BioShares Biotechnology Clinical Trials (BBC): $19.28, +$0.09, +4.7% YTD

BioShares Biotechnology Products (BBP): $34.22, -$0.08, +4.5% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures were trending lower, ahead of a bunch of key economic data including advanced estimate on fourth-quarter growth rate and durable goods orders. The dollar rose against a basket of currencies after President Donald Trump suggested he would push ahead with a 20 percent border tax on Mexico. European shares fell with UBS dragging bank stocks lower, after posting a drop in full-year profit and Asian markets recorded a mixed trading day. Oil declined as rising crude output from the United States was seen as offsetting efforts by OPEC and other producers to prop up the market. Gold was headed for its first weekly decline in 2017.

 

 

MARKET HIGHLIGHTS

 

Immune Pharmaceuticals has appointed Ranch C. Kimball, a highly regarded executive in healthcare, government, and private equity, as Chairman of its Board of Directors. Mr. Kimball’s appointment brings a substantial wealth of experience which he will leverage to strategically raise Immune’s profile for its recent re-organization. Daniel Kazado, Immune’s previous Chairman, will continue to remain as a Director.

 

BioDelivery Sciences International will host an event for analysts and investors from 12:00 PM – 2:30 PM Eastern Time on Wednesday, February 1st, 2017, in New York City, to discuss BELBUCA® (buprenorphine) buccal film (CIII) and plans for the commercialization of BELBUCA, as well as BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII).  The event follows the closing of BDSI’s previously announced agreement with Endo Pharmaceuticals, Inc. (Endo), which transferred the worldwide rights to BELBUCA back to BDSI.

 

Onconova Therapeutics will present a company overview at NobleCON13, Noble Capital Markets’ 13th annual small cap and emerging growth investor conference being held at the Boca Raton Resort & Club in Boca Raton, Florida, on Tuesday, January 31st.

 

Aurinia Pharmaceuticals has selected Worldwide Clinical Trials as its Clinical Research Organization for the AURORA Phase 3 study of volcosporin for the treatment of active lupus nephritis.

 

Emergent BioSolutions announced that the Paul-Ehrlich-Institut (PEI), the regulatory agency under the German Federal Ministry of Health, has approved the company’s large-scale manufacturing facility, Building 55, located in Lansing, Michigan. This approval allows Emergent to market BioThrax (Anthrax Vaccine Adsorbed) manufactured in Building 55 in Germany. BioThrax is the only anthrax vaccine licensed by the PEI for pre-exposure prophylaxis of anthrax disease. It is also the only anthrax vaccine licensed by the FDA for both pre-exposure prophylaxis and post-exposure prophylaxis of anthrax disease.

 

Novan announced top-line results from the Company’s two, replicate Phase III pivotal clinical trials for SB204 in the treatment of acne vulgaris. In the intent-to-treat analysis, Novan’s topical nitric oxide-releasing product candidate SB204 demonstrated statistical significance compared to vehicle on all three co-primary endpoints in NI-AC302, but demonstrated statistical significance on only one of three co-primary endpoints in NI-AC301. The three co-primary endpoints included the absolute changes in inflammatory and non-inflammatory lesion counts and proportion of patients achieving success on the Investigator Global Assessment, or IGA, at week 12. Success was defined as an improvement of at least two grades in the IGA score from baseline and an IGA score of 0 or 1, or "clear" or "almost clear."

 

Reuters reported that AbbVie‘s quarterly adjusted revenue missed analysts’ estimate, in part due to lower-than-expected sales of its hepatitis C drug and cancer treatment. The company reported adjusted revenue of $6.78 billion in the fourth quarter ended Dec. 31, below analysts’ average estimate of $6.91 billion, according to Thomson Reuters I/B/E/S/. The company said on Friday net profit fell to $1.39 billion, or 85 cents per share, in the fourth quarter ended Dec. 31, from $1.52 billion, or 92 cents per share, a year earlier. Excluding special items, the suburban Chicago drugmaker earned $1.20 per share, in line with the average analyst estimate. Net revenue rose to $6.80 billion from $6.40 billion. AbbVie said it expected 2017 adjusted earnings of $5.44 to $5.54 per share, compared with analysts’ estimate of $5.47.

 

Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion recommending XELJANZ (tofacitinib citrate) 5 mg twice daily (BID) for the treatment of patients with moderate to severe active RA. The CHMP’s opinion will now be sent to the European Commission (EC) for final decision. If approved, XELJANZ in combination with methotrexate (MTX) will be indicated for the treatment of moderate to severe active RA in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs. XELJANZ can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.

 

Amgen announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA has adopted a positive opinion for the Marketing Authorization of ABP 501 (biosimilar adalimumab), recommending approval for all available indications. ABP 501 has been recommended for approval for the treatment of certain inflammatory diseases in adults, including moderate-to-severe rheumatoid arthritis, psoriatic arthritis, severe ankylosing spondylitis (AS), severe axial spondyloarthritis without radiographic evidence of AS, moderate-to-severe chronic plaque psoriasis, moderate-to-severe hidradenitis suppurativa, non-infectious intermediate, posterior and panuveitis, moderate-to-severe Crohn’s disease and moderate-to-severe ulcerative colitis. The CHMP opinion also recommended approval for the treatment of certain pediatric inflammatory diseases, including moderate-to-severe Crohn’s disease (ages six and older), severe chronic plaque psoriasis (ages four and older), enthesitis-related arthritis (ages six and older) and polyarticular juvenile idiopathic arthritis (ages two and older).

 

Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation, announced that the EMA’s CHMP has adopted a positive opinion for the use of REVLIMID as monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma (MM) who have undergone autologous stem cell transplantation (ASCT). Once approved by the European Commission, REVLIMID will be the first and only licensed maintenance treatment available to these patients.

 

Reuters reported that the European Medicines Agency made the following recommendations for January 2017: The EU Medicines Agency recommended approval of Amgen‘s Amgevita and Solymbic, both containing adalimumab; EU Medicines Agency recommended approval of Eli Lilly’s Tadalafil for treatment of erectile dysfunction and signs, symptoms of benign prostatic hyperplasia; the EU Medicines Agency’s CHMP offerred positive opinion for Rolufta for the treatment of chronic obstructive pulmonary disease; Jylamvo (methotrexate) received a positive opinion for the treatment of rheumatological disorders and psoriasis, and for maintenance treatment of ALL.

 

Recordati announces that the European Union Commission has granted the European marketing authorization for its orphan medicinal product Cystadrops 3.8mg/mL. Cystadrops is the first eye-drop solution containing cysteamine hydrochloride approved in the European Union for "the treatment of corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis". The European Commission granted Cystadrops orphan drug designation in November 2008.

 

ImmunoGen announced that the first patient has been dosed in FORWARD I, the Company’s Phase III clinical trial evaluating mirvetuximab soravtansine as a single-agent therapy for the treatment of platinum-resistant ovarian cancer. Mirvetuximab soravtansine is a first-in-class, folate receptor alpha (FR?)-targeting ADC.

 

Athersys announced that it intends to offer for sale shares of its common stock, par value $0.001 per share, in an underwritten public offering pursuant to its effective shelf registration statement previously filed with the SEC, and all of the shares of Common Stock offered for sale in the public offering will be sold by Athersys.  William Blair & Company is acting as sole book-running manager and Needham & Company is acting as lead manager for the offering. In addition, Athersys expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of Common Stock offered in the public offering. Athersys currently intends to use the net proceeds from the offering for working capital and general corporate purposes, including funding towards its Phase III MultiStem Administration for Stroke Treatment and Enhanced Recovery Study-2 (“MASTERS-2”) clinical study and our other ongoing clinical programs.

 

Acucela, a wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., announced that on January 25, 2017, the first patient has enrolled in a study to evaluate Acucela’s leading drug candidate, emixustat hydrochloride in subjects with macular atrophy secondary to Stargardt disease.

 

Jounce Therapeutics announced the pricing of its IPO of 6,365,000 shares of common stock at a public offering price of $16.00 per share for aggregate gross proceeds of $101,840,000. In addition, Jounce granted the underwriters a 30-day option to purchase up to 954,750 additional shares of its common stock at the initial public offering price. The shares are scheduled to begin trading on The NASDAQ Global Select Market on January 27, 2017 under the ticker symbol “JNCE.”  J.P. Morgan and Cowen are acting as joint book-running managers for the offering. Wells Fargo Securities is acting as lead manager and Baird is acting as a co-manager for the offering.

 

Reuters reported that Teva Pharmaceutical’s Barr Laboratories has reached a $225 million settlement in an antitrust class action that accused the drugmaker of keeping a generic version of Bayer’s antibiotic Cipro off the market, court documents showed. The case, which began in 2000 in California state court, centers on a series of settlements in the late 1990s under which Bayer allegedly paid Barr Pharmaceuticals, since bought by Teva, $398 million not to market Cipro’s generic version. Bayer had earlier sued Barr claiming that generic Cipro would infringe a Bayer patent.

 

Adocia announced that it was notified in a letter dated January 26 from Eli Lilly its decision to terminate the December 2014 Collaboration Research and License Agreement for the development of Adocia’s ultra-rapid insulin, known as BioChaperone Lispro, for treatment in people with Type I and Type II diabetes. As a consequence of such decision and according to the terms of this agreement, the rights that Adocia has licensed to Lilly will revert to Adocia at no cost.

 

Biscayne Neurotherapeutics announced completion of a $3 million Series B financing. The financing was led by the Global Health Sciences Fund of Quark Venture and GF Securities, along with Mesa Verde Venture Partners. Existing Biscayne Pharmaceuticals investors and new private investors also participated. Biscayne Neurotherapeutics will primarily use the funds to conduct a Phase 1b trial of a new extended release form of its novel antiepileptic compound, BIS-001, in development for adults with refractory complex partial seizures.

 

Harvest One Capital increased the size of its previously announced private placement, disclosed in the news release of the Company dated January 17, 2017, from $15,000,000 to $22,000,000 plus an over-allotment option of up to an additional $3,000,000. Under the Increased Offering, the Company may issue up to 33,333,333 subscription receipts at a price of $0.75 per Subscription Receipt.

 

 

ANALYST RECOMMENDATIONS

 

Maxim analyst Gabrielle Zhou initiated coverage of Mateon Therapeutics with a “buy” rating and $2 price target, citing if a CA4P combination with Avastin is successful, even just slightly, there is upside at the current valuation.

 

Bank of America Merrill Lynch analyst Tazeen Ahmad initiated coverage of Clovis Oncology with a “buy” rating and $74 price target, citing takeout possibility.

 

Following Biogen’s earnings, Leerink analyst Geoffrey Porges decreased his price target to $305 from $359; Goldman analyst Terence Flynn decreased his price target to $310 from $328; Atlantic Equities analyst Steven Chesney increased his price target to $398 from $392; BMO analyst Ian Somaiya decreased his price target to $335 from $336; Bernstein analyst Aaron Gal decreased his price target to $310 from $345; Raymond James analyst Christopher Raymond decreased his price target to $325 from $386.

 

The following analysts initiated coverage of Bioverativ: Cowen analyst Eric Schmidt with a “market perform” rating and $47 price target; Goldman analyst Terence Flynn with a “buy” rating and $55 price target.

 

Cantor Fitzgerald analyst Steven Halper decreased his price target of Nanthelath to $15 from $17, citing a slower-than-expected ramp in its GPS Cancer test and related software and services revenue.

 

Oppenheimer analyst Jay Olson upgraded Neurocrine to “outperform” from “perform,” citing the recent selloff with no rationale.

 

Piper Jaffray analyst David Amsellem decreased his price target of Endo International to $12 from $15, citing near- and longer-term concerns, such as: the FDA panel meeting on Opana ER on March 13-14; continued pressure on pain-focused assets (Lidoderm, Voltaren Gel, Opana ER, which taken together should account for 10%-12% of 2017 EBITDA); uncertainty over Vasostrict’s exclusivity runway beyond a presumed 30-month stay expiring in 2019 if a filer emerges soon (Vasostrict accounts for around one-fifth of EBITDA); and inability to de-lever significantly; though potential asset sales could help, it is not clear to us if divestitures, particularly if they do not include Xiaflex, would be enough to dramatically improve leverage ratios.

 

Goldman analyst Salveen Richter increased her price target of Incyte to $149 from $116, citing INCY has transitioned into a profitable Large-cap Biotech through pipeline success and a disciplined strategy of cash-flow reinvestment into its R&D engine which continue to bear fruit.