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Regulatory

ADIL

Adial Pharmaceuticals has announced that Boudicca will support and advise the company on its companion diagnostic genetic test to ensure compliance with FDA guidelines.

Portfolio Pulse from Benzinga Newsdesk

August 13, 2024 | 12:30 pm

ADIL

Adial Pharmaceuticals has signed an agreement with Boudicca Dx to advance the regulatory strategy for a companion diagnostics genetic test for AD04.

Portfolio Pulse from Benzinga Newsdesk

August 13, 2024 | 12:30 pm

EVLV

Evolv Technology (NASDAQ:EVLV) has been awarded a patent by the USPTO for its unique weapons detection technology used in its flagship product, Evolv Express. This patent, which classifies objects as threats or non-threats using RF electromagnetic data, adds to Evolv's growing portfolio of over 30 issued patents. The technology is deployed in various public spaces globally.

Portfolio Pulse from Benzinga Newsdesk

August 13, 2024 | 12:14 pm

ENVB

Enveric Biosciences and Aries Science & Technology have announced the issuance of a key U.S. patent for a topical product aimed at treating radiation dermatitis. The patent strengthens Enveric's portfolio and is part of a Licensing Agreement between Enveric's subsidiary Akos Biosciences and Aries. The market opportunity for this treatment is estimated at $400 million annually.

Portfolio Pulse from Benzinga Newsdesk

August 13, 2024 | 12:08 pm

GM

General Motors (GM) is recalling nearly 22,000 Cadillac Lyriq electric SUVs due to a software defect that may cause a loss of braking ability. The recall affects model years 2023-2024 and will be addressed via a software update. No injuries or fatalities have been reported.

Portfolio Pulse from Anan Ashraf

August 13, 2024 | 12:07 pm

URGN

UroGen Pharma announced that the latest Duration of Response (DOR) data is expected to support a New Drug Application (NDA) for UGN-102, targeting low-grade intermediate-risk non-muscle invasive bladder cancer. The company plans to complete the NDA submission soon, with a potential FDA decision as early as Q1 2025, assuming priority review.

Portfolio Pulse from Benzinga Newsdesk

August 13, 2024 | 12:06 pm

CLSK

MARA

RIOT

Marathon Digital Holdings Inc. (NASDAQ:MARA) announced that all Bitcoin blocks mined by its MARA Pool will be labeled 'Made in USA,' following former President Donald Trump's pledge to make the US a global Bitcoin mining hub. This move positions Marathon Digital as the only large-scale miner capable of ensuring all its blocks are mined in the USA. The announcement comes amid increasing global competition in Bitcoin mining, with Russia recently legalizing cryptocurrency mining.

Portfolio Pulse from Aniket Verma

August 13, 2024 | 12:01 pm

CYBN

Cybin has completed an FDA Type B initial breakthrough therapy meeting and plans to initiate a Phase 3 program for CYB003 in treating major depressive disorder by late summer.

Portfolio Pulse from Benzinga Newsdesk

August 13, 2024 | 11:40 am

CYBN

Cybin is set to commence its Phase 3 pivotal program for CYB003 in late summer, following a Type B Initial Breakthrough Therapy meeting with the FDA. The company has selected 30 clinical sites across the US and Europe. In Phase 2, CYB003 showed a 75% remission rate from depression four months after two 16mg doses. Cybin expects to report 12-month efficacy data from Phase 2 in Q4 this year.

Portfolio Pulse from Benzinga Newsdesk

August 13, 2024 | 11:37 am

DIS

INDA

Reliance and Disney have proposed selling some TV channels to gain antitrust approval for their $8.5 billion media merger in India. However, the Indian antitrust body has stated that cricket rights cannot be sold.

Portfolio Pulse from Benzinga Newsdesk

August 13, 2024 | 11:36 am