BioShares Biotechnology Clinical Trials (BBC): $18.00, +$0.68, -38.0% YTD

BioShares Biotechnology Products (BBP): $30.06, +$1.17, -2.5% YTD

 

 

MARKET COMMENTARY

 

With all eyes on the U.S. presidential election, U.S. stock index futures pointed to a lower open as nervousness about the outcome kept investors jittery. Job openings and labor turnover data are scheduled to be released later in the day. European and Asian shares were little changed in cautious trading. Gold edged higher as the dollar dropped. Oil prices extended gains.

 

 

MARKET HIGHLIGHTS

 

Innate Pharma SA announced the publication of a late-breaking abstract on an interim efficacy analysis from a Phase 1/2 study of the combination of lirilumab and Opdivo (nivolumab) in the cohort of advanced platinum refractory squamous cell carcinoma of the head and neck (SCCHN). The abstract is available on the Society for Immunotherapy of Cancer’s (SITC) website.  In the abstract, data reports that among 29 evaluable patients with SCCHN, the objective response rate (ORR), as measured by Response Evaluation Criteria In Solid Tumors (RECIST), was 24 percent (n=7) and the disease control rate (DCR) was 52 percent (n=15). Seventeen percent (n=5) of these evaluable patients had deep responses, with reductions in tumor burden greater than 80 percent. Preliminary efficacy of lirilumab plus nivolumab in patients with advanced platinum-refractory SCCHN suggests clinical benefit with encouraging response rates and potential for deep and durable responses.

 

OncoSec Medical Incorporated announced that new clinical data are being presented from a Phase II Investigator Sponsored Trial led by the University of California, San Francisco (UCSF). This single-arm, open-label trial assessed the combination of OncoSec’s investigational intratumoral therapy, ImmunoPulse® IL-12, and Merck’s KEYTRUDA® (pembrolizumab) in patients with unresectable metastatic melanoma. A predictive biomarker was used to enroll patients that have a low likelihood of response to an anti-PD1 agent alone, and the purpose of the trial is to assess whether the addition of ImmunoPulse® IL-12 can increase response rates in these patients. The data will be presented at an oral poster presentation (#466) by Dr. Alain Algazi at the Society for Immunotherapy of Cancer ("SITC") Annual Meeting in National Harbor, MD on November 11, 2016 at 12:50 PM EST.

 

Aeglea BioTherapeutics announced findings from a preclinical study demonstrating that its lead product candidate, AEB1102, an engineered human arginase I enzyme designed to degrade the amino acid arginine in blood, exhibited enhanced inhibition of tumor growth in a mouse model in combination with immunotherapy checkpoint inhibitors. The study data will be presented by Scott Rowlinson, Ph.D., vice president of research at Aeglea, at the Society for Immunotherapy of Cancer (SITC) 2016 Annual Meeting in Maryland on Friday, November 11 from 12:15 p.m. – 1:30 p.m. ET (Abstract #275).

 

Eiger BioPharmaceuticals announced financial results for the three months and nine months ended September 30, 2016.  Net loss for the third quarter of 2016 was $11.4 million, or $1.49 per share basic and diluted, compared to a net loss of $2.9 million, or $14.70 per share basic and diluted for the third quarter of 2015.  Net loss for the nine months ended September 30, 2016 was $34.3 million, or $6.58 per share basic and diluted, compared to a net loss of $6.3 million, or $32.22 per share basic and diluted for the nine months ended September 30, 2015.  As of September 30, 2016, Eiger had cash and cash equivalents of $56.3 million, compared to $4.8 million at December 31, 2015. 

 

CoLucid Pharmaceuticals will provide a corporate overview at the Stifel 2016 Healthcare Conference on Tuesday, November 15th.

 

Moberg Pharma reported third quarter earnings per share of SEK0.68 on revenues of MSEK104.1.

 

Santhera Pharmaceuticals announced that the Swiss Agency for Therapeutic Products (Swissmedic) has accepted for review Santhera’s Marketing Authorization Application for Raxone® (idebenone) for the treatment of Duchenne muscular dystrophy in patients with respiratory function decline not taking concomitant glucocorticoids. Raxone was granted Orphan Drug Designation for DMD in Switzerland in 2012.

 

MediciNova will attend the Global Mizuho Investor Conference on Monday, November 14, 2016. 

 

Pernix Therapeutics Holdings announced the appointment of Graham G. Miao, Ph.D. and Dennis H. Langer, M.D., J.D. to its Board of Directors, effective immediately. The Board also determined that Dr. Langer is an independent director and appointed him as chairperson of the Compensation Committee and as a member of the Audit and Nominating Committees. Accordingly, Pernix regained compliance with NASDAQ Listing Rule 5605(c)(2)(A), which requires Pernix to have at least three independent directors on its Audit Committee for continued listing on The NASDAQ Global Market.

 

Achaogen reported financial results for the third quarter of 2016.  Net loss for the third quarter of 2016 was $11.0 million, or $0.41 per share, compared to a net loss of $8.8 million, or $0.48 per share, for the third quarter of 2015.  Unrestricted cash, cash equivalents and short-term investments totaled $61.1 million at September 30, 2016 compared to $58.7 million at December 31, 2015.

 

Zogenix announced financial results for the third quarter ended September 30, 2016.  Total net loss for the third quarter of 2016 was $17.0 million, or $0.69 per share, compared with net loss of $14.6 million, or $0.65 per share, for the third quarter a year ago.  Cash and cash equivalents at September 30, 2016 totaled $109.9 million, as compared to $155.3 million at December 31, 2015.


Zogenix will participate in a fireside chat at the Stifel 2016 Healthcare Conference on Tuesday, November 15th.

  

Rockwell Medical reported results for the third quarter of 2016.  Net loss for the third quarter was $4.5 million or ($0.09) per share compared to a $2.4 million loss or ($0.05) per share in the third quarter of 2015.  Cash and investments were $57.7 million as of September 30, 2016.

 

Ignyta announced financial results for the third quarter ended September 30, 2016.  For the third quarter of 2016, net loss was $23.3 million, or $0.56 per share, compared with $14.6 million, or $0.49 per share, for the third quarter of 2015.  At September 30, 2016, the company had cash, cash equivalents and available-for-sale securities totaling $152.5 million and current and long-term debt of $32.0 million. At December 31, 2015, the company had cash, cash equivalents and available-for-sale securities totaling $172.1 million and current and long-term debt of $31.0 million.

 

TRACON Pharmaceuticals will present a corporate overview at the Stifel 2016 Healthcare Conference on November 15th, the Jefferies 2016 London Healthcare Conference on November 17th, and the 28th Annual Piper Jaffray Healthcare Conference on November 30th.

 

Dow Jones reported that Valeant Pharmaceuticals International returned to slashing its annual outlook. The move to cut guidance, as the company also posted a $1.22 billion loss and wrote down the value of the Salix business it is trying to sell, is an about-face for Valeant after it had affirmed its guidance in August following a string of cuts. The Canadian firm now expects adjusted earnings of $5.30 to $5.50 a share on $9.55 billion to $9.65 billion in sales for the year, down sharply from its previous guidance for earnings of $6.60 to $7 a share and revenue between $9.9 billion and $10.1 billion. For the September quarter, Valeant posted a loss of $1.22 billion, or $3.49 a share, compared with a profit of $49.5 million, or 14 cents a share, a year earlier. On an adjusted basis that strips out some costs and uses a new tax-reporting method, earnings fell to $1.55 a share from $2.41. Revenue slid 11% to $2.48 billion, mostly owing to a decline in product sales but also dented by foreign currency exchange and other factors. Analysts were looking for adjusted earnings of $1.73 a share on $2.49 billion in revenue, according to Thomson Reuters.

 

Endo International reported 3Q16 non-GAAP EPS of $1.01, which compares to $1.02 for the same period a year ago. The company beat the First Call non-GAAP EPS mean estimate of $0.81. Total revenue for 3Q16 was $884.3 million, which compares to $745.7 million for the same period a year ago. This compares to a mean estimate of $862.3 million.

 

Orexigen Therapeutics announced that Valeant Pharmaceuticals International, through a wholly owned subsidiary, will commercialize Contrave (naltrexone HCl / bupropion HCl extended release) in Australia and New Zealand. Under the terms of the agreement between Valeant and Orexigen’s wholly owned subsidiary, Orexigen Therapeutics Ireland Ltd., Valeant will be responsible for obtaining regulatory approvals and for all commercialization activities. Orexigen will supply Contrave tablets to Valeant for an agreed transfer price and certain potential sales milestone payments. Orexigen expects Valeant to file for regulatory approvals in both countries in the first half of 2017.

 

Aegerion Pharmaceuticals held a special meeting of stockholders to consider and vote on the proposals set forth in the definitive proxy statement filed by the Company on October 6, 2016. The stockholders voted to adopt the Agreement and Plan of Merger, dated as of June 14, 2016, by and among the Company, QLT Inc. and Isotope Acquisition Corp., an indirect wholly-owned subsidiary of QLT. The merger agreement provides for the merger of MergerCo with and into the Company, with the Company surviving as an indirect wholly-owned subsidiary of QLT.

 

After yesterday’s close, Ultragenyx Pharmaceuticals reported 3Q16 GAAP EPS loss of $1.64 which compares to a loss of $1.03 for the same period a year ago. The company missed the First Call GAAP EPS mean estimate loss of $1.53. No revenue was reported. Following Ultragenyx’s earnings, Canaccord analyst Arlinda Lee decreased her price target to $108 from $120; JP Morgan analyst Cory Kasimov decreased his price target to $106 from $110; Piper Jaffray analyst Steven Breazzano decreased his price target to $79 from $82.  

 

After yesterday’s close, Acadia Pharmaceuticals reported 3Q16 GAAP EPS loss of $0.61 which compares to a $0.39 loss for the same period a year ago. The company missed the First Call GAAP EPS mean estimate loss of $0.54. Total revenue for 3Q16 was $5.3 million, which compares to no revenue reported for the same period a year ago. This compares to a mean estimate of $2.9 million. Following Acadia’s earnings, Leerink analyst Paul Matteis decreased his price target to $29 from $34; Bank of America/Merrill Lynch analyst Tazeen Ahmad upgraded the company to “buy” from “neutral” and decreased her price objective to $35 from $39.

 

Seattle Genetics and Takeda Pharmaceutical Company Limited announced completion of patient enrollment in the ECHELON-2 clinical trial. ECHELON-2 is a global Phase III randomized trial evaluating ADCETRIS (brentuximab vedotin) as part of a frontline combination chemotherapy regimen in patients with previously untreated CD30-positive mature T-cell lymphoma (MTCL). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on several types of non-Hodgkin lymphoma, including subsets of MTCL, as well as Hodgkin lymphoma. ADCETRIS is currently not approved for the frontline treatment of MTCL.

 

The Medicines Company announced the immediate discontinuation of the clinical development program for MDCO-216, its investigational cholesterol efflux promoter. Data from the recently-completed MILANO-PILOT trial did not show drug effects on intracoronary atherosclerotic plaque sufficient to warrant further development. The safety profile of MDCO-216 was excellent.

 

Innovus Pharmaceuticals announced it has entered into its second exclusive license and distribution agreement with Elis Pharmaceuticals. Under the agreement Innovus Pharma granted to Elis an exclusive license to market and sell Zestra for female arousal and desire in Lebanon. Innovus Pharma is eligible to receive up to $2.25 million in sales milestone payments plus an agreed-upon transfer price.

 

BD (Becton, Dickinson and Company announced the launch of the BD U-500 Insulin Syringe, the first insulin syringe developed for people with diabetes taking Humulin R U-500 insulin, which is manufactured by Eli Lilly.

 

Mylan N.V. and Biocon announced submission of Mylan’s BLA for MYL-1401O, a proposed biosimilar trastuzumab, to the FDA through the 351(K) pathway. This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast and gastric cancers. Mylan and Biocon believe that this has the potential to be the first submission of a proposed biosimilar trastuzumab in the U.S.

 

Mallinckrodt Pharmaceuticals announced the FDA has approved a Prior Approval Supplement for OFIRMEV (acetaminophen) injection available in an intravenous (IV) bag presentation, which will provide health care providers an additional delivery option. The Prior Approval Supplement to the approved OFIRMEV New Drug Application included the addition of a new container closure and manufacturer. The polypropylene bags will be manufactured by Fresenius Kabi. Mallinckrodt anticipates product availability in the second quarter of 2017.

 

Diffusion Pharmaceuticals announced that its shares of common stock were approved for listing on the NASDAQ Capital Market. Trading on the NASDAQ Capital Market will commence on November 9, 2016, and the Company’s shares of common stock will continue to trade under the ticker symbol "DFFN."

 

Lion Biotechnologies reported encouraging data in four poster presentations at the Society for Immunotherapy of Cancer (SITC) 31(st) Annual Meeting & Associated Programs in National Harbor, Maryland taking place November 9-13, 2016.

 

PhaseRx announced positive results from the company’s single escalating dose response study in non-human primates. The administration of mRNA delivered using the company’s proprietary Hybrid mRNA Technology platform in a large animal model was safe and well tolerated at all dose levels tested — an important step prior to advancing its lead mRNA drug candidate towards clinical development. The company has previously shown therapeutic effect in its lead program, PRX-OTC, in the preclinical model of Ornithine Transarbamylase Deficiency ("OTCD"), including both lowering of blood ammonia and rescue of 100% of treated mice.

 

Zosano Pharma announced completion of enrollment in its registration-enabling, pivotal efficacy trial (the Zotrip trial), of M207 for the treatment of acute migraine.

 

XOMA unveiled its interleukin-2 (IL-2) monoclonal antibody program, a series of novel agents from its scientific discovery research unit, and announced the advancement of its parathyroid hormone receptor 1 (PTH1R) antibody antagonists program. These novel monoclonal antibodies are further examples of the capability of XOMA’s antibody platform and its expertise in the identification of novel oncology and oncology-related candidates with potential to positively affect outcomes in cancer patients.

 

Reuters reported that the U.S. Senate Judiciary Committee urged federal antitrust regulators to launch a probe into maker Mylan broke the law by preventing schools from purchasing competing allergy treatments.

 

Cerenis Therapeutics announced the dosing of the last patient in the global Phase II CARAT study. CARAT is designed to assess the therapeutic efficacy of CER-001, a pre-beta HDL mimetic, in post-acute coronary syndrome (ACS) patients.

 

DBV Technologies announced that enrollment for Part B, or Phase II, of the Phase I/II study of Viaskin Milk for the treatment of patients with IgE-mediated cow’s milk protein allergy (CMPA) has been completed. The MILES trial is evaluating the efficacy and safety of Viaskin Milk in desensitizing children two to 17 years of age suffering from CMPA. The Viaskin Milk patch is based on DBV’s epicutaneous immunotherapy (EPIT), a proprietary technology platform that can deliver biologically active compounds to the immune system through the skin. The blinded part of the MILES study is expected to complete in the second half of 2017.

 

Karyopharm Therapeutics entered into Amendment No. 1 to Controlled Equity Offering Sales Agreement, dated December 7, 2015 with Cantor Fitzgerald & Co., as agent, pursuant to which the Company may issue and sell shares of its common stock, $0.0001 par value per share, having an additional aggregate offering price of up to $50,000,000 on or after November 7, 2016 through Cantor Fitzgerald. Also, on November 7, 2016, the Company is filing a prospectus supplement with the SEC in connection with the Offering under its existing shelf registration statement, which became effective on January 5, 2015 (File No 333-201366) and was amended by post effective amendments on March 15, 2016 and May 17, 2016, which became effective on such dates, respectively.

 

 

ANALYST RECOMMENDATIONS

 

Following Emergent Biosolutions’ earnings, JP Morgan analyst Jessica Fye decreased her price target to $33 from $36.

 

Following Depomed’s earnings, Cantor analyst Chiara Russo downgraded the stock to “hold” from “buy” and decreased her price target to $23 from $25; Janney analyst Ken Trbovich decreased his fair value estimate to $26 from $31.

 

Mizuho analyst Salim Syed initiated coverage of the following companies:  Amgen with a “buy” rating and $164 price target; Gilead with a “buy” rating and $88 price target; Celgene with a “buy” rating and $130 price target; Biogen with a “neutral” rating and $290 price target.

 

Morgan Stanley analyst Andrew Berens downgraded Cempra to “underweight” from “overweight” and decreased his price target to $5 from $35, citing numerous safety concerns highlighted by the FDA during the recent AdCom diminishes the drug’s value proposition.

 

Citi analyst Yigal Nochomovitz increased his price target of Ardelyx to $17 from $11, citing the introduction of Hyperkalemia into the thesis.

 

Following Nanthealth’s earnings, First Analysis analyst Tracy Marshbanks to $14 from $17; Cowen analyst Charles Rhyee decreased his price target to $17 from $19; Jefferies analyst Brandon Couillard decreased his price target to $16 from $17.50.

 

Cowen analyst Chris Shibutani decreased his price target of The Medicines Company to $39 from $45, citing the decision to discontinue development for MDCO-216.