The second quarter of 2020 is about to end in just over a week’s time. The names of some of the pharma/biotech companies whose data readouts are due this quarter are listed below.
1. AC Immune SA (ACIU)
AC Immune is a clinical-stage biopharmaceutical company developing drugs for neurodegenerative diseases.
The Company’s lead drug candidate is Semorinemab, being co-developed in collaboration with Roche’s Genetech and under phase II trial for the treatment of patients with prodromal to mild Alzheimer’s.
Also in the pipeline among others is ACI-35.030, an anti-phospho-Tau vaccine. ACI-35.030 is under a phase Ib/IIa clinical trial in Alzheimer’s disease.
— An interim analysis of the phase Ib/IIa trial of ACI-35.030 is due this quarter.
ACIU has traded in a range of $4.07 to $10.14 in the last 1 year. The stock closed Friday’s trading at $7.18, up 1.84%.
2. BioXcel Therapeutics Inc. (BTAI)
BioXcel Therapeutics is a clinical-stage biopharmaceutical company developing drugs utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology.
The Company’s two most advanced clinical development programs are BXCL501 in development for acute treatment of agitation resulting from neuropsychiatric disorders, and BXCL701 in development for the treatment of a rare form of prostate cancer and for treatment of pancreatic cancer in combination with other immuno-oncology agents.
BXCL501 is being evaluated in two phase III studies for the acute treatment of agitation in patients with schizophrenia, dubbed SERENITY I, and bipolar disorder, known as SERENITY II. A phase Ib/II trial of BXCL501 for the treatment of agitation associated with dementia, dubbed TRANQUILITY, is also underway.
— The topline results from the phase Ib/II TRANQUILITY study are due in mid-2020.
— The topline results from the pivotal phase III SERENITY trials are expected in July.
BTAI has traded in a range of $3.76 to $57.80 in the last 1 year. The stock closed Friday’s trading at $52.65, down 4.01%.
3. Intra-Cellular Therapies Inc. (ITCI)
Intra-Cellular Therapies is a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders.
The Company has one marketed drug – Caplyta (lumateperone), an atypical antipsychotic, which was approved for the treatment of schizophrenia last December.
Lumateperone is also being evaluated as adjunctive therapy in bipolar depression in a phase III study.
Also in the pipeline is ITI-214, which is under a phase II study in Parkinson’s and in a phase I/II study in heart failure.
— The topline data from the phase III trial of Lumateperone as adjunctive therapy in bipolar depression is expected in mid-2020.
— The topline results from the phase I/II study of ITI-214 in heart failure is due this quarter.
ITCI has traded in a range of $6.75 to $43.56 in the last 1 year. The stock closed Friday’s trading at $25.31, up 5.86%.
4. Molecular Templates Inc. (MTEM)
Molecular Templates is a clinical-stage biopharmaceutical company developing targeted biologic therapeutics, utilizing its proprietary drug platform technology, known as engineered toxin bodies, or ETBs.
The Company’s clinical-stage drug candidates include MT-3724 as monotherapy and combination therapy in phase II studies in Relapsed/Refractory Diffuse Large B Cell Non-Hodgkin’s Lymphoma and MT-5111, in a phase I study in patients with HER2-positive solid tumors.
— Data update from the MT-5111 phase I study is due this quarter.
MTEM has traded in a range of $4.51 to $19.12 in the last 1 year. The stock closed Friday’s trading at $14.50, down 0.34%.
5. 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.
The Marketing Authorization Application seeking approval for once-daily, oral Relugolix combination tablets for the treatment of women with moderate to severe symptoms associated with uterine fibroids was submitted to the European Medicines Agency in March. A New Drug Application for a once-daily Relugolix combination tablet for the treatment of women with heavy menstrual bleeding associated with uterine fibroids was submitted to the FDA earlier this month.
The results of a phase III study evaluating Relugolix combination therapy over 24 weeks in 623 women with endometriosis were reported in April. The study, dubbed SPIRIT 2, met its co-primary efficacy endpoints with a 75.2% response rate for dysmenorrhea (menstrual pain) and a 66.0% response rate for non-menstrual pelvic pain while achieving six key secondary endpoints and demonstrating minimal bone mineral density loss.
The top-line results from a phase III study evaluating Relugolix combination therapy in women with endometriosis, dubbed SPIRIT 1, are due this quarter. This study is a replicate of the SPIRIT 2 study.
MYOV has traded in a range of $4.14 to $19.58. The stock closed Friday’s trading at $16.67, down 0.18%.
6. Novavax Inc. (NVAX)
Novavax is a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases.
— A phase IIb clinical trial of Serum Institute of India’s malaria vaccine candidate is being conducted in Burkina Faso, in West Africa. Novavax’s Matrix-M vaccine adjuvant is a key component of the malaria vaccine candidate. Top-line data from the trial are expected in the second quarter of 2020.
An adjuvant helps to boost the immune response in people who are administered the vaccine.
The Rise and Rise of Novavax (NVAX)
NVAX has traded in a range of $3.54 to $66.06 in the last 1 year. The stock closed Friday’s trading at $64.75, up 9.25%.
7. Obseva SA (OBSV)
Obseva is a specialty biopharmaceutical company operating in the field of women’s health and reproductive medicine.
The Company’s lead drug candidate is Linzagolix, under two phase III trials for the treatment of heavy menstrual bleeding due to uterine fibroids, dubbed PRIMROSE 2 and PRIMROSE 1. The Company reported positive 24-week data from the PRIMROSE 2 trial last December. The study met the primary efficacy endpoint of the reduction in heavy menstrual bleeding at 24 weeks.
— The twelve-month results from the phase III PRIMROSE 2 trial and six-month primary endpoint data from the phase III PRIMROSE 1 trial are due this month.
OBSV has traded in a range of $1.63 to $12.21 in the last 1 year. The stock closed Friday’s trading at $5.83, up 4.29%.
Source: Read Full Article