Streetbeat News

Regulatory

IMAB

I-Mab and HI-Bio have announced that the FDA has granted Breakthrough Therapy Designation for Felzartamab for the treatment of primary membranous nephropathy. This could potentially expedite the development and review process for the drug.

Portfolio Pulse from Benzinga Newsdesk

November 02, 2023 | 12:13 pm

VXRT

Vaxart has begun dosing the first subject in a Phase 1 trial of its Norovirus vaccine candidate in lactating mothers. This marks a significant step in the development of the vaccine.

Portfolio Pulse from Benzinga Newsdesk

November 02, 2023 | 12:12 pm

OCUP

Ocuphire Pharma has announced a successful end-of-Phase 2 meeting with the FDA for oral APX3330 in Diabetic Retinopathy. The company and the FDA have agreed on the Phase 3 primary endpoint.

Portfolio Pulse from Benzinga Newsdesk

November 02, 2023 | 12:10 pm

OTLK

Outlook Therapeutics has been informed by the FDA that an additional adequate and well-controlled clinical trial will be required for the approval of ONS-5010 for the treatment of wet AMD.

Portfolio Pulse from Benzinga Newsdesk

November 02, 2023 | 12:08 pm

AMGN

Amgen has presented new data for its drug Krystexxa (Pegloticase) at the American Society Of Nephrology Kidney Week. The data shows a decrease in blood pressure during treatment in chronic gout refractory patients to oral urate-lowering treatment, both with and without chronic kidney disease.

Portfolio Pulse from Benzinga Newsdesk

November 02, 2023 | 12:07 pm

AUVI

Applied UV has secured a new patent approval from the USPTO for an interchangeable drain disinfecting device. The device is currently undergoing validation at Mt Sinai Hospital.

Portfolio Pulse from Benzinga Newsdesk

November 02, 2023 | 12:02 pm

PYPL

PayPal has received a subpoena from the SEC's Division of Enforcement related to its USD Stablecoin. The SEC has requested the production of documents, according to an SEC filing.

Portfolio Pulse from Benzinga Newsdesk

November 02, 2023 | 12:00 pm

INTS

Intensity Therapeutics presented safety, tolerability, and efficacy data from its ongoing Phase 1/2 trial of INT230-6 in relapsed, refractory, and metastatic sarcomas at the Connective Tissue Oncology Society 2023 Annual Meeting.

Portfolio Pulse from Benzinga Newsdesk

November 02, 2023 | 11:48 am

TRVI

Trevi Therapeutics has initiated its Phase 2A RIVER trial of Haduvio in refractory chronic cough patients. The topline data from this trial is expected to be released in the second half of 2024.

Portfolio Pulse from Benzinga Newsdesk

November 02, 2023 | 11:46 am

ACXP

Acurx Pharmaceuticals announced top-line results from Phase 2 trials of Ibezapolstat, showing a 96% clinical cure rate in patients with C. difficile infection. The drug was well tolerated with no serious adverse events reported. Further analyses are forthcoming, and preparations are underway for an End-of-Phase 2 FDA meeting and advancement to Phase 3. Despite the positive results, Acurx's shares experienced a selloff.

Portfolio Pulse from Charles Gross

November 02, 2023 | 11:45 am