BioShares Biotechnology Clinical Trials (BBC): $18.41

BioShares Biotechnology Products (BBP): $32.75

 

 

MARKET COMMENTARY

 

U.S. stock index futures pointed to a higher start for Wall Street on the first trading day of 2017, tracking positive sentiment across markets. Manufacturing PMI data from ISM and Markit are expected on the economic calendar. Strength in financials and commodity-related stocks continued to underpin European equity markets, and Britain’s FTSE 100 started the new year at record highs. Asian stocks closed higher on better-than-expected factory growth in China. The U.S. dollar racked up its biggest rise in two weeks, while gold edged lower. Oil hit 18-month highs, buoyed by hopes that a deal between OPEC and non-OPEC members to cut production.

 

 

MARKET HIGHLIGHTS

 

Cellect Biotechnology announced that Mr. Eyal Leibovitz formally steps-in to assume his role as the Company’s Chief Financial Officer, effective January 1, 2017.  Mr. Leibovitz has over 27 years of experience in senior management positions in finance, investor relations, M&A, and business development at global pharmaceutical and biotechnology companies.

 

Eiger BioPharmaceuticals announced that the first patient has completed 24 weeks dosing in the double-blind Phase 2 LIBERTY study and has now received treatment with ubenimex in the open-label extension. LIBERTY is a randomized, double-blind, placebo-controlled study of ubenimex administered orally for a total of 24 weeks in patients with pulmonary arterial hypertension (PAH). After completing the blinded treatment period, each patient may be eligible to enroll in an open-label extension to receive ubenimex for at least 24 weeks.  Ubenimex is a well-characterized, oral, small-molecule inhibitor of leukotriene A4 hydrolase (LTA4H), which blocks the production of leukotriene B4 (LTB4), an inflammatory mediator implicated in the pathogenesis of PAH.  

 

TRACON Pharmaceuticals has reached an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the protocol design, clinical endpoints and statistical analysis approach for the Company’s Phase 3 study evaluating TRC105 for the treatment of patients with advanced angiosarcoma.

 

BioTime and its majority-owned subsidiary, Cell Cure Neurosciences Ltd, today dedicated a new, 800 square meter (8,600 square feet), state-of-the-art, cGMP manufacturing center located in the Jerusalem Bio Park on the campus of Hadassah University Hospital in Jerusalem.

 

OncoSec Medical Incorporated will be making presentations at the 2017 East/West CEO Conference on January 7th, and the 9th Annual Conference Biotech Showcase on January 11th

 

Rexahn Pharmaceuticals will be presenting at the 9th Annual Biotech Showcase 2017 conference on Tuesday, January 10th.

 

Inotek Pharmaceuticals announced top-line results of MATrX-1, the first pivotal Phase III trial of trabodenoson for the treatment of primary open-angle glaucoma (POAG) or ocular hypertension (OHT). The trial did not achieve its primary endpoint of superiority in reduction of intraocular pressure (IOP) compared with placebo at all 12 time points. This was, in part, due to a placebo response that was 2-3 mmHg greater than that observed in Phase II. Trabodenoson, the Company’s lead clinical candidate, is a first-in-class, highly selective adenosine mimetic targeting the A(1) subreceptor. Trabodenoson lowers IOP by augmenting the eye’s natural function of the trabecular meshwork, the primary outflow pathway for aqueous humor and a site of pathology in glaucoma.

 

The New York Post reported that KKR is still interested in buying opioid maker Depomed, a publicly traded company that’s for sale and that’s taking final bids next Wednesday, two sources told The Post. A sale process is well under way, The Post has learned. KKR would combine the company with Arbor Pharmaceuticals, a company it already owns. Japan-based Daichi Sankyo is also expected to bid along with a few others, according to sources.

 

Protalix BioTherapeutics announced positive interim results from the Company’s Phase II clinical trial of alidornase alfa for the treatment of Cystic Fibrosis (CF) for the first 13 CF patients enrolled in the study. Fifteen patients have been enrolled in, and are expected to complete, the study. alidornase alfa is a plant cell expressed, chemically modified recombinant DNase enzyme resistant to inhibition by actin, which the Company has specifically designed to enhance the enzyme’s efficacy in CF patients.

 

Marinus Pharmaceuticals announced that the FDA has granted Orphan Drug Designation to its CNS-selective GABA(A) modulator, ganaxolone, for the treatment of Fragile X Syndrome (FXS).

 

Zynerba Pharmaceuticals announced that it has initiated the FAB-C (Treatment of Fragile X Syndrome Anxiety and Behavioral Challenges with CBD) exploratory Phase II clinical trial of ZYN002 cannabidiol (CBD) gel in children with Fragile X syndrome. ZYN002 CBD gel is the first and only patent-protected, synthetic CBD that is formulated as a permeation-enhanced gel for transdermal delivery.

 

Soligenix announced that it has extended its development agreement with Emergent BioSolutions to implement a commercially viable, scalable production technology for the RiVax drug substance protein antigen. RiVax is a vaccine candidate being developed to protect against ricin exposure. This specific agreement will build upon process development work conducted to date in support of manufacturing scale-up that will eventually be performed in accordance with current good manufacturing practices (cGMPs) at Emergent’s manufacturing facility located in Baltimore, MD.

 

Axsome Therapeutics announced that its IND for AXS-05 in the treatment of agitation in patients with Alzheimer’s disease (AD) has been cleared by the FDA. The IND clearance permits Axsome to proceed with its planned Phase II/III clinical trial of AXS-05 in this indication. Axsome anticipates commencing this trial in the first half of 2017.

 

Voyager Therapeutics announced the appointment of Jane Pritchett Henderson as senior vice president and CFO effective January 1, 2017. Ms. Henderson brings more than 28 years of life sciences industry and banking experience and leadership to her new role.

 

RedHill Biopharma announced the signing of an exclusive co-promotion agreement with a subsidiary of Concordia International, granting RedHill certain U.S. promotion rights for Donnatal , a prescription oral drug used with other drugs in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis (inflammation of the small bowel). Under the terms of the agreement, RedHill will be responsible for certain promotional activities related to Donnatal. Concordia will continue to be responsible for the manufacturing and supply of Donnatal in all territories. RedHill and Concordia will share the revenues generated from the promotion of Donnatal by RedHill based on an agreed upon split between them. The initial term of the co-promotion agreement with Concordia is for three years. RedHill expects to initiate gradual promotion of Donnatal in the coming months.

 

Inspyr Therapeutics announced the initiation of development programs focused on Mipsagargin combination therapies. To evaluate the potential of Mipsagargin in combination with Nexavar, Inspyr plans to conduct a preclinical study in liver PDX tumor models that express PSMA, the target of Mipsagargin. The tumor models selected express different levels of PSMA, including one that is resistant to Nexavar. The Company expects to share initial results of this study in the second quarter of 2017.

 

Anavex Life Sciences announced the dismissal with prejudice in its entirety of the Cortina v. Anavex Life Sciences Corp. et. al. lawsuit. In addition, the Judge refused to allow the plaintiff to amend their complaint.

 

Akari Therapeutics announced that the FDA has allowed on December 29th, 2016, its IND for the clinical development of Coversin in patients with PNH. The FDA’s allowance of the IND permits the Company to expand its clinical program for the development of Coversin in PNH to the United States. The Company has one currently treated eculizumab resistant PNH patient who has been on Coversin for approximately 11 months pursuant to an approved clinical protocol in the Netherlands and plans to open this ongoing Phase II trial of Coversin in eculizumab resistant PNH in the United States.

 

Dermira announced dosing of the first patients in the Phase III program evaluating the safety and efficacy of olumacostat glasaretil (formerly DRM01), a novel, small molecule designed to reduce sebum production following topical application, in patients with acne vulgaris.

 

Flamel Technologies SA, completed its previously announced cross-border merger with and into its wholly-owned Irish subsidiary, Avadel Pharmaceuticals, effective January 1, 2017, with Avadel surviving the merger as the public holding company. As a result of the merger, all of Flamel’s outstanding ordinary and American Depository Shares (ADSs) were canceled and exchanged on a one-for-one basis for Avadel ordinary shares and ADSs, respectively. Avadel ADSs will begin trading on the NASDAQ Global Market under trading symbol "AVDL" on January 3, 2017.

 

Abeona Therapeutics announced that the EMA Committee for Orphan Medicinal Products has granted Orphan Drug Designation for Abeona’s ABO-201 program (AAV-CLN3), the AAV-based single intravenous gene therapy program for juvenile Batten disease, a fatal lysosomal storage disease of the nervous system caused by autosomal-recessive mutations in the CLN3 gene.

 

Avenue Therapeutics, a Fortress Biotech company, announced that Notices of Allowance have now been received from the USPTO for two patent applications that cover methods of administration for its lead product candidate intravenous (IV) tramadol. These patent applications are continuation patent applications of issued U.S. patent 8,895,622, titled "Intravenous Administration of Tramadol." The patents to be issued from these allowed applications (U.S. Application Nos. 14/550,279 and 14/713,775), which carry a patent term to at least 2032, contain claims directed to Avenue’s proposed administration of IV tramadol for Phase III development. Issuance of both of these patents is expected early in the first quarter of 2017.

 

Sanofi and its vaccines global business unit Sanofi Pasteur confirmed the end of their vaccine joint-venture with MSD, Sanofi Pasteur MSD (SPMSD). Sanofi Pasteur and MSD will separately pursue their own vaccine strategies in Europe, integrating their respective European vaccines business into their operations. The change in operations took effect January 1, 2017. Since its announcement in March 2016, the project has been managed in an open dialogue with the SPMSD employees, unions and relevant external stakeholders, in compliance with the applicable rules and regulations. During the transitional period following the announcement of the ending of the joint-venture, SPMSD and Sanofi and Merck, its shareholders, have been focused on a smooth and orderly transition while achieving their public healthcare goals and upholding their commitments to their employees, customers and business partners.

 

Ardelyx announced the initiation of a Phase III clinical trial and an onset-of-action clinical trial evaluating RDX7675 in patients with hyperkalemia, a potentially life-threatening condition common in patients with cardiorenal disease.

 

Clovis Oncology announced that it has commenced an underwritten public offering of shares of its common stock to raise aggregate proceeds of approximately $175 million. All shares of the common stock to be sold in the offering will be offered by Clovis Oncology.

 

Eagle Pharmaceuticals announced that the 505(b)(2) NDA for its novel pemetrexed drug product has been submitted to the FDA. This 505(b)(2) NDA requests FDA approval of Eagle’s ready-to-dilute (RTD) Pemetrexed Injection product for the treatment of Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer, and Mesothelioma (in combination with cisplatin).

 

Tiziana Life Sciences announced the acquisition of an exclusive world-wide license for NI-1201, a fully human anti-interleukin-6 receptor (IL-6R) monoclonal antibody (mAb), from Novimmune. In exchange for the exclusive license from Novimmune the Company agreed to an upfront cash payment, milestone payments, and a royalty on future sales.

 

ContraVir Pharmaceuticals announced that the company was awarded a $297,875 CAD research grant from the National Research Council in Canada through the Council’s Industrial Research Assistance Program (IRAP). Proceeds from the grant will fund a substantial portion of personnel expenses, including the hiring of additional laboratory staff, which is expected to advance preclinical development of ContraVir’s potent cyclophilin inhibitor CRV431 for the Treatment of Hepatitis B (HBV).

 

Atara Biotherapeutics announced that pursuant to parallel scientific advice from the EMA’s Scientific Advice Working Group and several national Health Technology Assessment (HTA) Agencies in the EU, the Company plans to submit in 2018 an application for Conditional Marketing Authorization Approval (Conditional MAA) of ATA 129 in the treatment of patients with rituximab refractory EBV-PTLD following hematopoietic cell transplant (HCT). The Conditional MAA will be based on clinical data from Phase I and II trials conducted at Memorial Sloan Kettering Cancer Center (MSK) and supported by available data from the Company’s Phase III studies in rituximab refractory EBV-PTLD after HCT and solid organ transplantation (SOT), which will be ongoing at the time of filing.

 

Teligent announced it has received approval of three of the company’s ANDAs from the FDA of Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 units/gram and 1 mg/gram, Clindamycin Phosphate Topical Solution USP, 1% and Flurandrenolide Ointment USP, 0.05%. These approvals were received on December 30, 2016 and brings Teligent’s total approvals from its internally developed pipeline of topical generic pharmaceutical products in 2016 to nine.

 

Cellect Biotechnology announced that Mr. Eyal Leibovitz formally steps-in to assume his role as the Company’s CFO, effective January 1, 2017.

 

PixarBio announced a take-over bid to acquire InVivo Therapeutics the company PixarBio CEO Frank Reynolds founded in 2005. The deal is expected to close in Q1 2017.

 

Hologic announced that the FDA has granted PMA approval for the Company’s HIV-1 viral load monitoring assay. The Aptima HIV-1 Quant assay is a nucleic acid amplification test for the quantitative detection of RNA from HIV in plasma specimens.

 

MyoKardia announced that Sanofi has notified the Company that it has elected to continue the global cardiomyopathy research collaboration formed in August 2014. The terms of the research agreement provided Sanofi the option of either concluding the collaboration at year-end 2016 or extending the agreement. Per Sanofi’s decision to advance the collaboration, MyoKardia is now eligible for a $45 million milestone payment payable by January 31, 2017.

 

Kite Pharma announced that it has submitted an IND application with the FDA to initiate a Phase I trial of KITE-718, a T cell therapy engineered to express T cell receptors (TCRs) that target MAGE A3 and MAGE A6. MAGE A3/A6 are frequently found in common tumors including bladder, esophageal, head and neck, lung and ovarian cancers. KITE-718 recognizes the MAGE A3 and MAGE A6 fragments bound to a Class II HLA (DPB1*04:01) and therefore has the potential to kill tumor cells both directly and indirectly through activation of the immune system given it incorporates a class II TCR. Class II HLA (DPB1*04:01) is found in 50 percent to 70 percent of Caucasians. The trial is designed to assess the safety and anti-tumor effect of KITE-718 on these solid tumors.

 

MannKind confirmed that following the completion of initial formulation studies it received a $1 million milestone payment from Receptor Life Sciences (RLS) on Friday, December 30, 2016. This milestone payment is part of a previously announced collaboration and license agreement between the company and RLS.

 

Reuters reported that Novavax filed for a mixed shelf of up to $125 million.

 

 

ANALYST RECOMMENDATIONS

 

Leerink analyst Michael Schmidt increased his price target of Exelixis to $20 from $16, citing a more bullish stance on Cabometyx label extension opportunities in HCC and bladder cancer as well as incrementally higher Cotellic profit share estimates.

 

Following the news from Friday that OPKO‘s experimental drug for growth hormone deficiency in adults failed to provide a statistically significant benefit over a placebo in a late-stage study, Ladenburg Thalmann analyst Kevin DeGeeter decreased his price target to $19.50 from $20; Laidlaw analyst Yale Jen decreased his price target to $19 from $22.

 

Guggenheim analyst Louise Chen revised her “Best Ideas List,” adding Jazz Pharmaceuticals and removing Teva Pharmaceuticals.

 

Leerink analyst Michael Schmidt increased his price target of Seattle Genetics to $72 from $62 to reflect adjustments to the probability-adjusted revenue forecast of Adcetris, SGN-CD33A, and ASG-22ME as well as operating expenses.

 

Rodman & Renshaw analyst Raghuram Selvaraju initiated coverage of ChromaDex with a “buy” rating and $6 price target, citing CDXC is an unheralded yet highly innovative life sciences company that could provide significant upside based on its proprietary plant chemical-based technology platforms.

 

HC Wainwright analyst Corey Davis initiated coverage of Pacira Pharmaceuticals with a “buy” rating and $43 price target, citing the Street expectations for post-surgical pain drug Exparel are low and that new pending data and a new year of hospital budgets could start an upward inflection in Exparel leading to a concomitant positive stock response.

 

Oppenheimer analyst Leah Rush Cann downgraded CytomX to “perform” from “outperform,” and removed her price target of $22, citing CytomX’s stock currently trades in a range that reflects a level of risk for the company once it has completed its phase I trial successfully.

 

JMP analyst Liisa Bayko initiated coverage of Madrigal Pharmaceuticals with an “outperform” rating and $40, citing MDGL is a clinical-stage biopharmaceutical company developing small molecule agonists to thyroid hormone receptor-β to treat liver and cardiometabolic diseases.

 

Leerink analyst Ravi Misra decreased his price target of Endologix to $7 from $8, citing there could be more downside than upside risk to estimates as it’s still early to gauge the impact of the safety update on AFX2.