Streetbeat News

Regulatory

VERU

Veru has reached an agreement with the FDA to conduct a Phase 3 clinical trial for Sabizabulin for a broader indication, including all hospitalized adult patients with any type of virus-induced Acute Respiratory Distress Syndrome (ARDS). The study, which could begin as early as Q4 2023, will replace the second confirmatory Phase 3 COVID-19 study.

Portfolio Pulse from Benzinga Newsdesk

September 26, 2023 | 12:34 pm

BMRA

Biomerica, Inc. (NASDAQ:BMRA) announced that the Dubai government has approved insurance reimbursement for its EZ Detect colorectal disease at-home screening test. The test is designed to detect early signs of colorectal cancer and other colorectal diseases. The approval will make the test more accessible and affordable for individuals in Dubai.

Portfolio Pulse from Benzinga Newsdesk

September 26, 2023 | 12:21 pm

ENSC

Ensysce Biosciences (NASDAQ:ENSC) has completed the Site Initiation Visit (SIV) for the PF614-201 study, a critical step towards Phase 3. The study aims to evaluate the time of onset for PF614, a chemically modified opioid product. The trial results are expected by the end of 2023.

Portfolio Pulse from Benzinga Newsdesk

September 26, 2023 | 12:20 pm

MOTS

Motus GI has submitted a Special 510(K) to the FDA for market clearance of its Pure-Vu Gen 4 Gastro and Colon. The FDA usually reviews a Special 510(K) within 30 days of receipt.

Portfolio Pulse from Benzinga Newsdesk

September 26, 2023 | 12:19 pm

PBLA

Panbela Therapeutics (NASDAQ:PBLA) has announced the issuance of a new patent in China for a novel process for the production of SBP-101, a lead investigational product. The patent, developed in collaboration with Syngene International Ltd., reduces the number of synthetic steps from seventeen to six, making the production more scalable, efficient, and cost-effective. The patent is valid until 2039 and is expected to improve the overall competitiveness of SBP-101 in the market.

Portfolio Pulse from Benzinga Newsdesk

September 26, 2023 | 12:19 pm

AKBA

Australia's Therapeutic Goods Administration has approved Akebia Therapeutics' Vafseo (Vadadustat) for anemia associated with chronic kidney disease in adults on chronic maintenance dialysis.

Portfolio Pulse from Benzinga Newsdesk

September 26, 2023 | 12:15 pm

VCNX

Vaccinex, Inc. (NASDAQ:VCNX) has reported novel findings for its lead product, pepinemab, at two medical conferences. The findings suggest that pepinemab has the potential to prevent decline in brain metabolic activity and slow cognitive decline in neurodegenerative diseases like Huntington's and Alzheimer's. Additionally, pepinemab in combination with a checkpoint inhibitor has shown potential to induce formation of lymphoid structures in tumors, improving outcomes in head and neck cancer.

Portfolio Pulse from Benzinga Newsdesk

September 26, 2023 | 12:14 pm

LSCC

SLB

SPLK

TTOO

Insiders at Lattice Semiconductor Corporation (LSCC), Splunk Inc. (SPLK), Schlumberger Limited (SLB), and T2 Biosystems, Inc. (TTOO) have recently sold shares. While insider sales can sometimes indicate concern about a company's prospects, they can also be part of a preplanned sale. Rosenblatt reiterated LSCC with a Buy and maintained a $110 price target. Cisco announced it will acquire SPLK for roughly $28 billion. Citigroup maintained SLB with a Buy and raised the price target from $66 to $70. The FDA cleared TTOO's biothreat panel for commercial distribution.

Portfolio Pulse from Lisa Levin

September 26, 2023 | 12:09 pm

SENS

Senseonics Holdings, Inc. (NYSE:SENS) has announced the completion of the ENHANCE Pivotal Clinical Study for its 365-day Continuous Glucose Monitoring System. The study is designed to evaluate the accuracy and safety of the Eversense system for one year. The data gathered will be used to support the FDA submission for the system. The company aims to secure approval for the planned 365-day Eversense system in the coming quarters.

Portfolio Pulse from Benzinga Newsdesk

September 26, 2023 | 12:08 pm

ZIMV

ZimVie has announced that it has received FDA approval to launch a study on Mobi-C Hybrid, a new product in its portfolio.

Portfolio Pulse from Bill Haddad

September 26, 2023 | 12:07 pm