BioShares Biotechnology Clinical Trials (BBC): $18.55, +$0.14, +0.8% YTD

BioShares Biotechnology Products (BBP): $32.67, -$0.08, -0.2% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures indicated a higher start as investors looked forward for the Federal Reserve to release the minutes of its December meeting where it raised interest rates. Automakers will report sales data for last month. European shares traded lower with Britain’s FTSE slipping from previous session’s record high as shares in Next slumped after the retailer issued a profit warning. Asian shares ended on a mixed note. Gold was trading near 4-week highs and oil rose as dollar retreated from a 14-year peak against a basket of currencies.

 

 

MARKET HIGHLIGHTS

 

CymaBay Therapeutics has entered into an exclusive license agreement with Kowa Pharmaceuticals America for the development and commercialization of arhalofenate in the United States. Under the terms of the agreement, CymaBay will receive up to $15 million in upfront and near-term milestone payments and is eligible to receive up to an additional $190 million in payments based upon the achievement of specific development, regulatory and sales milestones.  CymaBay is also eligible to receive tiered, double digit royalties on future sales of arhalofenate products.  Kowa will be responsible for all development and commercialization costs. CymaBay had earlier reached agreement with the Food and Drug Administration (FDA) on the size and scope of the Phase 3 program which is estimated to cost $100 million. CymaBay retains full development and commercialization rights for the rest of the world.  Locust Walk served as a transaction advisor to CymaBay.

 

BioLife Solutions announced the restructuring of its biologistex CCM LLC joint venture formed with SAVSU Technologies, to develop and commercialize the evo Smart Shipper and related biologistex Cold Chain Management SaaS.  Pursuant to the restructuring, BioLife will convert its outstanding loan to the JV into a capital contribution and SAVSU will contribute all of its cold chain related operations, technology, IP and assets to the JV.  BioLife will continue to market and sell evo subscriptions and provide ongoing fulfillment and customer support in exchange for a 20% commission on revenue from its sales and marketing efforts and a fixed monthly fee for the first year.  In addition, certain BioLife employees have been transitioned to the JV, as well as related costs associated with evo and biologistex product development and marketing.  BioLife’s ownership interest in the JV will initially be reduced from 52% to 45%, and the JV’s operating results will no longer be consolidated with BioLife’s results. Mike Rice, BioLife CEO, will remain a member of the JV’s Management Committee.

 

GeNeuro provided an update on GNbAC1, its multiple sclerosis drug candidate. GNbAC1, the first drug candidate directly targeting a potential cause of MS, is a monoclonal antibody designed to neutralise MSRV-Env, a pathogenic protein which has been associated with both the inflammatory and neurodegenerative components of the disease.  Full enrollment of the CHANGE-MS Phase 2b study of GNbAC1 has been completed, several months ahead of schedule, and is indicative of strong interest from physicians in this pioneering new treatment for MS. Based on this accelerated timeline, GeNeuro now expects the availability of top-line results from this study early in the fourth quarter of 2017, versus the previous estimate of by year-end 2017. The double-blind, placebo-controlled study, CHANGE-MS (Clinical trial assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in Multiple Sclerosis), is evaluating the efficacy of GNbAC1 in reducing the number of new inflammatory lesions as well as measures of neurodegeneration on brain MRI in patients with remitting relapsing multiple sclerosis (RRMS). The CHANGE-MS Phase 2b study is fully funded through GeNeuro’s €362.5 million partnership with Servier, which was signed in 2014.

 

Bellerophon Therapeutics received confirmation from the U.S. Food and Drug Administration of the Agency’s acceptance of all modifications proposed by the Company to its Phase 3 program for INOpulse in Pulmonary Arterial Hypertension (PAH).  Under the newly modified Phase 3 program, the ongoing one-year INOvation-1 study, and a second confirmatory randomized withdrawal study with approximately 40 patients who will be crossing over from the INOvation-1 study, can serve as the two adequate and well-controlled studies to support a New Drug Application filing for INOpulse in PAH subjects on long term oxygen treatment.  INOvation-1 and the randomized withdrawal study are planned to be conducted on near parallel timelines, which could reduce the time to market for INOpulse in PAH by approximately two years.  

 

Eiger BioPharmaceuticals announced that it has completed a $25 million debt financing transaction with Oxford Finance LLC ("Oxford").  Proceeds of the financing are intended for use to advance Eiger’s diverse pipeline of clinical stage programs for the treatment of rare diseases, including the Company’s lead program for hepatitis delta virus (HDV) infection, the most severe form of viral hepatitis.  The financing is structured as a two-part transaction, comprising of an initial $15 million tranche drawn on December 30, 2016 and a second $10 million tranche, which can be taken at a future date at the Company’s discretion based on the achievement of pre-defined development milestones.  The initial payments to be made by Eiger on the facility will consist of interest-only payments for 18 months, through 2Q 2018.

 

Paratek Pharmaceuticals announced today that Evan Loh, M.D. has been promoted to the role of President and Chief Operating Officer. Dr. Loh, who is also a member of Paratek’s board of directors, had served in the role of President and Chief Medical Officer since 2014. He will continue to retain the title of Chief Medical Officer and will continue to report to Michael Bigham, Chief Executive Officer & Chairman.  Additionally, the company announced that Evan Tzanis has been promoted to Senior Vice President, Clinical Development and Clinical Operations. Jeanne Jew has been promoted to Senior Vice President, Business Development. Both Mr. Tzanis and Ms. Jew will report to Evan Loh.

 

Zealand Pharma reports that Sanofi announced today that Soliqua™ 100/33 (insulin glargine 100 Units/mL & lixisenatide 33 mcg/mL injection) is now available by prescription in U.S. pharmacies. Soliqua 100/33 is indicated for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 Units daily) or lixisenatide.  Adlyxin™ (lixisenatide), the once daily prandial GLP-1 analogue invented by Zealand and approved by the FDA in July 2016, is also available by prescription in U.S. pharmacies.

 

Ignyta will make a presentation at the 35th Annual J.P. Morgan Healthcare Conference on Tuesday, January 10, 2017, at 3:30 p.m. Pacific time.

 

Aimmune Therapeutics will present a company overview at the 35th Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, January 11, 2017, at 5:00 p.m. Pacific Time.

 

Heat Biologics announced the appointment of Jeff Hutchins, Ph.D., as Chief Scientific Officer and Senior Vice President of Preclinical Development. Dr. Hutchins will be overseeing Heat’s research efforts, bringing over 24 years of research and clinical development experience from both large pharmaceutical and biotechnology companies.

 

Agile Therapeutics announced positive top-line results from its Phase III SECURE clinical trial of Twirla, its investigational low-dose combined hormonal contraceptive patch. SECURE was a multicenter, single-arm, open-label, 13-cycle trial that evaluated the safety, efficacy and tolerability of Twirla in 2032 healthy women, aged 18 and over, at 102 experienced investigative sites across the U.S. The Company plans to resubmit its NDA for Twirla in the first half of 2017 on the basis of the SECURE results and other information relating to the manufacture of Twirla.

 

Ocular Therapeutix announced additional positive secondary endpoint results from its most recent successful Phase III clinical trial of DEXTENZA (dexamethasone insert) 0.4 mg, for the treatment of post-surgical ocular inflammation and pain. DEXTENZA is a product candidate administered by a physician as a bioresorbable intracanalicular insert and designed to release drug to the ocular surface for up to 30 days. The secondary endpoint, the absence of anterior chamber (AC) flare, an indicator of inflammation, was statistically superior to placebo at all measured time points. Approximately 46% of patients in the DEXTENZA treatment group were shown to have an absence of AC flare at day 4 after insertion, which Ocular believes provides further support of the early onset anti-inflammatory effect of DEXTENZA. Additional secondary efficacy endpoints included differences in the absence of AC cells and ocular pain on days 2, 4, 14, and 30 after insertion. As previously reported, all of these secondary endpoints were met with statistical significance with the exception of the endpoint for the absence of AC cells at day 2. As also previously announced, DEXTENZA successfully met the trial’s two primary efficacy endpoints, absence of ocular pain on day 8 and absence of ocular inflammation on day 14 when compared to placebo. In this Phase III clinical trial, for which the complete safety assessment will be available in the first quarter of 2017, no treatment-related serious adverse events were observed. DEXTENZA has exhibited a favorable safety profile and has been well tolerated in all clinical trials, regardless of indication.

 

Evoke Pharma provided additional data from the Phase III trial of Gimoti, its nasal delivery of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women. Although the Phase III trial failed to reach its primary endpoint, data also demonstrated that patients with moderate to severe symptoms, which included 105 of the 205 patients (51%) enrolled in the study, responded statistically significantly better when treated with Gimoti than those treated with placebo at multiple time points in the Intent-to-Treat (ITT) and Per Protocol populations. There were also clinically and statistically significant improvements in nausea and abdominal pain, which are two of the more severe and debilitating symptoms of gastroparesis.

 

Nivalis Therapeutics announced that its Board of Directors has initiated a process to explore and review a range of strategic alternatives focused on maximizing stockholder value from its clinical assets and cash resources. Nivalis has engaged Ladenburg Thalmann & Co. Inc. to act as its strategic financial advisor for this process. In conjunction with the exploration of strategic alternatives, the Company also intends to streamline its operations in order to preserve its capital and cash resources.

 

Trevena announced that it has completed enrollment of its Phase III APOLLO-1 and APOLLO-2 pivotal efficacy studies of oliceridine (TRV130) in moderate-to-severe acute pain following bunionectomy and abdominoplasty, respectively.

 

OncoCyte provided an update on the development of its product portfolio that currently includes a lung cancer diagnostic test, a breast cancer diagnostic test and a bladder cancer diagnostic test. While current biopsy tests use invasive surgical procedures to provide tissue samples in order to determine if a tumor is benign or malignant, OncoCyte is developing a next generation of diagnostic tests that will be based on liquid biopsies using blood or urine samples.

 

Compugen disclosed new animal model results demonstrating restoration of immune tolerance by CGEN-15001, the Company’s lead candidate for treatment of autoimmune diseases. Importantly, the immune tolerance established by CGEN-15001 was shown to be antigen-specific, indicating that treatment with CGEN-15001 has the potential to not only generate a durable response, but also to avoid the global immune suppression generated by other therapeutic agents for autoimmune diseases. CGEN-15001 is an Fc fusion protein based on a Compugen-discovered novel immune checkpoint protein.

 

Acura Pharmaceuticals announced that it is exploring a full range of financing and strategic alternatives, including a possible sale of the company. The Company has retained Roth Capital Partners to assist in this process. Alternatives to a sale of the company include a capital raising transaction, a licensing transaction and a sale of certain assets. There can be no assurance a transaction will result from this process and the company does not intend to disclose additional details unless and until it has entered into a specific transaction.

 

RedHill Biopharma announced that Ira Kalfus, MD, Medical Director at RedHill, will present the positive final results, announced in June 2015, of the first Phase III study with RHB-105 for the treatment of H. pylori infection, at the Innovations in Gastroenterology 2017 Symposium, on Friday, January 6, 2017 at 10:15 AM IST, at the Hilton Hotel, Tel Aviv, Israel.

 

Ionis Pharmaceuticals announced positive data from a Phase II study of IONIS-GCGRRx in 79 patients with Type II diabetes.  In this study, patients with Type II diabetes uncontrolled on stable, maximal metformin therapy treated with IONIS-GCGRRx achieved robust and sustained, statistically significant improvements in hemoglobin A1c (HbA1c) and other measures of glucose control after 26 weeks of treatment. Patients treated with 50 mg and 75 mg weekly doses achieved mean reductions in HbA1c of 0.7 percentage points (p ˂ 0.05) and 1.4 percentage points (p ˂ 0.001) from baseline, respectively, compared to a reduction of 0.1 percentage points for placebo-treated patients, in an intent to treat (ITT) analysis. A per protocol analysis showed additional improvements in HbA1c in both treatment groups compared to placebo. At baseline, mean HbA1c levels were approximately 8.8% for all cohorts. A substantial number of IONIS-GCGRRx-treated patients achieved HbA1c reductions of equal to or greater than 1 percentage point, including 42% of 50 mg-treated patients and 64% of 75 mg-treated patients, compared to 8% of the placebo-treated patients. IONIS-GCGRRx-treated patients experienced a mean increase in total GLP-1 from baseline compared to a decline in placebo-treated patients.

 

Enanta Pharmaceuticals announced that the FDA has granted Enanta’s drug candidate EDP-305, an FXR agonist, Fast Track designation for the treatment of patients with non-alcoholic steatohepatitis (NASH) with liver fibrosis.

 

Spark Therapeutics announced that it has earned a $15 million payment from Pfizer for achieving a pre-specified safety and efficacy profile development milestone in the ongoing hemophilia B Phase I/II trial of investigational SPK-9001. SPK-9001 has received breakthrough therapy and orphan product designations from the FDA.

 

TG Therapeutics announced the opening of an investigator initiated Phase II study at the University of Nebraska Medical Center (UNMC) to evaluate the safety and efficacy of TGR-1202, the Company’s oral PI3K delta inhibitor in combination with ibrutinib, in patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL). TG Therapeutics and Janssen Pharmaceuticals will each provide drug and equally share study-related costs.

 

Kura Oncology announced that the FDA accepted the company’s IND application to begin Phase I clinical testing of KO-947, its small molecule inhibitor of extracellular-signal-regulated kinases 1 and 2 (ERK1/2) as a treatment for cancers in which the mitogen activated protein kinase (MAPK) pathway is dysregulated. Additionally, Kura announced nomination of KO-539, an orally-available small molecule inhibitor of the menin-MLL interaction, as a development candidate for the treatment of mixed lineage leukemias, a genetically-defined subset of the two most common forms of acute leukemia, acute myeloid leukemia and acute lymphoblastic leukemia.

 

Amicus Therapeutics announced that the NICE Highly Specialised Technologies Evaluation Committee (EC) has issued a positive final evaluation determination (FED) for reimbursed patient access to Galafold (migalastat). NICE has recommended the commissioning of Galafold for use within the National Health Service (NHS) in England as a first line therapy for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (alpha-galactosidase A deficiency) and who have an amenable mutation. The Company expects to launch Galafold in England, Wales and Northern Ireland in early 2017.

 

Cidara Therapeutics announced the completion of patient enrollment in the RADIANT trial, a Phase II randomized trial evaluating the safety, tolerability and efficacy of two topical treatment regimens of the novel echinocandin antifungal, CD101, in women with moderate to severe acute vulvovaginal candidiasis (VVC). CD101 topical is the first and only agent in the echinocandin class being studied for the treatment and prevention of VVC.

 

RaNA Therapeutics announced the acquisition of the MRT platform, an mRNA therapy platform, developed by subsidiaries of Shire. In addition, Shire’s former MRT employees, the group focused on the development of this technology since 2008, have joined RaNA to continue to advance the platform with lead programs in cystic fibrosis (CF) and urea cycle disorders (UCD).

 

Allergan and Medicines360 announced that the FDA has accepted for filing the company’s sNDA to potentially extend the duration of use for the prevention of pregnancy from up to three years to up to four years for LILETTA (levonorgestrel-releasing intrauterine system) 52 mg. 

 

Xenetic Biosciences announced that it has appointed Curtis A. Lockshin, Ph.D. as Chief Scientific Officer.

 

Aptevo Therapeutics announced that it has resumed IXINITY manufacturing operations and anticipates that new supply of IXINITY will be available beginning in the second quarter of 2017. The announcement follows a Notice of Interruption in Manufacturing submitted by Aptevo to the FDA and reported in the Company’s Quarterly Report on Form 10-Q, filed on November 14, 2016. The IXINITY supply interruption relates to ongoing bulk drug substance (BDS) manufacturing challenges, which Aptevo believes have now been addressed.

 

Aevi Genomic Medicine announced that enrollment is complete in the SAGA (Study of Adolescent Glutamate Receptor Network Copy Number Variant ADHD) trial. All ongoing patients are expected to continue through the follow-up period in order to complete the study. The Company anticipates announcing top-line results during the first quarter of 2017.

 

Luminex announced that it has received FDA clearance for the ARIES Group B Streptococcus (GBS) Assay for antepartum detection of GBS colonization in pregnant women. This is the third assay the FDA has cleared for use on the Luminex ARIES Systems. The company has also achieved CE-IVD marking for the ARIES GBS Assay.

 

Sanofi announced that Soliqua 100/33 (insulin glargine 100 Units/mL & lixisenatide(*) 33 mcg/mL injection) is now available by prescription in U.S. pharmacies. Soliqua 100/33 is indicated for the treatment of adults with Type II diabetes inadequately controlled on basal insulin (less than 60 Units daily) or lixisenatide.

 

Fortress Biotech announced the formation of a new subsidiary company, Caelum Biosciences, to advance the development of CAEL-101 (11-1F4) for the treatment of amyloid light chain ("AL") amyloidosis. Caelum has entered into an agreement with Columbia University to secure exclusive worldwide license rights to CAEL-101, a chimeric fibril-reactive monoclonal antibody (mAb) currently being evaluated in a Phase Ia/Ib study. In addition, Fortress announced the appointment of Michael Spector as Caelum’s CEO.

 

Sobi Canada, a subsidiary of Swedish Orphan Biovitrum AB, announced that Health Canada has approved Orfadin (nitisinone) capsules for the treatment of hereditary tyrosinaemia type-1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. HT-1 is a rare genetic disease that affects infants and children. It is progressive and may result in liver, brain and kidney complications and can be fatal if untreated.

 

Catabasis Pharmaceuticals announced the publication of preclinical data on the edasalonexent program, a potential disease-modifying therapy for Duchenne muscular dystrophy (DMD). The preclinical data demonstrate that edasalonexent (CAT-1004) and an analog, CAT-1041, oral inhibitors of NF-kB, are effective in ameliorating the dystrophic process in two animal models of DMD in an article titled "Disease Modifying Effects of Orally Bioavailable NF-kB Inhibitors in Dystrophin-Deficient Muscle" in JCI Insight (JCI Insight 2016 Dec 22;1(21):e90341).

 

Ironwood Pharmaceuticals announced the FDA accepted for review a NDA for DUZALLO (fixed-dose combination of lesinurad and allopurinol) for the treatment of hyperuricemia in patients with uncontrolled gout. The PDUFA target action date is expected to occur in the second half of 2017 and, if approved, DUZALLO is expected to be commercially available in late 2017.

 

OncoMed Pharmaceuticals announced dosing of the first patient in a Phase Ib clinical trial of anti-DLL4/VEGF bispecific antibody (OMP-305B83) plus chemotherapy in patients with second-line metastatic colorectal cancer.

 

Sun Pharma announced successful Phase III confirmatory clinical trial results for Seciera (cyclosporine A, 0.09% ophthalmic solution), for the treatment of dry eye disease. Seciera is a patented, novel, proprietary nanomicellar formulation of cyclosporine A 0.09%. It is a clear, preservative-free, aqueous solution. Seciera is being developed by Ocular Technologies, a company recently acquired by Sun Pharma. Following this acquisition, Sun Pharma owns exclusive, worldwide rights to Seciera and is developing it to commercialize for global markets including US, Europe, and Japan, as well as several emerging markets.

 

AmpliPhi Biosciences announced that Peter-John Wormald, MD, Professor of Otolaryngology Head & Neck Surgery at the University of Adelaide, commented on the favorable results from the Phase I trial of AmpliPhi’s AB-SA01 in patients with chronic rhinosinusitis (CRS). On December 19, 2016, AmpliPhi Biosciences announced that AB-SA01, its proprietary investigational bacteriophage cocktail targeting Staphylococcus aureus (S. aureus) infections, met the Phase I trial’s primary endpoints of safety and tolerability in patients who had failed standard of care treatment, including previous sinus surgery. Additionally, all nine patients enrolled in the study experienced a reduction in the quantity of S. aureus infecting their sinuses, with some patients showing complete eradication of the bacterial infection.

 

CytRx announced that, in response to a request from the company, the FDA has agreed to a Type B pre-NDA meeting at which the company will seek input on its planned NDA for aldoxorubicin as a new second-line treatment for patients with soft tissue sarcomas (STS).  Assuming a positive outcome from this pre-NDA meeting, CytRx expects to submit an NDA for aldoxorubicin to the FDA in the last quarter of 2017, and, subject to FDA approval, bring aldoxorubicin to market next year.

 

Aptuit and Chiesi Farmaceutici (Chiesi) announced that they have entered an agreement under which Aptuit will conduct an integrated Discovery Project aimed at providing innovative drugs to treat Idiopathic Pulmonary Fibrosis.

 

M Pharmaceutical announced that the company has executed on a Letter of Intent to acquire the assets of Cincinnati based private research and development partnership 40J’s LLC (and related companies & technologies).  In return for approximately 80 million shares and $1.5 million in cash to be issued or paid over the next two years, together with certain milestone payments, the Company will acquire 100% of the worldwide rights to these products and technologies. The transaction is subject to due diligence, exchange approval and other normal closing requirements for transactions of this nature.

 

Affimed and The University of Texas MD Anderson Cancer Center announced an exclusive strategic clinical development and commercialization collaboration to evaluate Affimed’s TandAb technology in combination with MD Anderson’s natural killer cell (NK) product.

 

Paragonix Technologies announced entering into a supply agreement with Sanbor Medical for the manufacture and assembly of SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System.

 

PixarBio announced a response to InVivo Therapeutics press release dated January 3, 2017. The press release claims that, “InVivo has an exclusive license in the field of spinal cord injury to all patents and patent applications in prosecution covering the Neuro-Spinal Scaffold. Frank Reynolds is not an inventor on any of these patents or patent applications, so no assignment is required and none was requested.”

 

Knopp Biosciences announced it has received United States Patent No. 9,468,630 entitled “Compositions and Methods for Treating Conditions Related to Increased Eosinophils.” The patent relates to the company’s clinical-stage small molecule dexpramipexole, which Knopp expects to advance into pivotal trials in hypereosinophilic syndromes (HES) and Phase II trials in eosinophilic asthma in 2017. U.S. Patent No. 9,468,630 specifically claims methods of treating HES and asthma by administering therapeutically effective amounts of dexpramipexole. Issued claims are also directed to methods of treating nasal polyposis, eosinophilic gastroenteritis, eosinophilic esophagitis, and atopic dermatitis, by administering therapeutically effective amounts of dexpramipexole. Eosinophils are white blood cells associated with inflammation.

 

Cambrex announced the hiring of Tom Vadaketh as Executive Vice President and Chief Financial Officer, effective January 20, 2017.  Greg Sargen, CFO at Cambrex, will transition to a newly-created role, Executive Vice President, Corporate Development and Strategy.  In his new role, Mr. Sargen will assume responsibility for Corporate Development and Strategy and will continue to report directly to Steven M. Klosk, President and Chief Executive Officer.

 

Alnylam Pharmaceuticals announced that David-Alexandre "DA" Gros, M.D., Senior Vice President and Chief Business Officer, plans to leave the company for personal reasons. His resignation will be effective January 6, 2017, and the company will initiate a search for his replacement. Additionally, the Company announced the promotion of Pushkal Garg, M.D., Senior Vice President, Clinical Development, to the role of Chief Medical Officer, reporting to Akshay Vaishnaw, Executive Vice President of R&D.

 

Avadel Pharmaceuticals announced the addition of Gregory J. Divis as Executive Vice President and Chief Commercial Officer, a newly created role at the Company. Mr. Divis brings more than 25 years of experience in the pharmaceutical industry to the role and will be responsible for managing commercial strategy and execution across all of the Company’s portfolio products.

 

Adamas Pharmaceuticals announced the completion of a Phase I clinical trial of ADS-4101, an investigational drug in development for the treatment of partial onset seizures in patients with epilepsy. Derived from the Company’s development platform, ADS-4101 is chrono-synchronous lacosamide, an anti-epilepsy active ingredient previously approved by the FDA and currently marketed as VIMPAT (lacosamide).

 

Cellectis announced the submission of an IND application to the FDA requesting approval to initiate Phase I clinical trials of UCART123 the Company’s most advanced, wholly owned TALEN gene edited product candidate in patients with acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN). Pending regulatory clearance, Cellectis plans to initiate Phase I clinical trials in the first half of 2017. This is the first IND filing for human clinical applications of a gene edited allogeneic “off-the-shelf” product candidate in the U.S.

 

Bayer announced that the FDA has granted priority review status for the sNDA for Stivarga (regorafenib) tablets for the second-line systemic treatment of patients with hepatocellular carcinoma (HCC) in the U.S.

 

Ritter Pharmaceuticals announced that clinical microbiome data from its Phase IIa clinical trial of RP-G28 in patients with lactose intolerance were published in the Proceedings of the National Academy of Science ("PNAS-Plus") PNAS 2017; Early Edition, published ahead of print January 3, 2017.

 

Clovis Oncology announced the pricing of an underwritten public offering of 5,000,000 shares of its common stock at $41.00 per share, before underwriting discounts and commissions. The size of the offering was upsized from $175 million to $205 million. In addition, the underwriters have a 30-day option to purchase up to an additional 750,000 shares of common stock from Clovis Oncology on the same terms and conditions. The offering is expected to close on January 9, 2017, subject to customary closing conditions. 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.

 

 

ANALYST RECOMMENDATIONS

 

HC Wainwright analyst Ed Arce increased his price target of CymaBay Therapeutics to $2.50 from $1.50, citing CymaBay announced that, on December 30, it licensed U.S. rights to arhalofenate to Kowa Pharmaceuticals, a privately-held company based in Japan.

 

JP Morgan analyst Cory Kasimov initiated coverage of Global Blood Therapeutics with an “overweight” rating and $25 price target, citing lead candidate, GBT440, is an oral drug that has disease-modifying potential in sickle cell disease; if successful, it would be the first new sickle cell disease therapy approved in 2 decades.

 

Barclays analyst Jack Meehan revised his ratings and price targets of the following companies: Agilent upgraded to “overweight” from “equal-weight” and increased to $51 from $48; Bruker downgraded to “equal-weight” from “overweight” and decreased to $22 from $30; Genomic Health increased to $27 from $25; Hologic increased to $47 from $45; Illumina decreased to $135 from $142; Myriad Genetics decreased to $18 from $22; Qiagen increased to $31 from $30; Quest Diagnostics increased to $92 from $85; Thermo Fisher decreased to $170 from $175; Waters decreased to $148 from $153.

 

Roth analyst Mark Breidenbach initiated coverage of Kite Pharma with a “buy” rating and $68 price target, citing Kite’s pipeline offers optionality and several early stage programs could provide considerable upside.

 

Leerink analyst Paul Matteis initiated coverage of Achaogen with an “outperform” rating and $21 price target, citing Achaogen is a clinical-stage biopharmaceutical company developing lead product plazomicin, a novel aminoglycoside antibiotic for which positive Phase III data were recently generated in complicated urinary tract infection (cUTI) and carbapenem-resistant enterobacteriaceae.

 

Evercore analyst Ross Muken revised his ratings and price targets of the following companies: Charles River upgraded to “buy” from “hold;” Agilent increased to $51.50 from $51.00; Bruker increased to $23.50 from $23; Hologic downgraded to “hold” from “buy;” Intuitive Surgical downgraded to “hold” from “buy;” Parexel downgraded to “hold” from “buy;” Illumina decreased to $139 from $143; Qiagen increased to $29.50 from $28.

 

Rodman & Renshaw analyst Raghuram Selvaraju initiated coverage of Ritter Pharmaceuticals with a “buy” rating and $7, citing Ritter Pharmaceuticals is engaging the gut microbiome to combat lactose intolerance.

 

Cowen analyst Doug Schenkel revised his rating and price targets of the following companies: Agilent downgraded to “market perform” from “outperform;” Genomic Health downgraded to “market perform” from “outperform” and decreased his price target to $34 from $35.

 

Piper Jaffray analyst David Amsellem decreased his price target of Valeant to $11 from $16, citing prescription trends in VRX’s U.S. business remain challenging.

 

Janney analyst Ken Trbovich initiated coverage of AMAG Pharmaceuticals with a “buy” rating and $45 fair value estimate in anticipation of positive results from studies of Makena SQ in 1Q17.

 

Following Inotek’s announcement that MATrX-3, the company’s Phase 3 study of trabodenoson in glaucoma, failed, HC Wainwright analyst Corey Davis decreased his price target to $7 from $22; Roth analyst Sa’ar Yaniv decreased his price target to $3 from $10.