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U.S. stock index futures pointed to a positive start for Wall Street ahead of the key economic releases, including retail sales data, and import prices. Major European shares dipped into negative territory and Asian markets were broadly flat. The dollar took a breather from recent gains. Gold advanced, snapping a three-session losing streak. Copper prices tumbled as traders cashed in gains. Oil prices jumped on hopes that the OPEC could be closer to an output-cut deal.
SciClone Pharmaceuticals confirmed that it has received an unsolicited, nonbinding proposal from a consortium led by GL Capital Management GP Limited and ABG Management Limited to acquire all of the outstanding shares of SciClone not already owned by the consortium for $11.18 per share in cash, which proposal was subsequently filed by consortium members as an exhibit to their Schedule 13D/As with the Securities and Exchange Commission. The proposal is subject to a number of contingencies including financing, due diligence and documentation. Consistent with its fiduciary duties and in consultation with its financial and legal advisors, SciClone’s Board of Directors will carefully review and consider the proposal to determine the course of action that it believes is in the best interests of SciClone and its stockholders, taking into account SciClone’s current strategic plan and growth initiatives.
Vermillion announced that Marra Francis, MD has been appointed to the position of Chief Medical Officer as of November 8th. Dr. Francis is a board certified Obstetrician and Gynecologist with over 13 years of clinical experience in both Private Practice and the Women’s Health diagnostics industry.
Aimmune Therapeutics announced financial results for the third quarter of 2016. For the quarter and nine months ended September 30, 2016, net loss was $22.1 million and $55.7 million, respectively, compared to a net loss of $9.0 million and $19.8 million for the comparable periods in 2015. As of September 30, 2016, Aimmune had $159.3 million in cash, cash equivalents and investments compared to $199.8 million at December 31, 2015. Aimmune also recently announced a $145.0 million equity investment by Nestlé Health Science, which it expects to close in the fourth quarter.
Transgene presented a poster on TG1050 preclinical results at the AASLD (American Association for the Study of Liver Diseases) Liver Meeting 2016, Boston (MA). TG1050 is a therapeutic vaccine for the treatment of chronic hepatitis B (or HBV1 infection). The poster shows a meta-analysis of preclinical data obtained with TG1050 in HBV persistent mice and preliminary data on the mode of action of TG1050.
Eiger BioPharmaceuticals announced the presentation of additional data from the LOWR HDV (LOnafarnib With Ritonavir in Hepatitis Delta Virus) Program presented today at the American Association for the Study of Liver Diseases (AASLD) meeting in Boston, Massachusetts. The Company hosted a review of key findings from the LOWR HDV Program with HDV key opinion leaders and principal investigators and discussed regulatory plans. LOWR HDV is a multi-center, international Phase 2 program designed to identify optimal dosing of lonafarnib (LNF) with ritonavir (RTV) ± pegylated interferon (PEG IFN) for development in the treatment of hepatitis delta infection (HDV).
BIOPHYTIS announced that four posters on Sarconeos (BIO101), the Company’s lead drug candidate for the treatment of sarcopenia, have been accepted for presentation at the 9th International Conference on Cachexia, Sarcopenia and Muscle Wasting, being held December 10-11, 2016 in Berlin, Germany.
Alcobra announced financial results for the three and nine months ended September 30, 2016. The company reported a net loss for the three months ended September 30, 2016 of $7.8 million, or ($0.28) per share. Cash, marketable securities, and deposits totaled $54.3 million at September 30, 2016 compared with $61.1 million at June 30, 2016 and $69.7 million at the end of 2015.
Palatin Technologies announced results for its first quarter ended September 30, 2016. Palatin reported a net loss of $(13.1) million, or $(0.08) per basic and diluted share, for the quarter ended September 30, 2016, compared to a net loss of $(12.4) million, or $(0.08) per basic and diluted share, for the same period in 2015. Palatin’s cash, cash equivalents and investments were $10.2 million as of September 30, 2016, compared to cash and cash equivalents of $9.4 million at June 30, 2016. Current liabilities were $20.5 million as of September 30, 2016, compared to $13.9 million as of June 30, 2016. Palatin believes that existing capital resources will be adequate to fund our planned operations through the quarter ending December 31, 2016.
Kamada announced that it has signed a collaboration agreement with Yissum Research Development Company of the Hebrew University of Jerusalem, for the development of an efficient and robust eukaryotic expression system for recombinant human Alpha 1 Antitrypsin (rhAAT). The goal of this development work is to maximize protein yields and functionality.
Ignyta has received Expedited Access Pathway (EAP) designation from the United States Food and Drug Administration (FDA) and also “European Conformity” (CE) marking for its Trailblaze Pharos companion diagnostic test service. The EAP designation enables Ignyta and FDA to have more interactive discussions of the premarket approval application (PMA) for Trailblaze Pharos, which is the proposed companion diagnostic for entrectinib, the company’s investigational, orally available, CNS-penetrant tyrosine kinase inhibitor targeting tumors that harbor NTRK1/2/3, ROS1, or ALK gene fusions.
Albireo Pharma announced today that its lead product candidate, A4250, has been granted access to the PRIority MEdicines (PRIME) program of the European Medicines Agency (EMA) for the treatment of progressive familial intrahepatic cholestasis (PFIC).
Advaxis will present a company overview at the Jefferies 2016 London Healthcare Conference on Thursday, November 17.
BrainStorm Cell Therapeutics announced financial results for the third quarter ended September 30, 2016. Net loss for the third quarter was $1.6 million or ($0.09) per share as compared to a net loss of $2.6 million or ($0.14) per share for the third quarter of 2015. As of September 30, 2016, the Company had cash, cash equivalents, and short-term deposits of approximately $11.2 million.
Basilea Pharmaceutica announced that it has launched its antifungal Cresemba (isavuconazole) in France and that it has sponsored a symposium on current challenges and recent opportunities in the treatment of invasive mold infections.
Repros Therapeutics reported the topline results for both its pooled oral and vaginal delivery Phase II studies in the treatment of uterine fibroids. Both studies enrolled women with confirmed fibroids by MRI at baseline and who were experiencing more than 80 mL of blood loss during menses as confirmed by alkaline hematin assessment. Proellex at doses of both 6 and 12 mg, delivered by either route, substantially and significantly reduced excessive menstrual bleeding, the key symptom of uterine fibroids and the primary endpoint of the studies. The study of vaginal delivery enrolled 42 subjects and the oral delivery study’s intent-to-treat population included 41 subjects.
Viking Therapeutics announced additional data from its previously completed Phase Ib clinical trial of VK2809 in subjects with mild hypercholesterolemia. Data from an analysis of the study participants’ atherogenic protein levels demonstrated that subjects experienced statistically significant reductions in lipoprotein(a) [Lp(a)] and apolipoprotein B-100 (apo B). These results were highlighted in a poster presentation on November 14 at the American Heart Association (AHA) Scientific Sessions 2016, in New Orleans, LA.
Dow Jones reported that Teva Pharmaceutical Industries reported acquisition-driven revenue growth in its latest quarter, but sales fell across much of its specialty-drug business. Teva also disclosed that it had set aside $520 million as it was in advanced discussions with the U.S. Department of Justice and the SEC to settle potential violations of foreign corruption laws. The potential settlement relates to conduct in Russia, Mexico and Ukraine from 2007 to 2013. Teva said the conduct doesn’t involve its U.S. business. Teva said in response to the investigation that it had ended "problematic" business relationships, withdrawn from some countries, gotten rid of relevant employees and overhauled the management of several subsidiaries. Teva also cut its revenue guidance for the year but increased its adjusted earnings-per-share expectations. It now expects annual revenue of between $21.6 billion and $21.9 billion, down from between $22 billion and $22.5 billion previously. It also expects adjusted earnings per share between $5.10 and $5.20, down from $5.20 to $5.40 previously. During the quarter, the Israeli pharmaceutical company known for its generic-drugs business closed its $40.5 billion deal for Allergan’s generics business. For the quarter, Teva reported a profit of $412 million, or 35 cents a share, up from $103 million, or 12 cents a share, the same quarter last year. Excluding certain items, per-share earnings were $1.31, down from $1.35 a share in the prior-year quarter. Revenue grew 15% to $5.56 billion. Analysts polled by Thomson Reuters had expected earnings of $1.28 a share on $5.71 billion in revenue.
ZIOPHARM Oncology announced the publication of data demonstrating enhanced persistence of genetically modified T cells targeting leukemia through utilization of its non-viral Sleeping Beauty (SB) system to co-express membrane-bound IL-15 (mbIL15) and a CD19-specific chimeric antigen receptor (CAR). The article, titled "Tethered IL-15 augments antitumor activity and promotes a stem-cell memory subset in tumor-specific T cells," was published in the Proceedings of the National Academy of Sciences (PNAS) and is available online here.
Merus N.V. announced that it received two favorable rulings for its European patent EP 2147594 B1 (the "’594 patent") by the Opposition Division of the European Patent Office (the "EPO") as well by the Trial Board of the Japanese Patent Office for its Japanese counterpart JP 5749161 (the "’161 patent"). Both patents cover Merus’ genetically-modified mice and their use to produce common light chain human monoclonal antibodies.
Immunomedics announced the issuance of U.S. Patent 9,492,566, the 32(nd) U.S. patent protecting the use of sacituzumab govitecan (IMMU-132), the Company’s lead antibody-drug conjugate (ADC), for the treatment of patients with Trop-2-positive cancers.
uniQure N.V. announced the completion of a company-wide strategic review aimed at refocusing its pipeline, consolidating its manufacturing and enhancing overall execution to drive shareholder value. As a result of this initiative, the Company will prioritize programs in hemophilia B, Huntington’s disease and those associated with its landmark collaboration with Bristol-Myers Squib in cardiovascular disease. Additionally, the Company will restructure its research and development organization in the Netherlands and consolidate manufacturing in the United States. These actions are expected to reduce operating expenses and create a more efficient company focused on the successful and timely development of gene therapies for patients with serious unmet medical needs.
Biogen announced the addition of two members to the executive management team of Bioverativ, Biogen’s planned spin-off company focused on the discovery, research, development and commercialization of treatments for hemophilia and other blood disorders. Rogerio Vivaldi, M.D., will serve as executive vice president and chief global therapeutic operations officer of Bioverativ, and John T. Greene will serve as executive vice president and chief financial officer of Bioverativ. The spin-off of Bioverativ is on track to be completed in early 2017.
Marinus Pharmaceuticals presented preclinical data showing that the combination of its CNS-selective GABA(A) modulator ganaxolone and diazepam administered intravenously (IV) produced a synergistic effect in blocking pilocarpine-induced seizures in a benzodiazepine refractory model of status epilepticus (SE). Marinus is developing ganaxolone IV for the treatment of status epilepticus, a life-threatening medical emergency associated with high mortality and limited treatment options. The data was presented during a poster presentation at Neuroscience 2016, the annual meeting of the Society for Neuroscience, which occurred November 12 — 16, 2016 in San Diego, CA.
AbbVie announced 98 percent (n=102/104) of chronic hepatitis C virus (HCV) infected patients with severe chronic kidney disease (CKD) achieved sustained virologic response following 12 weeks of treatment (SVR(12) ) with its investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) in the primary intent-to-treat (ITT) analysis. In a modified intent-to-treat (mITT) analysis, SVR(12) was achieved in 100 percent (n=102/102) of severe CKD patients; mITT excludes patients who did not achieve SVR for reasons other than virologic failure. These new data from the Phase III EXPEDITION-4 study, evaluating patients with chronic HCV infection across all major genotypes (GT1-6) and severe CKD, will be presented as a late-breaker at The Liver Meeting(R), the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston. Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals for HCV protease inhibitors and regimens that include protease inhibitors.
Pfizer announced that new results from the Phase III Oral Psoriatic Arthritis TriaL (OPAL) studies, Broaden and Beyond, will be presented at the 2016 ACR/ARHP Annual Meeting (November 11-16, Washington, DC). OPAL Broaden and OPAL Beyond evaluated the efficacy and safety of XELJANZ (tofacitinib citrate) in adult patients with active psoriatic arthritis (PsA) who had an inadequate response (IR) to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or to tumor necrosis factor inhibitors (TNFis), respectively. Detailed results from OPAL Broaden will be presented during a plenary session [#2983] for the first time at ACR/ARHP. Additionally, results from OPAL Beyond will be presented during a late-breaking abstract poster session [#10L]. OPAL Broaden and OPAL Beyond met their primary efficacy endpoints showing a statistically significant improvement with tofacitinib 5 mg and 10 mg twice daily (BID) compared to treatment with placebo at three months as measured by American College of Rheumatology 20 (ACR20) response (OPAL Broaden: p≤0.05 and p<0.0001; OPAL Beyond: p<0.0001, respectively), and change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) score (OPAL Broaden: p≤0.05 and p<0.001; OPAL Beyond: p<0.0001 and p<0.001, respectively). OPAL Broaden, which was a 12-month duration trial with a three month placebo-controlled period, evaluated the efficacy and safety of tofacitinib 5 mg (n=107) and 10 mg (n=104) BID compared to placebo (n=105) in adult patients with active PsA who had an IR to at least one csDMARD and who were TNFi-naïve. OPAL Broaden included an active control arm of adalimumab 40 mg (n=106) administered subcutaneously every two weeks (q2 wk). The study was not designed for non-inferiority or superiority comparisons between adalimumab and tofacitinib. OPAL Beyond, a six-month duration trial with a three month placebo-controlled period, evaluated the efficacy and safety of tofacitinib 5 mg (n=131) and 10 mg (n=132) BID compared to placebo (n=131) in adult patients with active PsA who had an IR to at least one TNFi.2b OPAL Beyond focused exclusively on the TNFi-IR patient population. In both studies, patients who were initially randomized to placebo advanced to tofacitinib 5 or 10 mg BID in a blinded manner at three months.
Janssen Research & Development announced positive efficacy and safety results from a Phase II study investigating guselkumab, an anti-interleukin (IL)-23 monoclonal antibody administered by subcutaneous injection, for the treatment of active psoriatic arthritis. According to findings presented at the 2016 ACR/ARHP Annual Meeting, 58 percent of patients receiving guselkumab achieved at least a 20 percent improvement in signs and symptoms of disease (ACR 20) at week 24, the study’s primary endpoint, compared with 18.4 percent of patients receiving placebo (P < 0.001). Data from the trial also showed statistically significant improvements in all secondary endpoints including physical function, psoriatic skin lesions and other health related outcomes, compared with patients receiving placebo. The guselkumab Phase II results in active psoriatic arthritis follow positive Phase III study results in moderate to severe plaque psoriasis recently presented at the European Academy of Dermatology and Venereology Congress in Vienna.
Clearside Biomedical announced the enrollment of the first patient in a Phase I/II clinical trial (the "HULK" trial) of Zuprata, its proprietary suspension formulation of the corticosteroid triamcinolone acetonide, for the treatment of diabetic macular edema ("DME").
ACADIA Pharmaceuticals announced the initiation of ADVANCE, a Phase II study to evaluate pimavanserin for adjunctive treatment in patients with negative symptoms of schizophrenia. Studies show that about 40 to 50 percent of schizophrenia patients suffer from prominent negative symptoms. There is currently no drug approved by the FDA for the treatment of these negative symptoms. As a selective serotonin inverse agonist (SSIA), pimavanserin is a new class of antipsychotic medication with a distinct mechanism of action targeting serotonergic 5-HT(2A) receptors while avoiding activity at dopamine and other receptors commonly targeted by other antipsychotics.
Cytokinetics announced that additional results from COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), a Phase II trial evaluating omecamtiv mecarbil in patients with chronic heart failure and left ventricular systolic dysfunction, were presented by Tor Biering-Sørensen, Division of Cardiology, Brigham & Women’s Hospital and Harvard Medical School, in a Clinical Poster Session at the American Heart Association’s Scientific Sessions 2016 in New Orleans. The results presented show that omecamtiv mecarbil improved left atrial (LA) structure and function in patients with chronic heart failure with reduced systolic function. Omecamtiv mecarbil, a novel investigational cardiac myosin activator that increases cardiac contractility, is being developed by Amgen in collaboration with Cytokinetics for the potential treatment of heart failure.
Blueprint Medicines announced that Marion Dorsch, Ph.D., will succeed Christoph Lengauer, Ph.D., MBA, as Chief Scientific Officer, effective November 21, 2016. Dr. Dorsch will join the executive management team and will be responsible for setting the scientific strategy and priorities for Blueprint Medicines, as well as overseeing day-to-day research operations. Dr. Lengauer will transition to the role of Executive Vice President where he will drive an integrated approach to progressing Blueprint Medicines’ portfolio of investigational drugs.
TESARO announced that it has commenced an underwritten public offering of 1,750,000 shares of its common stock. In connection with this offering, TESARO plans to grant the underwriters an option to purchase up to an additional 262,000 shares of its common stock. Citigroup, Leerink Partners, Credit Suisse and Wells Fargo Securities are acting as bookrunners for the offering.
Portola Pharmaceuticals announced results from three substudies of the pivotal Phase III APEX Study of betrixaban, an oral, once-daily Factor Xa inhibitor anticoagulant in development for the prevention of venous thromboembolism (VTE) in acute medically ill patients. Findings from the analyses were presented by the PERFUSE Study Group at the American Heart Association (AHA) Scientific Sessions 2016.
Gilead Sciences announced detailed results from an open-label Phase II trial evaluating the investigational apoptosis signal-regulating kinase 1 (ASK1) inhibitor selonsertib (formerly GS-4997) alone or in combination with the monoclonal antibody simtuzumab (SIM) in patients with nonalcoholic steatohepatitis (NASH) and moderate to severe liver fibrosis (fibrosis stages F2 or F3). The data demonstrate regression in fibrosis that was, in parallel, associated with reductions in other measures of liver injury in patients treated with selonsertib for 24 weeks. These data were presented in a late-breaking abstract session at The Liver Meeting 2016 in Boston (#LB-3).
Mallinckrodt confirmed enrollment of the first patients in the company’s Phase IV clinical study assessing the efficacy of H.P. Acthar Gel (repository corticotropin injection) in Systemic Lupus Erythematosus (SLE) patients with persistently active disease. This randomized, double-blind, placebo-controlled trial builds on data from a pilot study of H.P. Acthar Gel in patients with active SLE, recently published online in the journal Lupus Science & Medicine in a manuscript titled "Efficacy and tolerability of repository corticotropin injection in patients with persistently active SLE: results of a Phase IV, randomized, controlled pilot study." H.P. Acthar Gel is approved by the FDA for use during an exacerbation or as a maintenance therapy in select patients with SLE.
Avidea Technologies and PsiOxus Therapeutics announced an agreement licensing PsiOxus’ PolyMAP multivalent adjuvant technology to Avidea. PolyMAP is a powerful platform technology that enables safer and more effective use of potent immunological stimulants with broad applications in vaccines or as standalone therapies for both infectious diseases and cancer.
Bayer announced a Phase III clinical study evaluating the efficacy and safety of a newly developed formulation of the investigational medication Nifurtimox in children of all age groups who have been diagnosed with Chagas disease. The announcement was made at the 65th annual meeting of the American Society of Tropical Medicine & Hygiene (ASTMH) in Atlanta. Nifurtimox is not approved by the FDA and there are no FDA-approved treatments for children with Chagas disease.
Applied DNA Sciences announced that the U.S. Defense Logistics Agency (DLA) has awarded the company a one-year firm-fixed price Indefinite Delivery Purchase Order (IDPO) contract for FSC 5962 microcircuits. This contract will ensure uninterrupted support of the current DNA program in place since December 2014 at the Product Test Center (PTC) located at the Agency’s Land and Maritime facility in Columbus, OH. This long-term contract (LTC) will provide supplies and services for DNA marking, creation of unique SigNature DNA marks, QC authentication testing, ink and supplies, and training. Also included in support of the effort is the customer facing portal which is the platform that was developed for use by PTC to capture data appropriate to the FSC 5962 commodities. The period of performance is one year with an additional one-year option period.
Panther Biotechnology announced that it has executed a share exchange agreement to merge with Brown Technical Media, a privately held corporation in Houston, Texas. Brown and Panther have executed a share exchange agreement whereby all of the outstanding capital stock of Brown will be exchanged for 32,000,000 shares of Panther common stock. Brown will be managed as a second division of Panther. The Board of Directors and Management of both companies voted unanimously to approve the transaction.
Synthetic Biologics announced the pricing of an underwritten public offering of 25,000,000 shares of its common stock and warrants to purchase 50,000,000 shares of its common stock at a price to the public of $1.00 per share and accompanying warrants. The gross proceeds to Synthetic Biologics from the offering, excluding the proceeds, if any from the exercise of the warrants, before deducting underwriting discounts and commissions and other offering expenses, are expected to be approximately $25.0 million. If exercised in full, the warrants could result in additional net financing proceeds to the Company of $78.8 million. The Underwriter has a 30-day option to purchase up to 3,750,000 additional shares of common stock and warrants to purchase up to 7,500,000 additional shares of common stock. The offering is expected to close on or about November 18, 2016, subject to customary closing conditions. The initial per share exercise price of the Series A warrant is $1.43 per share and the per share exercise price of the Series B warrant is $1.72 per share, each subject to adjustment as specified in the warrants. The Series A and Series B warrants may be exercised at any time on or after the date of issuance. The Series A warrants shall not be exercisable after and shall terminate and become void on the four-year anniversary following the date of original issuance. The Series B warrants shall not be exercisable after and shall terminate and become void on December 31, 2017. Cantor Fitzgerald is acting as the sole book-running manager for the offering.
Pfizer announced the pricing of a debt offering consisting of five tranches of notes: $1,000,000,000 aggregate principal amount of 1.700% notes due 2019; $1,000,000,000 aggregate principal amount of 2.200% notes due 2021; $1,750,000,000 aggregate principal amount of 3.000% notes due 2026; $1,000,000,000 aggregate principal amount of 4.000% notes due 2036; $1,250,000,000 aggregate principal amount of 4.125% notes due 2046. Pfizer intends to use the net offering proceeds to fund the purchase of its 6.200% Senior Notes due March 15, 2019 validly tendered and accepted for payment in Pfizer’s previously announced tender offer and to fund the redemption of any of the Tender Notes that remain outstanding after the completion of the Tender Offer in accordance with the terms of the make-whole provisions of the indenture governing the Tender Notes. Pfizer intends to use the remaining proceeds for general corporate purposes, including to refinance, redeem or repurchase existing debt and to repay a portion of its outstanding commercial paper. Citigroup Global Markets, Credit Suisse Securities, Merrill Lynch, Pierce, Fenner & Smith and RBC Capital Markets are acting as joint book-running managers for the offering.
Rigontec announced that Dr. Jörg Vollmer has joined the Company as Chief Scientific Officer. Dr. Vollmer brings to Rigontec more than 17 years of drug discovery and development experience including leadership roles at Nexigen GmbH, Pfizer and Coley Pharmaceutical Group. Dr. Vollmer will be responsible for leading Rigontec’s R&D efforts and advancing the Company’s RIG-I-based platform focused on discovering and developing treatments for oncological and infectious diseases. He will report to Dr. Christian Schetter, CEO of Rigontec, and will be based in Munich.
Bank of America/Merrill Lynch analyst Ying Huang increased his price objective of Aimmune to $38 from $36, citing increased confidence in the approvability of AR101.
Citi analyst Yigal Nochomovitz initiated coverage of CRISPR Therapeutics with a “neutral” rating and $19 price target, citing if the technology works as envisioned, it could revolutionize the treatment of diverse diseases with genetic basis.
Maxim analyst Jason Kolbert increased his price target of Sucampo to $19 from $17, citing underlying growth.
Morgan Stanley analyst David Risinger decreased his price target of Allergan to $250 from $274, citing generic risks in coming years.
Wells Fargo analyst David Maris decreased his valuation range for Valeant to $10-13 from $17-$22, citing risk of restructuring is increasing.
Aegis analyst Difei Yang initiated coverage of Akebia Therapeutics with a “buy” rating and $18 price target, citing novel mechanism of action for anemia treatment related to chronic kidney disease.
Piper Jaffray analyst Charles Duncan increased his price target of Cara Therapeutics to $21 from $16, citing sees the potential for significant upside due to upcoming clinical efficacy data from CARA’s three lead programs.
Yesterday, Citi analyst Joel Beatty downgraded Esperion Therapeutics to “neutral” from “buy,” and decreased his price target to $14 from $22, citing top-line ph3 results are not expected until mid-2018, uncertainty on whether regulators will require outcomes trial results before approval is likely to persist as an overhang, and cash into early 2019 is unlikely to be last through an FDA decision, creating a financing overhang.