BioShares Biotechnology Clinical Trials (BBC): $20.20, +$1.95, -30.5% YTD

BioShares Biotechnology Products (BBP): $33.73, +$3.33, +9.4% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures advanced, as investors took respite after a massive sell-off in risky assets and absorbed Republican Donald Trump’s U.S. presidential win. Weekly jobless claims and federal budget data are on the economic calendar, while Walt Disney and Nvidia are scheduled to report results later in the day. European stocks rose, following extraordinary gains in Asia. The dollar recouped losses against a basket of major currencies. Uncertainty over the economic policies of Trump, supported gold prices. U.S. crude surrendered gains.

 

 

MARKET HIGHLIGHTS

 

Prothena Corporation plc announced results from its Phase 1b multiple ascending dose study of PRX002, an antibody under investigation as a potentially disease-modifying treatment for Parkinson`s disease. PRX002, also known as RG7935, is the focus of a worldwide collaboration between Prothena and Roche.  PRX002 was found to have an acceptable safety and tolerability profile in patients with Parkinson`s disease, meeting the primary objective of this study. Robust CNS penetration was demonstrated by a dose-dependent increase in PRX002 levels in CSF, and a mean concentration of PRX002 in CSF of 0.3 percent relative to serum across all dose levels. Additional results showed a rapid, dose- and time dependent mean reduction of free serum alpha-synuclein levels of up to 97 percent after a single dose, which were statistically significant (p < 0.0001), and confirmed after two additional monthly doses.

 

SciClone Pharmaceuticals reported financial results for the quarter ended September 30, 2016.  In the third quarter of 2016, SciClone reported revenues of $40.5 million, compared to $42.9 million for the same period in 2015.  In the third quarter of 2016, SciClone reported GAAP diluted net income per share of $0.19, compared to GAAP diluted net income per share of $0.23 for the same period in 2015.  As of September 30, 2016, cash and cash equivalents totaled $130.1 million, compared to $101.4 million as of December 31, 2015.

 

ASPiRA LABS, a Vermillion company (VRML), today announced the inclusion of the OVA1 /"Multivariate Index Assay" in The American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin Number 174, dated November 2016. This bulletin outlines ACOG’s "new" clinical management guidelines for adnexal mass management.

 

CymaBay Therapeutics announced financial results for the quarter and nine months ended September 30, 2016.  Net loss for the three months ended September 30, 2016, was $5.9 million, or ($0.25) per diluted share, compared to $5.9 million, or ($0.27) per diluted share for the prior year period.  Cash, cash equivalents and short-term investments as of September 30, 2016, were $23.1 million, compared to $41.5 million at December 31, 2015.

 

CymaBay Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted the Company orphan drug designation for MBX-8025 to treat patients with primary biliary cholangitis (PBC). MBX-8025 is a potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist being evaluated by CymaBay in high unmet need and orphan diseases. The FDA has also granted orphan drug designation for MBX-8025 to treat patients with homozygous familial hypercholesterolemia (HoFH) and hyperlipoproteinemia types I or V (Fredrickson classification).

 

Aurinia Pharmaceuticals has entered into a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co. (“Cantor”) pursuant to which the Company may from time to time sell, through at-the-market (“ATM”) offerings with Cantor acting as sales agent, such common shares as would have an aggregate offer price of up to US$8,000,000.

 

VBI Vaccines is scheduled to present at the Society of Neuro-Oncology Annual Meeting on Friday, November 18, 2016 at 5:00 PM EST. The event is being held at the Scottsdale Fairmont Princess Hotel in Scottsdale, AZ.

 

CTD Holdings announced that the Swedish Medical Products Agency has approved CTD Holdings’ Clinical Trial Application to conduct a Phase I/II clinical study at Karolinska University Hospital in Sweden evaluating Trappsol® Cyclo™ in patients with Niemann-Pick Type C (NPC) Disease, a rare and fatal illness tied to an autosomal recessive genetic defect. Karolinska represents the third site in Europe approved to conduct this study. CTD Holdings expects that the first patient in this Phase I/II clinical trial will be dosed in the first quarter of 2017.

 

Kamada announced financial results for the three and nine months ended September 30, 2016.  Total revenues were $53.2 million in the 9-months ended September 30, 2016, a 20% increase from the $44.2 million in the same period of 2015.  Net loss for the 9-month period was $4.9 million, or $0.14 per share, compared to a net loss of $12.3 million, or $0.34 per share in the same period of 2015.  As of September 30, 2016, the Company had cash, cash equivalents and short-term investments of $27.2 million, compared with $28.3 million as of December 31, 2015.

 

VBL Therapeutics reported financial results for the third quarter and nine month period ended September 30, 2016.  The net loss for the nine-month period was approximately $11.2 million, or ($0.46) per share, compared to a net loss of $11.7 million, or ($0.59) per share in the same period of 2015. At September 30, 2016, the Company had cash, cash equivalents and short-term bank deposits totaling $48.9 million and working capital of $46.0 million.

 

MediciNova announced that the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending orphan medicinal product (orphan-drug) designation for MN-166 (ibudilast) for the treatment of amyotrophic lateral sclerosis (ALS).  Orphan-drug designation offers potential benefits including protocol assistance, fee waivers, and 10-year market exclusivity once the medicine is on the market in Europe.

 

Innate Pharma SA announced that the Company will host a conference call on November 14, 2016 to discuss lirilumab and IPH4102 clinical data published at the most recent scientific meetings of SITC, ESMO, and 3WCCL.

 

Foamix Pharmaceuticals will provide a corporate overview at the Jefferies London Healthcare Conference on November 17, being held at the Waldorf Hilton Hotel in London, UK.

 

Palatin Technologies will announce its first quarter, fiscal year 2017 operating results on Tuesday, November 15, 2016  before the open of the U.S. financial markets.

 

Zealand Pharma will provide a corporate update at the Bryan Garnier & Co. Annual Healthcare Conference on November 15, the Jefferies 2016 Healthcare Conference on November 16, and the Citi 2016 Global Healthcare Conference on December 7.

 

Aradigm Corporation will present an overview of the Company at the Stifel 2016 Healthcare Conference on Wednesday, November 16.

 

MannKind and Sanofi have entered into an agreement with the following terms: The promissory note and security agreement between MannKind and Aventisub, a Sanofi affiliate, were terminated, with Aventisub agreeing to forgive the full outstanding loan balance of $71.56 million.  MannKind also relieved from its obligation to pay $0.5 million in previously uncharged costs related to the collaboration. Sanofi will purchase $10.2 million worth of insulin from MannKind in early December as part of its preexisting commitment to purchase insulin following termination of the collaboration and MannKind’s exercise of a put option.  The balance of the insulin put option ($30.6 million) is accelerated with Sanofi completing the cash payment of $30.6 million to MannKind by January 9, 2017.  This payment will be made without MannKind being required to deliver any insulin to Sanofi. All issues arising out of the license and collaboration agreement, the supply agreement, the promissory note, the security agreement and the transition agreement are resolved.

 

Anthera Pharmaceuticals announced that the CHABLIS-SC1 clinical trial with blisibimod for the treatment of systemic lupus erythematosus (SLE) failed to meet its primary endpoint based upon the SLE Responder Index-6 (SRI-6) at 52 weeks. Although 47% of patients in the blisibimod arm versus 42% of patients in the placebo arm achieved this endpoint, the difference was not statistically significant. The SRI is a composite index comprised of SELENA-SLEDAI, BILAG and Physician Global Assessment criteria. A SRI-6 response requires a decrease of at least 6 points in SELENA-SLEDAI. The magnitude of blisibimod treatment effects for other SLE Response (SRI-4, and SRI-8) also did not achieve statistical significance.

 

Omeros announced pharmacokinetic and pharmacodynamic data from the evaluation of OMS906 in non-human primates. OMS906 inhibits mannan-binding lectin-associated serine protease-3 (MASP-3), the protein critical to activation of the alternative pathway of complement (APC), a key component of the immune system. MASP-3 is responsible for the conversion of pro-factor D to factor D. Converted factor D is necessary for the activation of the APC. The APC is involved in a wide range of diseases, including paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome, age-related macular degeneration, arthritis, asthma and traumatic brain injury.

 

Dow Jones reported that Perrigo acquiesced to an activist investor demand and said it was considering strategic alternatives for one of its drugs, and it swung to a quarterly loss, hurt by charges. Perrigo said it was exploring strategic alternatives for the lucrative royalty stream rights for its multiple sclerosis drug Tysabri. Perrigo also said it had taken an $804 million goodwill impairment charge and a $866 million charge for brand impairment, both related to its 2015 $4.5 billion purchase of Omega Pharma NV Perrigo said it would file an arbitral claim against the sellers of Omega before the end of the year. In all for the latest quarter, Perrigo posted a net loss of $1.26 billion, or $8.76 a share, compared with a net profit of $112.6 million, or 77 cents a share, last year. On an adjusted basis, which excludes the write-downs, profit per share was $1.65, down from $1.76 last year. Revenue rose 0.8% to $1.35 billion. Analysts polled by Thomson Reuters had expected adjusted earnings per share of $1.58 on $1.28 billion in revenue.

 

After yesterday’s close, Mylan reported 3Q16 non-GAAP EPS of $1.38, which compares to $1.43 for the same period a year ago. The company missed the First Call non-GAAP EPS mean estimate of $1.46. Total revenue for 3Q16 was $3.06 billion, which compares to $2.71 billion for the same period a year ago. This compares to a mean estimate of $3.12 billion. Following earnings, Deutsche Bank analyst Gregg Gilbert decreased his price target to $55 from $57; RBC analyst Randall Stanicky decreased his price target to $44 from $48.

 

After yesterday’s close, Juno Therapeutics reported 3Q16 GAAP EPS loss of $0.56, which compares to a $0.26 loss for the same period a year ago. The company beat the First Call GAAP EPS mean estimate loss of $0.60. Total revenue for 3Q16 was $20.8 million, which compares to $1.6 million for the same period a year ago. This compares to a mean estimate of $10.6 million. Following earnings, Goldman analyst Salveen Richter decreased her price target to $32 from $33.

 

Amgen announced a collaboration with Janssen Biotech to evaluate the combination of Amgen’s KYPROLIS (carfilzomib) and Janssen’s DARZALEX (daratumumab) in multiple clinical studies in patients with multiple myeloma. Under the terms of the agreement, the companies may elect to supply drug only or supply drug and share development costs on a study-by-study basis.

 

Adaptimmune announced that the FDA has removed the partial clinical hold on the planned study of its NY‑ESO SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell therapy in MRCLS. Under a revised protocol, Adaptimmune will initiate a study in up to 15 MRCLS patients. Patient screening is expected to begin in 4Q 2016. Results from this study will inform a potential future registration trial.

 

Aduro Biotech announced that Tom Dubensky Jr., Ph.D., chief scientific officer of Aduro, presented about the company’s personalized LADD technology at the Society for Immunotherapy of Cancer (SITC) distinct session titled New Cancer Immunotherapy Agents in Development being held in conjunction with the SITC annual meeting.

 

Reuters reported that Mylan said it was working to finalize a settlement with the U.S. government over Medicaid rebates for its EpiPen emergency allergy treatment, adding that money set aside for the settlement led to a third quarter loss. The company had previously said it agreed to terms of a settlement set at $465 million. However the U.S. Justice Department and other agencies have yet to confirm any such agreement.

 

Bristol-Myers Squibb announced that ONO-4538-12, a Phase III, randomized, double-blind clinical trial evaluating the efficacy and safety of Opdivo (nivolumab) in patients with unresectable advanced or recurrent gastric cancer refractory to, or intolerant of, standard therapy, met its primary endpoint of overall survival (OS). Ono Pharmaceutical Co. Ltd. of Japan, Bristol-Myers Squibb’s development partner for Opdivo, conducted the ONO-4538-12 trial. The companies will work with investigators on the future presentation of the study results.

 

Bristol-Myers Squibb and Nitto Denko announced the companies have entered into an agreement granting Bristol-Myers Squibb exclusive worldwide rights for the development and commercialization of Nitto’s investigational siRNA molecules targeting heat shock protein 47 (HSP47) in vitamin A containing formulations, which includes Nitto’s lead asset ND-L02-s0201, currently in Phase Ib study for the treatment of advanced liver fibrosis. The agreement also grants Bristol-Myers Squibb the option to receive exclusive licenses for HSP47 siRNAs in vitamin A containing formulations for the treatment of lung fibrosis and other organ fibrosis. The agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

 

Seattle Genetics announced that the FDA has granted Breakthrough Therapy Designation to ADCETRIS (brentuximab vedotin) for the treatment of patients with CD30-expressing mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) who require systemic therapy and have received one prior systemic therapy. MF and pcALCL are the most common subtypes of cutaneous T-cell lymphoma (CTCL), accounting for more than 75 percent of the disease. ADCETRIS has been evaluated in CD30-expressing CTCL in investigator- and corporate-sponsored clinical trials, including the Phase III ALCANZA study. The positive topline results of the ALCANZA trial were announced in August 2016 and an abstract was accepted for oral presentation at the upcoming American Society of Hematology (ASH) annual meeting, December 3-6, 2016 in San Diego, California. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30 which is expressed on skin lesions in approximately 50 percent of patients with CTCL. ADCETRIS is currently not approved for the treatment of CTCL.

 

RedHill Biopharma announced that it has concluded a positive Type B Meeting with the FDA discussing the chemistry, manufacturing and controls (CMC) aspects of the RHB-105 Phase III development program. RHB-105 is a proprietary, fixed-dose, oral combination therapy for the eradication of H. pylori infection.

 

Proteon Therapeutics announced the first patient was dosed in a Phase I clinical study evaluating a single administration of investigational drug vonapanitase delivered immediately following angioplasty to patients with peripheral artery disease (PAD).

 

Genmab A/S announced that daratumumab (DARZALEX) will be investigated in a Phase III clinical study in combination with carfilzomib (KYPROLIS(R) ) and dexamethasone in patients with relapsed/refractory multiple myeloma. The study will be conducted under a master clinical trial collaboration and supply agreement between Genmab’s licensing partner for daratumumab, Janssen Biotech and Onyx Pharmaceuticals, a wholly-owned subsidiary of Amgen. The agreement covers all potential opportunities for combining daratumumab and carfilzomib (a proteasome inhibitor) for the treatment of patients with cancer.

 

Halozyme Therapeutics and Genentech, a member of the Roche Group, announced an agreement to collaborate on clinical studies evaluating up to eight different tumor types beginning in 2017. The first study will be a Phase Ib/II open-label, multi-arm randomized global study, led by Genentech to evaluate their cancer immunotherapy Tecentriq (atezolizumab), an anti-PD-L1 monoclonal antibody, in combination with Halozyme’s investigational drug, PEGPH20 in six tumor types. Halozyme will supply drug only for the Genentech study. This study will have an initial focus on gastrointestinal malignancies, including pancreatic and gastric cancers. The second study will be a Phase Ib open-label randomized study led by Halozyme to assess Tecentriq in combination with PEGPH20 and chemotherapy in advanced or metastatic biliary and gallbladder cancers.

 

Reuters reported that Valeant Pharmaceuticals said it received an investigative subpoena from the California Department of Insurance in September over its ties to pharmacies and marketing. The request follows allegations against Valeant that it used speciality pharmacy Philidor Rx Services to force customers to pay higher prices for its drugs. The subpoena seeks materials including documents concerning Valeant’s former relationship with Philidor, now defunct, and certain California-based pharmacies, the marketing and distribution of its products in California, the company said in a filing.

 

Pfizer announced that the EC has approved IBRANCE (palbociclib) for the treatment of women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer. The approval is for IBRANCE to be used in combination with an aromatase inhibitor. The approval also covers the use of IBRANCE in combination with fulvestrant in women who have received prior endocrine therapy.

 

Reuters reported that AstraZeneca said it had given up on the idea of seeking an early approval of its immunotherapy drug durvalumab in head and neck cancer using mid-stage Phase II clinical trials data. The move follows recent changes in the competitive landscape, which has seen Merck’s similar Keytruda approved for the condition, reducing the case for special regulatory treatment of durvalumab. The decision to drop early filing plans in head and neck cancer follows a similar outcome in lung cancer, where AstraZeneca was also too late because Keytruda and Bristol-Myers Squibb’s Opdivo had already won approval.

 

Selecta Biosciences announced that it is receiving worldwide rights to intellectual property, data and materials generated through a discovery collaboration initiated and funded by Sanofi for the development of product candidates to treat peanut allergy and celiac disease. This follows Sanofi’s strategic review of its R&D portfolio, which resulted in a decision to exit this collaboration with Selecta. The transition of these discovery programs is not expected to have a material impact on Selecta’s cash runway.

 

Pluristem Therapeutics announced that its previously signed and announced term sheet for an investment into Pluristem of approximately $30,000,000 by China-based Innovative Medical Management Co., Ltd., has been approved by Innovative Medical’s Board of Directors and its shareholders. As a result of these approvals, the Term Sheet is now a binding agreement.

 

Theratechnologies announced that it has been notified by its partner, TaiMed Biologics, of the preliminary results for the safety and efficacy secondary endpoints of the 24-week Phase III trial with ibalizumab in patients with multi-drug resistant (MDR) HIV-1 (TMB-301). This Phase III trial confirms the safety and efficacy results of ibalizumab observed in the previously completed Phase IIb study, despite the fact that the patient population in the Phase III trial had higher levels of MDR HIV-1 and more advanced disease at time of enrollment.

 

Axsome Therapeutics announced today that it has entered into a $20 million term loan agreement with Silicon Valley Bank. Axsome intends to use the additional capital to support the ongoing development of its late-stage clinical pipeline.

 

Tonix Pharmaceuticals will announce new results from a retrospective analysis of the data from the AtEase study, a 12-week, randomized, double-blind, placebo-controlled Phase II clinical study evaluating TNX-102 SL*, 5.6 mg, in military-related PTSD. The retrospective analysis focused on patients whose total CAPS-5 entry score was greater than or equal to 33. The analysis revealed that at the 5.6 mg dose, TNX-102 SL had a significant improvement in reckless or self-destructive behavior, which can include dangerous driving, high-risk thrill-seeking, excessive alcohol or drug use, injurious behaviors to self or others, or suicidal behaviors.

 

Allergan announced the availability of TAYTULLA™ (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules), 1mg/20mcg, the first and only oral contraceptive in a softgel capsule for the prevention of pregnancy.

 

Galectin Therapeutics announced its plans to identify a strategic partnership for its galectin-3 inhibitor GR-MD-02 for the treatment of serious skin diseases, including moderate-to-severe plaque psoriasis and severe atopic dermatitis. The Company now has complete data on the therapy of five patients with moderate-to severe plaque psoriasis for up to 24 weeks with 8 mg/kg doses of GR-MD-02 delivered every other week. All five patients had significant clinical improvement (mean of 52% improvement) as measured by an objective measurement, the PASI (Psoriasis Area and Severity Index). The fifth patient, who also had the most severe baseline disease, had a 72% PASI improvement after the full thirteen infusions (24 weeks). The significant clinical improvement in the fifth patient is shown in the accompanying photographs; the same degree of improvement was evident in all body regions.

 

Imprimis Pharmaceuticals announced it has entered into a product purchase and supply agreement with the specialty pharmacy division of one of the nation’s largest pharmacy benefit managers (PBMs) to supply Imprimis’ complete formulary of low-cost compounded medications through the PBM’s national network of specialty pharmacies.

 

Illumina announced it has entered an agreement with Mayo Clinic to make advancements in next-generation sequencing technology with the intent to accelerate Mayo’s delivery of genetic and genomic expertise.

 

Oncolytics Biotech announced the appointment of Andres A. Gutierrez, MD, PhD to the role of Chief Medical Officer.

 

Fibrocell Science announced the appointment of Alfred T. Lane, MD, as Chief Medical Advisor of Fibrocell.

 

 

ANALYST RECOMMENDATIONS

 

Rodman &Renshaw analyst Raghuram Selvaraju initiated coverage of Cellect Biotechnology with a “buy” rating and $10 price target, citing a novel technology platform, Powered by Cellect™, which is aimed at optimizing the selection of stem cells by specifically eliminating harmful immune cells from bone marrow-derived cell populations taken from allogeneic donors.

 

Following Kite’s earnings, Citi analyst Robyn Kanauskas decreased her price target to $62 from $67.

 

Following Omeros’s earnings, Needham analyst Serge Belanger decreased his price target to $24 from $28.

                                       

Following Puma Biotechnology’s earnings, Bank of America/Merrill Lynch analyst Ying Huang increased his price objective to $89 from $83.

 

Rodman &Renshaw analyst Raghuram Selvaraju downgraded Valeant to “neutral” from “buy” and decreased his price target to $23 from $81, citing the continuing litany of risks that Valeant faces, including ongoing legal challenges, subpoenas, regulatory warning letters, and possible criminal investigations of its former executives.

 

Rodman &Renshaw analyst Raghuram Selvaraju decreased his price target of Evoke Pharma to $2.00 from $2.50, citing the future of its sole clinical-stage asset, Gimoti™, remains uncertain.

 

Leerink analyst Paul Matteis assumed coverage of the following stocks: WaVe Life Sciences with an “outperform” rating and $45 price target; Alnylam with a “market perform” and $43 price target; Ionis with a “market perform” rating and $40 price target.

 

Following Arrowhead Pharmaceuticals’ announcement of a clinical hold on Heparc-2004, Chardan analyst Madhu Kumar decreased his price target to $8 from $10; Jefferies analyst Eun Yang decreased her price target to $5.00 from $6.50

 

Susquehanna analyst Andrew Finkelstein upgraded Endo International to “positive” from “neutral” and decreased his price target to $20 from $22, citing a change in leadership has renewed focus on the core business after a cycle of boom and bust on M&A-driven growth.

 

Citi analyst Yigal Nochomovitz increased his price target of Keryx Biopharmaceuticals to $4 from $3, citing Patheon approval a good but necessary step, while the re-launch still looks risky.

 

Leerink analyst Puneet Souda resumed coverage of the following companies: Bio-Techne with an “outperform” rating and $122 price target; Thermo Fisher with an “outperform” rating and $175 price target; Waters with an “outperform” rating and $163 price target; Agilent with an “outperform” rating and $53 price target; Invitae with an “outperform” rating and $12 price target; Bruker with a “market perform” rating and $21 price target; Illumina with a “market perform” rating and $145 price target; T2 with a “market perform” rating and $5 price target.

 

Leerink analyst Punnet Souda initiated coverage Patheon with an “outperform” and $31 price target, citing PTHN is poised to gain share in the highly fragmented contract development industry given its scale and end-to-end service offering for early-stage biotech to large-cap biopharma companies.

 

Maxim analyst Jason McCarthy initiated coverage of Proteon with a “buy” rating and $19 price target, citing with binary event approaching and positive “skew” on the outcome.