BioShares Biotechnology Clinical Trials (BBC): $20.61, -$0.20, -29.1% YTD

BioShares Biotechnology Products (BBP): $31.53, -$0.27, +2.3% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures were little changed as concerns over rising bond yields kept investors in a broadly risk-averse mode. Import prices for August are expected on the economic calendar. European shares rose, led by mining shares, breaking a four-day losing streak as investors sought safe-haven assets. Asian stocks closed near 6-week lows, while the yen slipped to a one-week low against the dollar, after a report said the Bank of Japan is considering taking interest rates deeper into negative territory when the central bank meets next week. Gold held steady, recovering from the previous session’s losses. Oil prices rebounded as data from the American Petroleum Institute showed a smaller-than-expected build in U.S. crude stockpiles.

 

 

MARKET HIGHLIGHTS

 

Pernix Therapeutics Holdings announced that the United States Patent and Trademark Office has issued U.S. Patent Numbers 9,421,200 (‘200 patent) and 9,433,619 (‘619 patent), covering important safety information related to dosing patients with Zohydro® ER with BeadTek™. These patents, in addition to recently issued U.S. Patent Numbers 9,265,760 (‘760 patent), 9,326,982 (‘982 patent), 9,333,201 (‘201 patent) and 9,339,499 (‘499 patent), are broadly directed to methods of dosing patients with mild or moderate hepatic impairment with hydrocodone.  The ‘760, ‘982, ‘201, ‘499, ‘200, and ‘619 patents expire on July 25, 2033.

 

Rexahn Pharmaceuticals announced it has entered into a definitive agreement with institutional investors to purchase 24 million shares of its common stock and warrants exercisable for up to 18 million shares of its common stock for gross proceeds of $6 million.  The shares and warrants are being sold in units, each consisting of one share of common stock and a warrant to purchase 0.75 of a share of common stock, at an offering price of $0.25 per unit. The warrants will be exercisable six months following the date of issuance, will expire on the fifth anniversary of the initial exercise date and have an exercise price of $0.30 per share. The closing of the offering is expected to take place on or about September 19, 2016, subject to the satisfaction of customary closing conditions.

 

Palatin Technologies will announce its fourth quarter and fiscal year end 2016 operating results on Tuesday, September 20, 2016  before the open of the U.S. financial markets.

 

GeNeuro announces that enrollment has reached the halfway mark, ahead of schedule, in the CHANGE-MS Phase 2B study of GNbAC1 in patients with relapsing-remitting multiple sclerosis.  Preliminary results read-out confirmed in Q4 2017.

 

Allergan and Vitae Pharmaceuticals announced that they have entered into a definitive agreement under which Allergan will acquire Vitae for $21.00 per share, in cash, for a total transaction value of approximately $639 million. The Boards of Directors of both companies have unanimously approved the transaction. Pending approvals, Allergan anticipates closing the transaction by the end of 2016.

 

Asterias Biotherapeutics presented positive interim efficacy data from the 10 million cell cohort in the Company’s ongoing AST-OPC1 SCiSTAR Phase I/IIa multicenter clinical study in complete cervical spinal cord injury patients.  While early in the study, with only 4 of the 5 patients in the cohort having reached 90 days after dosing, all patients have shown at least one motor level of improvement so far and the efficacy target of 2 of 5 patients in the cohort achieving two motor levels of improvement on at least one side of their body has already been achieved.  Patient improvements are being measured by the ISNCSCI neurological classification scale widely used to quantify functional status of patients with spinal cord injuries.  As suggested by existing research, patients with complete cervical spinal cord injuries that show two motor levels of improvement on at least one side may regain the ability to perform daily activities such as feeding, dressing and bathing.

 

Heat Biologics announced that the company has resumed enrollment in its Phase Ib trial evaluating HS-110 in combination with nivolumab (Opdivo), a Bristol-Myers Squibb anti-PD-1 checkpoint inhibitor, for the treatment of non-small cell lung cancer (NSCLC). The decision to resume trial enrollment was based on the positive data reported in June, including two clinical responses in "cold tumor" patients, and enabled by additional company funding through the exercise of warrants, as reported in the latest company financial and corporate update.

 

Array BioPharma announced that it has reached agreement with the FDA regarding a Special Protocol Assessment (SPA) related to BEACON CRC, a global Phase III trial of encorafenib and Erbitux (cetuximab), with or without binimetinib, versus standard of care in patients with BRAF-mutant colorectal cancer (CRC) who have previously received first-or second-line systemic therapy.

 

Exelixis announced that the European Commission (EC) has approved CABOMETYX (cabozantinib) tablets for the treatment of advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. CABOMETYX was granted accelerated assessment by the European Medicines Agency, and is the first therapy to demonstrate in a phase 3 trial for patients with advanced RCC, robust and clinically meaningful improvements in all three key efficacy parameters — overall survival (OS), progression-free survival (PFS) and objective response rate (ORR). This approval allows for the marketing of CABOMETYX in all 28 member states of the European Union, Norway and Iceland. EC approval of CABOMETYX triggers a $60 million milestone payment to Exelixis under the licensing agreement with Ipsen for the commercialization and further development of CABOMETYX indications outside of the United States, Canada and Japan. The approval is based on the results of the large, randomized phase III METEOR trial.

 

Shire announced that the FDA has granted approval for CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] in adult and pediatric patients two years of age and older. CUVITRU is a treatment for patients with primary immunodeficiency (PI), a group of more than 300 genetic disorders in which part of the body’s immune system is missing or functions improperly; it affects up to six million people worldwide.

 

Novo Nordisk announced that results from a post hoc analysis of the three-year part of the Phase IIIa SCALE (Satiety and Clinical Adiposity – Liraglutide Evidence) Obesity and Prediabetes trial show that people treated with Saxenda (liraglutide 3 mg) experienced consistent weight loss and improved blood glucose control across baseline body mass index (BMI) categories over three years as compared to placebo treatment. These data were presented at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) 2016.

 

Pluristem Therapeutics announced the appointment of Dr. Hillard Lazarus of Case Western Reserve University as the Principal Investigator of the Company’s Phase I trial of its PLacental eXpanded (PLX)-R18 cells to treat incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT).

 

OncBioMune Pharmaceuticals announces that it is in discussions to acquire Vitel Laboratorios S.A. de C.V., a Mexico-based pharmaceutical company that develops and commercializes high specialty drugs in Mexico and other Latin American countries.

 

New real-world and clinical evidence demonstrates that TECFIDERA (dimethyl fumarate) consistently delivered strong, sustained efficacy in newly-diagnosed and previously treated patients with relapsing-remitting multiple sclerosis (RRMS) and affirms its well-characterized safety profile in patients who have had up to nine years of treatment. Biogen will present these data at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in London.

 

Dow Jones reported that Bayer AG it would buy Monsanto for $66 billion including debt, creating one of the world’s largest agrichemical firms. The deal ends a monthslong courtship by the German pharmaceuticals and chemicals giant of the U.S. seed maker and will be the largest foreign corporate takeover ever by a German firm. Bayer plans to pay $128 a share for Monsanto in an all-cash transaction, up from its latest offer last week of $127.50 a share, the companies said. The agreed total price was a roughly 6% increase over Bayer’s original offer in May of $122 a share. Bayer said it expected the deal to generate synergies of $1.5 billion after the third full year following the closing.

 

WaferGen Bio-systems presented T-cell receptor (TCR) sequencing results from its ICELL8 Single-Cell System at the Single Cell Genomics Conference in Cambridge, United Kingdom. The poster presentation, titled "A SMARTer Approach to Profiling the Human T-cell Receptor Repertoire Using the ICELL8 Single Cell System", demonstrates the ability to perform TCR sequencing from thousands of single cells and is a joint poster with Takara Bio USA (formerly known as Clontech Laboratories).

 

Novocure announced that two independent institutions published scientific research on Tumor Treating Fields (TTFields), representing increasing external interest from the scientific community in Novocure’s innovative, proprietary therapy. The published data support Novocure’s existing body of research establishing TTFields as a low-toxicity, effective cancer treatment while adding new insights to the mechanism of action beyond the known anti-mitotic properties of this modality.

 

Regen BioPharma announced submission to the FDA of a revised IND application focused on using a novel method to unleash the body’s innate ability to kill cancer.  The package submitted contained preclinical experiments as well as details of the proposed clinical trial.  Results of the studies clearly demonstrated that the approach outlined, using siRNA to silence a key enzyme related to inhibition of the immune system, is effective at stimulating the type of immune response associated with known checkpoint inhibitors.

 

Allergan and Medicines360 announced the launch of the new LILETTA (levonorgestrel-releasing intrauterine system) 52 mg IUD single-handed inserter (intrauterine device), for use by women to prevent pregnancy for up to three years.  The launch and availability of the single-handed inserter follows the FDA approval received in January 2016.

 

Merck has joined the DiViNe project, a European consortium of six companies to address the biggest challenges facing the development, manufacture and delivery of vaccines. The objective of the DiViNe project is to create an integrated, cost-effective purification program specifically tailored for vaccines that achieves higher yields while preserving product integrity. Merck’s specific focus will be on simplifying the process of vaccine purification that typically relies on affinity chromatography, a method of capturing antibodies. In support of this goal, Merck will be providing chromatographic materials and coupling technologies.

 

Aeterna Zentaris announced that the remaining 8,064 Series B Common Share Purchase Warrants  issued in connection with the Company’s March 2015 financing expired on September 12, 2016 without being exercised. The Company had 9,939,863 Common Shares issued and outstanding as of the close of business on September 13, 2016.

 

Vital Therapies provided a corporate update. 14 subjects have been enrolled at sites in the USA and EU in VTL-308, the Company’s phase III randomized, controlled, open-label trial, designed to evaluate the ELAD System in subjects with severe acute alcoholic hepatitis (sAAH).   There are now 24 sites open for enrollment in VTL-308 in the USA and EU.  The Company continues to expect to announce topline results in mid-2018.

 

Xenon Pharmaceuticals announced that the underwriters of the previously announced public offering of its common shares have exercised in full their option to purchase an additional 600,000 common shares, consisting of 450,000 common shares from Xenon and 150,000 common shares from the selling securityholders named in the final prospectus supplement for the offering. The closing of the sale of all common shares occurred today. Gross proceeds from the offering of an aggregate of 3,450,000 common shares by Xenon and the offering of an aggregate of 1,150,000 common shares by the selling securityholders were approximately $25.9 million to Xenon and approximately $8.6 million to the selling securityholders, respectively, at a public offering price of $7.50 per share, before underwriting discounts and commissions and offering expenses. Xenon will not receive any proceeds from the sale of the common shares by the selling securityholders.

 

Zynerba Pharmaceuticals announced that the Company’s Board of Directors granted James Fickenscher, the Company’s newly appointed Chief Financial Officer and Vice President, Corporate Development, an option to purchase 150,000 shares of the Company’s common stock as an inducement material to his acceptance of employment with the Company in accordance with NASDAQ Listing Rule 5635(c)(4).  The option will have an exercise price equal to the closing price of Zynerba Pharmaceuticals’ common stock on September 13, 2016.  The option will vest 25% on the first anniversary of the date of the grant, with the remainder vesting in 12 equal quarterly installments thereafter, subject to Mr. Fickenscher’s continued service with the Company through the applicable vesting dates.

 

Agios Pharmaceuticals announced that it is offering to sell, subject to market and other conditions, up to $150 million of its common stock in an underwritten public offering. Agios also intends to grant the underwriters a 30-day option to purchase from it up to an additional $22.5 million of shares. All of the shares in the offering are to be sold by Agios. The proceeds of the offering are expected to be used to fund the company’s clinical and research development activities. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.

 

AC Immune SA announced that it has commenced the initial public offering of 4,545,456 of its common shares pursuant to a registration statement on Form F-1 with the U.S. Securities and Exchange Commission.  In connection with the offering, AC Immune intends to grant the underwriters the option to purchase up to 681,818 additional common shares to cover over-allotments, if any.  The estimated price range for the initial public offering is $11.00 to $13.00 per common share.  AC Immune has applied to list its common shares on the NASDAQ under the ticker symbol "ACIU."

 

Venaxis announced that it has acquired BiOptix Diagnostics. BiOptix has developed a proprietary Enhanced Surface Plasmon Resonance ("ESPR") technology platform for the detection of molecular interactions. The technology was developed in conjunction with Dr. John ‘Jan’ Hall, Adjoint Professor, JILA (University of Colorado), who shared the Nobel Prize for Physics in 2005.

 

NANOBIOTIX has filed for market approval (CE Marking) in Europe for its lead product, a first-in-class radio-enhancer, NBTXR3.

 

Astute Medical said that newly published findings show that the Company’s NEPHROCHECK Test may help physicians identify risk of a serious complication in patients who have undergone transcatheter aortic valve implantation (TAVI; also called TAVR, transcatheter aortic value replacement). The study, published in BMC Anesthesiology, demonstrates that two urinary biomarkers measured by the test, TIMP-2 and IGFBP-7, are highly sensitive and specific for the prediction of moderate to severe acute kidney injury (AKI) in TAVI.

 

DS Biopharma announced the appointment of Dr. Markus Weissbach (MD, PhD) to the position of Chief Operating Officer. Markus is currently Medical Director of DS and will move to his new role with immediate effect.

 

Symphogen announced that Jesper Bramming has joined Symphogen as its new Chief Financial Officer, filling the position vacated by Martin Olin, M.Sc., EMBA, who was promoted to Chief Executive Officer and member of the Board of Directors.

 

Optra Health announced that Dr. Scott Kahn will serve as Chief Strategy Advisor overseeing strategic direction for the Company’s Knowledge Automation and Analytics Platform iPhronesis for genomics-related research, digital drug development, real world evidence and Personalized Healthcare.

 

 

ANALYST RECOMMENDATIONS

 

Raymond James analyst Elliot Wilbur initiated coverage of Aerie Pharmaceuticals with a “strong buy” rating and $48 price target, citing two innovative first-in-class therapies, Rhopressa and Roclatan, to market for the treatment of glaucoma.

 

Leerink analyst Geoffrey Porges decreased his price target of Amgen to $193 from $195, citing current trends in the prescription data, continued pricing power, and branded and biosimilar competition.

 

Credit Suisse analyst Alethia Young decreased her price target of Gilead Sciences to $95 from $115, citing HCV consensus is still too high, but HIV and pipeline remain positive.