BioShares Biotechnology Clinical Trials (BBC): $22.60, -$0.23, +22.8% YTD

BioShares Biotechnology Products (BBP): $38.19, +$0.17, +16.6% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures were little changed, as investors remained cautious ahead of the Federal Reserve Chair Janet Yellen’s speech later in the day. Gold was headed for the worst week since November on growing speculation of an interest rate hike this month by the U.S. central bank. Oil edged up on weaker dollar. European shares were mixed with Britain’s FTSE slipping on disappointing corporate results, while Asian stocks ended the day lower.

 

 

MARKET HIGHLIGHTS

 

Achaogen held an R&D Day to provide an overview of its Research and Development programs including the Company’s new orally-administered antibacterial candidate, C-Scape. The meeting consisted of presentations from members of Achaogen’s leadership team and medical community key opinion leaders.  The Achaogen R&D Day focused on the Company’s antibacterial development pipeline to support the following corporate objectives: Prepare for potential Food and Drug Administration (FDA) approval and product launch of plazomicin; Initiate clinical development of C-Scape, the Company’s orally-administered beta-lactam/beta-lactamase inhibitor combination; and Continue to advance novel research candidates for serious unmet needs, including infections caused by MDR pathogens.

 

Achaogen will be presenting at the Cowen and Company 37th Annual Health Care Conference in Boston. Achaogen management will present at 9:20 a.m. Eastern Time on Tuesday, March 7th, 2017.

 

Angsana Molecular & Diagnostics has announced today that it will be a partner molecular test laboratory for STARTRK-2 clinical trial sites in Asia working with Ignyta. Angsana Molecular & Diagnostics’ RNA-based fusions cancer panel will be used for screening TRK, ROS1 and ALK fusions in the STARTRK-2 clinical trial, a registration-enabling global Phase 2 basket clinical trial for entrectinib, Ignyta’s investigational, orally available, CNS-active tyrosine kinase inhibitor targeting tumors that harbor TRK, ROS1 or ALK fusions.

 

Prothena Corporation has sold 2,700,000 of its ordinary shares at a price to the public of $57.50 per ordinary share. Gross proceeds to Prothena from the ordinary shares to be sold by Prothena in the offering are expected to be $155.3 million, before deducting the underwriting discount and estimated offering expenses, but excluding any exercise of the underwriter`s option to purchase additional ordinary shares. The offering is expected to close on March 8, 2017, subject to customary closing conditions. All of the ordinary shares in the offering were sold by Prothena. In addition, Prothena has granted the underwriter a 30-day option to purchase up to an additional 405,000 of its ordinary shares.

 

BioLife Solutions announced that the Company’s fourth quarter and full year 2016 financial results will be released on Thursday, March 9, 2017, and that the Company will host a conference call and live webcast at 1:30 p.m. PT that afternoon. Management will provide an overview of the Company’s financial results and a general business update.

 

Kamada is hosting a Research and Development Day to highlight Graft versus Host Disease (GvHD) today in NYC from 12:00pm to 1:30pm Eastern Time.  The meeting will feature a presentation by key opinion leaders H. Joachim Deeg, MD (Fred Hutchinson Cancer Research Center) and David M. Gelmont, MD (formerly at Shire/Baxalta), who will discuss the current treatment landscape for GvHD in bone marrow transplant patients and the unmet medical need for patients who develop acute GvHD. Both KOLs will be available to answer questions following the lunch.

 

SCYNEXIS announced that the FDA has informed the Company to hold the initiation of any new clinical studies with the intravenous (IV) formulation of SCY-078 until the FDA completes a review of all available pre-clinical and clinical data of the IV formulation of SCY-078. Ongoing and future trials using the oral formulation of SCY-078 are unaffected by this regulatory action. A meeting with the FDA to discuss these data and to agree on subsequent clinical studies with the IV formulation of SCY-078 is scheduled for the second quarter of 2017. The clinical hold decision was issued by the FDA following a review of three mild-to-moderate thrombotic events in healthy volunteers receiving the IV formulation of SCY-078 at the highest doses and highest concentrations in a Phase I study. The potential contribution of the IV formulation of SCY-078 to these events cannot be ruled out even though rates of thrombotic events due to intravenous catheters reported in the literature are comparable to those observed in the Phase I study.

 

aTyr Pharma announced that the EMA has granted orphan drug designation to Resolaris for the treatment of limb girdle muscular dystrophy (LGMD) patients.

 

Karyopharm Therapeutics announced the results of a planned interim analysis of the Phase II SOPRA study evaluating single agent selinexor in relapsed/refractory acute myeloid leukemia (AML). The Company determined in concert with the study’s independent Data Safety Monitoring Board (DSMB) that SOPRA will not reach statistical significance for overall survival (OS), the study’s primary endpoint.  However, since selinexor-treated patients that achieved a complete response (CR) showed a substantial OS benefit as compared with the physician’s choice (PC) arm, Karyopharm and the DSMB agreed that patients would be permitted to continue on the selinexor arm or the PC arm, as applicable, following discussion between the patient and their treating physician. The Company plans to continue clinical development of selinexor in AML through investigator sponsored trials in multiple combination regimens, including with chemotherapy, given encouraging data to date across these settings.

 

Cardiome Pharma announced that it received authorization from the French Transparency Pricing Commission to begin selling XYDALBA in France and that it has subsequently launched XYDALBA in France. The EMA approved XYDALBA in 2015 for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and the single dose administration was approved in 2016. XYDALBA can be administered as either one 1500 mg dose or as a two-dose regimen of 1000 mg followed one week later by 500 mg, each administered intravenously over 30 minutes.

 

Dermira announced new data, from its glycopyrronium tosylate (formerly DRM04) and olumacostat glasaretil (formerly DRM01) clinical programs, were presented in separate poster sessions at the 75(th) Annual Meeting of the American Academy of Dermatology (AAD) in Orlando, Florida.

 

Concordia International commented on the issuance by the UK Competition and Markets Authority (CMA) of a Statement of Objections to Actavis UK (formerly Auden Mckenzie) and Concordia’s International segment in relation to the supply of 10mg hydrocortisone tablets in the United Kingdom between 2013 and 2016.

 

Sartorius signed an agreement to acquire U.S. based Essen BioScience from SFW Capital Partners, a specialized private equity firm that invests in mid-sized businesses providing analytical tools and related services. The transaction, which is subject to antitrust clearance, is expected to close by the end of the first quarter 2017.

 

Janssen Research & Development announced new findings from two pivotal Phase III studies reporting the efficacy and safety of guselkumab in the treatment of adults with moderate to severe plaque psoriasis. Data from the VOYAGE 2 study showed that patients treated with guselkumab experienced significant improvements in skin clearance and other measures of disease activity compared with placebo, and significantly greater improvements compared with the anti-tumor necrosis factor (TNF)-alpha treatment Humira (adalimumab). VOYAGE 2 is the second Phase III study to demonstrate superior efficacy of guselkumab versus adalimumab following VOYAGE 1. Data from a third Phase III study (NAVIGATE) showed that patients who had an inadequate response following treatment with the anti-interleukin (IL)-12/23 monoclonal antibody (mAb) STELARA (ustekinumab) and who then switched to guselkumab, showed significantly greater improvements in skin clearance compared with patients who continued to receive ustekinumab. These Phase III data are being presented at the 2017 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida, 3–7 March. Guselkumab, a subcutaneously administered anti-IL-23 mAb, is currently under review by health authorities in the US and EU for the treatment of adults living with moderate to severe plaque psoriasis.

 

MediWound announced that outcomes from an independent cost analysis review utilizing NexoBrid in severe burn management compared with standard-of-care (SOC) were published in the February edition of the journal, BioMedical Research International, in an article titled, “Cost Analysis of a Novel Enzymatic Debriding Agent for Management of Burn Wounds.”

 

Valerion Therapeutics announced that it has developed a fusion protein, VAL-1221, which combines its proprietary antibody delivery technology with recombinant human acid alpha-glucosidase (rhGAA) to improve the delivery of rhGAA into affected tissues of patients with Pompe disease (Glycogen Storage Disease, Type II; GSDII).  Pompe disease is caused by a deficiency of the lysosomal enzyme, GAA, that leads to accumulation of glycogen in multiple tissues, with cardiac and skeletal muscles being the most severely affected.  Glycogen, a complex sugar, is known to accumulate in both the lysosomes and cytoplasm of late-onset Pompe disease patients. However, the currently approved enzyme-replacement therapy is limited to the lysosome for therapeutic activity.

 

Sanofi and its vaccines global business unit Sanofi Pasteur announced an agreement with MedImmune, the global biologics research and development arm of AstraZeneca, to develop and commercialize a monoclonal antibody–called MEDI8897–for the prevention of Respiratory Syncytial Virus (RSV) associated illness in newborns and infants. According to the Centers for Disease Control and Prevention, RSV is the most common cause of lower respiratory tract infections in children younger than 1 year of age in the U.S and worldwide.

 

Hutchison China MediTech Limited announced top-line results from FRESCO, its Phase III pivotal registration trial of fruquintinib in 416 patients with locally advanced or metastatic colorectal cancer ("CRC") in China, who failed at least two prior chemotherapies, including fluoropyrimidine, oxaliplatin and irinotecan. The trial met its primary endpoint of demonstrating a clinically meaningful and a statistically significant increase in overall survival ("OS"), in the intention-to-treat (ITT) population of patients treated with fruquintinib plus best supportive care ("BSC") as compared to patients treated with placebo plus BSC. Chi-Med is currently preparing to submit a new drug application ("NDA") for fruquintinib to the China Food and Drug Administration.

 

Editas Medicine announced that its COO, Alexandra Glucksmann, Ph.D., will be leaving the Company, effective March 31. Dr. Glucksmann’s responsibilities will be reallocated among current members of the Company’s management team.

 

 

ANALYST RECOMMENDATIONS

 

HC Wainwright analyst Ed Arce increased his price target of Aurinia Pharmaceuticals to $12 from $8, citing landmark data drives increased confidence in Phase III and commercial uptake.

 

Following Achaogen’s R&D Day, Aegis Capital analyst Difei Yang reiterated her BUY rating and $29 target, citing encouragement by the pipline and management strength.

 

Following PTC Therapeutics’ announcement of the failure of the ACT CF trial, Barclays analyst Geoff Meacham downgraded the stock to “equal-weight” from “over-weight” and decreased his price target to $13 from $20; Jefferies analyst Gena Wang decreased her price target to $10 from $12.

 

HC Wainwright analyst Shaunak Deepak decreased his price target of Karyopharm Therapeutics to $14 from $15, citing AML loss is largely offset by reduced safety overhang for selinexor.

 

Goldman has suspended coverage of the following companies, citing Stephan Stewart’s departure: Akorn, Catalent, Concordia, Endo International, Horizon Pharma, Impax Laboratories, Jazz Pharmaceuticals, Mallinckrodt, Momenta, Pacira, PharMerica.

 

Mizuho analyst Irina Koffler increased her price target of Endo International to $17 from $15, citing the stock as increasingly derisked post-2017 guidance.

 

BMO analyst Gary Nachman decreased his price target of Endo International to $15 from $17, citing cautious tone regarding continuing headwinds with generics.

 

Stifel analyst Thomas Shrader downgraded Kite Pharma to “hold” from “buy,” citing the company now faces a unique launch with treatment centers that have not all used these cells before and are likely to move slowly.

 

Leerink analyst Paul Matteis assumed coverage of Edge Therapeutics with an “outperform” rating and $21 price target, citing a positive view ahead of Phase III data for lead product EG-1962 in aneurysmal subarachnoid hemorrhage (aSAH) in 2018 (full data expected ~3Q), with an interim analysis on track for 1Q18 as 43 sites are actively screening patients.

 

Mizuho analyst Irina Koffler increased her price target of Pacira Pharmaceuticals to $59 from $50, citing lower clinical risk and increased likelihood of takeout.