BioShares Biotechnology Clinical Trials (BBC): $22.53, -$1.47, +22.4% YTD

BioShares Biotechnology Products (BBP): $36.78, -$1.53, +12.3% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures edged lower, tracking global market sentiments, as concerns about Donald Trump’s economic growth agenda sparked a sell-off in risky assets. Existing home sales, monthly home prices and mortgage applications data are on the radar. Spot gold edged up on its safe-haven appeal, while the dollar hit a four-month low against the yen. Oil prices slipped after data showed U.S. crude inventories rose more than expected.

 

 

MARKET HIGHLIGHTS

 

BIOPHYTIS will present the full results of the safety, pharmacokinetics and pharmacodynamics of Sarconeos (BIO101), the Company’s lead drug candidate for the treatment of sarcopenia, in healthy elderly volunteers in the SARA-PK clinical study, as well as three other scientific studies, at the 7th International Conference on Frailty & Sarcopenia Research, held April 27-29th 2017 in Barcelona, Spain.

 

BrainStorm Cell Therapeutics will provide an update on new developments and a corporate overview at the Sachs Associates 2nd Annual Neuroscience Biopartnering and Investment Forum, being held on March 27th at the New York Academy of Sciences.

 

Minerva Neurosciences announced the recent exercise of warrants held by certain institutional stockholders in connection with a private placement that took place in March 2015, as well as a purchase of common stock completed on the open market by the chairman of Minerva’s board of directors.

 

OncoSec Medical Incorporated presented a poster titled "Intratumoral Electroporation-mediated IL-12 Gene Therapy Can Enhance Tumor Immunogenicity" (Poster #2074), at the Keystone Symposia Conference, "Cancer Immunology and Immunotherapy: Taking a Place in Mainstream Oncology," in Whistler, British Columbia, Canada. The poster included preclinical data demonstrating that in vivo electroporation of intratumoral plasmid IL-12 (ImmunoPulse® IL-12) enhances immunogenicity in poorly immunogenic mouse cancer models.  For more information about this meeting, please visit http://keystonesymposia.org.

 

Achillion Pharmaceuticals announced that the USPTO has issued the first U.S. Patent to Achillion resulting from its complement factor D research program. U.S. Patent No. 9,598,446 has been granted with claims to compositions of matter for compounds that inhibit complement factor D activity, a key mediator in the complement alternative pathway (AP). In addition, the USPTO has issued Notices of Allowance of four additional U.S. patent applications owned by Achillion, also with claims to compositions of matter, that are expected to issue as patents over the next few months.

 

Shire announced that the FDA has granted Fast Track designation for recombinant ADAMTS13 (SHP655 – historically known as BAX930) for treatment of acute episodes of hereditary thrombotic thrombocytopenic purpura (hTTP) in patients with a constitutional deficiency of the von Willebrand factor-cleaving (VWF) protease ADAMTS13. Hereditary thrombotic thrombocytopenic purpura is a life-threatening congenital disease caused by a deficiency in the enzyme ADAMTS13 which can cause clotting in the microvasculature with associated organ morbidities.

 

OPKO Pharmaceuticals, a subsidiary of OPKO Health, announced that the Company has received orphan drug designation from the FDA Office of Orphan Products Development for OPKO’s oligonucleotide-based AntagoNAT (CUR-1916) for the treatment of Dravet Syndrome.  Currently, there is no approved treatment for Dravet Syndrome in the U.S.  On March 7, 2017, OPKO Health received orphan drug designation for CUR-1916 for the treatment of Dravet Syndrome from the European Commission.

 

ChemoCentryx announced that the FDA has granted orphan drug designation for avacopan in the treatment of patients with C3 glomerulopathy (C3G).

 

Galapagos announced initiation of a Phase I study with novel potentiator GLPG3067 for cystic fibrosis (CF) in a Phase I study. Galapagos is to receive a $7.5 million milestone payment from its collaboration partner AbbVie for this achievement. The aim of the Phase I study is to evaluate the safety, tolerability and pharmacokinetics of oral single and multiple ascending doses of GLPG0367. The safety and tolerability of the combination of GLPG3067 and GLPG2222 will also be evaluated. The randomized, double-blind, placebo controlled, single center study is being conducted in at least 48 healthy volunteers in Belgium. In the first part of the study, single ascending doses of GLPG3067 will be evaluated. In the second part, multiple ascending doses will be administered daily for 14 days. In the last part of the study the combination of GLPG3067 and GLPG2222 will be administered for 14 days. Topline results from this Phase 1 study are expected to be disclosed at a future medical conference.

 

Novartis announced results from the global Phase III RELAX-AHF-2 study investigating the efficacy, safety and tolerability of RLX030 (serelaxin) in patients with acute heart failure (AHF). RELAX-AHF-2 did not meet its primary endpoints of reduction in cardiovascular death through Day 180 or reduced worsening heart failure through Day five when added to standard therapy in patients with AHF.

 

Gilead Sciences Canada announced, effective March 21, 2017, British Columbia will provide public access to EPCLUSA (sofosbuvir/velpatasvir) tablets, the first once-daily, pan-genotypic single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.  This listing will support patients to access curative therapy, and will advance Canada’s efforts to achieving its WHO commitment to eliminate hepatitis C by 2030.

 

AVEO Oncology announced that the first patient has been dosed in the Phase I/II AVEO-sponsored TiNivo trial evaluating tivozanib in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, Opdivo (nivolumab), in advanced renal cell carcinoma (RCC). The study, which will be led by the Institut Gustave Roussy in Paris, is under the direction of Professor Bernard Escudier, MD, Chairman of the Genitourinary Oncology Committee. The Phase I trial will evaluate the safety of tivozanib in combination with nivolumab at escalating doses of tivozanib and, assuming favorable results, is expected to be followed by an expansion Phase II cohort at the established combination dose.

 

XOMA announced it has fully prepaid the outstanding balance of approximately $6.5 million under the Company’s term loan with Hercules Technology Growth Capital, Inc., in accordance with the terms of the loan agreement.

 

Intec Pharma announced the initiation of a Phase I clinical trial of AP-CBD/THC, its Accordion Pill platform with the two primary cannabinoids contained in Cannabis sativa, cannabidiol (CBD) and tetrahydrocannabinol (THC), which is being developed by Intec for various indications, including low back pain and Fibromyalgia.

 

Cytokinetics announced that preclinical data for CK-2127107 were presented at the MDA Scientific Conference in Arlington, VA, showing that this next-generation fast skeletal troponin activator (FSTA) improves muscle function in mouse models of spinal muscular atrophy (SMA). In collaboration with Astellas Pharma, Cytokinetics is developing CK-2127107 as a potential treatment for people living with SMA and certain other debilitating diseases and conditions associated with skeletal muscle weakness and/or fatigue.

 

Allergan announced the availability of RESTASIS MULTIDOSE, which is the same preservative-free RESTASIS formulation, but now offered in a multidose bottle. RESTASIS is the first and only prescription medication FDA-approved to help patients with a type of Chronic Dry Eye make more of their own tears. RESTASIS MultiDose is the first and only FDA-approved preservative-free, prescription eye drop in the U.S. to be available in a multidose bottle. RESTASIS was accessible only in single-use vials, since its launch in 2003 until now.

 

Imprimis Pharmaceuticals announced that it has entered into agreements with two accredited investors for a registered direct placement of 1,312,000 shares of common stock at a price of $2.40 per share for aggregate gross proceeds of $3,148,800.  The offering is expected to close on or about March 27, 2017, subject to satisfaction of customary closing conditions. National Securities Corporation, a wholly owned subsidiary of National Holdings, acted as the exclusive placement agent for the offering.  The Liquid Venture Partners group at National Securities Corporation was responsible for sourcing and executing the offering.

 

Vital Therapies announced the pricing of an underwritten public offering of 8,750,000 newly issued shares of its common stock at a price to the public of $4.00 per share for gross proceeds of approximately $35.0 million.  All of the shares are being sold by Vital Therapies. The offering is expected to close on or about March 27, 2017, subject to customary closing conditions. In addition, Vital Therapies has also granted the underwriters a 30-day option to purchase up to an additional 1,312,500 shares of its common stock at the public offering price, less the underwriting discounts and commissions. Vital Therapies currently plans to use the net proceeds from this offering for the continuing clinical development of the ELAD System, working capital and other general corporate purposes. Raymond James & Associates, Inc. is acting as sole book-running manager for the offering.  National Securities Corporation, a wholly owned subsidiary of National Holdings, is acting as co-manager for the offering.

 

Adaptimmune Therapeutics announced that it intends to offer and sell ADSs in an underwritten public offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Adaptimmune also expects to grant the underwriters a 30-day option to purchase additional ADSs at the public offering price. All of the ADSs in the offering are to be sold by Adaptimmune, with net proceeds to be used to advance Adaptimmune’s wholly-owned pipeline of SPEAR® T-cell candidates through clinical trials as well as for other general corporate purposes. Citigroup, Cowen and Leerink Partners are acting as joint book-running managers for the offering.

 

Valeant Pharmaceuticals announced that it has closed its previously announced refinancing transactions. These transactions include its offering of $1.25 billion aggregate principal amount of 6.50% senior secured notes due 2022 and $2.0 billion aggregate principal amount of 7.00% senior secured notes due 2024, and its borrowing of an additional approximately $3 billion of new term loans maturing in 2022. The Company used the proceeds of the offering and the new term loan together with cash on hand to repay all term loans under its credit facility maturing in 2018, 2019 and 2020, $350 million of revolver borrowings and $1.1 billion of its 6.75% Senior Notes due 2018. In addition, as part of these transactions, the Company amended its existing credit agreement to remove the financial maintenance covenants from the term loans and modify the financial maintenance covenants under the revolving facility and to make certain other amendments.

 

Innovus Pharmaceuticals announced the cash redemption of all remaining outstanding convertible notes. With the redemption of the convertible notes, the Company has reduced its current debt obligation by approximately $1.3 million and eliminated approximately $0.3 million in derivative liabilities relating thereto.

 

Calithera Biosciences announced the pricing of its previously announced underwritten public offering of 6,830,000 shares of its common stock at a price to the public of $10.25 per share.  Gross proceeds to Calithera from the offering are expected to be approximately $70.0 million, before deducting underwriting discounts and commissions and estimated offering expenses.  All of the shares of common stock are being offered by Calithera. In addition, Calithera has granted the underwriters a 30-day option to purchase up to 1,024,500 of additional shares of common stock at the public offering price.  The offering is expected to close on March 27, 2017, subject to customary closing conditions. Leerink Partners is acting as sole book-running manager for the offering. Wells Fargo Securities is acting as a lead manager and JMP Securities is acting as a co-manager for the offering.

 

 

ANALYST RECOMMENDATIONS

 

JMP analyst Michael King increased his price target of Blueprint Medicines to $46 from $37, citing Blueprint initiated patient dosing in its Phase I dose-escalation study with its RET inhibitor candidate (BLU-667) in patients with non-small cell lung cancer, medullary thyroid cancer, and other advanced solid tumors that harbor a RET alteration.

 

JMP analyst Michael King initiated coverage of the following companies: Fortress Biotech with an “outperform” rating and $11 price target; Idera Pharmaceuticals with an “outperform” rating and $8 price target.

 

Ladenburg Thalmann analyst Wangzhi Li initiated coverage of Checkpoint Therapeutics with a “buy” rating and $20 price target, citing CKPT focuses on the acquisition, development and commercialization of combination treatments for solid tumors based on immuno-oncology (I-O) and targeted therapies against well-validated targets.

 

William Blair analyst Katherine Xu initiated coverage of Incyte with an “outperform” rating and $170 fair value, citing Epacadostat is the wild card in Incyte valuation and major driver of Incyte share performance in the near term.