Streetbeat News

Regulatory

ACLX

The FDA has lifted the partial clinical hold on Arcellx Inc's iMMagine-1 Phase 2 Clinical Program. Analysts from Needham and William Blair remain optimistic about the long-term therapeutic potential of Arcellx's CART-ddBCMA, despite a delay in the timeline for interim data and regulatory submissions. ACLX shares were up 5.8% at $35.65 on the last check Tuesday.

Portfolio Pulse from Vandana Singh

August 15, 2023 | 6:42 pm

GOOG

GOOGL

Alphabet Inc's YouTube has announced a new strategy to combat medical misinformation on its platform. The strategy will focus on three main areas: prevention, treatment, and denial. Content that contradicts widely accepted health advice will be removed. However, some content that breaches the new policy may remain online if it is deemed to be in the public interest.

Portfolio Pulse from Vandana Singh

August 15, 2023 | 6:33 pm

DCTH

Delcath Systems Inc's stock soared by 90% following the FDA's approval of its HEPZATO KIT for liver-directed treatment in certain adult patients. The approval triggers the second tranche of financing tied to a previously announced PIPE financing, potentially bringing in $34.9 million in additional funding. Further, if the company records at least $10 million in quarterly U.S. revenue from the commercialization of HEPZATO KIT, it could receive up to an additional $24.9 million in funding.

Portfolio Pulse from Vandana Singh

August 15, 2023 | 6:25 pm

BIOL

Biolase has been granted a U.S. patent titled 'Dental system and method (including at least one laser, one processor, and one storage medium)'. This could potentially strengthen the company's intellectual property portfolio and provide a competitive edge in the dental equipment market.

Portfolio Pulse from Benzinga Newsdesk

August 15, 2023 | 6:10 pm

MNK

Mallinckrodt is in advanced discussions with various stakeholders about entering into a restructuring support agreement, according to an SEC filing.

Portfolio Pulse from Benzinga Newsdesk

August 15, 2023 | 6:04 pm

BTAI

Mizuho analyst Graig Suvannavejh downgraded BioXcel Therapeutics, Inc. (NASDAQ:BTAI) to Neutral from Buy, lowering the price target to $4 from $40. The downgrade follows BioXcel's Q2 results, which showed a net loss of $53.5 million. The analyst also pushed out the potential launch of BioXcel's drug, Igalmi, from 2025 to 2029, due to the assumption that the FDA will require a second Phase 3 study. Truist Securities analyst Robyn Karnauskas also lowered the price target for BioXcel to $31 from $71.

Portfolio Pulse from Nabaparna Bhattacharya

August 15, 2023 | 6:02 pm

MNK

Trading of Mallinckrodt's shares has been halted due to pending news.

Portfolio Pulse from Benzinga Newsdesk

August 15, 2023 | 5:40 pm

AULT

Ault Alliance has reached a settlement with the SEC, agreeing to pay a civil penalty of $700,000. This penalty was fully accrued in Q4 2022, and the announcement has led to a decrease in the company's share price.

Portfolio Pulse from Benzinga Newsdesk

August 15, 2023 | 5:28 pm

XPEV

Shares of XPeng Inc (XPEV) are trading lower due to weak industrial production and retail sales data for July in China. The People's Bank of China's rate cut, indicating potential economic slowdown, has also impacted the stock. The automotive industry, including XPeng, could face repercussions on sales and growth due to these economic uncertainties.

Portfolio Pulse from Henry Khederian

August 15, 2023 | 4:49 pm

EDBL

Edible Garden has received a grant from the U.S. Department of Agriculture Certification Program, leading to a rise in its share prices.

Portfolio Pulse from Benzinga Newsdesk

August 15, 2023 | 4:26 pm