BioShares Biotechnology Clinical Trials (BBC): $21.63, +$0.03, -25.5% YTD

BioShares Biotechnology Products (BBP): $35.26, -$0.34, +14.4% YTD

 

 

MARKET COMMENTARY

 

After Wall Street took a breather in the previous session as investors cashed in on a post-election rally and waited for clarity on the next administration’s policies, U.S. stock index futures edged higher. European shares clawed higher, though gains were limited by worries that next month’s Italian referendum on constitutional reform could create political instability. Asian shares closed mixed, with the Nikkei index closing higher. Gold advanced as the dollar shed some of the hefty gains. Oil prices rose on hopes of OPEC-led production cut later this month.

 

 

MARKET HIGHLIGHTS

 

DelMar Pharmaceuticals summarized the Company’s presentations at the CNS Anticancer Drug Discovery and Development Conference and Society for NeuroOncology Annual meeting, which was held November 16-20, 2016 in Scottsdale, Arizona. During the conference, DelMar’s chairman and CEO, Jeffrey Bacha, delivered an oral address during CNS Anticancer Drug Discovery and Development sessions.  Mr. Bacha described DelMar’s research and recent clinical trial results and how these data position VAL-083 as a potential solution for newly diagnosed GBM patients whose cancer exhibits features, such as a high expression of MGMT, implicated in resistance to currently approved chemotherapy.

 

Aimmune Therapeutics announced that it will host an Investor Symposium in New York City on December 1, 2016. The event will bring together leading experts to discuss the emerging treatment landscape in peanut allergy. Topics will include a historical overview of immunotherapy approaches, considerations for developing regulated treatment options, Phase 2 data and experience with AR101, and treatment expectations in the peanut-allergic community. The Aimmune management team will also provide a corporate and clinical update and review upcoming milestones. A question and answer session will follow the formal presentations. AR101 is Aimmune’s investigational oral biologic desensitization therapy for peanut allergy, which is currently in Phase 3 clinical development.

 

Evogene announced its financial results for the third quarter and nine months ended September 30, 2016.  Net loss for the third quarter of 2016 was $5.1 million compared with a net loss of $3.4 million in the third quarter of 2015. Net loss for the nine months ended September 30, 2016, was $12.9 million compared with a net loss of $11.7 million for the same period in 2015.  As of September 30, 2016, Evogene had $93.1 million in cash, short-term bank deposits and marketable securities, representing a net cash usage of $3.9 million for the third quarter and $7.6 million for the nine months ended September 30, 2016.

 

Acorda Therapeutics announced that the MILESTONE clinical study did not show sufficient efficacy to support further development of dalfampridine to improve post-stroke walking difficulties (PSWD).

 

Retrophin announced additional results from the Phase II DUET study of sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS), a rare kidney disorder without an FDA-approved pharmacologic treatment that often leads to end-stage renal disease. These new findings were presented in the late-breaking High-Impact Clinical Trials oral session at the American Society of Nephrology (ASN) Kidney Week 2016 in Chicago. Following the news, BMO analyst Do Kim increased his price target to $46 from $40.  

 

Aduro Biotech announced that the FDA has lifted the partial clinical hold placed on its clinical trials evaluating the LADD (live, attenuated double-deleted) immunotherapy platform, enabling patient enrollment to resume in all Aduro-sponsored clinical studies.

 

RedHill Biopharma announced the presentation of a poster relating to YELIVA (ABC294640), the Company’s proprietary, first-in-class, orally-administered sphingosine kinase-2 (SK2) selective inhibitor, at the 2016 EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium, on November 29, 2016, in Munich, Germany.

 

GlaxoSmithKline and Innoviva announced the filing by GSK of a regulatory submission with the FDA for the once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) for patients with chronic obstructive pulmonary disease (COPD). This follows the announcement earlier this year of plans to bring forward the timing of the US filing from the first half of 2018.

 

Celyad announced the approval in Belgium to initiate the THINK clinical trial. THINK is the second clinical trial of its NKR-2 product candidate, a CAR-T cell therapy using NKG2D ligands as a target, to evaluate safety and efficacy in seven cancer indications including both solid and hematological malignancies.  THINK (THerapeutic Immunotherapy with NKR-2) is a multinational open-label Phase Ib study to assess the safety and clinical activity of multiple administrations of autologous NKR-2 T-cells in seven, refractory cancers including five solid tumors (colorectal, ovarian, bladder, triple-negative breast and pancreatic cancers) and two hematological tumors (acute myeloid leukemia and multiple myeloma). This trial will be conducted in the U.S and in Europe. It contains a dose escalation and an extension stage. The dose escalation will be conducted in parallel in the solid tumor and in the liquid cancer groups, while    the extension phase will evaluate in parallel each tumor independently.

 

Teva announced it has obtained approval from the EC for an indication extension of Trisenox (arsenic trioxide). This marks an important advancement in treatment for Acute Promyelocytic Leukemia (APL) patients in Europe, as it is the first time that a form of acute leukemia can be effectively treated with a regimen that is entirely chemotherapy-free. APL is a rare and aggressive type of acute leukemia that can kill within hours or days if left untreated.    Trisenox, in combination with retinoic acid, has shown a 99% overall survival rate with almost no relapses after more than four years (50 months) of median follow-up.

 

Kadmon Holdings announced additional data from its ongoing Phase IIa clinical study demonstrating the safety of tesevatinib, the Company’s oral tyrosine    kinase inhibitor, for the treatment of autosomal dominant polycystic kidney disease (ADPKD). The data was presented in a poster session at the American Society of Nephrology (ASN) Kidney Week 2016 in Chicago, IL. Recent findings from Kadmon’s ongoing Phase IIa study in patients with ADPKD have demonstrated that tesevatinib is well tolerated and have also identified tesevatinib 50 mg once daily (QD) as the optimal dose to treat ADPKD.

 

Pharming Group announced its financing plans to enable the completion of the acquisition of the North American commercialization rights to RUCONEST from Valeant Pharmaceuticals International, as announced on 9 August 2016.

 

Mallinckrodt confirmed that it will initiate a company-sponsored, Phase II proof-of-concept clinical trial to assess the efficacy of H.P. Acthar Gel (repository corticotropin injection) in patients with Amyotropic Lateral Sclerosis (ALS, also known as Lou Gehrig’s disease). The study is expected to begin in the first half of 2017. Mallinckrodt also announced the FDA has granted the company’s request for a Fast Track designation for its Acthar IND application in patients with ALS. The company is working closely with the FDA as it establishes the Phase II study design.

 

Lexicon Pharmaceuticals announced the appointments of Alexander Santini as chief commercial officer, Kiernan Seth, Ph.D. as vice president of marketing, and Gary Branch as vice president of sales. Mr. Santini will have responsibility for all commercial activities in the United States for telotristat ethyl, an investigational oral drug for the treatment of carcinoid syndrome, with Dr. Seth and Mr. Branch reporting directly to him.

 

Omeros announced the successful outcome of its recently completed post-marketing clinical trial of the effect of OMIDRIA (phenylephrine and ketorolac injection) 1% / 0.3% in pediatric patients undergoing cataract surgery. OMIDRIA is approved by the FDA for use in adult patients undergoing cataract or intraocular lens replacement surgery to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain and is not currently approved for use in patients less than 18 years of age.

 

Matinas BioPharma Holdings announced that it has initiated enrollment and the first group of patients have been dosed in its Phase II clinical study of lead anti-infective product candidate MAT2203 in patients with vulvovaginal candidiasis (VVC).

 

Stemline Therapeutics announced the oral presentation of clinical data from its ongoing Phase II trial of SL-701 in patients with second-line glioblastoma (GBM). The Phase II results were delivered by David A. Reardon, M.D., Clinical Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute and Professor of Medicine, Harvard Medical School, at the Society for Neuro-Oncology (SNO) annual meeting in Scottsdale, AZ. SL-701 is a subcutaneously delivered immunotherapy designed to generate a long-term T cell response against GBM.

 

Oragenics announced that the FDA granted Fast Track designation to AG013, the Company’s lead therapeutic candidate for the treatment of OM. Oragenics expects to file an IND update and initiate a Phase II study with AG013 in the United States and Europe in early 2017.

 

Veracyte announced the appointment of Keith Kennedy as CFO.

 

Rosetta Genomics announced that the Company has entered into a research agreement with Sheba Medical Center at Tel HaShomer, Israel, to develop a microRNA-based signature to predict response to Nivolumab, an immunotherapy drug marketed as Opdivo, which is approved for the treatment of lung cancer patients.

 

BioLineRx announced that it has signed an exclusive, worldwide agreement with Yissum Research Development Company of the Hebrew University of Jerusalem Ltd., for the in-licensing of a novel anti-inflammatory treatment for Dry Eye Syndrome (DES). This project, to be named BL-1230, is the third project in-licensed under the framework of the Company’s strategic collaboration with Novartis Pharma AG for the screening and development of novel drug candidates.

 

aTyr Pharma announced it has entered into a $20 million credit facility with Silicon Valley Bank and Solar Capital. aTyr intends to use the additional capital to pay off existing indebtedness and for general corporate purposes to further aTyr’s mission to bring meaningful therapies to patients based on its understanding of Physiocrine biology.

 

IntelGenx announced the signing of a binding term sheet for a license to Eli Lilly‘s tadalafil dosing patent, United States Patent No. 6,943,166 (the ’166 dosing patent). Any exclusivity associated with the tadalafil compound patent is not affected by this agreement.

 

Allergan announced that it has received an additional approval from Health Canada for FIBRISTAL (ulipristal acetate, 5 mg) for the intermittent treatment of moderate to severe signs and symptoms of uterine fibroids in adult women of reproductive age. Each treatment course is three months,(2) given in repeated courses.

 

Mast Therapeutics provided an update regarding its recently announced campaign to evaluate strategic opportunities. The Company has received several written indications of interest from privately-held companies, including companies with synergistic clinical-stage drug candidates, and is actively evaluating these opportunities. Concurrently, the Company will continue to explore ways to strategically monetize its vepoloxamer assets, including through licensing transactions.  In parallel with exploring strategic opportunities, the Company will continue to support ongoing and planned investigator-sponsored clinical studies of its lead asset, AIR001, for the treatment of patients with heart failure with preserved ejection fraction (HFpEF).

 

Absorption Systems announced the renewal of a technology licensing deal with Biogen. After years of contract testing by Absorption Systems using MDR1-MDCK cells, Biogen licensed the technology associated with the test system from Absorption Systems in October 2015 and is renewing the license for another year. This cell line is stably transfected with the human MDR1 gene, which codes for a protein known as multi-drug resistance protein or P-glycoprotein (P-gp).

 

Collegium Pharmaceutical announced that an independent review of Xtampza ER has been published in the peer-reviewed medical journal, Drugs. The review is titled "Oxycodone DETERx ER Capsules: A Review in Severe, Chronic Pain" and highlights data pertaining to the efficacy, safety, abuse-deterrent properties, and alternative modes of administration of Xtampza ER.

 

GSK announced it has received approval from the FDA’s Center for Biologics Evaluation and Research expanding the indication for FluLaval Quadrivalent (Influenza Vaccine) to include use in children 6 months and older. Prior to this, the vaccine was only approved for active immunization against influenza A subtype viruses and type B viruses, in persons 3 years of age and older.

 

CEL-SCI announced that it has submitted its response to the FDA regarding the previously announced partial clinical hold of CEL-SCI’s Phase III clinical trial of its investigational drug Multikine (Leukocyte Interleukin, Injection) in patients with squamous cell carcinoma of the head and neck.

 

ESSA Pharma announced that it has secured a US$10 million growth capital term loan facility from Silicon Valley Bank. Under the loan and security agreement, the Company will initially draw down $8 million and has a conditional option to receive an additional $2 million. The proceeds from the Term Loans will be used for the Company’s future working capital needs.

 

Halozyme Therapeutics announced that AbbVie has discontinued a development program using the Halozyme ENHANZE platform technology and the tumor necrosis factor alpha (TNF-alpha) target following completion of a Phase I study in which the target results were not achieved. Halozyme and AbbVie will continue to work collaboratively to identify additional targets for co-development under their 2015 Global Collaboration and Licensing agreement. TNF-alpha was the first nominated target of nine included as part of the agreement.

 

Mustang Bio, a Fortress Biotech Company, announced that Phase I clinical data and preclinical data on its MB101 (IL13Rα2specific Chimeric Antigen Receptor engineered CAR T cells (CAR T cells)) product candidate in development for the treatment of glioblastoma were presented by investigators from the City of Hope (“COH”) in oral sessions at the 21st Annual Meeting and Education Day of the Society for NeuroOncology (“SNO”) in Scottsdale, AZ. 

 

Swedish Orphan Biovitrum announced that the Ministry of Health in Kuwait has approved Elocta (efmoroctocog alfa), a recombinant human factor VIII Fc-fusion protein with an extended half-life, for the treatment of haemophilia A. Elocta is the first recombinant factor VIII Fc fusion protein therapy approved for the treatment of haemophilia A in the Middle East region.

 

Opthea has completed patient enrolment in the randomized dose expansion Phase IIA clinical trial of OPT-302, a novel VEGF-C/D ‘Trap’ therapy for wet age-related macular degeneration (wet AMD).

 

Innovus Pharmaceuticals announced the launch of Zestra Multi-dose in the U.S. Approximately 43% of women age 18 to 59, or 50 million, experience some form of Female Sexual Dysfunction (FSD) according to a published study.

 

ImmunoCellular Therapeutics announced the presentation of updated immune monitoring data from the phase II trial of ICT-107 in patients with newly diagnosed glioblastoma. Also presented were updated long-term survival data from the phase I trial of ICT-107. ICT-107 is a dendritic cell-based immunotherapy targeting multiple tumor-associated antigens on glioblastoma stem cells. ICT-107 is currently being tested in a phase III registration trial in patients with newly diagnosed glioblastoma. The updated phase I and phase II data were presented in two oral sessions on Friday, November 18th, at the 21st Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology, held in Scottsdale, AZ.

 

Ruga Corporation announced the company’s name change to Aravive Biologics, and the relocation of its business operations to Houston, Texas. The move follows the company’s award of a $20 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT), which is supporting the development of a novel drug candidate, Aravive-S6, as a potential treatment for acute myelogenous leukemia (AML) and solid tumors including ovarian, pancreatic, and breast cancers.

 

GlaxoSmithKline submitted a NDS for its candidate shingles vaccine, seeking approval for the prevention of herpes zoster (shingles) and its complications in Canadians aged 50 years or over.

 

Pfizer announced the expiration and results of the previously announced tender offer (the “Tender Offer”) to purchase for cash any and all of its outstanding 6.200% Senior Notes due March 15, 2019 (the “Notes”).

 

 

ANALYST RECOMMENDATIONS

 

HC Wainwright analyst Corey Davis initiated coverage of Kite Pharma with a “buy” rating and $78 price target, citing Kite should have a big first-mover advantage with KTE-C19, assuming it can indeed be the first FDA approved product in 2017.

 

Cowen analyst Ritu Baral downgraded Cempra to “market perform” from “outperform,” and removed her price target, citing lack of clarity on soli, questions regarding manufacturing issues, potential FDA action, and label warnings.

 

The following analysts initiated coverage of Myovant Sciences: Baird analyst Brian Skorney with an “outperform” rating and $20 price target; Barclays analyst Geoff Meacham with an “overweight” rating and $18 price target; JMP analyst Jason Butler with an “outperform” rating and $23 price target; Cowen analyst Phil Nadeau with a “outperform” and $11 price target.

 

William Blair analyst Tim Lugo initiated coverage of Allergan with a “market perform” rating and $209 price target, citing Botox growth is benefiting from therapeutic indications, but expect renewed competition.

 

The following analyst initiated coverage of Ra Pharmaceuticals: BMO analyst Ian Somaiya with an “outperform” rating and $26 price target; Jefferies analyst Eun Yang with a “buy” rating and $25 price target; SunTrust analyst Yatin Suneja with a “buy” rating and $32 price target; Credit Suisse analyst Kennen MacKay with an “outperform” and $19 price target.