BioShares Biotechnology Clinical Trials (BBC):

BioShares Biotechnology Products (BBP):

 

 

MARKET COMMENTARY

 

U.S. stock index futures were higher ahead of a rush of quarterly earnings reports that could give a steer to the markets. International trade, JOLTS job openings and consumer credit data are on the economic calendar, while Walt Disney, Gilead Sciences and Mondelez International are scheduled to report quarterly results later in the day. European stock markets rose supported by solid corporate results, while Asian shares closed mostly lower. The euro fell against the dollar and gold was little changed as investors remained wary about the French election. Oil steadied as the production cuts by OPEC balanced the increased U.S. drilling activity.

 

 

MARKET HIGHLIGHTS

 

BioTime announced the appointment of Stephana Patton, Ph.D., J.D., as General Counsel, a newly created position.  Dr. Patton brings more than 17 years of experience creating portfolio value at publicly-traded biotechnology and pharmaceutical companies. Dr. Patton was formerly the General Counsel and Commercial Compliance Officer at BioDelivery Sciences, a publicly-traded specialty pharmaceutical company.

 

VBI Vaccines announced today the receipt of positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medical Agency (EMA) regarding the company’s development path for its Sci-B-Vac™ vaccine in Europe. Sci-B-Vac™ is a third-generation hepatitis B vaccine with demonstrated safety and efficacy in over 300,000 patients in currently licensed markets.  In its letter, the CHMP expressed its support of VBI’s proposed plan to proceed to the Phase III clinical studies of Sci-B-Vac™. The CHMP also agreed that the product information, as well as data from ongoing studies, supports the Phase III clinical studies and VBI’s planned filing of a market authorization application (MAA) for Sci-B-Vac™.

 

Aurinia Pharmaceuticals announced its Board of Directors has appointed Dr. Richard M. Glickman L.LD (Hon), the Company’s founder and Chairman of the Board, as Aurinia’s Chairman and Chief Executive Officer (CEO). The board accepted the resignation of Charles Rowland as CEO and an executive member of the Board, effective immediately.  Dr. Glickman brings over 30 years of experience in the creation and operation of healthcare ventures, founding and co-founding numerous companies during his career.

 

Alcobra announced that it has reached a regulatory milestone in the development of ADAIR (Abuse-Deterrent, Amphetamine Immediate-Release), a novel product candidate for the treatment of attention deficit hyperactivity disorder (ADHD). Alcobra has been working on this proprietary product and its unique formulation with Capsugel, a global leader in delivering high-quality, innovative dosage forms and solutions. Alcobra recently held a pre-IND meeting with the U.S. Food and Drug Administration (FDA) to discuss the details of the proposed 505(b)(2) development program.  The FDA provided guidance on the necessary steps towards an NDA, which is expected to be submitted before the end of 2018. Alcobra expects its existing financial resources to support the development program of ADAIR to NDA filing. There are currently no such FDA-approved abuse-deterrent stimulants.

 

MediciNova announced the presentation of results from a completed Phase 1b trial of MN-166 (ibudilast) in methamphetamine dependence at a symposium titled “Neuroimmune Modulation in Addiction: Preclinical and Clinical Findings” at the 50th Winter Conference on Brain Research held from January 28 to February 2, 2017 in Big Sky, Montana.

 

CymaBay Therapeutics will provide a corporate overview at the BIO CEO & Investor Conference on Tuesday, February 14th @ 9:30amET.

 

Bio-Techne reported fiscal 2Q17 non-GAAP EPS of $0.81, which compares to $0.88 for the same period a year ago. The company missed the non-GAAP EPS mean estimate of $0.85. Total revenue for fiscal 2Q17 was $131.8 million, which compares to $120.9 million for the same period a year ago. This compares to a mean estimate of $134.5 million.

 

GW Pharmaceuticals reported the following numbers for 1Q17; revenue for the three months ended 31 December 2016 of £2.1 million ($2.5 million) compared to £3.7 million for the three months ended 31 December 2015; loss for the three months ended 31 December 2016 of £15.6 million ($19.3 million) compared to £17.7 million for the three months ended 31 December 2015; cash and cash equivalents at 31 December 2016 of £360.2 million ($444.6 million) compared to £374.4 million as at 30 September 2016.       

 

Dow Jones reported that Mallinckrodt reported better-than-expected earnings and sales in the most recent period as the company increased volume in its core segment. The pharmaceutical company also gave a downbeat 2017 sales forecast, projecting adjusted earnings of $7.40 to $8.00 per share on a revenue decline of 2% to 5%. Analysts polled by Thomson Reuters were expecting earnings of $7.55 on a 1.9% revenue decline. In all for the period, Mallinckrodt swung to a loss of $153.2, or $1.67 a share, compared with a profit of $211.1 million, or 89 cents per share, a year earlier. Excluding items such as impairment charges, earnings fell to $1.91 per share from $1.97 per share. The most-recent quarter included a $207.0 million impairment charge for its specialty generics segment. Revenue increased 2.3% to $829.9 million. Analysts polled by Thomson Reuters had forecast earnings of $1.82 on $826.9 million in revenue.

 

Actinium Pharmaceuticals announced that a Phase I clinical trial studying Actimab-M in multiple myeloma has been initiated.

 

Teva announced that Dr. Yitzhak Peterburg, who has served as Chairman of the Teva Board of Directors since January 2015, has been appointed Interim President and Chief Executive Officer, effective immediately. This follows the mutual agreement between the Board of Teva and Erez Vigodman that Mr. Vigodman is stepping down. Mr. Vigodman’s service on the Teva Board of Directors has also ended.

 

Cellectis has received an IND approval from the FDA to conduct Phase I clinical trials with UCART123, the Company’s most advanced, wholly owned TALEN gene-edited product candidate, in patients with acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN). This marks the first allogeneic, “off-the-shelf” gene-edited CAR T-cell product candidate that the FDA has approved for clinical trials. Cellectis intends to initiate Phase I trials in the first half of 2017.

 

Flexion Therapeutics announced that the FDA has accepted for filing the Company’s NDA for its lead investigational product candidate Zilretta (also known as FX006). Zilretta is being evaluated as a new treatment option for patients with osteoarthritis (OA) of the knee. In accordance with the FDA’s standard 10-month review designation, the agency has established a user fee goal date under the PDUFA of October 6, 2017.

 

Angionetics , a majority-owned subsidiary of Taxus Cardium Pharmaceuticals Group, reported that the FDA has granted Fast Track designation for the Phase III clinical investigation of Generx [Ad5FGF-4] cardiovascular angiogenic gene therapy as a one-time treatment for improving exercise tolerance in patients who have angina that is refractory to standard medical therapy and not amenable to conventional revascularization procedures (coronary artery bypass surgery and percutaneous coronary intervention and stents).

 

Reuters reported that Health Canada approved Roche’s Gazyva for patients with previously treated follicular lymphoma.

 

Aldeyra Therapeutics announced that it has enrolled the first patient in a Phase IIb clinical trial of ADX-102 for the treatment of allergic conjunctivitis.

 

OPKO Health announced the promotion of Thomas Nusbickel to the newly created position of Chief Commercial Officer of OPKO Health’s Renal Division, effective immediately. In this new role, Mr. Nusbickel will lead the continued commercialization of RAYALDEE (calcifediol) extended-release capsules for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. Mr. Nusbickel, previously Senior Vice President of Marketing and Market Access, will be responsible for all commercial activities, including sales, marketing and market access.

 

Perrigo announced that it has entered into an agreement with Starboard Value, which owns approximately 6.7 percent of Perrigo’s shares, regarding the membership and composition of the Perrigo Board of Directors and certain customary standstill restrictions. Under the terms of the agreement, Jeffrey Smith, Starboard’s CEO and Chief Investment Officer, Bradley Alford and Jeffrey Kindler have been appointed to the Perrigo Board, effective immediately, and Starboard will also be recommending two additional independent directors to be added to the Perrigo Board. Current directors, Herman Morris, Shlomo Yanai, Michael Jandernoa, and Gary Kunkle will step down from the Board effective immediately. Perrigo’s Board of Directors will be composed of 10 members until the appointment of an additional Board member. Ellen Hoffing will step down from the Board upon the appointment of the second additional Board member recommended by Starboard at a later date.

 

Perrigo announced that it has filed an ANDA with the FDA for clindamycin, benzoyl peroxide topical gel, the generic version of Onexton gel (clindamycin phosphate 1.2% and benzoyl peroxide 3.75%). Perrigo has notified Valeant Pharmaceuticals North America and Dow Pharmaceutical Sciences (Valeant) the owner of both the NDA and patents listed in FDA’s Orange Book, of its filing.

 

Oncobiologics announced an extension to the term for exercise of its publicly traded Series A warrants. The Series A warrants were issued as part of the units in Oncobiologics’ May 2016 initial public offering and are exercisable for shares of its common stock at an exercise price of $6.60 per share. The Series A warrants would have expired at 5:00 pm New York City time on February 18, 2017. The expiration date has now been extended to 5:00 p.m. New York City time on February 18, 2018. The Series A warrants and the common stock issuable upon exercise of the Series A warrants are covered by a registration statement on Form S-1, as amended, previously filed with and declared effective by the Securities and Exchange Commission.

 

NANOBIOTIX announced the appointment of Alain Dostie, a senior executive from the pharmaceutical industry, as its Chief Operating Officer (COO).

 

Lannett Company announced that it has completed the extraction of the core software supporting the operations of Kremers Urban Pharmaceuticals from UCB Pharma.

 

 

ANALYST RECOMMENDATIONS

 

Stifel analyst Stephen Willey initiated coverage of Achaogen with a “buy” rating and $27 price target, citing recently announced EPIC and CARE data provide a clear regulatory path forward and establish wholly-owned plazomicin as a desperately needed treatment option in the fight against expanded spectrum beta-lactamase producing and carbapenem-resistant Enterobacteriaceae.

 

Citi analyst Robyn Karnauskas upgraded Biogen to “buy” from “neutral” and increased her price target to $305 from $280.94, citing the real driver of shares over the next 12-18mo is uptake of Spinraza.

 

Morgan Stanley analyst Matthew Harrison initiated coverage of BioMarin with an “overweight” rating and $110 price target, citing BioMarin is best of breed out of the major orphan companies with both commercial and R&D success over a wide range of products.

 

Needham analyst Chad Messer initiated coverage of Athersys with a “buy” rating and $7 price target, citing Athersys is developing MultiStem, an off-the-shelf cell therapy that promotes tissue repair.

 

RBC analyst Michael Yee increased his price target of Esperion to $20 from $15, citing a positive AMGN CV outcomes result (confirmed last week) helps de-risk the LDL hypothesis and the ESPR story making it less likely they would have to complete their own CVOT prior to accelerated approval in 2019-2020.

 

RBC analyst Michael Yee increased his price target of Ariad Pharmaceuticals to $24 from $14, citing Takeda acquisition.