BioShares Biotechnology Clinical Trials (BBC): $21.91, +$0.21, +19.0% YTD

BioShares Biotechnology Products (BBP): $36.45, -$0.06, +11.3% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures pointed to a higher start for Wall Street with investors focused on first quarter results from some of the major corporate bellwethers. Visa and Mattel are scheduled to report quarterly results after markets close. The day’s economic calendar carries initial jobless claims and the Conference Board’s leading economic index. Upbeat results from Unilever boosted consumer stocks and helped European markets to trade higher. Asian stocks rose as commodity prices steadied and prompted some bargain hunting by investors. In currency markets, the New Zealand dollar was the biggest mover after the country’s inflation surged past 2 percent to its highest level in five years. The euro strengthened against the dollar despite looming uncertainty around French elections over the weekend and gold steadied. Oil prices recovered from losses in the previous session as leading Gulf oil producers signaled a likely extension of OPEC-led supply cuts beyond the middle of the year.

 

 

MARKET HIGHLIGHTS

 

Transgene announced the evolution and reinforcement of the Company’s Board of Directors. In the Annual General Meeting notice published today, Transgene’s Board of Directors has proposed a resolution to shareholders to appoint two new independent board members, Marie Landel and Maya Said. The notice also proposes resolutions on the renewal of the mandates of current Board members Philippe Archinard, Benoît Habert, Alain Mérieux, Dominique Takizawa.  Following the Shareholders General meeting on June 8, 2017, assuming shareholder approval of these proposals, Transgene’s Board of Directors will comprise ten members, with a majority of independent members.

 

Mateon Therapeutics announced that the Markey Cancer Center at the University of Kentucky has enrolled the first patient into a new phase 1 study of CA4P in combination with everolimus for the treatment of neuroendocrine tumors.

 

iCAD announced that updated clinical data on the use of intraoperative radiation therapy (IORT) using the Xoft® Axxent® Electronic Brachytherapy (eBx®) System will be presented during the American Brachytherapy Society (ABS) Annual Meeting in Boston, MA. The Xoft System and its suite of products will also be showcased at the Xoft booth (#T1) from April 21-22, 2017.

 

Immune Pharmaceuticals announced that it has entered into a letter of intent with Pint Pharma GmnH, a pharmaceutical company focused on Latin America and other markets (“Pint”), which binds the parties to seek agreement regarding an exclusive license by Pint of the rights to commercialize Ceplene throughout Latin America, including Argentina, Brazil, Chile, Colombia and Mexico. Immune and Pint target closing a final agreement within 30 days. Pursuant to the anticipated final agreement, Pint will be responsible for registration of Ceplene in Latin American countries based on the existing European marketing authorization and will carry out the full commercialization of the licensed product in the territory, including Ceplene registration, pricing and reimbursement, and sales and marketing activities.

 

CTD Holdings today corrected false and misleading statements published on April 18 in the on-line open access journal PLOS One.

 

BrainStorm Cell Therapeutics announced today that Chaim Lebovits, Chief Executive Officer, will present at the Alliance for Regenerative Medicine’s (ARM) 5th Annual Cell & Gene Therapy Investor Day on Thursday, April 27, 2017 at 9:40 EDT in Boston.

 

Oramed Pharmaceuticals announced that the European Patent Office has granted the Company a patent titled, "Methods and Compositions for Treating Diabetes: Capsules containing oil-based liquid compositions of combined therapeutic agents for treating diabetes." The patent covers Oramed’s invention, a combination therapy including both insulin and a GLP-1 analog in a single oral capsule.

 

ContraVir Pharmaceuticals announced new data demonstrating clinical antiviral activity, as well as safety and pharmacokinetic (PK) data of tenofovir exalidex (TXL). TXL is the Company’s proprietary liver targeting prodrug of the antiviral agent tenofovir for treating chronic hepatitis B virus (HBV), designed to offer equal or better HBV viral load reductions at doses lower than Viread (TDF), a commercially available tenofovir prodrug. ContraVir is also focusing on optimizing drug delivery of TXL to improve bioavailability and enhance its pharmacological activity.

 

Aldeyra Therapeutics announced that the FDA has granted Aldeyra’s novel compound ADX-102 orphan drug designation for the treatment of congenital ichthyosis, a severe skin disease characteristic of Sjögren-Larsson Syndrome (SLS). There are no FDA-approved therapies specifically indicated for the treatment of SLS, and ADX-102 is believed to be the only potential SLS therapy in clinical development.

 

AbbVie announced that 99 percent (n=145/146) of chronic hepatitis C virus (HCV) infected patients with genotype 1, 2, 4, 5 or 6 and compensated cirrhosis (Child-Pugh A) achieved sustained virologic response at 12 weeks post-treatment (SVR(12)) with its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P). These high SVR(12) rates were seen following 12 weeks of G/P treatment without ribavirin. Patients with specific virus strains associated with resistance or with a high quantity of the virus in their bloodstream before treatment initiation were not excluded from the study. These new data, from the Phase III EXPEDITION-1 study, will be featured as an oral presentation today at The International Liver Congress (ILC) 2017 in Amsterdam, The Netherlands.  Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals for HCV protease inhibitors and regimens that include protease inhibitors.

 

AbbVie announced that two Phase III studies evaluating veliparib, an investigational, oral poly (adenosine diphosphate ADP-ribose) polymerase (PARP) inhibitor did not meet their primary endpoints. The studies evaluated veliparib in combination with the chemotherapy regimen carboplatin and paclitaxel in patients with squamous non-small cell lung cancer (NSCLC) and triple negative breast cancer (TNBC). Full results will be presented at upcoming medical meetings or published in a peer-reviewed journal.

 

Targovax ASA announced that it has recruited the first patient in an exploratory Phase Ib clinical trial of TG02 in patients with locally recurrent RAS-mutated rectal cancer scheduled to have surgery. The trial is being conducted at clinical sites in Australia and New Zealand.

 

TESARO announced that ZEJULA (niraparib), an oral, once-daily poly(ADP-ribose) polymerase (PARP) inhibitor, is now available by prescription in the U.S. The FDA approved ZEJULA on March 27, 2017 for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response (CR or PR) to platinum-based chemotherapy. Following the news, Leerink analyst Seamus Fernandez decreased his price target to $158 from $186; Citi analyst Robyn Karnauskas decreased her price target to $216 from $232.

 

Novartis announced the publication of a study conducted by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) demonstrating that 58% of patients with treatment-naïve severe aplastic anemia (SAA) achieved complete response at six months when treated with eltrombopag at the initiation of and concurrently with standard immunosuppressive treatment. The study evaluated three sequential treatment groups, or cohorts. Cohort 3 added eltrombopag at the initiation of immunosuppressive therapy and showed a higher complete response rate than cohorts 1 and 2, where eltrombopag was initiated on day 14. The data is published in the latest issue of The New England Journal of Medicine.

 

Clearside Biomedical announced completion of enrollment of an exploratory clinical trial (the “HULK” trial) of CLS-TA for suprachoroidal administration, its proprietary suspension formulation of the corticosteroid triamcinolone acetonide, with or without intravitreal Eylea (aflibercept), for the treatment of diabetic macular edema (“DME”).

 

Celsion provided an update on its OVATION Study, a Phase Ib dose escalating clinical trial combining GEN-1, the Company’s DNA-based immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with advanced (stage III/IV) ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery.  GEN-1 is an IL-12 DNA plasmid vector formulated as a nanoparticle in a non-viral delivery system to cause the sustained local production and secretion of the Interleukin-12 (IL-12) protein loco-regionally to the tumor site.

 

Teva Pharmaceutical Industries announced the simultaneous launch of AirDuo RespiClick (fluticasone propionate and salmeterol) inhalation powder and its authorized generic for the treatment of asthma in patients aged 12 years and older who are uncontrolled on an inhaled corticosteroid (ICS) or whose disease severity clearly warrants the use of an ICS/long-acting beta(2)-adrenergic agonist (LABA) combination.

 

Agenus announced that the first patient has been dosed in a Phase I/II clinical trial of its anti-PD-1 antibody, AGEN2034.

 

Bicycle Therapeutics announced the receipt of a preclinical milestone in connection with the advancement of a Bicycle into preclinical development for the treatment of diabetic macular edema, under its ophthalmology alliance with ThromboGenics.

 

RedHill Biopharma announced the publication of an article describing the positive results from the Phase I clinical study with YELIVA (ABC294640) in advanced solid tumors. The article, entitled “A Phase I Study of ABC294640, a First-in-Class Sphingosine Kinase-2 Inhibitor, in Patients with Advanced Solid Tumors”, was authored by scientists from the Medical University of South Carolina (MUSC) Hollings Cancer Center and Apogee Biotechnology and was published in Clinical Cancer Research. The article is available online on the journal’s website.

 

uniQure announced that it will not pursue the renewal of the Glybera (alipogene tiparvovec) marketing authorization in Europe when it is scheduled to expire on October 25, 2017.

 

Prometic Life Sciences presented new results at the International Liver Congress ILC 2017 of the European Association for the Study of the Liver EASL in Amsterdam on the positive effects of PBI-4050 on reduction of non-alcoholic steatohepatitis (NASH) in a mouse model of obesity and metabolic syndrome.

 

H3 Biomedicine, a member of Eisai’s global Oncology Business Group, announced that is has extended its multi-year collaboration with Foundation Medicine for the discovery and development of precision medicines in oncology, which was signed in February 2015.

 

Allergan announced that it will collaborate with TARGET PharmaSolutions, a clinical data company focused on real world evidence, on its TARGET-NASH study. TARGET-NASH is a five-year longitudinal observational study that looks at patients with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH). 

 

SIGA Technologies announced the completion of enrollment and dosing in the final cohort of healthy subjects in a Phase I clinical study of an intravenous (IV) formulation of its lead drug candidate, TPOXX (tecovirimat).  TPOXX is being developed for the treatment of smallpox, as well as other orthopoxvirus infections. There were no drug-related Serious Adverse Events (“SAEs”) reported.

 

Tocagen announced the closing of its initial public offering of common stock, including the underwriters’ exercise of their option to purchase an additional 1,275,000 shares at the public offering price of $10.00 per share. The underwriters’ option brought the total number of shares of common stock sold by Tocagen to 9,775,000 shares and increased the amount of gross proceeds raised in the offering to approximately $97.8 million, prior to deducting the underwriting discount and estimated expenses of the offering. Leerink PartnersEvercore Group and Stifel, Nicolaus & Company acted as joint bookrunning managers for the offering.

 

Sorrento Therapeutics announced the closing of its previously announced underwritten public offering of 23,625,084 shares of its common stock at a public offering price of $2.00 per share, before deducting underwriting discounts and commissions and estimated offering expenses payable by Sorrento. The net proceeds to Sorrento from this offering were approximately $43.5 million, after deducting underwriting discounts and commissions and other estimated offering expenses. Cantor Fitzgerald & Co. acted as the lead book-running manager for the offering. FBR Capital Markets & Co. acted as a joint book-running manager. Oppenheimer & Co. and Aegis Capital Corp. acted as co-lead managers and Joseph Gunnar & Co.Rodman & Renshaw and Roth Capital Partners acted as co-managers.

 

ANALYST RECOMMENDATIONS

 

Roth analyst Mark Breidenbach initiated coverage of Mateon Therapeutics with a “buy” rating and $2 price target, citing positive results from a randomized Phase 2 study conducted by the Gynecologic Oncology Group (GOG), Mateon is conducting a pivotal trial (FOCUS) of its lead drug, CA4P, in a group with high unmet need—patients with platinum-resistant ovarian cancer.

 

Cantor Fitzgerald analyst Mara Goldstein increased her price target of NewLink Genetics to $32 from $20, citing increased conviction about indoximod and due to the IDO program overall, based on data presented at AACR.

 

Roth analyst Sa’ar Yaniv initiated coverage of the following companies: Zafgen with a “buy” rating and $9 price target; Poxel with a “buy” rating and €11 price target.  

 

Goldman analyst Terence Flynn revised his price target of the following companies: Amgen increased to $204 from $202; Biogen increased to $285 from $282.

 

JP Morgan analyst Chris Schott decreased his price target of Valeant to $10 from $15, citing a number of uncertainties around core business trends that are unlikely to be resolved in the near term.