BioShares Biotechnology Clinical Trials (BBC): $22.85, -$0.09, +24.1% YTD

BioShares Biotechnology Products (BBP): $37.76, +$0.03, +15.3% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures were little changed as investors turned cautious about global trade and U.S. President Donald Trump’s “America First” policies. The day’s economic calendar carries advance reading on first quarter growth, personal consumption expenditures and University of Michigan’s survey of consumer sentiments. Disappointing results from banking heavyweight Barclay’s weighed on Britain’s FTSE, while other bourses in Europe were little changed. Asian bourses ended mostly lower. Oil prices rebounded as investors started to buy at cheaper levels ahead of a May OPEC meeting at which producers could extend output cuts. Gold firmed as forecast-beating euro zone inflation boosted the euro against the dollar.

 

 

MARKET HIGHLIGHTS

 

BIOPHYTIS released its financial results for 2016.  The Company’s net loss was €8.0 million.  Cash was €3.1 million as of December 31, 2016, offset in April 2017 by a capital increase of €3.7 million and the implementation of a quasi-equity financing line of €15.0 million.

 

GeNeuro reported its full-year results for the year ended December 31, 2016.  The Company reported a 2016 net loss of €14.1 million, or €1.02 per share.  Cash and cash equivalents amounted to €34.5 million at December 31, 2016, compared with €18.6 million at December 31, 2015. This increase reflects to a large extent the impact of GeNeuro’s April 2016 IPO on Euronext’s regulated market in Paris, which raised net proceeds of €31.4 million.

 

La Jolla Pharmaceutical Company today reported financial results for the three months ended March 31, 2017.  As of March 31, 2017, the Company had $162.4 million in cash and cash equivalents, compared to $65.7 million of cash and cash equivalents at December 31, 2016. Cash used in operating activities for the three months ended March 31, 2017 was $22.1 million, compared to $13.0 million for the same period in 2016. Net loss for the three months ended March 31, 2017 was $23.2 million, or $1.26 per share, compared to $16.5 million, or $0.96 per share for the same period in 2016.

 

Ignyta today announced a comprehensive program update on entrectinib – an investigational, orally available, CNS-active tyrosine kinase inhibitor targeting tumors that harbor TRK, ROS1 or ALK fusions – currently being studied in a registration-enabling Phase 2 clinical trial known as STARTRK-2.  The entrectinib program is more than 85% enrolled to goal for the primary efficacy analysis to support a TRK tissue agnostic NDA submission.  More than 50 patients with ROS1 fusion-positive NSCLC are enrolled; interim data from 32 of these patients demonstrated 75% (24 of 32) confirmed RECIST ORR and 17.2 months DOR.  Confirmed RECIST ORR of 64% (7 of 11) in ROS1 NSCLC patients with CNS metastases.  Tracking towards dual NDA submissions in TRK and ROS1 in 2018 if supported by clinical data, with anticipated US commercial launch in both indications in 2019.

 

Genkyotex announced its cash & cash equivalents and liquid investments position for the first quarter ended March 31, 2017.  As of March 31, 2017, Genkyotex’s cash & cash equivalents was €21.8 million (vs. €26.7 million on December 31, 2016), in line with the Company’s expectations. The cash position does not include the expected reimbursement of Research Tax Credit (Crédit Impôt Recherche) for 2016, which the company has estimated to be at about €3.0 million.

 

Zealand Pharma reported first quarter 2017 royalty revenue from Sanofi`s sales of Lyxumia®/Adlyxin™ (lixisenatide) of DKK 5.1 million and from Soliqua® 100/33 of DKK 2.9 million.

 

Mainstay Medical International will present at the Deutsche Bank 42nd Annual Health Care Conference on Wednesday May 3rd at 3:30pm EST.

 

After yesterday’s close, Vertex reported 1Q17 non-GAAP EPS of $0.41, which compares to $0.09 for the same period a year ago. The company beat the non-GAAP EPS mean estimate of $0.39. Total revenue for 1Q17 was $482.3 million, which compares to $397.2 million for the same period a year ago. This compares to a mean estimate of $508.0 million. Following earnings, Baird analyst Brian Skorney increased his price target to $136 from $155; Leerink analyst Geoffrey Porges increased his price target to $132 from $128; Goldman analyst Terence Flynn increased his price target to $124 from $121; JMP analyst Liisa Bayko increased her price target to $125 from $121; Bank of America Merrill Lynch analyst Ying Huang increased his price target to $121 from $118; Piper Jaffray analyst Edward Tenthoff increased his price target to $137 from $129; BMO analyst Do Kim increased his price target to $132 from $128; Cowen analyst Philip Nadeau increased his price target to $100 from $175; Barclays analyst Geoffrey Meacham increased his price target to $115 from $100; Stifel analyst Adam Walsh increased his price target to $130 from $129; JP Morgan analyst Cory Kasimov increased his price target to $129 from $115.

 

After yesterday’s close, Seattle Genetics reported 1Q17 GAAP EPS loss of $0.42, which compares to a loss of $0.15 for the same period a year ago. The company matched the GAAP EPS mean estimate loss of $0.42. Total revenue for 1Q17 was $109.1 million, which compares to $111.2 million for the same period a year ago. This compares to a mean estimate of $102.9 million. Following earnings, Bank of America/Merrill Lynchanalyst Tazeen Ahmad increased her price target to $58 from $56; Cowen analyst Boris Peaker increased his price target to $61 from $53; JP Morgan analyst Cory Kasimov increased his price target to $58 from $52; HC Wainwright analyst Andrew Fein increased his price target to $75 from $65.

 

After yesterday’s close, Cytokinetics reported total revenues for the first quarter of 2017 were $4.2 million, compared to $8.4 million, during the same period in 2016. Net loss for the first quarter was $25.9 million, or $0.62 per basic and diluted share, respectively. This is compared to a net loss for the same period in 2016 of $12.5 million, or $0.31 per basic and diluted share. As of March 31, 2017, cash, cash equivalents and investments totaled $257.2 million. Following Cytokinetics’ earnings, Cowen analyst Ritu Baral increased her price target to $19 from $17; Piper Jaffray analyst Charles Duncan increased his price target to $24 from $15.

 

Regeneron Pharmaceuticals and Sanofi announced that the FDA has accepted the resubmission of the BLA for Kevzara (sarilumab) as a Class I response with a two month review timeline. Per the PDUFA, the new target action date is May 22, 2017. Kevzara is an investigational human monoclonal antibody directed against the IL-6 receptor being evaluated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs), such as methotrexate. The companies recently received a positive opinion for Kevzara from the EMA’s Committee for Medicinal Products for Human Use (CHMP), and the EC is expected to make a final decision on the MAA for Kevzara in the EU in the coming months. In Canada, Kevzara is approved for use in adult patients with moderately to severely active RA who have had an inadequate response or intolerance to one or more biologic or non-biologic DMARDs. The companies are also seeking approvals in a number of other countries globally.

 

Bristol-Myers Squibb announced that the CFDA has approved a direct-acting antiviral regimen comprised of Daklinza (daclatasvir) and Sunvepra (asunaprevir), for the treatment of treatment-naive or -experienced patients, with or without compensated cirrhosis, infected with genotype 1b chronic hepatitis C virus (HCV). This is China’s first all-oral, interferon- and ribavirin-free HCV treatment regimen. In addition, Daklinza has been approved in China for combination use with other agents, including sofosbuvir, for adult patients with HCV genotypes 1-6 infection. This is the only all-oral pan-genotypic regimen recommended by China’s HCV Prevention and Treatment Guideline. Daklinza must not be administered as monotherapy. Sofosbuvir is under review by the CFDA, and is not currently licensed in China.

 

Genmab announced that the European Commission (EC) has granted a marketing authorization for DARZALEX (daratumumab) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.  The EC approval follows a positive opinion issued for DARZALEX by the CHMP of the EMA in February 2017. This approval also converts the previous conditional marketing authorization for DARZALEX to a full approval.  DARZALEX is being developed under an August 2012 agreement in which Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize the product.

 

Bayer announced that the FDA approved Stivarga (regorafenib) tablets for the second-line treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar (sorafenib). Stivarga is the first and only treatment to demonstrate significant improvement in overall survival in second-line HCC patients. In the RESORCE trial, Stivarga was shown to provide a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo; the median OS was 10.6 [(n=379) (CI 9.1, 12.1)] vs 7.8 [(n=194) (CI 6.3, 8.8)] months, respectively (HR 0.63, 95% CI 0.50-0.79; p <0.0001). This translates to a 37% reduction in the risk of death. The number of deaths in each arm included 233 of 379 (62%) with Stivarga and 140 of 194 (72%) with placebo. Today’s FDA approval expands Bayer’s leadership in liver cancer with a treatment plan in HCC involving use of Stivarga directly after progression on Nexavar.

 

Celyad announced the dosing of the first patient of the second dose in the solid tumor arm of its THINK trial (THerapeutic Immunotherapy with NKR-2). This first ovarian cancer patient has been dosed at Roswell Park Cancer Institute (Buffalo, New York). At the first solid tumor dose-level, one pancreatic and two colorectal cancer patients were successfully dosed. None of these patients experienced dose limiting adverse events.

 

CEL-SCI announced that it has been notified that it will be granted a new patent on Multikine (Leukocyte Interleukin, Injection), its investigational cancer immunotherapy, from the European Patent Office. The patent is titled: A METHOD FOR MODULATING HLA CLASS II TUMOR CELL SURFACE EXPRESSION WITH A CYTOKINE MIXTURE.

 

Mallinckrodt announced new results from two company-sponsored studies: one study on use of H.P. Acthar Gel (repository corticotropin injection) in patients with infantile spasms (IS) and a second study on the economic burden of moderate-to-severe multiple sclerosis (MS) relapse. Findings from the IS study indicate treatment with H.P. Acthar Gel may be associated with a decline in medical resource utilization (MRU) in the three months following treatment completion, including the number of emergency room (ER) visits, hospitalizations and days hospitalized. Results from the MS study indicate the economic burden of moderate-to-severe MS relapse is underestimated within the scientific literature in terms of frequency, duration and impact, thereby underscoring an unmet need in appropriate assessment and treatment of relapse. These results were presented Tuesday, Apr. 25, 2017 at the American Academy of Neurology (AAN) 69(th) Annual Meeting in Boston, Mass.

 

TG Therapeutics announced preliminary results from its ongoing Phase II study of TG-1101 (ublituximab), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, in patients with relapsing forms of multiple sclerosis (RMS).  The data is being presented at the 69(th) American Academy of Neurology (AAN) annual meeting, taking place in Boston, MA.

 

Allergan announced it has successfully completed the acquisition of ZELTIQ Aesthetics. Allergan acquired ZELTIQ Aesthetics for approximately $2.4 billion in cash.

 

Medeor Therapeutics announced it has received clearance from the FDA for an IND application for the company’s lead product candidate MDR-101. In addition, the FDA has agreed to a Special Protocol Assessment (SPA) for the design of a pivotal Phase III clinical study of MDR-101 in recipients of human leukocyte antigen (HLA)-matched, living donor kidney transplants.

 

Flexion Therapeutics announced results from two new analyses of the company’s lead investigational drug candidate, Zilretta (also known as FX006), for the treatment of osteoarthritis (OA) related knee pain. The clinical findings will be presented at the Osteoarthritis Research Society International (OARSI) 2017 World Congress, taking place April 27-30 in Las Vegas.

 

Miragen Therapeutics presented at the Society for Investigative Dermatology (SID) 76(th) Annual Meeting. miRagen discussed previously announced interim results from its ongoing Phase I clinical trial of MRG-201. MRG-201 is designed to mimic the activity of microRNA-29, which has been shown to decrease the expression of certain genes that are involved in scar formation.

 

Savara announced the closing of its previously announced merger with Mast Therapeutics, under which the stockholders of Savara have become the majority owners of Mast, and the operations of Mast and Savara have combined. The post-merger company, named Savara, is based in Austin, TX and features three inhaled product candidates, each in advanced stages of clinical development. The company will be led solely by Savara’s current management team. Two independent members of the Mast board remain on the post-merger board together with all five members of the Savara board. Savara’s common stock will commence trading on April 28(th), 2017 on the Nasdaq Capital Market under the trading symbol "SVRA".

 

Adamas Pharmaceuticals announced the appointment of Richard A. King as Chief Operating Officer, reporting to Gregory T. Went, Ph.D., Chairman and Chief Executive Officer. Mr. King will be responsible for leading the Company’s commercial organization and its established teams in marketing, market access, manufacturing, and distribution, as well as overseeing the company’s planning and information technology operations.

 

United Therapeutics announced that its Board of Directors authorized the repurchase of up to $250 million of the company’s common stock. This program will become effective immediately, and will remain open through December 31, 2017. Purchases may be made in the open market, accelerated share repurchases or in privately negotiated transactions from time to time as determined by United Therapeutics’ management and in accordance with the requirements of the SEC and the Board’s authorization, which includes a maximum purchase price per share acquired under the program.

 

Sorrento Therapeutics announced the closing of a transaction whereby its cellular therapy focused subsidiary, TNK Therapeutics, has acquired Virttu Biologics Limited.

 

CytRx announced that it has priced a public offering of approximately 30 million shares of its common stock at a purchase price of $0.50 per share, for gross proceeds of approximately $15 million. The offering is expected to close on or about May 2, 2017, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as exclusive placement agent for the offering.

 

 

ANALYST RECOMMENDATIONS

 

Following Novocure’s earnings, Deutsche Bank analyst Gregg Gilbert increased his price target to $11 from $10.

 

Canaccord analyst Arlinda Lee increased her price target of Blue Print Medicines to $52 from $42, citing model adjustments following an update from Dr. Michael Heinrich.

 

Following Alkermes’ earnings, Cowen analyst Chris Shibutani decreased his price target to $63 from $65; Goldman Sachs analyst Terence Flynn increased his price target to $51 from $48.

 

Following Exact Sciences’ earnings, Lake Street analyst Bruce Jackson increased his price target to $30 from $15; Craig Hallum analyst Kevin Ellich increased his price target to $35 from $28; Canaccord analyst Mark Massaro increased his price target to $38 from $27; Leerink analyst Puneet Souda increased his price target to $38 from $30; BTIG analyst Sean Lavin analyst increased his price target to $35 from $30. 

 

Following Sarepta’s earnings, Leerink analyst Joseph Schwartz increased his price target to $52 from $47; RBC analyst Matthew Eckler decreased his price target to $60 from $91.