BioShares Biotechnology Clinical Trials (BBC): $21.98, -$0.21, +19.4% YTD

BioShares Biotechnology Products (BBP): $37.94, -$0.46, +15.8% YTD

 

 

MARKET COMMENTARY

 

Wall Street was set for a higher start and the dollar gained against a basket of currencies after comments from Federal Reserve officials raised expectations of an interest rate hike this month. A flurry of economic data including consumer spending, personal income, reading on manufacturing activity from ISM and Markit, and construction spending are scheduled for release later in the day. European share markets rose after U.S. President Donald Trump’s pledge of increased infrastructure spending bolstered basic resource stocks. Asian bourses closed higher, gaining support from upbeat manufacturing data from China, Japan and Australia. OPEC production cuts pushed oil prices higher even as increased U.S. oil output capped gains. Gold fell as focus shifted towards Fed Chair Janet Yellen’s speech on Friday, which may strengthen the dollar.

 

 

MARKET HIGHLIGHTS

 

Zogenix announced that the European Commission (EC) has designated ZX008 (fenfluramine) as an orphan medicinal product for the treatment of Lennox Gastaut Syndrome (LGS), a refractory, debilitating childhood-onset epilepsy. The EC’s approval follows a positive opinion in January from the European Medicine Agency’s (EMA) Committee for Orphan Medicinal Products (COMP).

 

Eli Lilly and Company today announced the successful completion of its acquisition of CoLucid Pharmaceuticals. The tender offer for all outstanding shares of common stock of CoLucid, at a price of $46.50 per share, expired as scheduled on Tuesday, February 28, 2017.

 

BrainStorm Cell Therapeutics has signed a Memorandum of Understanding (MOU) with The Medical Research, Infrastructure, and Health Services Fund of the Tel Aviv Sourasky Medical Center (Ichilov Hospital) to explore the possibility of making NurOwn® available to Amyotrophic Lateral Sclerosis (ALS) patients under the provisions of  Hospital Exemption regulation.  The MOU also covers the participation of Tel Aviv Sourasky Medical Center in the planned Phase 3 trial that will investigate NurOwn in ALS.

 

Albireo Pharma will make a corporate presentation and provide a business update at the 37th Annual Cowen and Company Health Care Conference at the Boston Marriott Copley Place on Wednesday, March 8, 2017, at 8:00 a.m. ET.

 

Aimmune Therapeutics will present a company overview at the Cowen and Company 37th Annual Health Care Conference on Wednesday, March 8, 2017, at 10:00 a.m. Eastern Time and at the Barclays Capital Global Healthcare Conference on Thursday, March 16, 2017, at 11:15 a.m. Eastern Time.

 

Alcobra will host an investor forum on Tuesday, March 28 from 8:00-9:30 a.m. EST in New York City. The forum will feature several experts in the field of prescription medication abuse and the treatment and management of attention deficit and hyperactivity disorder (ADHD). In addition, Alcobra’s executive management team will provide an evidence-based overview of the commercial potential for its proprietary Abuse-Deterrent, Amphetamine Immediate Release product candidate called ADAIR.

 

TiGenix NV will be presenting at the 37th Annual Cowen and Company’s Health Care Conference in Boston on Monday, March 6 at 3:20-3:50PM.

 

Attune Pharmaceuticals will present new data for ATN-249 in a late-breaking poster at the 2017 American Academy of Allergy, Asthma & Immunology Annual Meeting (AAAAI 2017).  The poster presentation highlights potency, selectivity, pharmacokinetic, and safety attributes of ATN-249, a novel orally administered plasma kallikrein inhibitor for the treatment Hereditary Angioedema (HAE). Preclinical studies demonstrated ATN-249 was highly selective and potent at plasma kallikrein inhibition in both biochemical and contact activation assays. Pharmacokinetic data support once daily administration with a wide therapeutic index.

 

Mylan reported 4Q16 non-GAAP EPS of $1.57, which compares to $1.22 for the same period a year ago. The company beat the non-GAAP EPS mean estimate of $1.42. Total revenue for 4Q16 was $3.3 billion, which compares to $2.5 billion for the same period a year ago. This compares to a mean estimate of $3.2 billion.

 

Akorn Incorporated reported 4Q16 non-GAAP EPS of $0.58, which compares to $0.60 for the same period a year ago. The company beat the non-GAAP EPS mean estimate of $0.57. Total revenue for 4Q16 was $283.7 million, which compares to $280.0 million for the same period a year ago. This compares to a mean estimate of $288.0 million.

 

After yesterday’s close, Jazz Pharmaceuticals reported 4Q16 non-GAAP EPS of $2.71, which compares to $2.81 for the same period a year ago. The company beat the non-GAAP EPS mean estimate of $2.65. Total revenue for 4Q16 was $396.6 million, which compares to $340.9 million for the same period a year ago. This compares to a mean estimate of $398.3 million. Following earnings, Janney analyst Ken Trbovich increased his price target to $138 from $125; Leerink analyst Jason Gerberry decreased his price target to $170 from $182; Piper Jaffray analyst David Amsellem decreased his price target to $181 from $188; Bernstein analyst Aaron Gal increased his price target to $141 from $131; Stifel analyst Annabel Samimy decreased her price target to $190 from $200.  

 

After yesterday’s close, TESARO reported 4Q16 GAAP EPS loss of $2.60, which compares to a loss of $1.89 for the same period a year ago. The company missed the GAAP EPS mean estimate loss of $1.95. Total revenue for 4Q16 was $4.23 million, which compares to $0.2 million for the same period a year ago. This compares to a mean estimate of $5.8 million. Following earnings, Wedbush analyst David Nierengarten increased his price target to $200 from $186; Guggenheim analyst Tony Butler increased his price target to $207 from $177; Morgan Stanley analyst Andrew Berens increased his price target to $186 from $172.

 

Reuters reported that Pacira Pharmaceuticals announced 2016 financial results. The company’s Q4 non-GAAP earnings per share was $0.09 and Q4 GAAP loss per share was $0.11. Q4 revenue was $72.9 million compared to I/B/E/S view of $73.1 million. Q4 earnings per share view was $0.01, according to Thomson Reuters I/B/E/S. The company sees FY 2017 exparel net product sales of $290 million to $310 million, sees 2017 exparel net product sales of $290 million to $310 million, and sees FY 2017 non-GAAP gross margins of approximately 70%.

 

Sarepta Therapeutics reported financial results for the three and twelve months ended December 31, 2016. For the fourth quarter of 2016, Sarepta reported a net loss of $88.5 million, or $1.62 per share, compared to a net loss of $64.7 million for the same period of 2015, or $1.44 per share. The Company commenced shipments of EXONDYS 51 to customers at the end of the third quarter of 2016 following the accelerated approval by the FDA on September 19, 2016. For both the fourth quarter and full-year of 2016, the Company recognized net revenues of $5.4 million. For the same periods of 2015, the Company recognized $1.3 million of revenue from the contract finalization of the Ebola portion of the July 2010 Department of Defense contract. Following Sarepta’s earnings, Needham analyst Chad Messer decreased his price target to $75 from $78; Leerink analyst Joseph Schwartz decreased his price target to $27 from $32; JMP analyst Liisa Bayko decreased her price target to $48 from $65; Jefferies analyst Gena Wang decreased her price target to $27 from $32; Piper Jaffray analyst Ed Tenthoff decreased his price target to $43 from $68; RBC analyst Simos Simeonidis decreased his price target to $91 from $98.

 

Dynavax Technologies announced that the FDA has accepted for review Dynavax’s responses to the CRL issued by the FDA in November 2016 for the BLA for HEPLISAV-B, the company’s vaccine candidate for immunization against hepatitis B infection in adults 18 years of age and older. The FDA has established August 10, 2017 as the PDUFA action date.

 

NeuroDerm announced that a preliminary analysis of trial 006 demonstrated that the trial successfully met its primary, key secondary and additional secondary endpoints. Trial 006 was an international open label, blinded rater, phase II study of ND0612H, NeuroDerm’s high dose continuous, subcutaneously delivered levodopa/carbidopa (LD/CD) liquid formulation, in patients with advanced Parkinson’s disease.

 

Ligand Pharmaceuticals announced that it has expanded its license with Sermonix Pharmaceuticals to include worldwide rights to develop and commercialize oral lasofoxifene. Ligand originally licensed the U.S. rights to oral lasofoxifene to Sermonix in February of 2015, and has now expanded the agreement to include the rest of the world. Sermonix is focused on breast and ovarian cancer treatment with oral lasofoxifene, particularly an indication in the treatment of advanced Estrogen Receptor positive (ER+) endocrine-resistant breast cancer.

 

Lexicon Pharmaceuticals announced that the FDA has approved XERMELO (telotristat ethyl) 250 mg as a first and only orally administered therapy for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.

 

Audentes Therapeutics announced the commencement of LUSTRO, a prospective study designed to characterize the disease course in patients living with Crigler-Najjar Syndrome.  LUSTRO will evaluate subjects prior to potential enrollment in VALENS, the planned Phase I/II clinical study to evaluate the safety and preliminary efficacy of AT342, the Audentes product candidate being developed to treat Crigler-Najjar Syndrome.

 

Icahn Enterprises announced that Icahn Capital LP, its wholly owned subsidiary, has hired Dr. Richard C. Mulligan as a Portfolio Manager. Dr. Mulligan will be focused on biotechnology investments for Icahn Partners LP and Icahn Partners Master Fund LP, the private investment funds comprising Icahn Enterprises’ Investment segment.

 

Bristol-Myers Squibb announced today its equity investment and plans for a research collaboration with GRAIL Inc., a life sciences company whose mission is to detect cancer early when it potentially can be cured. By combining the power of high intensity cancer DNA sequencing, leading edge computer science and large clinical studies into a diagnostic platform, GRAIL aims to develop highly sensitive blood tests that detect cancer in its early stages to enable earlier intervention with targeted therapies.

 

Sangamo Therapeutics announced today that the FDA has granted orphan drug designation to SB-913, a genome editing product candidate for the treatment of Mucopolysaccharidosis Type II (MPS II), a rare lysosomal storage disorder. Orphan drug designations are granted to drugs and biologics intended to treat rare diseases with a patient population less than 200,000 in the U.S. The designation provides incentives to advance development and commercialization of rare disease drugs. Sangamo has also submitted an application to the FDA for rare pediatric disease designation for SB-913.

 

XTL Biopharmaceuticals announced the company has regained compliance with the listing requirements of The Nasdaq Stock Market (Nasdaq).

 

Eli Lilly announced the successful completion of its acquisition of CoLucid Pharmaceuticals. The tender offer for all outstanding shares of common stock of CoLucid, at a price of $46.50 per share, expired as scheduled on Tuesday, February 28, 2017.

 

OMEICOS Therapeutics announced the first closing of a Series B financing round of €8.3 million and the initiation of a Phase II clinical trial with lead compound OMT-28 for the treatment of atrial fibrillation. The financing was led by Vesalius Biocapital II S.A. SICAR and SMS Company Group, along with existing investors KFW Group, VC Fonds Technologie Berlin, High-Tech Gründerfonds II GmbH & Co. KG (HTGF), The Falck Revocable Trust, Ascenion GmbH and members of the management team. The funding will be used to support the newly initiated clinical program and to further leverage the therapeutic potential of the technology.

 

Alnylam Pharmaceuticals announced that the EMA has granted access to its Priority Medicines (PRIME) scheme for givosiran (ALN-AS1), an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) for the treatment of acute hepatic porphyrias. The purpose of the PRIME initiative is to bring treatments to patients faster by enhancing the EMA’s support for the development of medicines for diseases where there is an unmet medical need and where early clinical data show potential to benefit patients.

 

Aerie Pharmaceuticals announced that it resubmitted its NDA  for Rhopressa to the FDA after notification by its contract drug product manufacturer that the vendor’s Tampa, Florida facility is now ready for pre-approval inspection by the FDA for Rhopressa. As background, the Rhopressa NDA was withdrawn in October 2016 due to the contract manufacturer not yet being prepared for pre-approval inspection by the FDA at that time.

 

Omeros announced additional positive data from the ongoing Phase II clinical trial evaluating OMS721 in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HCT-TMA). These data were presented at the combined annual meetings of the Center for International Blood & Marrow Transplant Research (CIBMTR) and the American Society for Blood and Marrow Transplantation (ASBMT). The presentation, “Early Results of a Phase II Study Using OMS721 in Patients with Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy (HCT-TMA),” summarized clinical data from the seven HCT-TMA patients who to date have been treated with OMS721. Samer Khaled, M.D., Assistant Clinical Professor of Hematology & Hematopoietic Cell Transplantation at City of Hope, presented the data Saturday, February 25, 2017.

 

PDL BioPharma announced that the company’s board of directors has authorized the repurchase of up to $30 million of the company’s common stock through March 2018.  Purchases may be made in open-market transactions, block transactions on or off an exchange, in privately negotiated transactions, or other means as determined by PDL’s management and in accordance with the regulations of the Securities and Exchange Commission.

 

Celgene and Agios Pharmaceuticals announced that the FDA has accepted Celgene’s NDA for enasidenib (AG-221/CC-90007) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutation. The NDA was granted Priority Review and has been given a PDUFA action date of Aug. 30, 2017. Celgene completed the NDA submission in late December 2016.

 

Stellar Biotechnologies and Amaran Biotechnology have entered into an exclusive multi-year supply agreement in connection with clinical development studies of immunotherapies for metastatic breast cancer and other cancers.

 

Perrigo announced it has received final approval from the FDA for its ANDA referencing Eli Lilly‘s Axiron Topical Solution, 30 mg/1.5 mL (Testosterone Topical Solution, 30 mg/1.5 mL).

 

Achieve Life Science and OncoGenex Pharmaceuticals announced a strategic collaboration with the National Center for Complementary and Integrative Health (NCCIH) at the NIH to conduct non-clinical studies in support of an overall clinical development plan for cytisine as a smoking cessation treatment. As part of the collaboration, Achieve is providing cytisine to the NIH to conduct a series of non-clinical studies required by the FDA to support the submission of an IND application. The collaboration commenced in March 2015 and results of the initial study are expected in the second-quarter of 2017.

 

Mallinckrodt announced the results from its 2017 Annual General Meeting. Separately, Mallinckrodt’s Board of Directors authorized an incremental $1.0 billion repurchase of ordinary shares, reflecting the company’s ongoing strong performance and future prospects. This authorization is in addition to prior authorizations approved by the Board, provides significant additional capacity to acquire shares within the company’s capital allocation framework, and recognizes the company’s commitments to all stakeholders. The share repurchase program is open-ended in time.

 

Aytu BioScience announced the successful completion of its tender offer to amend and exercise certain categories of existing warrants originally issued to investors participating in the company’s May 2016 and October 2016 financings.  The tender offer expired at 11:59 P.M. Eastern Time on the evening of February 27, 2017. Joseph Gunnar & Co., LLC and Fordham Financial Management, Inc. assisted the company as warrant solicitation agents.

 

Dermira announced that it intends to offer 3,700,000 shares of its common stock in an underwritten public offering. Dermira also expects to grant to the underwriters a 30-day option to purchase up to 555,000 additional shares of its common stock in the offering. All of the shares will be offered and sold by Dermira. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Leerink Partners, Evercore Group and Guggenheim Securities are acting as joint book-running managers for the offering. Needham & Company is acting as co-manager.

 

Pfizer announced the pricing of a debt offering consisting of four tranches of notes: €1,250,000,000 aggregate principal amount of floating rate notes due 2019; €1,000,000,000 aggregate principal amount of 0.000% notes due 2020; €1,000,000,000 aggregate principal amount of 0.250% notes due 2022; €750,000,000 aggregate principal amount of 1.000% notes due 2027. Interest on the floating rate notes will be three month EURIBOR plus 0.20%, reset quarterly. Pfizer intends to use the net offering proceeds for general corporate purposes, including to repay a portion of its outstanding commercial paper.  Pfizer intends to apply to list the notes on the New York Stock Exchange. Barclays Bank, BNP Paribas, Goldman Sachs and J.P. Morgan Securities are acting as joint book-running managers for the offering.

 

ATA announced that Ms. Shelly Jiang, the Company’s Interim CFO, has tendered her resignation effective April 1, 2017 to pursue other interests. Ms. Amy Tung, who has served in a variety of financial and operational positions within ATA over the past 11 years, including Acting CFO in 2010, will be appointed as CFO, as well as Financial and Principal Accounting Officer.

 

 

ANALYST RECOMMENDATIONS

 

Citi analyst Robyn Karnauskas initiated coverage of Vertex with a “buy” rating and $105 price target, citing 2017 is an important year for VRTX and there is upside into triple combination data.

 

Following Kite’s announcement yesterday morning that topline results from its ZUMA-1 trial of Axi-Cel were an overwhelming success; Raymond James analyst Reni Benjamin increased his price target to $82 from $61.

 

Following Endo International’s earnings, Citi analyst Liav Abraham decreased his price target to $16 from $20; Cowen analyst Ken Cacciatore decreased his price target to $16 from $30; Piper Jaffray analyst David Amsellem decreased his price target to $10 from $12; Leerink analyst Jason Gerberry increased his price target to $13 from $12; JP Morgan analyst Christopher Schott decreased his price target to $16 from $20; Goldman analyst Stephan Stewart decreased his price target to $16 from $17.

 

Following Ophthotech’s earnings, Stifel analyst Stephen Willey decreased his price target to $4 from $7; SunTrust analyst Yatin Suneja decreased his price target to $4 from $7; Citi analyst Yigal Nochomovitz decreased his price target to $4 from $5.

 

Raymond James analyst Reni Benjamin initiated coverage of Leap Therapeutics with an “outperform” rating and $13 price target, citing the value of two assets targeting novel pathways in the immune-oncology (I/O) axis, multiple combination trial initiations and data readouts expected within the next 12 months, the potential for a strategic partnership, and a cash position of $28 million (pro forma) represent a buying opportunity for long-term oriented, risk-tolerant investors.