Streetbeat News

Regulatory

BGNE

Luye has announced that its Goserelin Microspheres for injection has received approval from China's National Medical Products Administration for treating breast cancer. The company is partnering with Beigene Ltd to commercialize the product in mainland China.

Portfolio Pulse from Benzinga Newsdesk

September 11, 2023 | 12:50 pm

BLRX

CRNX

NBY

Crinetics' Paltusotine achieved all endpoints in Phase 3 study, potentially boosting CRNX's stock. NovaBay Pharmaceuticals announced an agreement with BioStem Technologies to commercialize Avenova® Allograft, which could positively impact NBY's stock. BioLineRx received FDA approval for APHEXDA™ in combination with Filgrastim for patients with Multiple Myeloma, which may increase BLRX's stock.

Portfolio Pulse from ryanfaloona@benzinga.com

September 11, 2023 | 12:48 pm

AAPL

BTCUSD

ETHUSD

SPY

TSLA

The S&P 500 and Nasdaq are expected to bounce back due to the strength of Tesla and Apple. Analysts predict a positive year-end without 'too much damage'. Cryptocurrencies such as Bitcoin, Ethereum, and Dogecoin are falling as investors await key inflation numbers. Tesla and Apple stocks are moving higher in the pre-market session. Meanwhile, Coinbase CEO calls for the removal of Gary Gensler from SEC, and Apple's value plummets by $190B in two days.

Portfolio Pulse from Akanksha Bakshi

September 11, 2023 | 12:44 pm

DAWN

Day One Biopharmaceuticals has announced updated data for its FIREFLY-1 study of Tovorafenib, a treatment for relapsed or progressive pediatric low-grade glioma. The data shows an overall response rate of over 50%, with a median duration of treatment of 15.8 months.

Portfolio Pulse from Benzinga Newsdesk

September 11, 2023 | 12:36 pm

DAWN

Day One Biopharmaceuticals has submitted a rolling New Drug Application (NDA) to the FDA for Tovorafenib, a treatment for relapsed or progressive pediatric low-grade glioma. The company expects the FDA to file the application by mid-November.

Portfolio Pulse from Benzinga Newsdesk

September 11, 2023 | 12:35 pm

PRFX

Painreform has announced plans to commence the second part of its Phase 3 clinical trial for PRF-110 in patients undergoing bunionectomy surgery. The trial is expected to start in mid-Q4 2023, with results anticipated in mid-2024. This follows a review of the Drug Master File by the FDA.

Portfolio Pulse from Benzinga Newsdesk

September 11, 2023 | 12:32 pm

BLRX

The FDA has approved BioLineRx's Aphexda plus filgrastim for use in mobilizing hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in multiple myeloma patients. This has led to an increase in the company's share price.

Portfolio Pulse from Benzinga Newsdesk

September 11, 2023 | 12:32 pm

GENE

Genetic Technologies has received approval in Australia for its Genetype tests for pancreatic cancer, melanoma, and atrial fibrillation, according to an 8K filing.

Portfolio Pulse from Benzinga Newsdesk

September 11, 2023 | 12:17 pm

BB

BlackBerry has launched an 'Intrinsically Safe' certified solution for hazardous materials carriers. This comes amid increased regulatory scrutiny of the rail industry following several high-profile safety incidents.

Portfolio Pulse from Benzinga Newsdesk

September 11, 2023 | 12:17 pm

APRE

Aprea Therapeutics has announced updated preclinical data for ATRN-1051, a potential therapy for ovarian cancer. The company suggests that the selective properties of ATRN-1051 may make it more effective than other Wee1 inhibitors currently in development. Aprea anticipates submitting an Investigational New Drug (IND) application by the end of 2023.

Portfolio Pulse from Benzinga Newsdesk

September 11, 2023 | 12:14 pm