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BioShares Biotechnology Clinical Trials (BBC): $20.10, +$0.39, -30.8% YTD

BioShares Biotechnology Products (BBP): $34.41, +$0.63, +11.6% YTD

 

 

MARKET COMMENTARY

 

U.S. stock indexes were little changed a day after major indexes set fresh record highs as a month-long rally continued following the presidential election of Donald Trump. U-Mich sentiment preliminary figures for December and October wholesale trade data is on the economic calendar. European markets were mostly higher after the European Central Bank extended its stimulus program. The Nikkei rose to its highest level in a year, supported by a weaker yen. Gold edged lower, weighed down by a stronger U.S. dollar and expectations of a Federal Reserve rate hike next week. Oil prices rose on hopes that non-OPEC producers meeting in Vienna would agree to cut output.

 

 

MARKET HIGHLIGHTS

 

TxCell SA and Inserm Transfert, on behalf of Inserm, the Nantes University and the Nantes CHU, today announce the signature of an exclusive worldwide licensing agreement.  As per the terms of this agreement, TxCell has been granted an exclusive worldwide license to two patent families filed by the Center for Research in Transplantation and Immunology (CRTI), a center of excellence in the field of transplantation and immunology. The CRTI is a research unit (UMR 1064) affiliated to both Inserm, a French public organization dedicated to human health, and to the Nantes University (Nantes, France). 

 

OncoSec Medical announced financial results for the fiscal first quarter 2017.  For the first quarter of fiscal 2017, OncoSec reported a net loss of $5.6 million or $0.29 per share, compared to a net loss of $7.0 million, or $0.47 per share for the same period last year.  At October 31, 2016, OncoSec had $24.4 million in cash and cash equivalents, as compared to $28.7 million of cash and cash equivalents at July 31, 2016. OncoSec expects these funds to be sufficient to allow it to continue to operate its business for at least the next 12 months.

 

Valneva SE announced that its vaccine candidate VLA15 against Lyme disease is now progressing into clinical testing (Phase I) following the Investigational New Drug application (IND) clearance from the Food & Drug Administration (FDA) and the approval of the Clinical Trial Application (CTA) in Europe (Belgium).

 

MediciNova announced that principal investigator Dr. Benjamin Rix Brooks, Director, Carolinas HealthCare System’s Neuromuscular/ALS-MDA Center, presented exploratory interim data from MediciNova’s ongoing clinical trial of MN-166 (ibudilast) in amyotrophic lateral sclerosis (ALS) at the 27th International Symposium on ALS/MND (amyotrophic lateral sclerosis/motor neurone disease) in Dublin, Ireland.

 

Health Canada has approved ZINBRYTA (daclizumab beta), a new once-monthly, self-administered, subcutaneous treatment for adult patients with active relapsing remitting multiple sclerosis (RRMS), who have had an inadequate response to, or are unable to tolerate, one or more therapies indicated for the treatment of multiple sclerosis, Biogen and AbbVie announced.

 

Biogen announced it will present new data from the Phase Ib (PRIME) study of aducanumab, its investigational treatment for early Alzheimer’s disease (AD), at the 9th Clinical Trials on Alzheimer’s Disease (CTAD) meeting in San Diego. Data presentations include interim results from the titration cohort of the placebo-controlled period of the Phase Ib study as well as data from the first year of the long-term extension (LTE). The results support the ongoing Phase III studies of aducanumab for early AD. Following Biogen’s topline data for Aducanumab, Baird analyst Brian Skorney increased his price target to $309 from $284; Stifel analyst Thomas Shrader increased his price target to $298 from $291.

 

Eli Lilly and AstraZeneca announced a worldwide agreement to co-develop MEDI1814, an antibody selective for amyloid-beta 42 (Aβ42), which is currently in Phase I trials as a potential disease-modifying treatment for Alzheimer’s disease (AD). This agreement builds on the existing collaboration related to AZD3293, a BACE inhibitor in two pivotal Phase III trials. Under the terms of the new agreement, Lilly will make a $30 million upfront payment to AstraZeneca. Lilly will recognize the upfront of $30 million (pretax), or approximately $0.02 per share (after-tax), as a charge to earnings in the fourth quarter of 2016.

 

Eli Lilly presented detailed results of its Phase III EXPEDITION3 trial at the 9(th) Clinical Trials on Alzheimer’s Disease (CTAD) meeting. As previously disclosed, solanezumab did not meet the primary endpoint in the EXPEDITION3 clinical trial, a study of solanezumab initiated in people with mild dementia due to Alzheimer’s disease (AD), and Lilly will not pursue regulatory submissions for solanezumab for the treatment of mild dementia due to AD.

 

Synergy Pharmaceuticals announced positive top-line results from the first of two pivotal Phase III clinical trials evaluating the efficacy and safety of plecanatide, an investigational once-daily orally-administered compound, in 1,135 adult patients with irritable bowel syndrome with constipation (IBS-C).

 

Cytokinetics announced that new data was presented at the 27th International Symposium on ALS/MND in Dublin, Ireland, including patient baseline characteristics from VITALITY-ALS and results of an international physician survey on the use of noninvasive ventilation (NIV) in the treatment of ALS.

 

Emergent BioSolutions announced that the U.S. Department of Health and Human Services (HHS) is advancing its anthrax preparedness strategy with multiple contract actions for the company’s anthrax vaccines. Following the news, JP Morgan analyst Jessica Fye increased her price target to $35 from $33; Laidlaw analyst Jim Molloy increased his price target to $50 from $45.

 

Novartis announced additional analyses from the Phase III MONALEESA-2 study that show LEE011 (ribociclib) plus letrozole significantly prolonged progression-free survival (PFS) across pre-planned patient subgroups with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer, including post-menopausal women diagnosed de novo, those with visceral liver and lung metastases, and those with bone-only disease.

 

Galapagos NV reported the first dosing of a patient in the SELECTION Phase IIb/III study with filgotinib in ulcerative colitis. The start of the SELECTION study triggers a $10 million milestone payment from Gilead. The worldwide SELECTION Phase IIb/III study will investigate efficacy and safety of 100 mg and 200 mg filgotinib once-daily compared to placebo in 1,300 patients with moderately to severely active disease, including those with prior biological therapy failure. The DIVERSITY Phase III study in Crohn’s disease with filgotinib started in November.

 

Myriad Genetics announced results of a large head-to-head study comparing the efficacy of six tests used to predict the recurrence of breast cancer. A key finding was that EndoPredict (EPclin), a second-generation test, was superior to Oncotype Dx (RS), a first-generation test, in predicting the long-term recurrence of breast cancer. The results are being featured today in a podium presentation at the 2016 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas.

 

Genomic Health announced results from multiple studies demonstrating the unparalleled value of the Oncotype DX test in individualizing breast cancer treatment decisions for patients with various stages of the disease. Presentations included two overviews of prospective outcomes data and clinical evidence supporting use of the test in early-stage breast cancer patients with node-positive and node-negative disease. Data also included new results from the Surveillance, Epidemiology, and End Results (SEER) Registry program of the National Cancer Institute (NCI) analyzing outcomes and clinical utility of the Breast Recurrence Score (RS) in patients with high-grade tumors, and findings from a clinical evaluation of the Breast DCIS Score in patients with ductal carcinoma in situ (DCIS).

 

Vyome Biosciences presented two posters at the Re-Entering Antibacterial Discovery and Development Summit 2016 in Boston. The first poster details how its Dual Action Rational Therapeutics (DARTs) technology-based novel drug candidates may have the potential to bypass and/or suppress antibiotic resistance for severe antibiotic-resistant infections caused by orthopedic implants caused by S. epidermidis, a skin opportunist pathogen. The second poster details the potential of Vyome’s library of novel antibiotics currently in development for skin opportunist pathogens, and their low propensity to develop antibiotic resistance.

 

DRGT announced the Phase I clinical results of its DRGT-45 program, a new composition of Abiraterone Acetate – a major drug in the fight against metastatic, castration-resistant prostate cancer. DRGT-45, a novel Super-API composition was developed by DRGT to eliminate the pharmacokinetic issues associated with the marketed drug. Zytiga requires high-dose administration (1,000 mg daily) under strict fasted conditions due to a very significant (10-fold) food effect and high variability.

 

 

Analyst Recommendations

 

Mizuho analyst Irina Koffler downgraded Horizon Pharma to “neutral” from “buy” and decreased her price target to $14 from $30, citing if Express Scripts continues to exclude Horizon’s drugs, it could erode investor confidence in Horizon management, especially after a negative FA readout.

 

UBS analyst Jeffrey Hung increased his price target of Selecta to $29 from $19, citing the details for the gene therapy programs, better-than-expected sales of Krystexxa, and the licensing agreement with Spark Therapeutics, and the potential opportunity of the pipeline.