16.12.2019 04:48:15
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Will These Pharma Stocks Soar Or Swoon This Month? (ACER, ACST, ADMS, SLGL)
(RTTNews) - Clinical trial results can send a company's stock soaring or swooning. The standard estimates for overall success rates, from phase I through to FDA approval, are between 9 and 11 percent. However, a new study by researchers at the Massachusetts Institute of Technology puts the success rate at 14%. (Source: CenterWatch).
Listed below are some of the pharma companies whose phase III trial results might be reported this month.
1. Acer Therapeutics Inc. (ACER)
Acer Therapeutics is a pharmaceutical company developing therapies for serious rare and life-threatening diseases with significant unmet medical needs.
ACER-001, the Company's drug candidate for urea cycle disorder is under a pivotal trial evaluating its bioavailability and bioequivalence against FDA-approved Buphenyl.
The trial consists of two parts - Part A and Part B.
Part A is a single-center, single-blind, randomized, single-dose crossover trial designed to evaluate the relative bioavailability of three different oral suspension formulations of ACER-001 compared to Buphenyl in 20 healthy adult subjects. The goal of Part A of this study is to provide data to help identify the optimal formulation of ACER-001 for further evaluation in Part B.
Results from the Part A bioequivalence trial of ACER-001 are due this quarter.
ACER has traded in a range of $1.87 to $28.25. The stock closed Friday's trading at $3.64, down 2.41%.
2. Acasti Pharma Inc. (ACST)
Acasti is focused on the research, development, and commercialization of its prescription drug candidate CaPre for the treatment of severe hypertriglyceridemia.
CaPre for the treatment of severe hypertriglyceridemia is under two phase III trials, dubbed TRILOGY 1 and TRILOGY 2.
The topline data from TRILOGY 1 trial is expected in December 2019, and that from TRILOGY 2 is anticipated in January 2020. The topline results will include a readout of the primary endpoint, which is intended to show CaPre's overall impact on lowering triglycerides (TGs) after 12 weeks compared to placebo.
ACST has traded in a range of $0.66 to $2.95 in the last 1 year. The stock closed Friday's trading at $2.04, up 16.57%.
3. Adamas Pharmaceuticals Inc. (ADMS)
Adamas is a fully-integrated pharmaceutical company and developer of Gocovri, the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease.
The Company began commercial promotion of GOCOVRI in January 2018. The net product sales of the drug were $34.0 million in full-year 2018, and $38.3 million for the nine months ended September 30, 2019.
A phase III study of Gocovri in walking impairment in multiple sclerosis patients, dubbed INROADS, is underway. The topline results from this study are expected in the second half of December 2019.
ADMS has traded in a range of $3.35 to $12.57 in the last 1 year. The stock closed Friday's trading at $6.66, up 2.54%.
4. Sol-Gel Technologies Ltd. (SLGL)
Sol-Gel Technologies is a clinical-stage dermatology company.
Two phase III clinical trials evaluating the efficacy and safety of Twyneo, a topical cream containing encapsulated tretinoin and encapsulated benzoyl peroxide, compared to vehicle when applied once daily for 12 weeks in patients with moderate-to-severe acne vulgaris, are underway. The top-line results of the two pivotal trials are due this quarter.
The Company's lead drug candidate is Epsolay for papulopustular rosacea for which a New Drug Application is expected to be filed in the first half of next year.
SLGL has traded in a range of $5.41 to $11.36. The stock closed Friday's (Dec.13) trading at $8.68, down 0.69%.
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