Streetbeat News

Regulatory

SNGX

Soligenix has reached an agreement with the European Medicines Agency (EMA) on the design of a second confirmatory placebo-controlled trial for HyBryte, a treatment under development.

Portfolio Pulse from Benzinga Newsdesk

April 03, 2024 | 11:31 am

GKOS

The U.S. Centers for Medicare and Medicaid Services has assigned a unique, permanent J-code for Glaukos' iDose TR (Travoprost Intracameral Implant) 75 mcg, aimed at reducing intraocular pressure. This development is significant for Glaukos as it facilitates billing and reimbursement processes for their product, potentially increasing its accessibility and usage.

Portfolio Pulse from Benzinga Newsdesk

April 03, 2024 | 11:25 am

AAPL

Apple Inc. has released the first beta version of iOS 17.5, allowing users in the European Union to download apps directly from developer websites, in compliance with the EU's Digital Markets Act. This update follows Apple's previous adaptations to the EU's app distribution regulations, including app sideloading and direct web downloads under specific conditions. Developers eligible for this feature must meet certain criteria and will be charged a €0.50 Core Technology Fee per download, bypassing Apple's commission.

Portfolio Pulse from Rounak Jain

April 03, 2024 | 11:11 am

KTRA

Kintara Therapeutics (KTRA) and TuHURA Biosciences have agreed to merge in an all-stock transaction. TuHURA plans to advance a Phase 3 trial for its IFx-2.0 personalized cancer vaccine with Keytruda for advanced Merkel cell carcinoma in 2H 2024, aiming for FDA's accelerated approval. The merger includes a $31 million financing for TuHURA, expected to extend its cash runway into late 2025. TuHURA's bifunctional Antibody Drug Conjugates (ADCs) also present potential partnering opportunities.

Portfolio Pulse from Benzinga Newsdesk

April 03, 2024 | 11:07 am

LENZ

Lenz Therapeutics announced positive Phase 3 CLARITY study results for two formulations of Aceclidine, LNZ100 and LNZ101, for Presbyopia. LNZ100, now the lead candidate, showed 71% of participants achieving significant vision improvement at 3 hours, with effects starting at 30 minutes and lasting up to 10 hours. A New Drug Application submission is anticipated in mid-2024.

Portfolio Pulse from Benzinga Newsdesk

April 03, 2024 | 11:07 am

VNDA

Vanda Pharmaceuticals' Fanapt received FDA approval for the acute treatment of bipolar I disorder, leading to a rise in VNDA shares.

Portfolio Pulse from Benzinga Newsdesk

April 03, 2024 | 11:05 am

CANF

Can-Fite BioPharma Ltd. has submitted an IND application to the FDA for a Phase IIb clinical trial of Namodenoson in MASH patients, aiming to address metabolic dysfunction-associated steatohepatitis (NASH).

Portfolio Pulse from Benzinga Newsdesk

April 03, 2024 | 11:03 am

INFU

InfuSystem received a notice from NYSE American for the late filing of its annual report on Form 10-K. The company aims to regain compliance with the Exchange's listing standards, but there's no guarantee of achieving this.

Portfolio Pulse from Benzinga Newsdesk

April 03, 2024 | 10:33 am

FXI

China's Central Bank Monetary Policy Committee announced it will meet the reasonable financing demands of real estate enterprises, irrespective of their ownership types, according to Reuters.

Portfolio Pulse from Charles Gross

April 03, 2024 | 9:13 am

FXI

China's Central Bank Monetary Policy Committee has committed to correcting pro-cyclical behavior and preventing the risk of exchange rate overshooting, according to Reuters.

Portfolio Pulse from Charles Gross

April 03, 2024 | 9:12 am