Streetbeat News

Regulatory

AUTL

Autolus Therapeutics has submitted a Biologics License Application (BLA) to the FDA for obecabtagene autoleucel, a treatment for relapsed/refractory adult B-cell acute lymphoblastic leukemia. The company is also planning to submit an application to the European Medicines Agency in the first half of 2024.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 12:11 pm

FXI

China's Central Bank has announced plans to replenish its monetary policy toolkit and is determined to fend off overshooting risks. Additionally, the bank aims to maintain a basically stable Yuan exchange rate, according to Reuters.

Portfolio Pulse from Charles Gross

November 27, 2023 | 12:10 pm

GMAB

Genmab has been granted FDA Breakthrough Therapy Designation for Epcoritamab, aimed at treating relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. Additionally, the European Medicines Agency has validated an application for Epcoritamab for the same indication.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 12:03 pm

RDHL

RedHill Biopharma has been granted a 5-year US market exclusivity for Talicia by the FDA, with intellectual property protection extending to 2034. This exclusivity enhances the company's competitive position in the market for Talicia, a treatment for Helicobacter pylori infection.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 12:02 pm

KRYS

Krystal Biotech has announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application for VYJUVEK, a treatment for Dystrophic Epidermolysis Bullosa. This validation is a significant step in the regulatory process, indicating that the application is complete and the EMA will now begin its formal review.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 12:02 pm

GNLX

Genelux Corporation has received FDA Fast Track Designation for Olvi-Vec, a treatment for platinum-resistant/refractory ovarian cancer. This designation could expedite the development and review process for Olvi-Vec, potentially bringing it to market more quickly to address an unmet medical need.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 12:01 pm

META

Meta Platforms Inc.'s spokesperson, Andy Stone, has been added to Russia's criminal wanted list, according to Russia's interior ministry website. The specific reasons for Stone's listing are undisclosed. Meta, which owns Facebook, Instagram, and WhatsApp, was declared a 'terrorist and extremist' entity by Moscow last year following Russia's invasion of Ukraine. This has led to increased legal actions against Meta's users in Russia. Social media platforms like Facebook and Instagram are banned in Russia and can only be accessed via VPNs. WhatsApp was fined in Russia for not removing banned content, and a Russian lawmaker proposed a ban on WhatsApp for state institutions.

Portfolio Pulse from Ananya Gairola

November 27, 2023 | 11:32 am

LILM

Lilium N.V. (NASDAQ:LILM), an eVTOL jet developer, has achieved a significant milestone by receiving Design Organization Approval from the European Union Aviation Safety Agency (EASA). This approval positions Lilium as a leading entity in the eVTOL industry in Europe, authorized to hold a type-certificate for such aircraft.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 11:27 am

NUTX

Nutex Health Inc. (NUTX) has received a 180-day extension from Nasdaq to meet the minimum bid price requirement of $1.00. The company must maintain a closing bid price of $1.00 or higher for at least 10 consecutive business days by May 20, 2024, to regain compliance.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 10:36 am

GSK

GSK announced positive results from the DREAMM-7 Phase 3 trial of Belantamab Mafodotin for relapsed or refractory multiple myeloma, meeting its primary endpoint of progression-free survival. The treatment, combined with bortezomib and dexamethasone, showed a significant extension in time to disease progression or death compared to the standard of care, daratumumab with BorDex. Additionally, a notable overall survival trend was observed.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 10:12 am