BioSpace News Archive

Protocol Amendment allows for increase in TIGRIS sites to 15 while potentially accelerating patient enrolling and offsetting any COVID-19 pandemic-related delays

Interim 8-Week Top-Line Data From Etokimab ECLIPSE Phase 2 Trial in Chronic Rhinosinusitis with Nasal Polyps Did Not Demonstrate Statistical Significance For Either Q4W or Q8W Versus Placebo; Company Plans To Assess Path Forward for Etokimab After Complete 16-Week Trial Data by year-end 2020 Following Orphan Drug Designation by the FDA, Additional Topline Data from GALLOP Phase 2 Clinical Trial of Imsidolimab Monotherapy in Moderate-to-Severe Generalized Pustular Psoriasis on Track for Fourth Q

Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage immunotherapy company, today announced that the first patient has been dosed in an investigator-initiated multi-center clinical trial of Allocetra TM in COVID-19 patients with severe illness and respiratory failures. The clinical trial has been designed to assess Allocetra TM in combination with standard of care therapy in patients with COVID-19 associated lung dysfunction. Safet

Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ: NVCN / TSX: NVCN) announced today that it has entered into definitive agreements with certain healthcare-focused institutional investors for the sale of an aggregate of 4,532,772 common shares at a purchase price of US$2.77575 per common share in a registered direct offering (the “Offering”) priced at-the-market under the Nasdaq Capital Market (the “Nasdaq”) rules for ag

Recently Reported Preliminary First-Half 2020 Sales Were x3 Higher than Same Period in 2019, Demonstrating Significant Growth as Cryoablation Technology Continues to Gain Global Awareness

The high throughput test will be available in the Fall with next-day turnaround time and will enable Helix to scale its capacity to 100,000 tests per day

Seneca Biopharma, Inc. (Nasdaq: SNCA), a biopharmaceutical company focused on developing novel treatments for diseases of high unmet medical need, announced that its 2020 Annual Meeting of Stockholders that convened on August 7, 2020 has been adjourned until September 4, 2020 at 2:00 p.m. Eastern Time

Werewolf Therapeutics, Inc., an oncology biotherapeutics company developing next-generation, transformative cancer therapeutics, today announced the appointment of Ellen Lubman to the company’s newly created position of Chief Business Officer. In this role, Ms. Lubman will oversee corporate and business development, portfolio st

The company announced that the Brazilian regulatory agency, Anvisa, has granted permission to commence a Phase III study of lenzilumab in patients with COVID-19 in Brazil.

In July, SCYNEXIS announced that it had successfully conducted pre-NDA meetings with the FDA regarding ibrexafungerp for the treatment of Vulvovaginal Candidiasis (VVC) more commonly known as vaginal yeast infection. NDA submission for this indication remains on track for Q4 2020. In July, SCYNEXIS held an investor event with two key opinion leaders (KOLs) to discuss patient perspectives, unmet needs and treatment options in VVC, as well as the related commercial opportunity. This event fo