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BioShares Biotechnology Clinical Trials (BBC): $21.85, -$0.69, +18.8% YTD

BioShares Biotechnology Products (BBP): $36.55, -$0.57, +11.6% YTD

 

 

MARKET COMMENTARY

 

U.S. stocks index futures were little changed as markets turned cautious by signs the Federal Reserve might start paring asset holdings later this year just as the chance of early U.S. fiscal stimulus seems to be evaporating. Weekly jobless claims data is on the economic radar. The euro declined and hit a three-week low on dovish comments from the head of the European Central Bank and gold edged up. Banking stocks dragged European bourses lower, and Asian shares declined. Oil prices rose after recovering from losses triggered by record high U.S. crude inventories.

 

 

MARKET HIGHLIGHTS

 

Eiger BioPharmaceuticals announced that abstracts from its LOWR HDV (LOnafarnib With Ritonavir in Hepatitis Delta Virus) Program will be presented at the European Association for the Study of the Liver (EASL) meeting in Amsterdam, Denmark, April 19 to 23, 2017.  Forty-eight week data from the Phase 2 LOWR HDV Program will be presented.

 

iCAD announced the Company will highlight PowerLook® Tomo Detection, an innovative, concurrent-read computer aided detection solution for digital breast tomosynthesis that can save radiologists valuable reading time without compromising clinical performance, at its booth #300 at the SBI/ACR Breast Imaging Symposium from April 6-9, 2017 in Los Angeles, California. PowerLook Tomo Detection received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) on March 24, 2017 and is the latest innovation available on the PowerLook® Breast Health Solutions platform.

 

BioTime announced the formation of AgeX Therapeutics, which will consolidate certain BioTime subsidiaries and programs in the field of interventional gerontology. The formation of AgeX continues the implementation of BioTime’s strategy to simplify its corporate structure and operations as well as focus resources on the continued clinical development of its two lead programs; Renevia, a proprietary cell delivery matrix designed to facilitate the stable engraftment of transplanted cells that is currently in a pivotal clinical trial, and OpRegen, a pluripotent cell-derived cell therapy that is in a Phase I/IIa clinical trial for the dry form of age related macular degeneration (dry-AMD). The formation of AgeX provides the new BioTime subsidiary greater flexibility to explore external financing alternatives as well as strategic options to grow its technology platform.

 

TiGenix NV reported its financial highlights for 2016.  The profit for the year 2016 amounted to €3.8 million compared to a loss of €35.1 million in 2015.  Cash and cash equivalents amounted to €78.0 million on December 31, 2016.

 

Regeneron Pharmaceuticals announced that the FDA has granted Breakthrough Therapy Designation status to evinacumab for the treatment of hypercholesterolemia in patients with Homozygous Familial Hypercholesterolemia (HoFH), an inherited disorder that can lead to premature cardiovascular disease due to very high levels of LDL cholesterol. Evinacumab is an investigational monoclonal antibody to angiopoietin-like protein 3 (ANGPTL3). ANGPTL3 acts as an inhibitor of lipoprotein lipase and endothelial lipase, and appears to play a central role in lipoprotein metabolism.

 

Ultragenyx Pharmaceutical and Kyowa Kirin International, a wholly owned subsidiary of Kyowa Hakko Kirin Co., Ltd., announced positive 64-week data from a pediatric Phase II study of burosumab (KRN23) for the treatment of X-linked hypophosphatemia (XLH) in children aged five to 12 years of age. The data demonstrated that serum phosphorus levels, rickets, growth rates, and other functional outcomes improved with burosumab, and these treatment effects were sustained through 64 weeks of treatment. In addition, interim 24-week data from the separate pediatric Phase II study in patients aged one to five years demonstrated that burosumab increased serum phosphorus levels into the low normal range. Adverse events were consistent with what has been previously observed for burosumab for the treatment of XLH. Ultragenyx is conducting the studies under a collaboration and license agreement with Kyowa Hakko Kirin to develop and commercialize burosumab.

 

Supernus Pharmaceuticals announced that the FDA has granted final approval to the Company’s sNDAs requesting a label expansion for Trokendi XR to include prophylaxis of migraine headache in adults and adolescents 12 years and older. Supernus was granted tentative approval of one of the two sNDAs in August 2016, with final approval subject to the pediatric exclusivity of the innovator’s drug in the adolescent population, which expired March 28, 2017.

 

Allergan announced topline data from a Phase II study with Major Depressive Disorder (MDD). The study evaluated the efficacy, safety and tolerability of a single administration of 2 different doses of BOTOX (30 units or 50 units) relative to placebo in adult females with MDD over duration of up to 24 weeks.   The BOTOX 30 U dose demonstrated numerically superior efficacy in MADRS total score compared to placebo. The treatment (LS mean) difference for 30 U was -4.2 at 3 weeks (p- value 0.005); -3.7 at week 6 (p-value 0.053) and -3.6 at week 9 (p-value 0.049). The primary end point was at week 6. The 50 U did not demonstrate superior efficacy over placebo (LS mean difference was 1.3). Both secondary efficacy variables (CGI-S and HAMD-17) showed numerically superior efficacy over placebo and trended in the same direction as the primary efficacy variable for 30 U, but not for 50 U. Both 30 U and 50 U were well tolerated.

 

Jazz Pharmaceuticals announced that certain of its subsidiaries have entered into agreements with Hikma Pharmaceuticals and related entities resolving patent litigation related to Xyrem (sodium oxybate) oral solution. The litigation, which has been pending in the U.S. District Court for the District of New Jersey since 2010, resulted from the submission by Roxane Laboratories (which was subsequently acquired by Hikma) of an ANDA to the FDA seeking approval to market a generic version of Xyrem. Following the news, Mizuho analyst Irina Koffler downgraded the stock to “neutral” from “buy” and decreased her price target to $150 from $162; Leerink analyst Jason Gerberry increased his price target to $170 from $169; Cantor analyst William Tanner increased his price target to $197 from $189; Janney analyst Ken Trbovich upgraded to “buy” from “neutral” and increased his fair value estimate to $175 from $138; Deutsche Bank analyst Gregg Gilbert increased to $176 from $148.

 

Tenax Therapeutics provided an update related to its business strategy, the clinical development of its product candidates and its management team. The Company’s Board of Directors is conducting a comprehensive review of strategic alternatives focused on maximizing stockholder value and has formed a strategic committee of three independent board members to supervise management in this review. In addition, the Company has engaged Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services, as its financial advisor to assist in the strategic review process; including, but not limited to a merger, a business combination, a strategic investment into the Company, or a purchase, license or other acquisition of assets. This process may not result in any transaction and the Company does not intend to disclose additional details unless and until it has entered into a specific transaction. Effective April 3, 2017, John Kelley resigned as CEO of the Company and from the Company’s board of directors, but has agreed to provide consulting services to the Company for a period of time following his resignation. The Company’s Board of Directors appointed Michael Jebsen, the Company’s current President and CFO, as Interim CEO, effective immediately upon Mr. Kelley’s resignation. Mr. Jebsen previously served as Interim CEO for the Company from 2011 to 2013.

 

AnaptysBio announced first-in-human dosing of its wholly-owned proprietary anti-Interleukin-36 receptor (IL-36R) antibody, ANB019, in a healthy volunteer Phase I clinical trial. The double-blind, placebo-controlled, single and multiple ascending dose trial is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ANB019 through subcutaneous and intravenous routes of administration.

 

Lµbris BioPharma announced that Novartis has exercised an option to in-license ECF843, Lµbris’ proprietary recombinant human lubricin for ophthalmic indications worldwide (outside Europe) including the treatment of dry eye. The closing of the deal is subject to customary closing conditions including regulatory approvals. Lµbris retains rights to commercialize products outside of ophthalmology. Financial terms were not disclosed.

 

Achillion Pharmaceuticals announced initiation of patient dosing in a Phase II open-label study of ACH-4471, Achillion’s first orally-administered, small molecule factor D inhibitor, for patients with paroxysmal nocturnal hemoglobinuria (PNH). This proof of concept study will assess the efficacy, safety, and pharmacokinetics of ACH-4471 in untreated patients with PNH.

 

Galapagos announces dosing of the first patient with psoriatic arthritis in the EQUATOR Phase II study. This achievement triggers a $10 million milestone payment from Gileadto Galapagos. The EQUATOR Phase II study will be a multi-center, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of the selective JAK1 inhibitor filgotinib in adult patients with moderately to severely active psoriatic arthritis.

 

Cardiome Pharma updated that its partner, SteadyMed Therapeutics, announced the successful completion of a clinical study of Trevyent with a press release discussing the study on April 5, 2017. Cardiome licensed the commercial rights to Trevyent from SteadyMed for many international markets in 2015.

 

Spark Therapeutics announced updated preliminary data today from 10 infused participants in the ongoing Phase I/II clinical trial of investigational SPK-9001 for hemophilia B. All participants have experienced consistent and sustained increases in factor IX activity following administration of the investigational therapy. These data will be presented at the Hemostasis and Thrombosis Research Society (HTRS) 2017 Scientific Symposium in Scottsdale, Arizona on Friday, April 7, by Adam Cuker, M.D., assistant professor of medicine at the Perelman School of Medicine of the University of Pennsylvania and a clinical investigator at Children’s Hospital of Philadelphia.

 

Innocrin Pharmaceuticals announced the appointment of Fred Eshelman, PharmD, of Eshelman Ventures as CEO, effective March 15, 2017. Innocrin also announced that the FDA granted a second Fast Track Designation for seviteronel (VT-464). The new designation is for the treatment of women with advanced AR+ triple-negative breast cancer (TNBC) and women or men with advanced estrogen receptor-positive (ER+) breast cancer.

 

Immune-Onc Therapeutics announced today it has entered into an exclusive license and collaboration agreement with The University of Texas Health Science Center at Houston and The University of Texas Southwestern Medical Center, two member institutions of The University of Texas System.

 

BlackThorn Therapeutics announced preclinical study results demonstrating that its investigational novel kappa opioid receptor (KOR) antagonist BTRX-335140 is selective and short-acting. Results of the study, which was conducted by BlackThorn and researchers at the University of California, San Francisco (UCSF), were presented this week at the Fourth Conference on the Therapeutic Potential of Kappa Opioids in Philadelphia. BlackThorn is building its proprietary KOR antagonist program through a partnership with The Scripps Research Institute.

 

Imprimis Pharmaceuticals announced that it has entered into an licensing agreement for the exclusive worldwide rights to Klarity, an innovative and patented ophthalmic topical solution and gel technology for patients with dry eye disease.

 

Allergan and ZELTIQ Aesthetics announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 has expired with respect to Allergan’s proposed acquisition of ZELTIQ.

 

Myriad Genetics announced that it has entered into a companion diagnostic development collaboration with BeiGene to accelerate precision medicine in oncology.

 

Biostage presented preclinical data of its Cellspan Esophageal Implant at the Society for Biomaterials 2017 Annual Meeting and Exposition, being held April 5-8, 2017 in Minneapolis, MN.

 

Valeant Pharmaceuticals International‘s wholly owned subsidiary, Bausch Lomb, announced it has received 510(k) clearance from the FDA for the Stellaris Elite Vision Enhancement System, the company’s next generation phacoemulsification cataract platform.

 

FibroGen announced that the company has priced an underwritten follow-on offering, which is expected to raise gross proceeds of approximately $120 million. FibroGen is offering 5,228,750 shares of its common stock at an offering price of $22.95 per share, before underwriting discounts and commissions. All of the shares are being offered by FibroGen. The offering is expected to close on April 11, 2017, subject to customary closing conditions.

 

Cara Therapeutics announced the closing of its underwritten public offering of 5,117,500 shares of its common stock at a public offering price of $18.00 per share, which included 667,500 shares sold pursuant to the full exercise by the underwriters of their option to purchase additional shares. The gross proceeds from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by Cara Therapeutics, are expected to be approximately $92.1 million. The proceeds of the offering are expected to be used to fund the company’s clinical and research development activities, including the completion of the Phase III program for I.V. CR845 in uremic pruritus, two Phase III trials of I.V. CR845 in acute pain and a Phase IIb trial of oral CR845 in osteoarthritis pain, as well as for working capital and general corporate purposes. Piper Jaffray & Co. and Stifel acted as joint book-running managers for the offering. Canaccord GenuityNeedham & CompanyJanney Montgomery Scott and H.C. Wainwright & Co. acted as co-managers.

 

Merrimack Pharmaceuticals announced that its Board of Directors has authorized and declared a special cash dividend of $140 million on the company’s common stock. This special dividend will be paid from the proceeds of the company’s asset sale to Ipsen S.A., which was completed on April 3, 2017.

 

China Cord Blood Corporation announced that the Company received notification of exercise of all 7% senior convertible notes ("Notes") held by Golden Meditech Stem Cells (BVI) Company Limited ("GMSC", the "Holder"), a subsidiary of Golden Meditech Holdings Limited beneficially owning 65.4% of the Company on a fully diluted basis.

 

Ocular Therapeutix announced the appointment of George Migausky as interim CFO. 

 

Ironwood Pharmaceuticals announced the appointment of Christopher Wright, M.D., MMSc., Ph.D., as senior vice president of global development and chief development officer.

 

 

ANALYST RECOMMENDATIONS

 

Rodman & Renshaw analyst Joseph Pantginis assumed coverage of Rexahn Pharmaceuticals with a “buy” rating and $2 price target, citing the company is on the cusp of the transition to meaningful clinical data readouts this year with well thought out clinical studies.

 

Jefferies analyst Brian Abrahams assumed coverage of Ultragenyx, downgraded the stock to “hold” from “buy,” and decreased his price target to $66 from $109, citing potential headwinds they may face building into small/less well-defined markets– which alongside split economics for some programs could impact potential LT revenue opportunities.

 

William Blair analyst Tim Lugo initiated coverage of the following companies: Retrophin with an “outperform” rating; Akari Therapeutics with an “outperform” rating.

 

Citi analyst Liav Abraham downgraded Synergy to “sell” from “neutral” and decreased her price target to $3.70 from $6.50, citing updated operating expense assumptions to more adequately reflect the promotional investment required in the launch of Trulance.

 

Jefferies analyst Brian Abrahams made price target changes to the following companies: Incyte to $165 from $140; Biogen to $281 from $289; Gilead to $82 from $83. Jefferies analyst Matthew Andrews increased his price target of Spectrum Pharmaceuticals to $8.50 from $7.50.

 

Leerink analyst Michael Schmidt increased his price target of Seattle Genetics to $74 from $70, citing an adjusted forecast for Adcetris.