Streetbeat News

Regulatory

VXRT

Vaxart, Inc. (NASDAQ:VXRT) has announced top-line data from the Phase 2 challenge study of its oral tablet monovalent norovirus vaccine candidate. The study met 5 of 6 primary endpoints, showing the vaccine to be safe and well tolerated with no serious adverse events. The vaccine led to a statistically significant reduction in infection rate and a substantial reduction in viral shedding. However, it did not achieve a statistically significant reduction in norovirus acute gastroenteritis.

Portfolio Pulse from Happy Mohamed

September 06, 2023 | 8:30 pm

CRVS

Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS) has confirmed plans to initiate a Phase 3 clinical trial of soquelitinib, its ITK inhibitor product candidate, in relapsed peripheral T cell lymphoma (PTCL) in Q1 2024. The trial is designed to enroll 150 patients and will compare soquelitinib to standard of care chemotherapy. The company is recruiting U.S. and international investigators and anticipates participation from leading academic and private medical centers.

Portfolio Pulse from Happy Mohamed

September 06, 2023 | 8:29 pm

TCNNF

Kim Rivers, CEO of Trulieve Cannabis Corp (OTCQX:TCNNF), expressed optimism about the potential federal rescheduling of cannabis, which would remove it from the federal prohibited list. This change would significantly impact the cannabis industry, particularly in terms of tax implications. Trulieve has paid over $220 million in 280E-related taxes in the last 24 months. The rescheduling could provide relief from this burden, enabling further investment in growth opportunities. Rivers also emphasized the need for Congress to push forward with the SAFE Banking Act.

Portfolio Pulse from Joana Scopel

September 06, 2023 | 8:27 pm

PEPG

PepGen Inc. has received clearance from Health Canada to begin the FREEDOM-DM1 Phase 1 study of PGN-EDODM1 in patients with Myotonic Dystrophy Type 1. This marks a significant step in the company's efforts to develop treatments for this rare genetic disorder.

Portfolio Pulse from Benzinga Newsdesk

September 06, 2023 | 8:10 pm

KORE

KORE Group Holdings, Inc. (NYSE:KORE) has received a notice from the New York Stock Exchange (NYSE) for not complying with the continued listing standards. The average closing price of KORE's common stock was less than $1.00 per share over a consecutive 30 trading-day period. KORE intends to respond to the NYSE within ten business days and has a six-month period to regain compliance with the NYSE's minimum share price requirement.

Portfolio Pulse from Happy Mohamed

September 06, 2023 | 8:08 pm

AMRX

Amneal Pharmaceuticals has received approval from the U.S. FDA for its calcium gluconate in sodium chloride injection, a product currently on the FDA shortage list. The approval received the FDA's Competitive Generic Therapy designation with 180-day exclusivity. The product is used for the treatment of acute symptomatic hypocalcemia in pediatric and adult patients. U.S. annual sales for the product were $107 million for the 12 months ended June 2023.

Portfolio Pulse from Happy Mohamed

September 06, 2023 | 8:00 pm

BSX

Boston Scientific has received FDA approval for its latest-generation WATCHMAN FLX Pro Left Atrial Appendage Closure Device. This approval could potentially boost the company's revenues and market share in the medical devices sector.

Portfolio Pulse from Benzinga Newsdesk

September 06, 2023 | 8:00 pm

SPY

The U.S. Senate has voted to advance Federal Reserve nominee Lisa Cook towards confirmation. The voting process is still ongoing.

Portfolio Pulse from Happy Mohamed

September 06, 2023 | 7:59 pm

SPY

Senate Minority Leader Mitch McConnell has vowed to complete his term in office despite health concerns. McConnell, who had two public health scares over the summer, has been evaluated by the attending physician for the U.S. Congress, who confirmed that the senator is able to perform his duties and found no evidence of a stroke.

Portfolio Pulse from Happy Mohamed

September 06, 2023 | 7:43 pm

JOBY

Joby Aviation has received FAA approval for its Certification Plans for the Energy Storage and Distribution System onboard its aircraft. This includes the batteries, high-voltage power distribution, and associated electrical wiring. The company now has more than two thirds of its Certification Plans accepted and is on track to launch commercial electric air taxi service in US cities in 2025.

Portfolio Pulse from Happy Mohamed

September 06, 2023 | 7:37 pm