Clinical trials are binary speculative events that could make or break biotech stocks.
The week that just rolled by saw Amarin Corporation plc (AMRN) gain as much as 446%, thanks to positive results from REDUCE-IT, the cardiovascular outcomes study of Vascepa.
On the contrary, TG Therapeutics Inc. (TGTX) lost 46% as investors were not happy with the news related to phase III trial of Ublituximab plus Umbralisib in refractory Chronic Lymphocytic Leukemia, dubbed UNITY-CLL.
Knowing the timing of announcement of clinical trial results helps limit risk and maximize profits when trading/investing in biotech stocks.
Now, here are some of the pharma/biotech stocks to watch out for in the week starting October 1.
1. Antares Pharma Inc. (ATRS)
Antares Pharma is a revenue-generating, specialty pharmaceutical company, focusing on self-injection pharmaceutical products and technologies, and topical gel-based products.
Watch out for…
The FDA decision on the Company’s resubmitted NDA for Xyosted, proposed for the treatment of testosterone deficiency (hypogonadism), due September 29, is awaited.
This is Xyosted’s second go-around with the FDA. The U.S. regulatory agency had declined to approve Xyosted last October, citing concerns of an increase in blood pressure and the occurrence of depression and suicidality.
Robert Apple, President and Chief Executive Officer of Antares is slated to make a presentation at the Ladenburg Thalmann 2018 Healthcare Conference on Tuesday, October 2, 2018 at 9:00 a.m. Eastern Time.
ATRC closed Friday’s trading at $3.36, unchanged from the previous day’s close.
2. 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.
Also in the pipeline are GLPG1690 for idiopathic pulmonary fibrosis, a triple combination therapy for cystic fibrosis, MOR106 for atopic dermatitis, GLPG1972 for osteoarthritis, and a number of preclinical drug candidates for various indications.
Watch out for…
Topline results from part one of FALCON trial, due in Q3, 2018, are awaited. The FALCON trial is a phase II study of the investigational triple combination therapy in cystic fibrosis patients. The FALCON trial was initiated in April of this year.
The investigational triple combination therapy is a combination of GLPG2451, GLPG2222 and GLPG2737.
GLPG closed Friday’s trading at $101.36, down 0.49%.
3. Omeros Corp. (OMER)
Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing, and commercializing small-molecule and protein therapeutics targeting inflammation, complement-mediated diseases and disorders of the central nervous system.
The Company’s marketed drug is OMIDRIA, indicated for use during cataract surgery or intraocular lens) replacement to maintain pupil size.
The lead drug candidate in the pipeline is OMS721, under phase III trial for atypical Hemolytic Uremic Syndrome, IgA Nephropathy, and Stem Cell Transplant-Associated TMA. OMS721 is also under phase II studies in the indications of Lupus Nephritis & other renal diseases.
Also in the pipeline are OMS824 for Huntington’s and Schizophrenia, OMS405 for Opioid and Nicotine Addiction, and OMS201 for Ureteroscopy. The Company also has a couple of pre-clinical programs.
Watch out for…
Data from the phase II trial of OMS721 in IgA nephropathy due this month are awaited.
Gregory Demopulos, chairman and CEO of Omeros, is scheduled to make a presentation at the 2018 Cantor Global Healthcare Conference in New York on Tuesday, October 2, 2018 at 1:05 p.m. EDT.
OMER closed Friday’s trading at $24.41, down 0.85%.
4. Audentes Therapeutics Inc. (BOLD)
Audentes is a biotechnology company focused on developing and commercializing innovative gene therapy products for patients living with serious, life-threatening rare diseases.
The Company has 4 gene therapy products in development – AT132 under phase I/II trial for X-Linked Myotubular Myopathy; AT342 under phase I/II trial for Crigler-Najjar Syndrome; AT982 for Pompe disease and AT307 for the treatment of CASQ2-related Catecholaminergic Polymorphic Ventricular Tachycardia, both of which are under IND enabling stage.
Watch out for…
New interim data from ASPIRO, the phase I/II clinical trial of AT132 in patients with X-linked Myotubular Myopathy is scheduled to be presented at the 23rd International Congress of the World Muscle Society (WMS) in Mendoza, Argentina, on October 5.
The presentation will be from 48-weeks of follow-up in the earliest treated patients in dose Cohort 1 (1×1014 vg/kg), and preliminary safety and efficacy data for the sentinel patient treated in dose Cohort 2.
In August 2018, Audentes reported promising safety, efficacy and muscle biopsy data out to the 24-week timepoint from the first dose cohort of ASPIRO study.
BOLD closed Friday’s trading at $39.59, up 3.29%.
5. Acceleron Pharma Inc. (XLRN)
Acceleron Pharma is a biopharmaceutical company focused on developing TGF-beta therapeutics to treat serious and rare diseases.
The most advanced drug candidate in Acceleron’s pipeline is Luspatercept, which is under phase III testing in myelodysplastic syndromes, dubbed MEDALIST, and transfusion-dependent beta-thalassemia study known as BELIEVE.
Also in the pipeline are ACE-083, under phase II studies in Facioscapulohumeral Muscular Dystrophy and Charcot-Marie-Tooth disease; ACE-2494 proposed for neuromuscular indications, under phase I study; Sotatercept, under phase II study in pulmonary arterial hypertension, and ACE-1334 for pulmonary disease under preclinical testing.
Watch out for…
Data from Part 1 of each its ongoing phase II trials of ACE-083 in patients with facioscapulohumeral muscular dystrophy and Charcot-Marie-Tooth disease will be presented at the 23rd International Annual Congress of the World Muscle Society to be held in Mendoza, Argentina, on October 5.
XLRN closed Friday’s trading at $57.23, up 0.70%.
by RTTNews Staff Writer
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