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Regulatory

CANF

Can-Fite Biopharma announced that its Phase 3 study for Namodenoson, a treatment for advanced liver cancer, is now recruiting at 31 medical centers. Namodenoson has received Orphan Drug status from both the FDA and the European Medicines Agency, as well as FDA Fast Track status. Additionally, a compassionate use program is ongoing in Israel and Romania.

Portfolio Pulse from Benzinga Newsdesk

June 05, 2024 | 11:18 am

ESTA

The FDA's Center for Devices and Radiological Health has completed its review of Establishment Labs' premarket approval application for Motiva Implants. The application is deemed approvable pending an acceptable FDA inspection of the manufacturing facilities, which has been rescheduled to occur within the next thirty days.

Portfolio Pulse from Benzinga Newsdesk

June 05, 2024 | 11:13 am

ACET

Adicet Bio shares are trading higher after the company was granted FDA Fast Track Designation to ADI-001 in lupus nephritis.

Portfolio Pulse from Benzinga Newsdesk

June 05, 2024 | 11:07 am

ACET

Adicet Bio announced that the FDA has granted Fast Track Designation to ADI-001 for the treatment of relapsed/refractory Class III or Class IV Lupus Nephritis. This designation aims to expedite the development and review of drugs for serious conditions with unmet medical needs.

Portfolio Pulse from Benzinga Newsdesk

June 05, 2024 | 11:04 am

BMY

IMAB

I-Mab has entered a clinical collaboration with Bristol Myers Squibb to evaluate the combination of givastomig, an investigational bispecific antibody, with nivolumab and chemotherapy for treating advanced Claudin 18.2-positive gastric and esophageal cancers. The study will be a multi-national Phase 1 trial conducted by I-Mab, with Bristol Myers Squibb supplying nivolumab.

Portfolio Pulse from Benzinga Newsdesk

June 05, 2024 | 11:02 am

IMMP

Trading halt status for IMMP was updated at 7:00:00 AM ET. The halt was due to news and resumption times.

Portfolio Pulse from Benzinga Newsdesk

June 05, 2024 | 11:00 am

ITRG

Integra Resources announced that the Mine Plan of Operations for the Delamar and Florida Mountain Project has met the content requirements of the US Code of Federal Regulations Title 43 Subpart 3809, as confirmed by the US Bureau of Land Management.

Portfolio Pulse from Benzinga Newsdesk

June 05, 2024 | 10:35 am

MNOV

MediciNova has received a Notice of Allowance from the US Patent and Trademark Office for a pending patent application covering MN-166 (Ibudilast) for the prevention of metastasis in various cancers.

Portfolio Pulse from Benzinga Newsdesk

June 05, 2024 | 10:02 am

TSLA

Tesla Inc (NASDAQ:TSLA) will halt production for five days in June at its Berlin gigafactory to implement efficiency upgrades. This is the third production halt this year, following an arson attack in March and a one-day shutdown in May due to protests. Despite these interruptions, Tesla plans to expand the factory's capacity significantly.

Portfolio Pulse from Anan Ashraf

June 05, 2024 | 10:02 am

NVX

Trading for NVX has been halted as of 3:58:13 a.m. ET due to pending news. Investors should stay tuned for further updates.

Portfolio Pulse from Benzinga Newsdesk

June 05, 2024 | 7:58 am