Streetbeat News

Regulatory

ADIL

Adial Pharmaceuticals (NASDAQ:ADIL) reported its Q2 2023 financial results, revealing a cash position of $1.2M, down from $4M at the end of 2022. The company received positive feedback from US and EU regulatory meetings and is planning to conduct two Phase 3 trials with AD04. The sale of Purnovate significantly reduced the company's cash burn rate. Adial also received an upfront payment of $450K from Adovate, LLC for the purchase of Purnovate's assets and business, with potential for up to $83M in total consideration.

Portfolio Pulse from Happy Mohamed

August 21, 2023 | 12:32 pm

GILD

Gilead Sciences has announced a partial clinical hold for its Magrolimab studies in Acute Myeloid Leukemia (AML). However, patients already enrolled may continue receiving the study medicine and studies in solid tumors remain unaffected.

Portfolio Pulse from Benzinga Newsdesk

August 21, 2023 | 12:31 pm

PHAT

Phathom Pharmaceuticals has submitted six-month stability data for its Erosive GERD New Drug Application (NDA) for vonoprazan. The data remains more than 10x below the acceptable intake limit set by the FDA, supporting the requested product shelf life. This submission satisfies Phathom's stability data submission requirements for the NDA, with a PDUFA goal date of November 17, 2023.

Portfolio Pulse from Benzinga Newsdesk

August 21, 2023 | 12:14 pm

ENVB

Enveric Biosciences (NASDAQ:ENVB) has completed the manufacturing of its drug material, EB-373, enabling the completion of preclinical work. The company will now commence remaining GLP studies to provide data required to initiate human trials for EB-373. The company expects to complete all remaining preclinical studies required for Human Research Ethics Committee (HREC) submission in Australia before the end of 2023. The high purity of EB-373 allows Enveric and its partners to handle and ship the drug without restrictions required for controlled substances.

Portfolio Pulse from Happy Mohamed

August 21, 2023 | 12:13 pm

STRW

Strawberry Fields REIT, Inc. has filed a registration statement with the U.S. Securities and Exchange Commission (SEC) for a proposed underwritten public offering. The timing, number of shares, and price range for the offering have not yet been determined and will depend on market conditions. The registration statement has not yet been declared effective by the SEC.

Portfolio Pulse from Happy Mohamed

August 21, 2023 | 12:10 pm

ANEB

Anebulo Pharmaceuticals has received positive feedback from the FDA regarding the advancement of Phase 3 clinical development of ANEB-001. The company has also completed dosing of Phase 2 extension.

Portfolio Pulse from Benzinga Newsdesk

August 21, 2023 | 12:04 pm

AVGO

VMW

Vmware's acquisition by Broadcom has achieved significant regulatory milestones, leading to a rise in Vmware's share prices.

Portfolio Pulse from Benzinga Newsdesk

August 21, 2023 | 12:03 pm

GERN

The FDA has accepted Geron Corporation's new drug application for Imetelstat, a treatment for lower risk Myelodysplastic Syndromes (MDS).

Portfolio Pulse from Benzinga Newsdesk

August 21, 2023 | 12:02 pm

EDBL

Edible Garden has received a notice of allowance for a US patent for its self-watering display. The company's innovative technology could potentially revolutionize the way plants are grown and maintained, providing a significant competitive advantage.

Portfolio Pulse from Benzinga Newsdesk

August 21, 2023 | 12:01 pm

FXI

SPY

China's Premier Li Keqiang has announced that China will continue to expand market access and comprehensively optimize its business environment, according to Reuters. This could potentially impact US-listed ETFs such as FXI and SPY.

Portfolio Pulse from Charles Gross

August 21, 2023 | 11:43 am