BioShares Biotechnology Clinical Trials (BBC): $19.71, +$1.16, +7.1% YTD

BioShares Biotechnology Products (BBP): $34.24, +$1.57, +4.5% YTD

 

 

MARKET COMMENTARY

 

Futures pointed towards a flat to slightly lower opening for major U.S. indexes. The U.S. dollar dipped against a basket of currencies on profit-taking, after the Chinese yuan posted big gains for the second day. Gold rose to its highest in four weeks. Investors will watch for weekly jobs, private payrolls and Markit PMI data. Britain’s FTSE reached a record high helped by gains in miners and housebuilders. Asian markets ended on a high note as strong Chinese data added to optimism about global growth and inflation. Oil rose following reports that Saudi Arabia has begun talks on supply cuts with customers.

 

 

MARKET HIGHLIGHTS

 

Gemphire Therapeutics provided the following update on the Company’s three clinical trials for its product candidate, gemcabene.  Enrollment is greater than 90% complete toward the target enrollment of 104 patients in Gemphire’s ROYAL-1 Phase 2b trial designed to investigate gemcabene in the treatment of patients with hypercholesterolemia not adequately controlled on high-intensity or moderate-intensity stable statin therapy.  Due to the faster than expected enrollment, Gemphire now expects to complete enrollment in January and release top line data from ROYAL-1 trial in the third quarter of 2017.  Gemphire expects to announce interim results for its open-label COBALT-1 trial investigating gemcabene in patients with clinically diagnosed HoFH during the week of January 30, 2017.  Gemphire commenced its Phase2b INDIGO-1 trial in SHTG patients in December 2016 with a successful Investigators’ Meeting representing over 30 clinical sites, followed by the first SHTG patient pre-screened.  The Company expects to report top-line results from INDIGO-1 in the fourth quarter of 2017.

 

Achaogen announced the appointment of Halley Gilbert, Senior Vice President and Chief Legal Officer of Ironwood Pharmaceuticals, Inc., to its Board of Directors. Ms. Gilbert brings significant strategic leadership and two decades of experience navigating biopharmaceutical companies through various phases of growth and opportunity.

 

Neovacs announced its collaboration with Professor Robert Kerbel and his team at the Sunnybrook Research Institute of Toronto, Canada for preclinical development of Neovacs’ VEGF Kinoid, specifically to obtain the proof of concept for the treatment of colorectal and ovarian cancer.

 

CymaBay Therapeutics has successfully concluded its scientific advice discussions with the European Medicines Agency (EMA) on the Phase 3 development program for arhalofenate.  CymaBay reached agreement with the EMA on all of the key elements of the planned Phase 3 program which is very similar to that agreed upon with the Food and Drug Administration (FDA) last year. It will include two pivotal studies of arhalofenate in combination with febuxostat (40 mg) in patients with chronic gout and a third study in combination with febuxostat (80 mg) in subjects with tophaceous gout, a more advanced form of the disease.

 

Valneva SE has signed a research license agreement with MSD Animal Health, known as Merck Animal Health in the United States and Canada.  The agreement grants MSD Animal Health the rights to research new vaccine candidates using Valneva’s EB66® technology.  MSD Animal Health and Valneva had already signed a commercial license agreement in 2009 allowing MSD Animal health to develop and commercialize EB66®-based vaccines for an undisclosed indication.

 

Heron Therapeutics announced positive topline results from its Phase 2 study of the investigational agent HTX-011 in subjects undergoing abdominoplasty (Study 203). HTX-011 demonstrated statistically significant reductions in both pain intensity and the use of opioid rescue medications through 96 hours following surgery.  The Company also announced data from its Phase 2 study of HTX-011 in patients undergoing bunionectomy (Study 208) that establishes, for the first time, the synergy between the local anesthetic bupivacaine and the anti-inflammatory meloxicam in HTX-011, an extended-release combination product for the prevention of post-operative pain.

 

Vermillion and ASPiRA LABS announced the receipt of an FDA Clarification Letter regarding OVA1 (MIA) and Overa (MIA2G).  This letter is in reference to the September 7, 2016 FDA Safety Communication advising women and their physicians against the use of ovarian cancer screening tests for asymptomatic women.  In order to avoid any confusion as well as to document the FDA position on OVA1 (MIA) and Overa (MIA2G), Jeffrey Shuren, M.D, J.D, Director: Center for Devices and Radiological Health at the FDA, sent a letter to Vermillion, dated December 21, 2016.  In the letter, Dr. Shuren stated: “We agree that this safety communication does not apply to Vermillion’s FDA-cleared tests, OVA1 (MIA) and Overa (MIA2G), which are not screening tests for ovarian cancer.”

 

Ocera Therapeutics announced positive results from a Phase 1 clinical study of orally-administered OCR-002 (ornithine phenylacetate) in patients with cirrhosis. The Company is developing oral OCR-002 for chronic use to maintain remission of hepatic encephalopathy (HE), a neurocognitive disorder associated with serious liver disease.

 

BrainStorm Cell Therapeutics will provide a corporate overview at the 9th Annual Biotech Showcase on Monday, January 9th.

 

Onconova Therapeutics will present a company overview at the Biotech Showcase 2017 being held at the Hilton Hotel in San Francisco, California on Wednesday, January 11th.

 

Prothena Corporation plc will present and participate in the 35th Annual J.P. Morgan Healthcare Conference on January 12th at 11:00 AM PT.

 

Fibrocell Science announced that the FDA has granted Fast Track designation to FCX-007, the Company’s clinical-stage candidate for the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)–a rare, devastating genetic skin disease for which no FDA-approved therapies exist.

 

Pieris Pharmaceuticals and Servier announced a broad collaboration in immuno-oncology (IO). Despite the impressive clinical efficacy of checkpoint inhibitors to date, a majority of patients fail to respond to approved therapies. The collaboration seeks to address this significant unmet clinical need by advancing a series of novel molecules, including multiple dual immune checkpoint blockade approaches. The financial terms of the collaboration include an upfront payment to Pieris of EUR30 million (approximately $31.3 million). Pieris may also receive FTE funding for specific projects, an option fee upon potential expansion of the collaboration as well as development-dependent and commercial milestone payments for PRS-332 and each additional program. The total development, regulatory and sales-based milestone payments to Pieris could reach EUR324 million (approximately $338 million) for PRS-332, and up to EUR193 million (approximately $201 million) for each of the other programs. Pieris and Servier will share preclinical and clinical development costs for each co-developed program. In addition, Pieris will be entitled to receive tiered royalties up to low double digits on the sales of commercialized products in the Servier territories.

 

Aeterna Zentaris announced that the confirmatory Phase III clinical trial of Macrilen (macimorelin) failed to achieve its objective of validating a single oral dose of macimorelin for the evaluation of growth hormone deficiency in adults (“AGHD”), using the insulin tolerance test (the “ITT”) as a comparator. The Company is evaluating the outcome of the trial and will determine in the near future whether it will continue with the development of Macrilen.

 

CTI BioPharma announced that the full clinical hold (February 2016) implemented by the FDA on all clinical trials conducted under the IND application for pacritinib has now been removed. The Company’s complete response submission included, among other items, final Clinical Study Reports for both PERSIST-1 and 2 trials and a dose-exploration clinical trial protocol that the FDA requested. The new trial, PAC203 plans to enroll up to approximately 105 patients with primary myelofibrosis who have failed prior ruxolitinib therapy to evaluate the safety and the dose response relationship for efficacy (spleen volume reduction at 24 weeks) of three dose regimens: 100 mg once-daily, 100 mg twice-daily (BID) and 200 mg BID. The 200 mg BID dose regimen was used in PERSIST-2. The Company expects to start the trial in the second quarter of 2017.

 

Halozyme Therapeutics reported topline results from the combined analysis of Stages 1 and 2 and Stage 2 alone of its HALO 202 study, a Phase II randomized, multi-center clinical trial of lead investigational drug PEGPH20 in combination with ABRAXANE (nab-paclitaxel) and gemcitabine in stage IV pancreas cancer patients. Among the findings, the overall study population showed a statistically significant increase in progression-free survival (PFS) in patients with high levels of hyaluronan (HA-High) treated with PEGPH20 plus ABRAXANE and gemcitabine when compared to HA-High patients receiving ABRAXANE and gemcitabine alone. Stage 2 of the study, which completed enrollment in February 2016, showed a 91 percent improvement in median PFS for HA-High patients in the PEGPH20 arm, 8.6 months compared to 4.5 months in the control arm, and achieved its primary endpoint to evaluate and demonstrate a reduction in the rate of thromboembolic events in the PEGPH20 arm.

 

Cesca Therapeutics announced that the Company received approval from the FDA for significant revisions to the Company’s pivotal study for treatment of Critical Limb Ischemia (CLI). The CLI clinical trial is designed to demonstrate the safety and efficacy of the Company’s point-of-care SurgWerks system for the treatment of CLI patients with limited or no treatment options. The study was first approved by FDA in June 2015, but was not initiated at that time pending funding.

 

Genocea Biosciences announced positive clinical results from a planned interim analysis of its ongoing placebo-controlled Phase IIb trial evaluating GEN-003 for the treatment of genital herpes infections. Even in a trial this small, at six months after dosing, GEN-003 demonstrated statistically significant improvements versus placebo across multiple clinical endpoints.

 

Arena Pharmaceuticals announced that it has amended its BELVIQ (lorcaserin HCl) marketing and supply agreement with Eisai Co. and Eisai Inc. Under the revised agreement, Eisai is acquiring global commercialization rights to BELVIQ, including in the territories retained by Arena under the parties’ prior agreement, with control over global development and commercialization decisions, and is responsible for all lorcaserin development expenses going forward. The financial terms of the revised agreement are expected to provide Arena with $23 million of cash payments and over $80 million of potential cost relief on current lorcaserin development obligations. Arena will continue to be eligible to receive royalty payments on net sales of BELVIQ and participate in the upside potential of lorcaserin from additional geographies and clinical trials such as the ongoing cardiovascular outcomes trial, CAMELLIA.

 

Sangamo BioSciences announced that the FDA has cleared the Company’s IND for its SB-525 gene therapy program for the treatment of hemophilia A. The IND is now active and enables clinical development to assess the safety, tolerability and potential efficacy of SB-525 in adults with hemophilia A.

 

Reuters reported that Alexion Pharmaceuticals filed its delayed third-quarter 2016 financial report with U.S. regulators and said an investigation into allegations regarding sales practices found no need to restate previous financial results. The company disclosed in November it was investigating allegations made by a former employee regarding sales practices involving its costly blood disorder drug Soliris. Alexion said its board’s audit and finance committee found no instances of improper revenue recognition, but did find a material weakness in internal controls over financial reporting as of December 31, 2015 and subsequent quarters. This was attributed to "senior management not setting an appropriate tone at the top." Alexion said it would report full-year 2016 results, and its financial outlook, on February 16. The company said it still expected full-year 2016 adjusted earnings per share of $4.50 to $4.65 on revenue of $3.05 billion to $3.10 billion.

 

RedHill Biopharma announced the signing of a new collaboration agreement with the Department of Molecular Biology and Genetics of Denmark-based Aarhus University ("AU") for the evaluation of RedHill’s Phase II-stage oncology drug candidate, MESUPRON (upamostat).

 

Otonomy announced positive results from its pivotal Phase III clinical trial of OTIPRIO (ciprofloxacin otic suspension) in patients with acute otitis externa (AOE), also known as swimmer’s ear. This single administration trial of OTIPRIO met the primary endpoint by showing a statistically significant increase in clinical cure rate compared to sham (no treatment) at Day 8 (p<0.001). Treatment with OTIPRIO was also well tolerated. Based on these positive results, Otonomy expects to submit a sNDA with the FDA in the first half of 2017.

 

Synthetic Biologics announced positive topline data from its Phase IIb clinical trial for SYN-004 (ribaxamase), the Company’s first-in-class oral enzyme designed to protect the gut microbiome from disruption caused by certain intravenous (IV) beta-lactam antibiotics.

 

Orexigen Therapeutics provided an update on recent progress and key business priorities for 2017 that will be covered during the Company’s presentation at the 35(th) Annual J.P. Morgan Healthcare Conference in San Francisco, which is taking place January 9-12.

 

Five Prime Therapeutics announced that Bristol-Myers Squibb has exercised its option to extend the research term of its discovery collaboration agreement with Five Prime for the discovery, development and commercialization of immuno-oncology therapies directed toward targets in three undisclosed immune checkpoint pathways. The original collaboration agreement was established in March 2014 and focused on two undisclosed immune checkpoint pathways. In January 2016, the companies added a third immune checkpoint pathway to the collaboration. Bristol-Myers Squibb has now elected to extend the research term from its original ending date of March 2017 to March 2018, and will provide additional research funding for the 12-month extension of the research term.

 

Arno Therapeutics announced that it has concluded not to enroll the remaining 3 patients in the Company’s ongoing Phase II clinical trial of onapristone in combination with Zytiga (abiraterone acetate) in men with advanced castration-resistant prostate cancer (CRPC) who have failed Zytiga alone. This Phase II study protocol requires an efficacy review after the enrollment of 18 patients. To date, 15 patients have been enrolled. The Company does not believe the data collected from the first 12 patients in this study justifies the enrollment of additional subjects. The Company’s decision was not based on any safety signal and it will continue to monitor and to provide Onapristone to all patients currently enrolled in this trial.

 

Clearside Biomedical announced the appointment of Richard L. Beckman, M.D. to the position of Chief Medical Officer.

 

Abbott announced it has completed the acquisition of St. Jude Medical, establishing the company as a leader in the medical device arena. The transaction provides Abbott with expanded opportunities for future growth and is an important part of the company’s ongoing effort to develop a strong, diverse portfolio of devices, diagnostics, nutritionals and branded generic pharmaceuticals. 

 

Clovis Oncology announced that the underwriters of its recently announced public offering of its common stock have exercised in full their option to purchase an additional 750,000 shares. Clovis Oncology intends to use the net proceeds of the offering for general corporate purposes, including commercial planning and sales and marketing expenses associated with the launch of Rubraca (rucaparib) in the U.S and, if approved by the EMA, in Europe, funding of its development programs, general and administrative expenses, acquisition or licensing of additional product candidates or businesses and working capital. J. P. Morgan Securities and BofA Merrill Lynch are acting as joint book-running managers for the offering. Stifel and SunTrust Robinson Humphrey are acting as co-managers for the offering.

 

Celyad announced that the first patient of the Therapeutic Immunotherapy with NKR-2 (THINK) trial started cell processing in Belgium. Blood was collected from this patient and first CAR-T NKR-2 dose level infusion (3×10(8) cells) is expected in January 2017.

 

Nicox S.A. provided certain regulatory and clinical updates for NCX 4251, its novel ophthalmic suspension of fluticasone propionate nanocrystals being developed for the first time as a topical treatment for acute exacerbation of blepharitis. Based on feedback from a recent pre- IND meeting with the FDA, Nicox is finalizing the design of a first-in-human Phase II clinical trial evaluating the efficacy and safety of NCX 4251 versus a vehicle comparator in patients with acute exacerbation of blepharitis. This multi-center, dose-ranging study will be conducted in the U.S. The primary objective of the study is to demonstrate a statistically significant and clinically relevant difference in the proportion of subjects with clinical cure (defined as the absence of lid margin redness, lid debris, and lid discomfort) obtained with each dose of NCX 4251 versus vehicle. An additional objective of the study is to identify the recommended Phase III dose of NCX 4251. Subject to IND filing and acceptance, Nicox plans to initiate this Phase II clinical trial during the fourth quarter of 2017 and expects the trial to take approximately 1 year to complete.

 

Ultragenyx Pharmaceutical and Kyowa Kirin International, a wholly owned subsidiary of Kyowa Hakko Kirin Co., announced that the EMA has accepted for review the MAA for KRN23 for the treatment of X-linked hypophosphatemia (XLH). The MAA was filed and accepted in late 2016, and an opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected in the second half of 2017. Ultragenyx and Kyowa Hakko Kirin entered into a collaboration and license agreement in August 2013 to develop and commercialize KRN23.

 

Janssen Biotech announced that the company has entered a clinical trial collaboration with Bristol-Myers Squibb to evaluate the combination of the first CD38-directed cytolytic antibody daratumumab (DARZALEX) and checkpoint inhibitor nivolumab (OPDIVO) in Phase Ib/Phase II clinical studies in multiple myeloma and several solid tumor types. Nivolumab is developed and commercialized by BMS. Janssen licensed daratumumab from Genmab and is responsible for all global development, marketing and manufacturing.

 

Dermira announced the appointment of Lori Lyons-Williams as Chief Commercial Officer.

 

Marinus Pharmaceuticals provided a business overview to outline the clinical status of its CNS-selective GABA(A) modulator, ganaxolone, and an overview of near-term value-creating milestones expected in 2017.

 

Merus and the Institute for Research in Biomedicine (IRB) Barcelona announced entry into a research collaboration to jointly develop novel agents that target the tumor microenvironment. The research collaboration will combine Merus’ Biclonics technology platform for the discovery and development of therapeutic bispecific antibodies and IRB’s unique cell and animal models to evaluate therapeutic targeting of stromal cells that support tumor growth and metastasis.

 

Reuters reported that Allergan said it expects mid-single digit net revenue percentage growth this year, helped by new launches and higher sales of key products. The company, which will report its fourth-quarter results in February, also said it expects to achieve double-digit adjusted earnings growth in 2017. Analysts on average expected 2017 adjusted earnings of $16.04 per share and revenue of $15.31 billion, according to Thomson Reuters I/B/E/S.

 

PTC Therapeutics announced that its joint development program in Spinal Muscular Atrophy (SMA) with Roche and the SMA Foundation (SMAF) initiated a clinical study in infants with Type I SMA. The study, named FIREFISH, will investigate the safety, tolerability and efficacy of RG7916 in babies aged 1 to 7 months. RG7916 is an oral small molecule splicing modifier that directly targets the underlying molecular deficiency of SMA by modulating SMN2 splicing to increase expression of stable full-length SMN protein from the SMN2 gene.

 

Catabasis Pharmaceuticals announced the publication of preclinical data on CAT-5571, a novel activator of autophagy and potential oral treatment for cystic fibrosis (CF). The preclinical data demonstrate an increase in CF transmembrane conductance regulator (CFTR) activity and trafficking which are detailed in an article titled "Fatty Acid Cysteamine Conjugates as Novel and Potent Autophagy Activators that Enhance the Correction of Misfolded F508del-CFTR" in the Journal of Medicinal Chemistry (J Med Chem. 2016 Dec 23. doi: 10.1021/acs.jmedchem.6b01539).

 

Seattle Genetics announced enrollment of the first patient in a multicenter Phase I clinical trial of SGN-CD352A for patients with relapsed or refractory multiple myeloma (MM). SGN-CD352A is an investigational CD352-targeted antibody-drug conjugate (ADC) utilizing Seattle Genetics’ proprietary ADC technology, an engineered cysteine antibody (EC-mAb) stably linked to a highly potent cytotoxic agent called a pyrrolobenzodiazepine (PBD) dimer. CD352 is broadly expressed on B-cell cancers including multiple myeloma, chronic lymphocytic leukemia and non-Hodgkin lymphoma, while exhibiting low expression on normal white blood cells. The trial is designed to assess the safety and antitumor activity of SGN-CD352A. This study represents Seattle Genetics’ first clinical-stage ADC program in development for MM, demonstrating the breadth of potential therapeutic applications for its industry-leading ADC technology platform.

 

Protagonist Therapeutics announced that a key patent has issued covering orally stable peptides from the company’s most advanced development program. This new U.S. patent, No. 9,518,091, together with previously granted U.S. patent No. 9,273,093, provides protection for the company’s alpha4beta7 integrin peptide inhibitors, which includes the company lead clinical candidate, PTG-100.

 

Cascadian Therapeutics announced an overview of recent progress for its investigational drug portfolio in addition to several anticipated key objectives for 2017.

 

Fate Therapeutics announced that the first patient has been treated in its PROTECT clinical trial of ProTmune for the prevention of acute graft-versus-host disease (GvHD).

 

Lipocine announced plans to initiate a dosing flexibility ("DF") study in addition to its previously announced dosing validation ("DV") study for LPCN 1021. LPCN 1021 is an oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. The DF study will assess LPCN 1021 in hypogonadal males on a fixed daily dose of 450 mg divided into three equal doses whereas the DV study is assessing the impact of LPCN 1021 in hypogonadal males on a fixed daily dose of 450 mg divided into two equal doses. Lipocine expects resubmission of the LPCN 1021 NDA to the FDA to contain data from both the DV study and the DF study.

 

Amorsa Therapeutics announced a research, option and license agreement with Janssen Pharmaceuticals to develop and commercialize a novel small molecule drug candidate for treatment-resistant depression based on Amorsa’s proprietary ketamine analog technology. Amorsa’s product candidates are designed to show efficacy as rapidly acting antidepressants with an extended duration of action, possess an attractive side-effect profile, and enable oral dose administration.

 

Synthetic Genomics announced that it has entered a research and licensing option agreement with Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, to apply Synthetic Genomics’ proprietary replicon RNA technology toward the design and development of novel RNA-based medicines for specific infectious diseases. The deal was facilitated by Johnson & Johnson Innovation.

 

Exact Sciences announced that the Blue Cross Blue Shield Association’s (BCBSA) Center for Clinical Effectiveness "Evidence Street" recently released a positive review of Cologuard to its members.

 

Pfizer announced that the comparative, confirmatory REFLECTIONS B538-02 study met its primary objective by demonstrating equivalent efficacy as measured by the American College of Rheumatology 20 (ACR20) response rate at Week 12. This trial is evaluating the efficacy, safety, and immunogenicity of PF-06410293 compared to Humira (adalimumab), each taken in combination with methotrexate, in patients with moderate to severe rheumatoid arthritis. PF-06410293 is being developed as a potential biosimilar to Humira.

 

XTL Biopharmaceuticals announced the company intends to pursue Sjögren’s syndrome as the second indication for its lead drug candidate hCDR1. Currently in development for the treatment of systemic lupus erythematosus (SLE), hCDR1 has been tested in over 400 patients, and is set to enter a global Phase II trial for SLE.

 

OncoMed Pharmaceuticals pre-announced its 2016 year-end cash balance and reviewed key anticipated events for 2017.

 

The FDA approved supplemental New Drug Applications for three Type II diabetes medicines within the empagliflozin family to include data from the landmark EMPA-REG OUTCOME trial. The data show that empagliflozin reduced the risk for cardiovascular death compared with placebo when added to standard of care Type II diabetes and cardiovascular medicines in adults with Type II diabetes and established cardiovascular disease. The data have been added to the "Clinical Studies" sections of the Prescribing Information for Synjardy (empagliflozin/metformin hydrochloride), Synjardy XR (empagliflozin/metformin hydrochloride extended-release) and Glyxambi (empagliflozin/linagliptin) tablets, all of which are marketed by Boehringer Ingelheim and Eli Lilly. SYNJARDY, SYNJARDY XR and GLYXAMBI are indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type II diabetes. Empagliflozin, a component of these medicines, is indicated to reduce the risk of cardiovascular death in adults with Type II diabetes and established cardiovascular disease. However, the effectiveness of SYNJARDY, SYNJARDY XR and GLYXAMBI on reducing the risk of cardiovascular death in adults with Type II diabetes and cardiovascular disease has not been established.

 

AbCellera Biologics announced a new therapeutic antibody discovery collaboration with Pfizer. AbCellera will apply its proprietary monoclonal antibody (mAb) screening platform to attempt to discover function-modulating antibodies against undisclosed membrane protein targets.

 

ENTEROME SA announced the launch of a Phase I clinical study with its lead small molecule drug candidate EB8018, a small molecule designed to block FimH, as a potential new treatment for Crohn’s disease. 

 

Bicycle Therapeutics announced the appointment of Nicholas Keen, Ph.D., as Chief Scientific Officer.

 

Zymeworks announced the successful achievement of a research milestone in a second immune-modulating bispecific antibody in its collaboration with Eli Lilly using Zymeworks’ proprietary Azymetric platform. In accordance with the terms of the licensing and collaboration agreement, Zymeworks is to receive an undisclosed milestone payment from Lilly.

 

Soligenix announced that the company had received positive Scientific Advice from the EMA for the development of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy.  The Scientific Advice from the EMA indicates that a single, double-blind, placebo-controlled, multinational, Phase III pivotal study (IDR-OM-02), if successful, in conjunction with the Phase II dose-ranging study IDR-OM-01, is generally considered sufficient to support a marketing authorization application (MAA) to the EMA for potential licensure in Europe.  The advice also provides several constructive suggestions to strengthen the study design and data collection that will be integrated into the final protocol.

 

Molecular Stethoscope announced that it has completed an $8.2 million seed financing. Investors include DCVC (Data Collective), Pfizer, Index Ventures, one of the top five U.S. research universities, and several prominent individual investors. The funding will enable Molecular Stethoscope to continue development of its proprietary first-in-class liquid biopsy tests for its initial applications in cardiometabolic and neurodegenerative diseases and to accelerate discovery in additional markets

 

PixarBio announced that on Friday, December 30, 2016, it sold to Henry Sargent all of the membership interests in Buddhi Mat, the Company’s wholly owned subsidiary.

 

ProMetic Life Sciences announced that it has amended its licensing agreement originally entered into with Hematech BioTherapeutics in May 2012 (the "License Agreement"). ProMetic has reacquired the rights initially granted to Hematech in the License Agreement, to a 50% share of the worldwide profits related to plasminogen congenital deficiency sales (the "Rights").

 

Eli Lilly announced a series of changes to its organization and leadership structure to better align them with the company’s growth opportunities.

 

Loxo Oncology announced the pricing of its underwritten public offering of 3,870,000 shares of common stock at a public offering price of $31.00 per share. Gross proceeds to Loxo Oncology from this offering are expected to be approximately $120 million. Loxo Oncology intends to use the net proceeds from this offering for early commercialization activities for larotrectinib, new and ongoing research and development activities, and general corporate purposes, which may include increased working capital, acquisitions or investments in businesses, products or technologies, and capital expenditures.

 

 

ANALYST RECOMMENDATIONS

 

Jefferies analyst Brian Abrahams increased his price target of the following companies, citing a stabilizing political backdrop and increasingly pro-industry regulatory environment offsetting some of the negativity, and an uptick in M&A should catalyze momentum particularly for mid-caps and help improve mixed sentiment: Biogen to $312 from $310; Celgene to $142 from $140; Gilead to $93 from $91; Immunomedics to $6 from $5.50; Incyte to $118 from $109; Vertex to $104 from $102.

 

Citi analyst Yigal Nochomovitz increased his price target of Atara Biotherapeutics to $10 from $8, citing plans to submit a conditional MAA in 2018 for EBV-CTL (ATA 129) for the treatment of rituximab refractory EBV-PTLD following hematopoietic cell transplant (HCT).

 

Citi analyst Liav Abraham revised his ratings and price targets of the following stocks: Endo International downgraded to “neutral” from “buy” and decreased his price target to $20 from $25; Mylan downgraded to “neutral” from “buy” and decreased his price target to $44 from $59; Teva Pharmaceuticals decreased $47 from $75.

 

Credit Suisse analyst Alethia Young increased her price target of Tesaro to $151 from $122, citing the next underappreciated opportunity is within their immuno-oncology platform.

 

Leerink analyst Joseph Schwartz assumed coverage of Intellia Therapeutics with an “outperform” rating and $29 price target, citing NTLA is a leader in the rapidly emerging CRISPR/Cas9 space which has enormous potential to deliver major breakthroughs in gene editing capabilities.

 

HC  Wainwright analyst Shaunak Deepak initiated coverage of Calithera Biosciences with a “buy” rating and $9 price target, citing Calithera is developing oral drugs that target feeding of cancer cells and immune cells.

 

Oppenheimer analyst Derek Archila initiated coverage of the following companies: Trevena with an “outperform” rating and $13 price target; Synergy Pharmaceuticals with an “outperform” rating and $10 price target.

 

Stifel analyst Adam Walsh initiated coverage of Galapagos with a “hold” rating and $65 price target, citing risk/reward is balanced at current valuation.

 

Rodman & Renshaw analyst Raghuram Selvaraju upgraded Evoke Pharma to “buy” from “neutral” and increased his price target to $6 from $2.50, citing additional Gimoti data released yesterday increases odds of approval.