Clinical trials are major catalysts for biotech/pharma companies as positive study data can boost the 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 are expected to report their phase III clinical trial results *this month (if the companies stick to their timeline).
1. Alnylam Pharmaceuticals Inc. (ALNY)
Alnylam Pharma is a commercial-stage RNA interference (RNAi) company. RNAi therapeutics represent a powerful, clinically validated approach for the treatment of people afflicted with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system (CNS)/ocular diseases.
Watch out for…
Top-line results from a phase III study of Givosiran, an investigational RNAi therapeutic, for the treatment of acute Hepatic Porphyrias, dubbed ENVISION, are expected in March 2019.
Hepatic porphyria refers to an abnormal increase of pigments called Porphyrins in the body. It is a rare genetic disease characterized by episodic and potentially life-threatening acute neurologic attacks, which occur most commonly in women in child-bearing years. (Source: Rare Disease Report).
ALNY has traded in a range of $60.27 to $153.99 in the last 1 year. The stock closed Friday’s trading at $85.37, up 0.44%.
2. Ascendis Pharma A/S (ASND)
Ascendis Pharma is a clinical-stage biopharmaceutical company applying its innovative TransCon technology to develop therapeutics that address significant unmet needs.
Watch out for…
Top-line results from a phase III trial comparing once-weekly TransCon hGH with a daily growth hormone therapy in treatment-naïve pediatric subjects with growth hormone deficiency, dubbed heiGHt Trial, are due this quarter.
If the Company sticks to its deadline, the phase III heiGHt Trial data will be reported this month.
We had alerted our premium subscribers to ASND in March 2015 when it was trading around $17.80. In the last 1 year, the stock has traded in a range of $53.21 to $76.99. It closed Friday’s trading at $69.31, down 4.82%.
3. Galapagos NV (GLPG)
Galapagos is a clinical-stage biotechnology company developing medicines for cystic fibrosis, inflammation, and other indications.
The Company’s lead drug candidate is Filgotinib, a highly selective JAK1 inhibitor. Filgotinib is being evaluated in phase III programs in rheumatoid arthritis, Crohn’s disease and ulcerative colitis, and in phase II studies in small bowel Crohn’s disease, fistulizing Crohn’s disease, Sjögren’s syndrome, ankylosing spondylitis, psoriatic arthritis, cutaneous lupus erythematosus, lupus membranous nephropathy, and uveitis.
Watch out for.
Top-line results from phase III trials of Filgotinib in rheumatoid arthritis, dubbed FINCH 1 and FINCH 3, are expected this month.
We had alerted our readers to GLPG in July 2015 when it was trading around $55.30. The stock has traded in a range of $85.00 to $122.28 in the last 1 year. It closed Friday’s trading at $102.30, up 4.79%.
4. Proteon Therapeutics Inc. (PRTO)
Proteon is a late-stage biopharmaceutical company developing therapies to address some of the most urgent needs of hemodialysis and peripheral artery disease patients.
The Company’s lead drug candidate is Vonapanitase, which is under phase III study in patients with chronic kidney disease undergoing surgical creation of a radiocephalic arteriovenous fistula for hemodialysis, dubbed PATENCY 1 AND PATENCY-2.
The PATENCY 1 results were announced in December 2016. Although the trial did not meet its primary endpoint of improved primary unassisted patency, compared to placebo, it showed a 34% reduction in the risk of secondary patency loss over one year, compared to placebo, and a 45% relative increase in fistula use for hemodialysis, compared to placebo. Secondary patency refers to time to fistula abandonment.
Watch out for…
Top-line data from the PATENCY-2 clinical trial are expected in March 2019.
Improvement in fistula use for hemodialysis and secondary patency are the co-primary endpoints in the PATENCY-2 clinical trial.
PRTO has traded in a range of $1.50 to $3.10 in the last 1 year. The stock closed Friday’s trading at $2.71, down 6.87%.
5. Urovant Sciences Ltd. (UROV)
Urovant is a clinical-stage biopharmaceutical company developing innovative therapies for urologic conditions.
The Company’s lead drug candidate is Vibegron, which is under a phase III trial in adults with symptoms of overactive bladder, dubbed EMPOWUR, and a phase II study in women with irritable bowel syndrome (IBS)-associated abdominal pain.
Watch out for…
Top-line data from the EMPOWUR trial are expected by the end of March 2019.
UROV has thus far hit a low of $4.06 and a high of $14.32. The stock went public on the NASDAQ on September 27, 2018, offering its shares at a price of $14 each.
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