30.01.2019 02:21:18
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6 Top Gainers In Healthcare Sector (OCX, KZIA, AVDL...)
(RTTNews) - The following are some of today's top gainers in the pharma/biotech sector.
1. OncoCyte Corporation (OCX)
Gained 224.73% to close Tuesday's (Jan.29) trading at $5.91.
News: The Company announced positive results from its key R&D Validation study demonstrating the accuracy of its DetermaVu liquid biopsy test for lung cancer.
The R&D Validation study demonstrated a sensitivity of 90% and specificity of 75% of DetermaVu on a prospectively collected cohort of 250 patient blood samples that were blinded to laboratory operators.
DetermaVu Lung is on track for commercial availability in the second half of 2019, according to the Company.
2. Voyager Therapeutics Inc. (VYGR)
Gained 38.31% to close Tuesday's trading at $11.12.
News: The Company has formed a strategic collaboration with Neurocrine Biosciences Inc. (NBIX) focused on the development and commercialization of Voyager's gene therapy programs, VY-AADC for Parkinson's disease and VY-FXN01 for Friedreich's ataxia, as well as rights to two programs to be determined.
Neurocrine Biosciences gains development and commercialization rights to gene therapy programs VY-AADC, VY-FXN01 and two additional programs to be determined. In turn, Voyager receives $165 million upfront, along with funding for ongoing development of each program, and up to $1.7 billion in potential development, regulatory and commercial milestone payments.
3. Zynerba Pharmaceuticals, Inc. (ZYNE)
Gained 25.26% to close Tuesday's trading at $4.81.
News: No news
Clinical Trials & Near-term Catalysts:
-- A pivotal trial of ZYN002 in Fragile X Syndrome, dubbed CONNECT-FX, is underway, with topline results expected in the second half of 2019. -- A phase II clinical trial evaluating ZYN002 in children and adolescents (three through 17 years) with developmental and epileptic encephalopathies, dubbed BELIEVE 1, is ongoing, with topline data expected in the third quarter of 2019. -- The Company expects to initiate an open-label Phase 2 study in pediatric patients with Autism Spectrum Disorder in Australia in the first half of 2019. -- A phase II study in pediatric patients with 22q is expected to be initiated in Australia in the first half of 2019.
4. Conatus Pharmaceuticals Inc. (CNAT)
Gained 25.26% to close Tuesday's trading at $4.81.
News: No news
Clinical Trials & Near-term Catalysts:
In collaboration with Novartis, Conatus is conducting three randomized, double-blind, placebo-controlled Phase 2b clinical trials evaluating Emricasan in patients with fibrosis or cirrhosis caused by NASH namely, ENCORE-NF (for NASH Fibrosis), ENCORE-PH (for Portal Hypertension), and ENCORE-LF (for Liver Function).
-- Top-line results from ENCORE-NF are expected in the first half of 2019. -- Last December, the Company announced that the ENCORE-PH trial did not meet the primary endpoint. The study has an ongoing six-month extension with 48-week liver function and clinical outcome results expected in mid-2019. -- Top-line results from ENCORE-LF are also expected in mid-2019.
5. Kazia Therapeutics Limited (KZIA)
Kazia Therapeutics is an innovative oncology-focused biotechnology company, based in Sydney, Australia.
Gained 23.33% to close Tuesday's trading at $3.70.
News: No news
Clinical Trials & Near-term Catalysts:
The lead program is GDC-0084, which is being developed to treat glioblastoma multiforme, the most common and most aggressive form of primary brain cancer. The compound was licensed from Genentech in late 2016.
A phase II trial of GDC-0084 in Glioblastoma Multiforme (GBM), a phase II trial of GDC-0084 in Breast Cancer Brain Metastases (BCBM), and a phase I trial of GDC-0084 in Diffuse Intrinsic Pontine Glioma (DIPG) are underway.
Also in the pipeline is Cantrixil, currently in phase I trial for ovarian cancer.
6. Avadel Pharmaceuticals plc (AVDL)
Gained 19.47% to close Tuesday's trading at $2.70.
Avadel is a branded specialty pharmaceutical company, generating revenue primarily from the sale of pharmaceutical products, previously sold in the U.S. without FDA approval ("Unapproved Marketed Products" or "UMDs").
Pipeline:
The lead drug candidate FT218 for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy is under phase III testing. The study is expected to be completed in September 2019 (Source: ClinicalTrials.gov).
Another company by the name Jazz Pharmaceuticals plc (JAZZ) is developing a drug, Solriamfetol, as a treatment to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA). Solriamfetol is under FDA review, with a decision date set for March 20, 2019.
Near-term Catalyst:
The Company is expected to report Q4 and full year 2018 financial results in March.
For full-year 2018, the Company expects revenue to be in the range of $90 million to $105 million. Analysts polled by Thomson Reuters have a consensus revenue estimate of $96.78 million for the year. Revenue in full year 2017 was $172.7 million.
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