26.12.2018 06:40:01
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8 Biotech Stocks To Watch This Week
(RTTNews) - Clinical trials are major catalysts for biotech/pharma companies as positive study data can boost their stock price while unfavorable results can send the stocks plummeting.
The success rate of phase I clinical programs is the highest, say 63%, while it is the lowest for phase II trials - i.e. 30%. The phase III trials, which are the longest and most expensive trials to conduct, are said to have a success rate of 58%, according to a report from the Biotechnology Innovation Organization on "Clinical Development Success Rates" over the past decade (2006-2015).
Listed below are some of the companies that may report their clinical trial results *this week (if the companies stick to their timeline).
1. AC Immune SA (ACIU)
AC Immune is a Swiss-based, clinical-stage biopharmaceutical company focused on developing drugs for neurodegenerative diseases.
The Company's lead product candidate is Crenezumab, out-licensed to Genentech, under phase III testing for the treatment and prevention of Alzheimer's disease including the first-ever Alzheimer's disease prevention trial.
Next in the pipeline is ACI-24, a liposomal therapeutic anti-Abeta vaccine, wholly owned by AC Immune. ACI-24 is under phase II study in patients with mild Alzheimer's disease, and under phase 1b study for the treatment of Alzheimer's disease-like characteristics in adults with Down Syndrome (DS).
The other clinical candidates include ACI-35, outlicensed to Janssen Pharmaceuticals, under phase 1b study in patients with mild to moderate Alzheimer's disease, and RO7105705, outlicensed to Genentech, under phase II study in people with prodromal-to-mild Alzheimer's disease.
Watch out for...
Interim data from low dose cohort of the phase Ib study of ACI-24 for the treatment of Alzheimer's disease-like characteristics in adults with Down Syndrome is due this month.
ACIU has traded in a range of $7.16 to $17.40 in the last 1 year. The stock closed Monday's (Dec.24) trading at $8.93, up 1.94%.
2. ASLAN Pharmaceuticals Ltd (ASLN)
ASLAN Pharmaceuticals is a clinical-stage oncology-focused biotechnology company.
The Company's lead drug candidate is Varlitinib, which is being tested in gastric cancer, biliary tract cancer, breast cancer and colorectal cancer.
Watch out for...
Topline data from a pivotal global phase II study of Varlitinib in gastric cancer, and interim phase Ib data on Varlitinib as first line treatment for biliary tract cancer are due this quarter.
ASLN has traded in a range of $2.86 to $10.43 in the last 1 year. The stock closed Monday's trading at $2.86, down 18.29%.
3. Cocrystal Pharma Inc. (COCP)
Cocrystal Pharma is a clinical stage biotechnology company developing therapies for hepatitis, influenza, norovirus and gastroenteritis.
The Company's lead program, CC-31244, is under a phase IIa study (University of Maryland) for the treatment of hepatitis C.
Watch out for...
The interim topline results from the phase IIa study of CC-31244 in hepatitis C are expected this month.
COCP has traded in a range of $1.51 to $6.90 in the last 1 year. The stock closed Monday's trading at $2.95, down 4.53%.
4. Cytori Therapeutics Inc. (CYTX)
Cytori is focused on developing nanoparticle-delivered oncology drugs and autologous adipose-derived regenerative cell (ADRC) therapies.
Watch out for...
The 6-month data readout from French SCLERADEC II clinical trial in scleroderma patients is due this month.
SCLERADEC II is a randomized, double-blind, placebo-controlled, parallel group, multi-center clinical trial evaluating the safety and efficacy of Habeo Cell Therapy in up to 40 subjects with impaired hand function due to scleroderma (systemic sclerosis).
CYTX has traded in a range of $0.25 to $5.40 in the last 1 year. The stock closed Monday's trading at $0.27, down 6.67%.
5. Flexion Therapeutics Inc. (FLXN)
Flexion Therapeutics is focused on developing novel, local therapies for the treatment of patients with osteoarthritis, a type of degenerative arthritis.
The Company's lead product is Zilretta, which received FDA approval last October, for Osteoarthritis (OA) Knee Pain.
Zilretta is also being tested in patients with OA of the shoulder or hip. A phase II study, dubbed SHIP, in this indication is underway.
Watch out for...
Results from the SHIP study are anticipated by year-end 2018.
FLXN has traded in a range of $11.14 to $29.10 in the last 1 year. The stock closed Monday's trading at $11.47, down 1.29%.
6. Heat Biologics Inc. (HTBX)
Heat Biologics is a biopharmaceutical company developing immunotherapies against cancer.
The Company's lead drug candidate is HS-110, which is being evaluated in combination with Bristol-Myers Squibb Co.'s (BMY) Opdivo, for the treatment of advanced non-small cell lung cancer in a phase II trial.
Watch out for...
Updates regarding interim phase II data of HS-110 in advanced non-small cell lung cancer are due this quarter.
HTBX has traded in a range of $1.00 to $4.50 in the last 1 year. The stock closed Monday's trading at $1.01, up 1%.
7. Marinus Pharmaceuticals Inc. (MRNS)
Marinus is a biopharmaceutical company focused on developing innovative therapeutics to treat epilepsy and neuropsychiatric disorder. Its lead drug candidate is Ganaxolone, which is being developed in three different dose forms, IV, capsule and liquid.
Watch out for...
A phase II proof-of-concept study of Ganaxolone IV in patients with refractory status epilepticus is underway, with initial data due this month.
Refractory status epilepticus (RSE) is defined as status epilepticus that continues despite treatment with benzodiazepines and one antiepileptic drug. Status epilepticus refers to a continuous seizure lasting more than 30 minutes, or two or more seizures without full recovery of consciousness between any of them. (Source: NCBI).
MRNS has traded in a range of $2.36 to $10.54 in the last 1 year. The stock closed Monday's trading at $2.60, up 8.33%.
8. Sesen Bio Inc. (SESN)
Sesen Bio, formerly Eleven Biotherapeutics Inc., is a late-stage clinical company developing next-generation antibody-drug conjugate therapies for the treatment of cancer.
The Company's lead drug candidate is Vicinium, which is under a phase III trial in patients with high-grade non-muscle invasive bladder cancer, dubbed VISTA.
On May 21, 2018, the Company reported encouraging three-month data from its ongoing VISTA study. However, despite the encouraging data, Sesen shares tumbled 23% that day as 4 treatment-related serious adverse events that were reported in the trial, including acute kidney injury or renal failure and cholestatic hepatitis, spooked the investors.
Watch out for...
The six-month data from the ongoing VISTA trial is due this month.
SESN has traded in a range of $0.75 to $3.50 in the last 1 year. The stock closed Monday's trading at $1.02, up 6.24%.
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