Streetbeat News

Regulatory

TSHA

Taysha Gene Therapies has announced that the second patient has been dosed with TSHA-102 in the REVEAL Phase 1/2 adult trial for the treatment of Rett syndrome. The company expects to complete enrollment in the low-dose cohort in Q4 2023 and to dose the first pediatric patient in Q1 2024. The FDA has cleared the Investigational New Drug application for TSHA-102 in pediatric patients, and the company has submitted a Clinical Trial Application to the UK's MHRA.

Portfolio Pulse from Benzinga Newsdesk

September 26, 2023 | 12:04 pm

PHAT

Phathom Pharmaceuticals has announced the submission of a New Drug Application (NDA) for Vonoprazan for the treatment of non-erosive gastroesophageal reflux disease (GERD).

Portfolio Pulse from Bill Haddad

September 26, 2023 | 12:02 pm

ONCY

Oncolytics Biotech, Inc. (NASDAQ:ONCY) has been selected by the Pancreatic Cancer Action Network (PanCAN) to receive a $5 million Therapeutic Accelerator Award. The award is in recognition of Oncolytics' work on pelareorep, an investigational immunotherapy treatment for pancreatic cancer. The grant will fund the next stage of research, which includes a clinical trial of pelareorep in combination with modified FOLFIRINOX chemotherapy. If successful, the treatment may advance to late-stage clinical development through the PanCAN Precision Promise adaptive clinical trial platform.

Portfolio Pulse from Benzinga Newsdesk

September 26, 2023 | 12:02 pm

TSLA

VGK

Tesla Inc. is under investigation by the European Union for potentially benefiting from Chinese subsidies. The probe was initiated after evidence suggested that Tesla, among other companies, may have benefited from these subsidies. This could lead to levies aimed at offsetting the subsidies.

Portfolio Pulse from Benzinga Newsdesk

September 26, 2023 | 11:54 am

TSLA

Tesla, Inc. (NASDAQ:TSLA) shares are expected to drop due to demand concerns and EU regulatory scrutiny. The stock slipped 1.17% to $244.10 in premarket data. Weekly China car insurance registrations for Tesla fell short of the Q2 record. Tesla is expected to report lower-than-expected Q3 deliveries next week. EU regulators are investigating Chinese subsidies benefiting Tesla and other domestic EV manufacturers.

Portfolio Pulse from Shanthi Rexaline

September 26, 2023 | 11:46 am

EW

VGK

Edwards Lifesciences, a cardiovascular medical device company, was reportedly targeted in an EU antitrust raid on September 19, causing its shares to fall.

Portfolio Pulse from Charles Gross

September 26, 2023 | 11:41 am

ABEO

Abeona Therapeutics has submitted a Biologics License Application to the FDA for approval of EB-101, a treatment for Recessive Dystrophic Epidermolysis Bullosa.

Portfolio Pulse from Benzinga Newsdesk

September 26, 2023 | 11:40 am

BYDDY

HYMTF

KIMTF

Hyundai Motor Co and Kia Corp plan to reduce the prices of several electric vehicles (EVs) in response to the South Korean government's decision to expand subsidies for clean vehicles. The price cuts, which will affect models such as the Ioniq 5, Ioniq 6, Kona EV, EV6, Niro EV, and Niro Plus, are set to begin next month and last until the end of 2023. This move could intensify the price competition in the South Korean automotive industry and potentially increase international tension surrounding EV pricing.

Portfolio Pulse from Shivani Kumaresan

September 26, 2023 | 11:39 am

AAPL

EWQ

Apple has released a software update for the iPhone 12, but it is currently only available in France, according to Belgian Telecom Regulator BIPT. The impact on Apple's stock and the France ETF (EWQ) is yet to be determined.

Portfolio Pulse from Charles Gross

September 26, 2023 | 11:37 am

SPY

XHB

The US Commerce Department has revised August building permits to a 6.8% increase from the previously reported 6.9%. The annual rate has been adjusted to 1.541 million units from 1.543 million units.

Portfolio Pulse from Charles Gross

September 26, 2023 | 11:36 am