(RTTNews) - The following are some of today's top gainers in the healthcare sector.
1. Outlook Therapeutics Inc. (OTLK)
Outlook Therapeutics is a clinical-stage biopharmaceutical company focused on developing its lead clinical program, ONS-5010, for the treatment of wet age-related macular degeneration (wet AMD) and other retinal diseases.
Gained 54.37% to close Tuesday's (Dec.3, 2019) trading at $159.
News: The Company has received agreement from the FDA on three Special Protocol Assessments for three additional registration clinical trials for its ongoing Phase 3 program for ONS-5010.
ONS-5010 is currently under two phase III clinical trials for wet age-related macular degeneration, dubbed NORSE 1 and NORSE 2. The primary data from the NORSE 1 study is expected in the third quarter of calendar 2020.
The agreements reached with the FDA on the Special Protocol Assessments cover the protocols for NORSE 4, a registration clinical trial to treat branch retinal vein occlusion (BRVO), and NORSE 5 and NORSE 6, two registration clinical trials to treat diabetic macular edema (DME).
Outlook Therapeutics intends to initiate NORSE 4, 5 and 6 trials in 2020.
2. Corvus Pharmaceuticals Inc. (CRVS)
Corvus Pharma is a clinical-stage biopharmaceutical company developing precisely targeted oncology therapies.
Gained 41.01% to close Tuesday's trading at $4.47.
News: No news
Clinical Trials & Near-term Catalysts:
-- An amended Phase 1b/2 clinical trial of Ciforadenant in combination with Genentech's Tecentriq in renal cell cancer is ongoing. -- An amended Phase 1b/2 clinical trial evaluating Ciforadenant in combination with Genentech's Tecentriq in patients with prostate cancer is underway. -- A phase 1/1b clinical trial evaluating CPI-006 as a single agent and in combination with either Ciforadenant or Merck's Keytruda against various solid tumors and Non-Hodgkin lymphoma is underway. -- A phase 1/1b study of CPI-818 in patients with several types of T-cell lymphomas, including peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL) and others is ongoing, with initial data from the study expected in late 2019 or early 2020.
3. Atreca Inc. (BCEL)
Atreca is a biopharmaceutical company developing novel antibody-based immunotherapeutics to treat a range of solid tumor types.
Gained 32.34% to close Tuesday's trading at $13.34.
News: The FDA has given the go-ahead for the Company to initiate a first-in-human Phase 1b clinical trial of ATRC-101 in patients with solid tumors. It marks the first IND clearance of a clinical candidate derived from Atreca's differentiated drug discovery platform.
The Company went public on the Nasdaq Global Select Market on June 20, 2019, offering its shares at a price of $17.00 per share.
The Phase 1b clinical trial of ATRC-101 in patients with solid tumors is expected to be initiated in early 2020.
4. ViewRay Inc. (VRAY)
ViewRay designs, manufactures and markets the MRIdian radiation therapy system that can image and treat cancer patients simultaneously.
Gained 30.59% to close Tuesday's trading at $4.44.
News: The Company has entered into collaborations with Elekta AB (EKTA-B.ST) and Medtronic (MDT).
Elekta has committed to invest capital for up to a 9.9% minority interest in ViewRay and Medtronic has also committed to invest in a minority interest in ViewRay, subject to conditions.
ViewRay's largest shareholder, Fosun International Limited has also committed capital up to an amount that would enable it to maintain its current beneficial ownership percentage in ViewRay.
In other news, ViewRay announced that it has commenced an underwritten public offering of $75.0 million of shares of its common stock. In addition, the Company expects to grant the underwriters a 30-day option to purchase up to an additional $11.25 million of shares of common stock.
5. Iterum Therapeutics plc (ITRM)
Iterum Therapeutics is a clinical-stage pharmaceutical company developing next-generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings.
Gained 20.23% to close Tuesday's trading at $3.15.
News: No news
Clinical Trials & Near-term Catalysts:
Three phase III trials are underway namely, SURE 1, SURE 2, and SURE 3.
-- In SURE 1, oral Sulopenem etzadroxil combined with probenecid in a bilayer tablet (oral sulopenem) is compared to oral ciprofloxacin in women with uncomplicated urinary tract infections (uUTI). Topline data from this trial is expected in Q1, 2020. -- In SURE 2, IV sulopenem followed by oral sulopenem etzadroxil combined with probenecid in a bilayer tablet (oral sulopenem) is compared to IV ertapenem followed by oral ciprofloxacin in adults with complicated urinary tract infections (cUTI). Topline data from this trial is expected in Q1, 2020. -- In SURE 3, IV sulopenem followed by oral sulopenem is compared to IV ertapenem followed by a combination of oral ciprofloxacin and oral metronidazole in adults with complicated intra-abdominal infections (cIAI). Topline data from this trial is due this quarter (Q4, 2019).
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.