Streetbeat News

Regulatory

TCBP

TC Biopharm's stock price has risen following the announcement that the FDA has cleared the Phase 1B Investigational New Drug (IND) application for TCB-008, a treatment for Acute Myeloid Leukemia.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 2:47 pm

EIS

Talks of extending the truce between Israel and Hamas are underway, with international support. 58 hostages have been released, and the fate of additional American hostages in Gaza is uncertain. Elon Musk visited an Israeli kibbutz attacked by Hamas and agreed not to activate Starlink over Gaza without Israel's approval. Israeli stocks are slightly down, while the shekel is up. The iShares MSCI Israel ETF (EIS) is expected to resume trading after a four-week winning streak.

Portfolio Pulse from Piero Cingari

November 27, 2023 | 2:36 pm

PLSE

Pulse Biosciences announced it has received all necessary regulatory approvals and completed required activities to begin its planned catheter ablation feasibility study, with the first procedures scheduled for mid-December 2023.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 2:21 pm

RDHL

Redhill Biopharma's stock is trading higher following the announcement that the FDA has granted Talicia five years of market exclusivity.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 2:17 pm

REGN

SNY

Regeneron Pharmaceuticals Inc and Sanofi SA announced positive results from the second Phase 3 trial (NOTUS) of Dupixent for treating COPD, showing significant reduction in exacerbations and improvements in lung function. The EMA is reviewing Dupixent for COPD, and the companies plan to submit trial data to the FDA by year-end. Interim analysis results will be the primary analysis for the trial. Sanofi also plans to spin off its consumer healthcare business to focus on innovative medicines and vaccines. REGN shares closed at $798.30, and SNY stock is up 0.89% at $47.60 in premarket trading.

Portfolio Pulse from Vandana Singh

November 27, 2023 | 2:17 pm

RDHL

RedHill Biopharma Ltd's stock (NASDAQ:RDHL) surged over 100% after the FDA granted five years' market exclusivity for its gastrointestinal drug Talicia under the GAIN Act QIDP designation. Talicia, a treatment for H. pylori infection, also received approval for a more flexible dosing regimen. The drug is protected by intellectual property until 2034, adding to its three years' exclusivity for FDA approval under section 505(b)(2).

Portfolio Pulse from Vandana Singh

November 27, 2023 | 2:15 pm

BDRX

Biodexa has entered into agreements to acquire an exclusive worldwide license for Tolimidone, a drug that is ready to enter Phase II trials for the treatment of Type 1 Diabetes.

Portfolio Pulse from Bill Haddad

November 27, 2023 | 2:10 pm

TSLA

Tesla, Inc (NASDAQ:TSLA) may face a ban on selling its 'full self-driving' technology in the UK as the Department for Transport plans to introduce new laws. These laws will prevent the use of terms like 'self-drive' unless vehicles meet strict standards. The Automated Vehicles Bill, expected by 2024, aims to regulate marketing to avoid misleading consumers. Tesla's 'full self-driving' feature, which requires driver monitoring, is unlikely to meet these criteria. The company has been selling this feature globally, but it's only active in North America. Tesla has been promoting 'Full Self-Driving Capability' since 2016 and charges for it in the UK, despite it not being activated. Tesla is preparing to launch its self-driving systems in the UK and Europe but faces legal challenges. In the US, Tesla's Autopilot and Full Self-Driving systems have been under investigation due to accidents. TSLA shares were up 0.34% in premarket trading.

Portfolio Pulse from Anusuya Lahiri

November 27, 2023 | 2:10 pm

AIM

AIM ImmunoTech has been granted two US patents, one for 'Compositions for cancer therapy and methods' and another for 'Methods for improving exercise tolerance in myalgic encephalomyelitis patients'. These patents could potentially enhance the company's intellectual property portfolio and provide a competitive edge in the development of treatments for cancer and myalgic encephalomyelitis.

Portfolio Pulse from Bill Haddad

November 27, 2023 | 2:06 pm

ANIX

Anixa Biosciences, Inc. (NASDAQ:ANIX) announced that the European Patent Office intends to grant a patent for its ovarian cancer vaccine technology, which was developed in partnership with Cleveland Clinic. The technology, which targets AMHR2-ED expressed in ovarian cancers, has already been granted a U.S. patent and is being developed with the collaboration of the National Cancer Institute's PREVENT program.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 1:44 pm