The end of the first quarter is just around the corner. Will the biotech/pharma companies like the ones listed below, which are slated to report the trial results this quarter, stick to the deadline?
1. Akero Therapeutics Inc. (AKRO)
Akero Therapeutics is a clinical-stage biotechnology company developing therapies for metabolic diseases like nonalcoholic steatohepatitis (NASH).
The Company’s sole product candidate is AKR-001, a potential treatment for patients with NASH, which is under a phase IIa study, dubbed BALANCED.
The Company remains on track to report the primary endpoint results of the BALANCED study in the first quarter of 2020. Top-line results related to secondary endpoints, including safety and tolerability as well as paired biopsies for patients who achieve at least 30% relative reduction in liver fat at week 12, are expected n the second quarter of 2020.
Akero’s cash, cash equivalents, and short-term marketable securities on December 31, 2019, were $136.4 million.
AKRO has traded in a range of $10.78 to $34.00 in the last 1 year. The stock closed Monday’s trading at $16.56, down 1.90%.
2. Allakos Inc. (ALLK)
Allakos is a clinical-stage biotechnology company focused on developing therapeutic antibodies for the treatment of various eosinophil and mast cell-related diseases.
The lone product candidate of Allakos is AK002, which is being developed as treatment for Eosinophilic Gastritis, Eosinophilic Esophagitis, Indolent Systemic Mastocytosis, Chronic Urticaria and Severe allergic conjunctivitis.
The clinical safety and efficacy results from a six-month, open-label phase I study of AK002 in patients with Mast Cell Gastrointestinal Disease (MGID), are due in the first quarter of 2020.
Allakos ended the year 2019 with $495.9 million in cash, cash equivalents and marketable securities.
ALLK has traded in a range of $30.32 to $139.99. The stock closed Monday’s trading at $56.62, down 3.90%.
3. Arbutus Biopharma Corp. (ABUS)
Arbutus is a biopharmaceutical company developing a cure for patients suffering from chronic Hepatitis B infection.
The Company’s lone clinical drug candidate is AB-729 for people with chronic hepatitis B.
A phase 1a/1b clinical trial of AB-729 in healthy volunteers and in subjects with chronic hepatitis B (CHB) infection is underway. Preliminary safety and efficacy data from both healthy subjects and several single-dose cohorts of subjects with chronic hepatitis B infection are due this quarter.
Arbutus had cash, cash equivalents and short-term investments totaling $90.8 million as of December 31, 2019.
ABUS has traded in a range of $0.82 to $4.56 in the last 1 year. The stock closed Monday’s trading at $1.65, up 14.58%.
4. Axsome Therapeutics Inc. (AXSM)
Axsome is a clinical-stage biopharmaceutical company developing novel medicines for the management of central nervous system disorders.
The Company has two drug candidates in phase III testing – AXS-05 for treatment-resistant depression, Alzheimer’s disease and major depressive disorder, and AXS-07 for the treatment of migraine.
Topline results from a phase III trial of AXS-05 in treatment-resistant depression, dubbed STRIDE, and topline results from a phase III trial of AXS-07 in treatment of migraine, known as INTERCEPT, are due this quarter.
The Company ended the year 2019 with $220.0 million in cash.
AXSM has traded in a range of $12.76 to $109.94 in the last 1 year. The stock closed Monday’s trading at $63.91, up 17.48%.
5.Immunovant Inc. (IMVT)
Immunovant is the result of the merger between publicly-traded Health Sciences Acquisitions Corp. and privately held Immunovant Sciences Ltd. that occurred last December.
The Company’s lead product candidate is IMVT-1401, a novel, fully human monoclonal antibody targeting the neonatal Fc receptor (FcRn), with the potential to address a variety of immunoglobulin G (IgG)-mediated autoimmune diseases as a subcutaneous injection.
Initial results from ASCEND-GO 1, the phase IIa clinical trial of IMVT-1401 for the treatment of Graves’ ophthalmopathy, are due in the first quarter.
The Company ended the year 2019 with cash of $123.5 million.
IMVT has traded in a range of $8.34 to $18.69 in the last 1 year. The stock closed Monday’s trading at $11.01, up 18.64%.
6. Iterum Therapeutics plc (ITRM)
Iterum Therapeutics is a clinical-stage pharmaceutical company developing next-generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens.
The Company’s lead and first compound, Sulopenem, a novel penem anti-infective compound, is in phase III clinical development in oral and IV formulations.
The topline results from a phase III trial of oral Sulopenem in uncomplicated urinary tract infections, dubbed SURE 1, and topline results from a phase III trial of oral and IV Sulopenem in complicated urinary tract infections, dubbed SURE 2, are on track to be reported around the end of this quarter.
As of December 31, 2019, Iterum had cash and cash equivalents of $4.8 million. In January 2020, the Company raised net proceeds of $46.7 million from the private placement with accredited investors.
ITRM has traded in a range of $1.40 to $9.30 in the last 1 year. The stock closed Monday’s trading at $1.94, up 7.78%.
7. Myovant Sciences (MYOV)
Myovant is a healthcare company focused on developing innovative treatments for women’s health and prostate cancer.
The Company’s lead drug candidate is Relugolix for the treatment of uterine fibroids, endometriosis, and advanced prostate cancer.
Topline data from a phase III study evaluating the safety and efficacy of Relugolix combination therapy in women with pain associated with endometriosis, dubbed SPIRIT 2 is due in the first quarter of 2020.
As of December 31, 2019, the Company had cash, cash equivalents, and marketable securities of $98.9 million and $286.3 million of available borrowing capacity under the loan facility from Sumitomo Dainippon Pharma.
MYOV has traded in a range of $4.14 to $26.02 in the last 1 year. The stock closed Monday’s trading at $7.49, unchanged from the previous day’s close.
8. Novavax Inc. (NVAX)
Novavax is a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases.
The Company has two late-stage product candidates NanoFlu, a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine, and ResVax, an aluminum adjuvanted respiratory syncytial virus (RSV) fusion (F) protein recombinant nanoparticle vaccine.
Topline data from a phase III clinical trial evaluating the immunogenicity and safety of NanoFlu against the quadrivalent formulation of Fluzone is due this month. The primary objective of this trial is to demonstrate non-inferior immunogenicity of NanoFlu as measured by hemagglutination inhibition (HAI) titers of vaccine homologous influenza strains and safety compared against the approved Fluzone Quadrivalent.
As of December 31, 2019, Novavax had $82.2 million in cash, cash equivalents, marketable securities, and restricted cash.
NVAX has traded in a range of $3.54 to $17.71 in the last 1 year. The stock closed Monday’s trading at $10.76, up 3.96%.
9. Ovid Therapeutics Inc. (OVID)
Ovid Therapeutics is a clinical-stage company focused on developing treatments for rare neurological disorders.
The Company’s most advanced investigational medicine is OV101, currently in clinical development for the treatment of Angelman syndrome and Fragile X syndrome. Ovid is also developing OV935 (soticlestat) in collaboration with Takeda Pharm for the potential treatment of rare developmental and epileptic encephalopathies (DEE).
Initial data from an ongoing open-label phase II study of Soticlestat in CDKL5 deficiency disorder and Dup15q syndrome, dubbed ARCADE, is due by the end of the first quarter of 2020.
As of December 31, 2019, the Company’s cash, cash equivalents, and short-term investments totaled $76.7 million.
OVID has traded in a range of $1.53 to $5.24 in the last 1 year. The stock closed Monday’s trading at $2.42, up 5.68%.
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