Biotech stocks are mostly driven by clinical trial results and regulatory decisions. According to a recent report by the Tufts Center for the Study of Drug Development, 532 phase III clinical trials were underway as of August 2018, spanning 264 indications.
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 await FDA decision or are expected to report their clinical trial results *this month (if the companies stick to their timeline).
1. Aquestive Therapeutics Inc. (AQST)
Aquestive Therapeutics Inc.'s (AQST) APL-130277, proposed as an intermittent therapy to overcome episodic off periods in Parkinson's disease, awaits the FDA decision on January 29, 2019.
APL-130277 is a sublingual film formulation of Apomorphine, a non-ergot dopamine agonist. Sunovion Pharmaceuticals Inc. is Aquestive Therapeutics' partner and sponsor of APL-130277.
If approved, APL-130277 is expected to bring in peak sales of $700 million.
AQST closed Thursday's trading at $7.54, down 5.51%.
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...
New safety and efficacy data from its ongoing multicentre phase Ib/II study of Varlitinib plus gemcitabine and cisplatin in first-line biliary tract cancer are scheduled to be presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium on January 18, 2019.
Data from a pooled analysis of three phase I studies of Varlitinib in combination with platinum-based regimens in biliary tract cancer are also slated to be presented at the same conference.
ASLN has traded in a range of $2.51 to $10.43 in the last 1 year. The stock closed Thursday's trading at $4.20, down 4.55%.
3. Aurinia Pharmaceuticals Inc. (AUPH)
Aurinia is a clinical-stage biopharmaceutical company focused on developing and commercializing therapies in disease areas of high unmet medical need.
The Company's lead drug candidate is Voclosporin, under phase III trial in lupus nephritis, dubbed AURORA; under phase II study in focal segmental glomerularsclerosis, and under phase II study in dry eye syndrome.
Watch out for...
Data from the phase II study of Voclosporin in dry eye syndrome is expected to be reported before the end of January.
Data from the ARORA trial is expected by the end of 2019.
AUPH closed Thursday's trading at $7.11, up 0.28%.
4. 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 top-line 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 Thursday's trading at $3.65, up 4.29%.
5. Exelixis Inc. (EXEL)
The FDA decision on Exelixis' (EXEL) supplemental New Drug Application for Cabometyx tablets as a treatment for patients with previously treated advanced hepatocellular carcinoma is expected on January 14, 2019.
Hepatocellular carcinoma (HCC), the most common type of liver cancer, is the fastest-rising cause of cancer-related death in the U.S. It is the second-leading cause of cancer death worldwide, accounting for more than 700,000 deaths and nearly 800,000 new cases each year.
Cabometyx, available in 3 strengths of 20mg, 40mg, and 60mg, is already approved in the United States for the treatment of patients with advanced renal cell carcinoma.
The drug is also approved in the European Union, Norway, Iceland, Australia, Switzerland, South Korea, Brazil and Taiwan for the treatment of advanced renal cell carcinoma (RCC) in adults who have received prior VEGF-targeted therapy, and in the European Union for previously untreated intermediate- or poor-risk advanced RCC.
Cabometyx generated $324.0 million in net product revenue in full-year 2017 and $428.3 million in the first nine months of 2018.
EXEL closed Thursday's trading at $24.07, up 1.69%.
6. MediWound Ltd. (MDWD)
MediWound is focused on developing innovative therapies to address unmet needs in severe burn and wound management.
The Company's lead biopharmaceutical product is NexoBrid, which has received approval from the European Medicines Agency as well as the Israeli, Argentinian, South Korean and Russian Ministries of Health, for removal of dead or damaged tissue, known as eschar, in adults with deep partial and full-thickness thermal burns.
In the U.S., NexoBrid is under a phase III trial in 175 burn patients, dubbed DETECT. The study's primary endpoint is complete eschar removal.
Watch out for…
The top line results from the DETECT study are expected in January 2019.
MDWD closed Thursday's trading at $4.37, up 0.92%.
7. Rexahn Pharmaceuticals Inc. (RNN)
Rexahn Pharma is a clinical-stage biopharmaceutical company developing innovative therapies to improve patient outcomes in cancers that are difficult to treat.
The Company's lead product candidate is RX-3117, under phase II clinical trial in combination with FDA-approved Abraxane in patients newly diagnosed with metastatic pancreatic cancer. Encouraging preliminary safety and efficacy data from this trial was presented last October.
According to the trial results announced last October, combined administration of RX-3117 and Abraxane showed preliminary signs of efficacy in newly diagnosed metastatic pancreatic cancer patients. Of the 14 subjects that had at least one on-study scan (after 2 cycles of therapy), 1 patient experienced a complete response (CR) after 6 cycles of therapy; 3 patients exhibited a partial response, and an additional 8 patients experienced stable disease for at least 2 cycles.
Watch out for...
Updated data from the phase II study of RX-3117 in combination with Abraxane in newly diagnosed metastatic pancreatic cancer is slated to be presented at the American Society of Clinical Oncology Annual Gastrointestinal Cancers Symposium (ASCO-GI) being held January 17-19, 2019.
RNN closed Thursday's trading at $1.04, down 0.95%.
8. Tyme Technologies Inc (TYME)
Tyme Technologies is a clinical-stage biotechnology company developing novel cancer therapeutics.
The lead product candidate is SM-88, which is currently being evaluated in two ongoing Phase II clinical trials for metastatic pancreatic cancer and prostate cancer.
Watch out for…
Interim safety and efficacy data from Stage 1 of the phase II clinical trial of SM-88 in metastatic pancreatic cancer, dubbed TYME-88-PANC, is expected this month.
TYME closed Thursday's trading at $2.70, down 8.16%.
9. Verona Pharma plc (VRNA)
Verona Pharma is a clinical-stage biopharmaceutical company developing innovative therapies for respiratory diseases.
The Company's lead product candidate is RPL554, which is being developed for the treatment of chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), and potentially asthma.
A phase II clinical trial evaluating RPL554 as an add-on to dual bronchodilator therapy for COPD maintenance treatment is underway.
Watch out for…
Top-line data from the phase II clinical trial of RPL554 as an add-on to dual bronchodilator therapy for COPD maintenance treatment is expected in January 2019.
VRNA closed Thursday's trading at $9.99, up 0.91%.
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