has reported Phase 3 tumor PD-L1 biomarker data showing increased efficacy of Multikine and its potential for combination with checkpoint inhibitors for head and neck cancer. The company has filed a patent for the use of Multikine in tumors expressing low levels of PD-L1.

Portfolio Pulse from Benzinga Newsdesk

July 11, 2023 | 12:46 pm

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

DWAC

Digital World Acquisition Corp (DWAC) has appointed Eric Swider as the permanent CEO, effective July 6, 2023. The company recently settled an $18 million SEC investigation into its planned merger with Trump Media & Technology Group. Elon Musk welcomed Donald Trump back to Twitter after acquiring it for $44 billion. In April, DWAC appointed Katherine Chiles as CFO, Alexander Cano as President and secretary, and Frank Andrews as the non-executive chairman. DWAC shares are trading 1.26% lower at $13.28 premarket.

Portfolio Pulse from Anusuya Lahiri

July 11, 2023 | 12:40 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

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

BTTX

CRKN

DSS

GDTC

IOVA

VRDN

Several stocks are experiencing significant pre-market movements. CytoMed Therapeutics (GDTC) surged 109.2% after a 9% gain on Monday. Better Therapeutics (BTTX) gained 51.1% following FDA approval of its AspyreRx treatment. Crown ElectroKinetics (CRKN) rose 42.2% after a 14% decline on Monday. On the downside, DSS, Inc. (DSS) fell 17.1% after naming a new Chief Investment Officer. Viridian Therapeutics (VRDN) fell 14.4% after announcing trial data, and Iovance Biotherapeutics (IOVA) fell 12.5% after pricing its public offering.

Portfolio Pulse from Lisa Levin

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