OPK To Report Data In Q1, EIDX Cheers Investors, Busy Year Ahead For VRCA
The following are some of today’s top gainers in the pharma/biotech sector.
1. OPKO Health Inc. (OPK)
Gained 20.55% to close Monday’s (Nov.12) trading at $3.72.
News: The Company reported a narrower loss and slightly improved revenue for the third quarter of 2018.
Net loss during the third quarter of 2018 decreased to $27.7 million or $0.05 per share from $35.9 million or $0.06 per share for the comparable period of 2017. Total revenue improved to $249.8 million for the third quarter 2018, from $246 million in the comparable year-ago quarter.
The total revenue includes revenue from services, revenue from products, and revenue from transfer of intellectual property.
Looking forward to the fourth quarter, the Company expects revenues from services to be between $185 million and $205 million. Revenue from services in the third quarter of 2018 was $202.8 million.
— Topline results from a phase 2b clinical trial for once-weekly oxyntomodulin dual GLP1-Glucagon agonist to treat type 2 diabetes and obesity are anticipated during 1Q 2019.
— Enrollment in phase 2b trial for SARM (selective androgen receptor modulator) to treat benign prostatic hyperplasia is expected to be completed by the end of this year.
— Premarket Approval application for Claros point-of-care PSA test is under review by FDA, with a decision anticipated during 1H 2019.
2. Verrica Pharmaceuticals Inc. (VRCA)
Gained 16.76% to close Monday’s trading at $14.00.
News: No news
The Company’s lead product candidate is VP-102, which is currently being evaluated in two phase III clinical trials for the treatment of molluscum, and in a phase II clinical trial for the treatment of common warts.
— Topline results from the two phase III trials of VP-102 for the treatment of molluscum are expected in the first quarter of 2019.
— Topline results from the phase II trials of VP-102 in common warts, dubbed COVE-1, are expected in the first half of 2019.
3. Eidos Therapeutics Inc. (EIDX)
Gained 14.87% to close Monday’s trading at $14.60.
News: The Company announced positive results of its phase II clinical trial of AG10 in subjects with symptomatic transthyretin (TTR) amyloidosis cardiomyopathy (ATTR-CM).
The study met its primary objective of establishing that AG10 was well tolerated with no safety signals of potential clinical concern related to the administration of AG10 in symptomatic ATTR-CM patients.
— Advance AG10 into phase III pivotal trials in subjects with symptomatic transthyretin (TTR) amyloidosis cardiomyopathy in the first half of 2019.
4. Cocrystal Pharma Inc. (COCP)
Gained 12.02% to close Monday’s trading at $2.05.
News: The Company announced its financial results for the quarter ended September 30, 2018 and provided a corporate update.
The net loss for the third quarter of 2018 narrowed to approximately $1.87 million from $2.26 million in the year-ago quarter.
— Announce interim topline results from the U.S. Phase 2a clinical study of CC-31244 for the ultra-short treatment of HCV-infected individuals in December 2018.
— Commence Hong Kong Phase 2a open-label study of CC-31244.
— Initiate Phase 1 study evaluating CC-42344 for the treatment of influenza in 2019.
5. Caladrius Biosciences Inc. (CLBS)
Gained 11.76% to close Monday’s trading at $5.13.
News: No news
Clinical Trials & Near-term Catalysts:
— A phase II clinical trial of CLBS03 as a treatment for recent-onset type 1 diabetes (T1D), dubbed T-Rex study, is underway. Top line data is expected in early 2019.
— A phase II clinical trial with its proprietary CD34 cell therapy (CLBS12) for the treatment of no-option critical limb ischemia (“CLI”) was initiated in March of this year in Japan. The trial is designed to enroll 35 patients, with final results expected in mid-late 2019.
— A phase I/II proof of concept study of CLBS14 in patients with coronary microvascular dysfunction and without obstructive coronary artery disease is ongoing. Results from this study are expected by the end of 2019.
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