BioShares Biotechnology Clinical Trials (BBC): $18.14, -$0.21, -37.6% YTD

BioShares Biotechnology Products (BBP): $28.94, -$0.34, -6.1% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures rose, though investors largely held back as the contentious presidential campaign entered its final week. Investors keenly await a busy economic release schedule, including manufacturing PMI data by ISM and Markit, construction spending, and domestic vehicle sales. Gilead Sciences, Electronic Arts, and Herbalife are amongst several on the earnings calendar. European shares are poised for a seventh straight session of falls. Asian stocks bounced, erasing early losses, helped by stronger-than-expected factory activity in China. Gold prices inched up as the dollar edged lower. Oil prices rose from one-month lows after OPEC agreed on a long-term strategy.

 

 

MARKET HIGHLIGHTS

 

STRATA Skin Sciences announced that its Board of Directors has named Mr. McCaney, 61, as the company’s next President and Chief Executive Officer, effective November 1, 2016. 

 

BioTime announced that an abstract evaluating Renevia® in ‘run-in’ patients with HIV-associated facial lipoatrophy from the Renevia-02 trial will be presented at the 14th annual International Federation for Adipose Therapeutics and Science meeting (IFATS) taking place from November 17-20, 2016, in San Diego, California. The data will be reported in an oral presentation on Thursday, November 17.

 

OncoSec Medical Incorporated announced today that members of its leadership team will be making presentations at two high-profile events in November: 31st Annual Meeting & Associated Programs of the Society for Immunotherapy of Cancer ("SITC") and the Stifel Nicolaus Weisel Healthcare Conference 2016.

 

Achaogen announced that it will report its third quarter 2016 financial results on Monday, November 7, 2016 after the close of the U.S. financial markets.

 

Alcobra will report its financial results for the third quarter ended September 30, 2016 before the market open, and will host a corporate update conference call and webcast on Tuesday, November 15, at 8:30 am Eastern Time.

 

BioDelivery Sciences International will host conference call and webcast to report its financial results for the third quarter ended September 30, 2016, on Wednesday, November 9, 2016 before the market open and host a conference call and webcast at 8:00 am Eastern Time.

 

Pernix Therapeutics Holdings will report financial results for the third quarter ended September 30, 2016, after the market close on Thursday, November 10.

 

Moberg Pharma AB present its interim report for January-September 2016 on November 8.

 

Dow Jones reported that Pfizer lowered its earnings outlook for the year and said it was ending the development of a drug in the massive cholesterol-treatment sector. Pfizer said it ended development of its cholesterol treatment bococizumab because it was losing efficacy over time in lowering so-called bad cholesterol. The company plans to record a charge of 4 cents a share in the fourth quarter because of costs from the program’s discontinuation. For the full year, Pfizer said it now expects earnings per share of $2.38 to $2.43, reducing the high-end of the range by 5 cents. It also now expects revenue of between $52 billion to $53 billion, increasing the low end of the revenue forecast by $1 billion. In the latest quarter, Pfizer reported a profit of $1.32 billion, or 21 cents a share, down from $2.13 billion, or 34 cents a share a year prior. Excluding certain items, adjusted earnings were 61 cents a share, up from 60 cents. Revenue rose 7.9% to $13.05 billion. Analysts polled by Thomson Reuters had forecast adjusted earnings of 62 cents a share on revenue of $13.05 billion.

 

Incyte reported 3Q16 GAAP EPS of $0.19, which compares to a loss of $0.22 for the same period a year ago. The company beat the First Call GAAP EPS mean estimate loss of $0.03. Total revenue for 3Q16 was $269.5 million, which compares to $187.6 million for the same period a year ago. This compares to a mean estimate of $261.4 million.

 

Lexicon reported 3Q16 non-GAAP EPS loss of $0.35, which compares to a loss of $0.34 for the same period a year ago. The company beat the First Call non-GAAP EPS mean estimate loss of $0.49. Total revenue for 3Q16 was $27.7 million, which compares to $0.6 million for the same period a year ago. This compares to a mean estimate of $9.7 million.

 

Shire reported 3Q16 non-GAAP EPS of $3.17, which compares to $3.24 for the same period a year ago. The company matched the First Call non-GAAP EPS mean estimate of $3.17. Total revenue for 3Q16 was $3.45 billion, which compares to $1.66 billion for the same period a year ago. This compares to a mean estimate of $3.55 billion.

 

Ionis Pharmaceuticals announced positive data from a Phase II placebo-controlled study evaluating IONIS-FXI(Rx) in patients with end-stage renal disease (ESRD) on hemodialysis. In this Phase II study patients treated with IONIS-FXI(Rx) achieved statistically significant, dose-dependent reductions in Factor XI activity. There were no clinically meaningful reductions in platelet levels and no treatment-related major or clinically relevant non-major bleeding events.

 

Bellicum Pharmaceuticals and Ospedale Pediatrico Bambino Gesù announced that they have entered into an expanded collaboration focused on preclinical and clinical development of CD19 and other CAR T and TCR therapeutics engineered with Bellicum’s CaspaCIDe molecular safety switch technology.

 

Can-Fite BioPharma announced that it has reached an agreement with the EMA on the final design of a global pivotal Phase III trial for its lead drug candidate, Piclidenoson (CF101), in the treatment of psoriasis. Can-Fite intends to initiate the Phase III trial in the second half of 2017.

 

Novartis announced that the FDA accepted the company’s NDA for filing and granted Priority Review for LEE011 (ribociclib) as first-line treatment of postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with letrozole. The NDA is based on a comprehensive clinical package, including results of the Phase III MONALEESA-2 trial. The trial, which was presented at the European Society for Medical Oncology (ESMO) 2016 Congress and published simultaneously in the New England Journal of Medicine, showed LEE011 plus letrozole reduced the risk of progression or death by 44% (HR = 0.556, 95% CI: 0.429-0.720; P = 0.00000329) over letrozole alone, significantly extending progression-free survival (PFS) across all patient subgroups. The company also announced that the EMA has accepted for review the marketing authorization application for LEE011 plus letrozole in the same patient population.

 

Flexion Therapeutics reported top-line results from a clinical trial to assess the effects of its investigational lead drug candidate, Zilretta (also known as FX006), on blood glucose levels in adults with osteoarthritis (OA) of the knee who also have Type II diabetes. Results from the trial demonstrated Zilretta is associated with a statistically significant and clinically relevant reduction in the rise of blood glucose compared to that observed following immediate-release (IR) triamcinolone acetonide (TCA) injection in patients who also have knee OA. Zilretta has previously demonstrated clinically meaningful improvement of pain, stiffness and function in its Phase III pivotal trial in patients with knee OA.

 

Endo International announced that one of its operating companies, Par Pharmaceutical, has begun shipping four dosage strengths (50 mg, 150 mg, 200 mg and 300 mg) of quetiapine fumarate extended release (ER) tablets, the generic version of AstraZeneca‘s SEROQUEL XR. As marketer and distributor of the product, Par will have 180 days of marketing exclusivity for these four strengths and will share profits with its partners Handa Pharmaceuticals and Deerfield Generics, a portfolio company of Deerfield Management Company, L.P.

 

Pluristem Therapeutics announced that the United Kingdom’s Medicines & Healthcare Products Regulatory Agency (MHRA) has cleared Pluristem’s application to begin the pivotal Phase III trial of PLX-PAD cells in the treatment of Critical Limb Ischemia (CLI) for patients who are unsuitable for revascularization. Pluristem’s CLI program was previously selected by the EMA for its Adaptive Pathways pilot project, which may allow for conditional marketing approval after a single pivotal Phase III trial.

 

Cempra announced the receipt of a $10 million milestone payment from Toyama Chemical Co., Ltd. a subsidiary of FUJIFILM Holdings Corporation, triggered by Toyama progressing to Phase III studies with solithromycin in Japan, the world’s second largest antibiotic market.

 

Portola Pharmaceuticals announced that it has expanded its existing clinical collaboration agreement with Daiichi Sankyo to develop AndexXa (andexanet alfa) as an antidote for edoxaban, Daiichi Sankyo’s Factor Xa inhibitor. AndexXa is currently under EMA review for reversal of Factor Xa inhibition in patients experiencing a life-threatening or uncontrolled bleed and for patients requiring urgent or emergency surgery. As part of the updated agreement, Portola will expand the ongoing ANNEXA-4 study in bleeding patients in Germany.

 

Propanc Health Group announced it has submitted an application for Orphan Medicinal Product Designation (OMPD) to the EMA for PRP, a solution for intravenous administration of pancreatic proenzymes trypsinogen and chymotrypsinogen. The proposed orphan drug indication for PRP is for the treatment of ovarian cancer.

 

Reuters reported that AstraZeneca Canada said Lynparza (olaparib) PHASE III SOLO-2 trial shows significant progression-free survival benefit for women with ovarian cancer. Results from the trial show clinically-meaningful, statistically-significant improvement of progression-free survival among patients.

 

Aytu BioScience announced that it presented five posters demonstrating the clinical potential of MiOXSYS, Aytu’s rapid in vitro diagnostic system for the qualitative measurement of static oxidation-reduction potential (sORP) in human semen, to be used as an aid in the diagnosis of infertility in men.

 

Theravance Biopharma announced the presentation of positive new data from several studies of VIBATIV (telavancin), the Company’s proprietary FDA-approved antibiotic.  Results of the studies included reporting of high clinical cure rates in patients with osteomyelitis, greater in vitro potency against challenging MRSA pathogens as compared to other commercialized antibiotics, and similarities in the overall healthcare costs and renal function impact for VIBATIV as compared to vancomycin.  These study findings were presented at IDWeek 2016, which was held in New Orleans, LA on October 26 – 30, 2016. 

 

AmpliPhi Biosciences announced that it has been granted Small and Medium Enterprise (SME) designation by the EMA.

 

Berkeley Lights announced a two-year strategic collaboration agreement with F. Hoffman-LaRoche, Ltd. and Hoffman-LaRoche Inc. (Roche).  The collaboration focuses on the innovation and automation of Roche’s antibody discovery technology using BLI’s platforms.  As part of the collaboration, Roche and Berkeley Lights will leverage BLI’s opto-nanofluidic systems and devices to increase efficiency, selection, and speed with which novel therapeutics are discovered.

 

DURECT Corporation provided an update on the DUR-928 development program including a description of data from the first cohort of a Phase Ib study with DUR-928 in patients with nonalcoholic steatohepatitis (NASH).

 

Lexicon Pharmaceuticals announced that the Journal of Clinical Oncology published detailed results from Lexicon’s pivotal Phase III TELESTAR clinical study of telotristat ethyl in patients with carcinoid syndrome.

 

Medivir announced that the company has entered into an agreement with Karo Pharma regarding the sale of Medivir’s subsidiary BioPhausia to Karo Pharma. The purchase price will be SEK 908 million on a cash and debt free basis, including a normalized working capital. The transaction is expected to close by mid-December 2016.

 

Ferring Pharmaceuticals announced the launch of NOQDIRNA (oral lyophilisate desmopressin) – the only licensed treatment for the symptomatic treatment of nocturia due to idiopathic nocturnal polyuria in adults including the over 65s – following approval by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

 

Xbrane Biopharma has signed a non-binding term sheet with a leading Chinese pharmaceutical company regarding the distribution of Spherotide in the Chinese market. The commercial terms are negotiated and the intended transaction will give the Chinese company exclusive rights to sell and market Spherotide in China. According to the agreed structure of the intended deal Xbrane will receive a downpayment of SEK 17 million at the signing of the final contract, which is expected in Q1 2017, as well as three equally sized milestone payments totalling approximately SEK 70 million until the product launch scheduled for 2021. The Chinese partner will be responsible for and finance the clinical trials required to obtain market authorization in China.

 

Diamyd Medical announced that production of a proprietary GABA drug has started. Concurrently, the Scientific and Medical Advisory Board is expanded with two leading experts in rheumatoid arthritis and type 2 diabetes, Professor Daniel Furst, University of California, Los Angeles (UCLA) and Associate Professor Michael Alvarsson, Clinic Director at the Karolinska University Hospital.

 

NeuroVive Pharmaceutical announced positive pre-clinical results with one of its cyclophilin inhibitors, NVP018, in an experimental model of the chronic and common liver condition NASH (non-alcoholic steatohepatitis). The NASH project is in line with the company’s updated business strategy which includes increased and accelerated efforts in moving high potential discovery projects forward with the aim of out-licensing them in the preclinical phase.

 

Takara Bio announced that its SMART-Seq v4 Ultra Low Input RNA Kit for Sequencing has been selected for the development of gene expression profiles of individual brain cells as part of the Allen Cell Types Database, a public resource available from the Allen Institute for Brain Science. This database will extend knowledge about the various cell types in the brain, which in turn may shed light on how the healthy brain functions and what goes wrong in diseases such as autism, Alzheimer’s and Parkinson’s.

 

Oculus Innovative Sciences announced the sale of the company’s Latin American-related assets to Invekra S.A.P.I. de C.V. of Mexico for $19.5 million in cash. Additionally, Invekra will pay Oculus a three percent payment on all Latin American revenues outside of Mexico, with a minimum payment of $250,000 per year for the next ten years, to be paid quarterly in Mexican pesos.

 

Galena Biopharma announced that on October 26, 2016, the Board of Directors approved a reverse stock split of its shares of common stock at a ratio of 1-for-20. The reverse stock split was authorized by the Company’s stockholders at the Special Meeting of Stockholders held on October 21, 2016. The reverse stock split will become effective on November 11, 2016 and the Company’s common stock will commence trading on a split-adjusted basis when the market opens on Monday, November 14, 2016.

 

Immunovaccine announced that Gabriela Rosu, M.D., has been named the company’s first chief medical officer (CMO), effective November 7, 2016.

 

Allergan announced that it has successfully completed the acquisition of Tobira Therapeutics. Allergan acquired Tobira for an upfront payment of $28.35 per share, in cash, and additional Contingent Value Rights (CVRs) that may be payable based on the successful completion of certain development, regulatory and commercial milestones.

 

Acerus Pharmaceuticals announced that it has appointed Tricia Symmes to the position of Chief Operating Officer, effective November 1, 2016.

 

Cynosure announced the promotion of Douglas J. Delaney, Executive Vice President of Worldwide Sales, to Chief Commercial Officer.

 

 

ANALYST RECOMMENDATIONS

 

Mackie Research analyst Andre Uddin initiated coverage of Aurinia Pharmaceuticals with a “speculative buy” rating and $8 price target, citing a strong management team and an ideal acquisition candidate.

 

Aegis analyst Difei Yang initiated coverage of Aerie Pharmaceuticals with a “buy”

rating and $63 price target, citing Glaucoma is a multiple-billion dollar market with significant unmet medical needs.

 

Roth Capital analyst Mark Briedenbach initiated Global Blood Therapeutics with a “buy” rating and $47 price target, citing GBT440 has the potential to improve the standard of care for patients who suffer from Sickle Cell Anemia.

 

Mizuho analyst Irina Koffler decreased her price target of Allergan to $293 from $299, citing lower product estimates to incorporate feedback and to updates for the latest M&A and regulatory developments.

 

Wedbush analyst Liana Moussatos downgraded Sangamo BioSciences to “neutral” from “outperform” and decreased her price target to $4 from $30, citing the pipeline overhaul has created a gap and lack of material clinical catalysts for the Street until 2018.

 

William Blair analyst Katherine Xu downgraded Vertex to “market perform” from “outperform” and decreased her price target to $81 from $105, citing increasing competitive risks after attending the NA Cystic Fibrosis Conference.

 

Lake Street analyst Bruce Jackson increased his price target of Exact Sciences to $15 from $8, citing better than expected unit growth in Q3 despite what is typically a seasonally weak quarter.