Streetbeat News

Regulatory

OCGN

Ocugen has announced an update from its Phase 1/2 trial of OCU400, with 83% of subjects showing stabilization or improvement in the treated eye. The study also demonstrated a 'favorable safety and tolerability profile'.

Portfolio Pulse from Bill Haddad

September 13, 2023 | 12:17 pm

INFI

Infinity Pharmaceuticals has received a delisting determination letter from Nasdaq. The company's stock will be suspended on September 14, unless it requests a review of this decision. However, the company does not plan to request a review.

Portfolio Pulse from Benzinga Newsdesk

September 13, 2023 | 12:16 pm

AWH

Aspira Women's Health has regained compliance with the Nasdaq Stock Market's requirement for the market value of listed securities. The company received a written notice from Nasdaq confirming this.

Portfolio Pulse from Benzinga Newsdesk

September 13, 2023 | 12:13 pm

AKLI

Akili Interactive Labs has announced its plan to transition to a non-prescription business model. The company intends to pursue regulatory approval for over-the-counter (OTC) labeling of its products.

Portfolio Pulse from Bill Haddad

September 13, 2023 | 12:02 pm

TAK

The FDA has accepted Takeda's Biologics License Application (BLA) for the subcutaneous administration of ENTYVIO, a maintenance therapy for moderately to severely active Crohn's disease.

Portfolio Pulse from Bill Haddad

September 13, 2023 | 12:01 pm

BABA

FXI

KWEB

Alibaba Group Holding Limited (BABA) stock traded lower in line with broader indexes iShares China Large-Cap ETF (FXI) and KraneShares Trust KraneShares CSI China Internet ETF (KWEB). Alibaba announced plans to offer public access to its AI model Tongyi Qianwen, indicating regulatory approval. The company also announced a leadership change in its cloud business, with Eddie Wu taking over as interim Chair and CEO.

Portfolio Pulse from Anusuya Lahiri

September 13, 2023 | 12:01 pm

VIRT

Virtu Financial, Inc. (NASDAQ:VIRT) is being sued by the U.S. Securities and Exchange Commission (SEC) over allegations of false and misleading disclosures relating to customer information barriers. The SEC alleges that Virtu's database was accessible to practically anyone, including proprietary traders, through generic usernames and passwords. Virtu believes the SEC's actions are politically motivated and plans to defend itself in court.

Portfolio Pulse from Nabaparna Bhattacharya

September 13, 2023 | 11:42 am

AMGN

CVS

MDT

Three health care stocks with over 3% dividend yields have been recommended by Wall Street's most accurate analysts. These include Amgen Inc. (NASDAQ:AMGN) with a dividend yield of 3.28%, Medtronic plc (NYSE:MDT) with a yield of 3.39%, and CVS Health Corporation (NYSE:CVS) with a yield of 3.52%. Recent news for these companies include FTC approval for Amgen's acquisition of Horizon Therapeutics Plc, FDA's recommendation against the approval of Medtronic's blood pressure treatment device, and FDA's warning to CVS Health for violating federal law.

Portfolio Pulse from Lisa Levin

September 13, 2023 | 11:35 am

OCUL

Ocular Therapeutix has submitted a request for Special Protocol Assessment to the FDA. The request is to determine whether the protocol for the first of two planned OTX-TKI pivotal trials in Wet AMD could support marketing approval.

Portfolio Pulse from Charles Gross

September 13, 2023 | 11:13 am

ALNY

Shares of Alnylam Pharmaceuticals have been halted ahead of the FDA Cardiovascular and Renal Drugs Advisory Committee meeting on the supplemental New Drug Application (sNDA) for Onpattro.

Portfolio Pulse from Charles Gross

September 13, 2023 | 10:59 am