Streetbeat News

Products Services

TRDA

Entrada Therapeutics presented positive clinical and preclinical data at the World Muscle Society Congress, supporting its Duchenne franchise. The data reinforces the safety of ENTR-601-44 and supports upcoming regulatory filings for Phase 2 trials.

Portfolio Pulse from Benzinga Newsdesk

October 09, 2024 | 11:15 am

KYMR

Kymera Therapeutics has received FDA clearance for its investigational new drug application for KT-621. The company plans to start a Phase 1 trial in October 2024 and expects to report data in the first half of 2025.

Portfolio Pulse from Benzinga Newsdesk

October 09, 2024 | 11:13 am

ALNY

Alnylam Pharmaceuticals has submitted a supplemental New Drug Application to the FDA for Vutrisiran, targeting ATTR amyloidosis with cardiomyopathy. This submission could potentially expand the use of Vutrisiran, impacting Alnylam's market position.

Portfolio Pulse from Benzinga Newsdesk

October 09, 2024 | 11:10 am

UNCY

Unicycive Therapeutics has completed the Phase 1 study of UNI-494 in healthy volunteers. The results will guide the dosing and scheduling for a potential Phase 2 trial targeting acute kidney injury.

Portfolio Pulse from Benzinga Newsdesk

October 09, 2024 | 11:08 am

VKTX

Viking Therapeutics announced positive results from its Phase 1b trial of VK0214 in patients with X-linked adrenoleukodystrophy. The trial showed VK0214 to be safe and well-tolerated, with significant reductions in plasma levels of very long-chain fatty acids and other lipids compared to placebo.

Portfolio Pulse from Benzinga Newsdesk

October 09, 2024 | 11:07 am

VTRS

Viatris announced successful topline results from its Phase 3 study in Japan, evaluating Effexor (Venlafaxine) for treating generalized anxiety disorder in adults. The study met its primary objective, demonstrating superior anxiolytic effects compared to a placebo at 8 weeks.

Portfolio Pulse from Benzinga Newsdesk

October 09, 2024 | 11:04 am

NVAX

Novavax announced that the European Commission has granted marketing authorization for its updated 2024-2025 Nuvaxovid COVID-19 vaccine. This follows a positive opinion from the EMA's Committee for Medicinal Products for Human Use.

Portfolio Pulse from Benzinga Newsdesk

October 09, 2024 | 11:03 am

CANF

The FDA has granted Orphan Drug Designation to Can-Fite Biopharma's Namodenoson for the treatment of pancreatic cancer. This designation is significant as it provides certain benefits to the company, including market exclusivity and potential tax credits.

Portfolio Pulse from Benzinga Newsdesk

October 09, 2024 | 11:02 am

PLL

Piedmont Lithium has received a Mine Operating Permit from the Minerals Commission of Ghana for the Ewoyaa Lithium Project, a joint venture in Ghana.

Portfolio Pulse from Benzinga Newsdesk

October 09, 2024 | 10:55 am

CLSD

Clearside Biomedical's ODYSSEY Phase 2b trial of CLS-AX for neovascular age-related macular degeneration achieved its primary and secondary outcomes, maintaining stable visual acuity and anatomical control over 9 months with a positive safety profile. 67% of participants did not require additional treatment for up to 6 months, reducing treatment burden by 84%.

Portfolio Pulse from Benzinga Newsdesk

October 09, 2024 | 10:36 am