Streetbeat News

Regulatory

GNPX

Genprex has received Fast Track designation from the FDA for its small cell lung cancer drug candidate. This could potentially expedite the drug's development and review process.

Portfolio Pulse from Benzinga Newsdesk

July 11, 2023 | 1:16 pm

PULM

Pulmatrix, Inc. (NASDAQ:PULM) has submitted an investigational new drug (IND) application to the FDA for PUR3100, a drug under development to treat acute migraine. The drug uses Pulmatrix's proprietary dry powder delivery technology, iSPERSE™. The IND includes a Phase 2 clinical protocol to investigate the safety and preliminary efficacy of PUR3100 in patients with acute migraine. Phase 1 study data showed similar pharmacokinetics to intravenous DHE with fewer side effects.

Portfolio Pulse from Happy Mohamed

July 11, 2023 | 1:06 pm

BAC

The Consumer Financial Protection Bureau (CFPB) has ordered Bank of America (NYSE:BAC) to pay over $100 million for illegal practices including charging junk fees, withholding credit card rewards, and opening unauthorized accounts. The bank will pay $90 million in penalties to the CFPB and $60 million to the Office of the Comptroller of the Currency (OCC). This is not the first time Bank of America has faced such enforcement action.

Portfolio Pulse from Happy Mohamed

July 11, 2023 | 1:00 pm

ANIX

Anixa Biosciences, Inc. (NASDAQ:ANIX) has been granted a Canadian patent for its Chimeric Antigen Receptor-T cell (CAR-T) cancer treatment technology. The technology, which is currently being evaluated for the treatment of ovarian cancer in a Phase 1 clinical trial, has been licensed from The Wistar Institute and is being developed in partnership with Moffitt Cancer Center. The patent covers a nucleic acid that encodes a chimeric protein used to treat certain types of cancer.

Portfolio Pulse from Happy Mohamed

July 11, 2023 | 12:51 pm

USO

The Saudi Cabinet has reaffirmed its commitment to bolster OPEC+ precautionary measures to stabilize oil markets, according to Reuters. This could potentially impact the United States Oil Fund (USO).

Portfolio Pulse from Benzinga Newsdesk

July 11, 2023 | 12:50 pm

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