June 04, 2024

Takeda Delivers Positive Narcolepsy Study Results at SLEEP 2024

Pharmaceutical company, Takeda (NYSE: TAK) has announced that it will present positive results from its Phase 2b trial of TAK-861 in narcolepsy type 1 (NT1) as a late-breaking data presentation at SLEEP 2024. SLEEP 2024 is the annual meeting of the American Academy of Sleep Medicine and the Sleep Research Society. Takeda says that TAK-861,… [Read More]
June 04, 2024

Allakos Doses First Patient in Urticaria Clinical Trial

Biotechnology company, Allakos (Nasdaq: ALLK) has dosed the first patient in a Phase 1 clinical trial evaluating a treatment for chronic spontaneous urticaria (CSU). CSU, also known as hives, is characterized by the appearance of urticaria three to four times a week, for at least six weeks. The reaction can occur with or without a… [Read More]
June 03, 2024

PRISM MedDevice Mover Microbot (MBOT) Up ~98% on FDA Approval For Human Clinical Trial

The PRISM MedDevice Index company and the developer of the innovative LIBERTY® Endovascular Robotic Surgical System, Microbot Medical (MBOT) has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to proceed with its pivotal human clinical trial under its Investigational Device Exemption (IDE) application for the LIBERTY® system. The study… [Read More]
June 03, 2024

Candel Therapeutics Secures FDA Orphan Drug Designation for Glioma Candidate

Candel Therapeutics’ (Nasdaq: CADL) share price rose by nearly 10% in intraday trading on Friday after the company announced it had been granted Orphan Drug Designation by the FDA for CAN-3110, a next generation oncolytic viral immunotherapy for the treatment of recurrent high-grade glioma (rHGG). The company presented Phase 1b data regarding the feasibility and… [Read More]
May 31, 2024

Iterum Therapeutics Tops PRISM Emerging Women’s Health Index, Receives PDUFA Date from FDA

Clinical-stage pharmaceutical company, Iterum Therapeutics (Nasdaq: ITRM), is topping the PRISM Emerging Women’s Health Index on Friday after the company announced that the FDA has acknowledged receipt of the company’s resubmitted New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women. The company’s share… [Read More]
May 31, 2024

Biomea Fusion Completes Enrollment in Type 2 Diabetes Trial

Shares in Biomea Fusion (Nasdaq: BMEA) climbed this week after the company announced it has completed the enrollment of 260 type 2 diabetes in the first three dose expansion arms of its COVALENT-111 study. Biomea is evaluating BMF-219, an investigational novel covalent menin inhibitor developed to regenerate insulin-producing beta cells, directly addressing the root cause… [Read More]
May 31, 2024

Oncocyte’s VitaGraft KidneyTM Utilized in Study Published in Peer-Reviewed Journal, Makes Use-Case for Potential Global Adoption of Test

Oncocyte Corporation’s (Nasdaq: OCX) VitaGraft TM Kidney diagnostic test for transplant monitoring has been successfully utilized in a Phase 2 clinical trial published in the peer-reviewed New England Journal of Medicine. The company’s shares rose 3.77% after-market on Thursday, and more than 10% in morning trading on Friday following the news. The study’s results point… [Read More]
May 31, 2024

Stocks making the biggest moves premarket: Dell Technologies, Ulta Beauty, Ambarella, Gap and more

Catch up with the firms making waves in premarket business activity. Dell Technologies — The personal computer and technology business saw its stocks plunge over 16% after leaders forewarned continuing margin strain. Dell’s first-quarter profits surpassed predictors on both ends, yet the company anticipates its gross margin will recede approximately 150 basis points by 2025…. [Read More]