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BioShares Biotechnology Clinical Trials (BBC): $23.95, +$0.42, +30.1% YTD

BioShares Biotechnology Products (BBP): $37.90, -$0.36, +15.7% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures edged higher after the Federal Reserve raised interest rates, as expected, but hinted at no plan to accelerate the pace of monetary tightening. A weaker dollar pushed oil prices higher, while gold futures climbed close to 2 percent. Building permits, housing starts, Philadelphia Fed business index and jobless claims data are on the economic calendar. European shares hit their highest level in 15 months, as basic resource and banking stocks rose after center-right Prime Minister Mark Rutte won elections in the Netherlands, and Asian stocks closed higher.

 

 

MARKET HIGHLIGHTS

 

Gemphire Therapeutics announced financial results for the fourth quarter and full fiscal year ended December 31, 2016.  Net loss attributable to common stockholders for the three months and full year ended December 31, 2016 were $7.2 million and $15.0 million, respectively, compared to $3.8 million and $13.0 million for the three months and full year ended December 31, 2015, respectively.  Cash and cash equivalents at December 31, 2016 totaled $24.0 million compared to $3.6 million at December 31, 2015. 

 

Rockwell Medical reported results for the year ending December 31, 2016.  For the year ended December 31, 2016, sales were $53.3 million compared to $55.4 million in 2015, primarily due to lower contract manufacturing sales and lower international concentrate sales.  Net loss was $19.8 million or ($0.39) per share versus $14.4 million or ($0.29) per share in 2015.  Cash and investments were $57.9 million as of December 31, 2016.

 

Tigenix NV will participate in the Deutsche Bank Depositary Receipts Virtual Investor Conference on March 23rd at 9am Eastern Time.

 

Pernix Therapeutics Holdings will report financial results for the fourth quarter and year ended December 31, 2016, after the market close on Tuesday, March 28, 2017. 

 

Onconova Therapeutics will release its year end 2016 financial results pre-market on March 27, 2017. The Company will host a conference call at 9:00 a.m. Eastern Time on the same day.

 

Vermillion will report its fourth quarter and full year 2016 financial results on Wednesday, March 29, 2017, followed by an investor conference call and webcast at 4:30 p.m. Eastern Time.

 

Heat Biologics announced that Natasa Strbo, M.D., D.Sc., Research Assistant Professor of Microbiology and Immunology at the University of Miami Miller School of Medicine, received a three-year $981,901 grant from the Florida Department of Health 2016-17 Zika Research Grant Initiative to further develop and test gp96-based Zika vaccine.  This vaccine is being developed under a collaboration between the University of Miami and Heat’s wholly-owned subsidiary, Zolovax, which has licensed the patent.

 

Trovagene and Nerviano Medical Sciences announced that they have signed a license agreement that grants Trovagene exclusive global development and commercialization rights to NMS-1286937, which Trovagene refers to as PCM-075.  PCM-075 is an oral, investigative drug and a highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK 1).

 

PTC Therapeutics announced it has entered into an asset purchase agreement with Marathon Pharmaceuticals to acquire all rights to Emflaza (deflazacort). Emflaza is the first treatment approved in the United States for all Duchenne muscular dystrophy (DMD) patients five years and older, regardless of their genetic mutation. DMD is a rare and fatal genetic disorder that results in progressive muscle weakness from early childhood and leads to premature death due to heart and respiratory failure. Emflaza aligns with PTC’s mission to bring therapies to patients who have rare diseases with limited or no treatment options.

 

Shire announced that the EC has approved a label extension granting three new indications for CINRYZE (C1 inhibitor [human]), broadening its use to children with Hereditary angiodema (HAE), a rare, genetic disorder that results in recurring attacks of edema (swelling). The body sites most commonly affected are mainly the extremities and abdomen. CINRYZE is now indicated for routine prevention of angioedema attacks in children (ages 6 years and above) with severe and recurrent attacks of HAE who are intolerant to or insufficiently protected by oral preventions treatments, or patients who are inadequately managed with repeated acute treatment.

 

Medivir announced that it has come to agreement with Janssen to outlicense the commercial rights to the Nordics for simeprevir and future simeprevir containing products. In exchange Medivir will receive royalties on sales of all simeprevir containing products in the Nordics, as it already does in the rest of the world, and additional performance based milestones totaling up to approximately 6 MEUR based on certain sales targets for the Nordics of a combination product containing simeprevir.

 

Innovus Pharmaceuticals announced the pricing of a public offering of 25,666,669 shares of common stock, one-year warrants to purchase up to 25,666,669 shares of common stock and five-year warrants to purchase up to 25,666,669 shares of common stock, with expected total gross proceeds of approximately $3.85 million.

 

Alkermes announced the initiation of a new phase III study of ALKS 8700, a novel, oral monomethyl fumarate (MMF) prodrug candidate in development for the treatment of relapsing forms of multiple sclerosis (MS). ALKS 8700 is designed to rapidly and efficiently convert to MMF in the body and offer differentiated features as compared to the currently marketed dimethyl fumarate, TECFIDERA. The five-week, head-to-head study will evaluate the gastrointestinal (GI) tolerability of ALKS 8700 compared to TECFIDERA in approximately 420 patients with relapsing-remitting MS (RRMS). This elective study is part of the ongoing clinical development program for ALKS 8700, named EVOLVE-MS (Endeavoring to Advance Treatment for Patients Living with Multiple Sclerosis). The company plans to submit a NDA for ALKS 8700 for the treatment of RRMS to the FDA in 2018.

 

Acceleron Pharma announced that in the second half of 2017 it plans to initiate a Phase II clinical trial of ACE-083, the Company’s locally acting muscle agent, for the treatment of patients with Charcot-Marie-Tooth disease (CMT), one of the most common inherited neurologic diseases leading to focal muscle weakness.

 

Seres Therapeutics announced plans to initiate a new SER-109 Phase II clinical study (ECOSPOR III) in patients with multiply recurrent Clostridium difficile (C. difficile) infection. The ECOSPOR III study design was finalized following a positive Type B meeting with the FDA.

 

CytoSorbents announced that they have entered into a partnership with Dr. Reddy’s Laboratories for the South African market. Under the terms of the agreement, Dr. Reddy’s has the exclusive rights to distribute CytoSorb for intensive care, cardiac surgery, and other hospital applications in South Africa. This multi-year agreement is subject to annual minimum purchases of CytoSorb to maintain exclusivity.

 

Oncolytics Biotech announced that cancer charity Myeloma UK launched MUK eleven, a first-of-its-kind immunotherapy trial that aims to modulate the immune system to target myeloma. The Phase Ib trial will study immuno-viral therapy, REOLYSIN (pelareorep), in combination with Celgene Corporation’s immunomodulatory drugs (IMiDs), Imnovid (pomalidomide) or Revlimid(®) (lenalidomide), as a rescue treatment in relapsing myeloma patients.

 

Jazz Pharmaceuticals announced that the first patient has been enrolled in a Phase III clinical study evaluating JZP-258, an investigational oxybate product candidate with 90 percent less sodium content than Xyrem (sodium oxybate) oral solution, as a potential treatment for cataplexy and excessive daytime sleepiness (EDS) in adult narcolepsy patients.  The clinical study will be conducted across approximately 60 centers in the European Union and the United States.

 

Pfizer China announced that it has received approval from the CFDA to market its oral Janus kinase (JAK) inhibitor, XELJANZ (tofacitinib citrate), in China for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX). It may be used in combination with MTX or other non-biologic disease-modifying antirheumatic drugs (DMARDs).

 

Celyad announced that the USPTO has decided to reject a new reexamination request of Celyad’s U.S. Patent No. 9,181,527, relating to allogeneic human primary T-cells that are engineered to be TCR-deficient and express a CAR. The patent remains valid and enforceable.

 

KemPharm presented clinical data from two of its opioid prodrug candidates, KP511, KemPharm’s prodrug of hydromorphone, and KP201/IR, KemPharm’s prodrug of hydrocodone, at the American Academy of Pain Medicine (AAPM) Annual Meeting, held March 15-19, 2017. In the study, KemPharm observed comparable hydromorphone exposure between 4 mg Dilaudid(TM) Oral Liquid (hydromorphone HCl) and an equimolar 8 mg dose of KP511, as measured by AUC(last) (90% CI: 83.1%-101.6%) and AUC(inf )(90% CI: 83.7%-106.2%).  Peak exposure (C(max)) was approximately 19% lower for KP511. Similar reductions of approximately 15% and 17%, respectively, in dose-adjusted peak hydromorphone exposure were observed for the 4 mg and 16 mg doses of KP511 with dose-linear C(max) values across all three doses. Median time to peak exposure (T(max)) was 0.5 hours for all treatments. Adverse events were also similar for KP511 and Dilaudid Oral Liquid and were typical for oral opioids.

 

Cellceutix announced that, next week, the Company will be providing additional detailed data from its ongoing Phase IIa Proof-of-Concept (PoC) study of Brilacidin for the treatment of Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD).

 

Kadimastem announced that it has been granted a patent from the USPTO for its technology in the field of cell based treatment for diseases of the nervous system. The United States patent joins additional patents granted in Israel and Europe.

 

 

ANALYST RECOMMENDATIONS

 

Leerink analyst Paul Matteis decreased his price target of Ionis Pharmaceuticals to $47 from $48, citing reduced 2017+ Spinraza forecasts.

 

Piper Jaffray analyst Charles Duncan increased his price target of Biocryst to $13 from $8, citing BioCryst recently raised $48M in net proceeds from a follow-on offering, bringing pro forma cash in the model to >$95M; the cash, together with the recent APeX-1 (Part 1) results, reduces execution and clinical risk for the second-gen kallikrein inhibitor ‘7353 in HAE attack prevention.

 

Following Trovagene’s earnings, Maxim analyst Jason Kolbert downgraded the stock to “hold” from “buy;” Piper Jaffray analyst William Quirk downgraded the stock to “underweight” from “neutral” and decreased his price target to $0.50 from $1.70.

 

Jefferies analyst Biren Amin increased his price target of Kite Pharma to $101 from $82, citing increased Axi-Cel price estimate.

 

Following Evoke Pharma’s earnings, Ascendiant Capital Markets analyst Edward Woo increased his price target to $6 from $5; Rodman & Renshaw analyst Raghuram Selvaraju increased his price target to $9 from $6.

 

Societe Generale analyst Delphine Le Louët upgraded DBV Technologies to “buy” from “hold” and increased her price target to €82 from €66, citing the new P&L (no change in revenue but in R&D), the roll-out of the DCF model to 2017 and the excellent clinical development of Viaskin Peanut for peanut-allergy patients.

 

Morgan Stanley analyst Matthew Harrison downgraded Biogen to “equal-weight” from “overweight” and decreased his price target to $305 from $369, citing limited near-term upside drivers in light of the recent appreciation.

 

Following Inovio Pharmaceuticals’ earnings, Maxim analyst Jason McCarthy upgraded the stock to “buy” from “hold,” and established a $10 price target; Piper Jaffray analyst Charles Duncan downgraded the stock to “neutral” from “overweight” and decreased his price target to $9 from $13.  

 

FBR analyst Ed White initiated coverage of Syndax Pharmaceuticals with an “outperform” rating and $27 price target, citing Syndax is a biotechnology company that has received breakthrough designation from the FDA for its lead product candidate, entinostat, which is in Phase III development for the treatment of hormone receptor positive (HR+) breast cancer.

 

Leerink analyst Paul Matteis downgraded Biogen to “market perform” from “outperform” and decreased his price target to $300 from $305, citing a slower than expected ramp for Spinraza, and the completion of the series of important catalysts that have evolved over the last few months

 

Credit Suisse analyst Alethia Young initiated coverage of United Therapeutics with a “underperform” rating and $120 price target, citing potential near-term and generic risk starting late 2017-2018.

 

Cantor Fitzgerald analyst Elemer Piros initiated coverage of Global Blood Therapeutics with an “overweight” rating and $61 price target, citing the company’s lead candidate, GBT440, has demonstrated compelling potential for the treatment of sickle cell disease (SCD), based on its reported clinical efficacy and safety data.

 

Oppenheimer analyst Leah Rush Cann initiated coverage of the following companies: Exelixis with a “perform” rating; Seattle Genetics with a “perform” rating.

 

Credit Suisse analyst Alethia Young initiated coverage of Bioverativ with a “underperform” rating and $45 price target, citing the company’s current valuation does not reflect enough risk from new long-acting therapies and novel pipeline competitors.

 

WBB Securities analyst Steve Brozak upgraded Kadmon Holdings to “hold” from “buy” and decreased his price target to $3.25 from $7.50, citing recent price depreciation.

 

JP Morgan analyst Anupam Rama decreased his price target of Neurocrine to $60 from $64, citing model adjustments.

 

Raymond James analyst Elliot Wilbur initiated coverage of Dermira with an “underperform” rating, citing the belief that current enterprise fair value is closer to the $1.0B level, implying share prices in the low-to-mid $20 range based on shares outstanding post DERM’s recent offering.