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Regulatory

AKRO

Akero Therapeutics announced that its Phase 2b SYMMETRY Cohort D study met safety and tolerability endpoints. EFX was well tolerated with comparable results between EFX and placebo groups, and the tolerability profile was similar to previous BALANCED and HARMONY studies.

Portfolio Pulse from Benzinga Newsdesk

June 05, 2023 | 11:12 am

FHTX

The FDA has lifted the clinical hold on Foghorn Therapeutics' Phase 1 study of FHD-286 in acute myelogenous leukemia and myelodysplastic syndrome. The company plans to commence Phase 1 study of FHD-286 plus decitabine or cytarabine in relapsed/refractory AML in Q3 2023.

Portfolio Pulse from Benzinga Newsdesk

June 05, 2023 | 11:12 am

NAMS

NewAmsterdam Pharma announced that its Phase 2b dose-finding trial evaluating obicetrapib in Japanese patients achieved its primary endpoint with a statistically significant 45.8% median reduction in LDL-C. The trial also showed favorable safety and tolerability, and the data will enable PMDA regulatory path alignment with the rest of the world.

Portfolio Pulse from Benzinga Newsdesk

June 05, 2023 | 11:10 am

ALVR

AlloVir announced results from its Phase 2 randomized, placebo-controlled trial evaluating Posoleucel treatment, showing clinically meaningful reductions in BK viral load compared to placebo.

Portfolio Pulse from Benzinga Newsdesk

June 05, 2023 | 11:09 am

GKOS

Glaukos has completed enrollment and randomization in its second Phase 3 trial for Epioxa. The results of this trial, along with the first Phase 3 trial, are expected to support Glaukos' targeted NDA submission for Epioxa by the end of 2024.

Portfolio Pulse from Benzinga Newsdesk

June 05, 2023 | 11:08 am

EYPT

EyePoint Pharmaceuticals has completed enrollment in its Phase 2 PAVIA clinical trial of EYP-1901 for non-proliferative diabetic retinopathy. This marks a significant milestone for the company's drug development program.

Portfolio Pulse from Benzinga Newsdesk

June 05, 2023 | 11:07 am

CGEN

Compugen announced that data on COM701, a triple immunotherapy combination for recurrent metastatic MSS endometrial cancer, will be presented at the Society for Immunotherapy of Cancer (SITC) conference. The data shows preliminary durable anti-tumor activity.

Portfolio Pulse from Benzinga Newsdesk

June 05, 2023 | 11:06 am

AAPL

DISH

PANW

QQQ

SPY

Stocks are expected to pause after last week's strong rally, with concerns about a potential recession and the upcoming June Federal Open Market Committee meeting. Analyst Quincy Crosby warns of significant headwinds due to the Treasury's upcoming auction of $1 trillion worth of notes, which could sap liquidity from financial markets. In premarket trading, SPY and QQQ ETFs eased, while stocks like PANW, DISH, and AAPL saw movement.

Portfolio Pulse from Shanthi Rexaline

June 05, 2023 | 10:52 am

SYBX

Synlogic has initiated its Synpheny-3 Phase 3 study to evaluate the efficacy and safety of SYNB1934 as a potential treatment for Phenylketonuria. The study will enroll approximately 150 patients.

Portfolio Pulse from Benzinga Newsdesk

June 05, 2023 | 10:48 am

SWTX

SpringWorks Therapeutics' PDUFA date for Nirogacestat NDA has been extended by three months from August 27, 2023, as the FDA requires more time to review additional analyses of previously submitted data.

Portfolio Pulse from Benzinga Newsdesk

June 05, 2023 | 10:31 am