BioShares Biotechnology Clinical Trials (BBC): $19.96, +$0.03
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U.S. stock index futures were little changed, a day after the Dow hit a record high. Durable goods and international trade balance data are on the economic calendar. European shares extended gains, with the utilities sector leading the market higher and Asian stocks strengthened. The dollar held steady against a basket of currencies, while the euro was slightly lower against the greenback. Expectations of an increase in U.S. interest rates this month hurt gold prices. Oil prices slipped on oversupply concerns.
AzurRx BioPharma announced that it has reached an agreement in principle with TransChem, Inc. to license TransChem’s proprietary transition state chemistry technology for MTAN inhibition. MTAN plays a key role in bacterial quorum sensing. Specifically, MTAN (methylthioadenosine/S-adenosylhomocysteine nucleosidase) disrupts the synthesis of autoinducers essential for bacterial quorum sensing. The absence of nucleosidase in mammals suggests that MTAN is likely to be an attractive target for antimicrobial design. While the proposed TransChem license is intended to cover a range of compounds and bacterial species specific targets, at this time, the Company’s initial focus for research and development is H. Pylori and its ability to form biofilms.
CymaBay Therapeutics announced that the World Health Organization (WHO) has recommended seladelpar as the designated international nonproprietary name for MBX-8025.
Onconova Therapeutics and Cellworks announced the presentation of their collaborative effort to identify higher-risk MDS (HR-MDS) patients that are likely to respond to rigosertib at the 2016 ASH Annual Meeting in San Diego California, taking place December 3-6, 2016. The presentation by Dr. Guillermo Garcia-Manero from the MD Anderson Cancer Center, lead investigator from the ONTME trial, used Cellworks’ proprietary bio-simulation platform to retrospectively correlate clinical benefit to IV rigosertib treatment in the Phase 3 ONTIME study in HR-MDS patients with molecular and cytogenetic data. This computer simulation led to the characterization of certain biological pathways that predict response to IV rigosertib in HR-MDS patients. Notably, patients with these predictive biological pathways also shared common cytogenetic abnormalities – trisomy of chromosomes 8 and 21 – that correlated with positive clinical outcome in ONTIME.
Mateon Therapeutics announced the poster presentation of data from its on-going phase 1b OX1222 study of OXi4503 in combination with cytarabine in patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS). OXi4503 is one of Mateon’s two VDAs currently in clinical development. OX1222 is a dose-ranging study of OXi4503 combined with cytarabine in relapsed/refractory AML and MDS. The poster presented at the 58th Annual Meeting of the American Society of Hematology (ASH) describes results from the initial two cohorts of OX1222, which represent the lowest doses of OXi4503 in the study.
VBI Vaccines announced that it has raised $23.6 million in concurrent equity and debt financing transactions with Perceptive Advisors. Under the terms of the equity financing, VBI sold an aggregate of 3,475,000 of its common shares at a price of $3.05 per share in a private placement to Perceptive Advisors, for total gross proceeds of approximately $10.6 million. Additionally, Perceptive Advisors increased its current credit agreement with VBI by funding an additional $13 million in secured debt. In conjunction with the additional debt funding, VBI issued a warrant to Perceptive Advisors for the purchase of an aggregate of 1,341,282 common shares at an exercise price of $3.36 per share.
BrainStorm Cell Therapeutics will hold a conference call on December 19 at 8:30 am Eastern Time. Mr. Chaim Lebovits, BrainStorm’s President and Chief Executive Officer, will provide an update to shareholders to discuss ongoing progress with NurOwn® in the treatment of amyotropic lateral sclerosis (ALS). Mr. Lebovits will lay out plans for 2017, including a discussion on a planned registration trial as well as a new pathway that may potentially provide patients with access to NurOwn.
TiGenix NV announced that it intends to offer and sell, subject to market and other conditions, 2.75 million American Depositary Shares ("ADSs") representing 55 million ordinary shares in an initial public offering in the United States (the "Offering"). In connection with the Offering, TiGenix intends to grant the underwriters a 30-day option to purchase additional ordinary shares in the form of ADSs, provided that the number of such additional ADSs shall not exceed 15% of the ADSs sold in the Offering. Each of the ADSs offered represents the right to receive twenty (20) ordinary shares.
Heat Biologics reported topline response and survival results in the ongoing Phase Ib study evaluating HS-110, in combination with Bristol-Myers Squibb‘s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo), for the treatment of non-small cell lung cancer (NSCLC), at the International Association for the Study of Lung Cancer Annual Meeting in Vienna, Austria.
TherapeuticsMD announced positive top-line results from its pivotal Phase III Replenish Trial of TX-001HR, an investigational bio-identical hormone therapy combination of 17ß-estradiol and progesterone in a single, oral softgel, for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause in post-menopausal women with an intact uterus. Following the news, Stifel analyst Annabel Samimy increased her price target to $17 from $14; Goldman analyst Jami Rubin increased her price target to $13 from $10.50.
Sage Therapeutics announced its expedited development plan for SAGE-547 following receipt of formal meeting minutes from a breakthrough therapy meeting with the FDA. This program is intended to support a potential filing for approval in the treatment of postpartum depression (PPD).
Omeros announced that, following physician request, it will provide continued supply of OMS721 for a pediatric patient with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) who is currently receiving the drug under the company’s compassionate use program. The patient’s treating physician requested extended access to OMS721 for his 15 year-old patient given her positive results with OMS721 treatment, including discontinuation of dialysis. HSCT-TMA most commonly affects the kidneys but can also damage the lungs, gastrointestinal tract and central nervous system, and severe cases often require dialysis and carry a mortality rate in excess of 90 percent. OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2). In addition to its Phase II clinical program in TMA, OMS721 is currently in a Phase III program for patients suffering from atypical hemolytic uremic syndrome and in a Phase II program for renal diseases, including immunoglobulin A (IgA) nephropathy and membranous nephropathy.
A new analysis shows people with cancer treated with XARELTO (rivaroxaban) for blood clots had significantly fewer emergency room (ER) visits and lower healthcare costs at initiation of therapy than those given standard treatment. The analysis presented by Janssen Pharmaceuticals and its development partner, Bayer, at the 2016 American Society of Hematology (ASH) Annual Meeting examines the use of XARELTO in cancer-associated thrombosis, an area of critical unmet need. Also presented were economic research and real-world evidence confirming the overall safety and efficacy profile of XARELTO in this patient group.
Merck announced updated findings evaluating KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, in two trials of patients with relapsed or refractory classical Hodgkin lymphoma (cHL). In the KEYNOTE-087 and KEYNOTE-013 trials, KEYTRUDA demonstrated overall response rates (ORR) of 69.0 percent and 58 percent, respectively. KEYNOTE-013, which had a median follow up of 29 months, showed responses of 12 months or greater in 70 percent of patients who responded to therapy. These findings will be presented at the 58(th) Annual Meeting of the American Society of Hematology (ASH). Additionally, data from these trials supported the recently announced regulatory filing with the FDA.
Merck announced that updated findings from the Phase Ib KEYNOTE-028 study investigating the use of KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, in previously treated patients with advanced small cell lung cancer (SCLC) and malignant pleural mesothelioma, showed clinical activity and durable responses in some patients. These data were featured in oral presentations at the 17th World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer.
Bristol-Myers Squibb announced updated results for Opdivo monotherapy (3 mg/kg every two weeks [n=98]) and in combination with Yervoy (Opdivo 1 mg/kg plus Yervoy 3 mg/kg every three weeks [n=61]) in previously treated small cell lung cancer (SCLC) patients, a cohort of the Phase I/II open-label CheckMate -032 trial. The confirmed objective response rate (primary objective) was 25% (95% CI: 15, 37) in patients who received Opdivo plus Yervoy and was 11% (95% CI: 6, 19) with Opdivo alone with additional follow-up. Response was observed regardless of platinum sensitivity or prior lines of therapy. With the combination, three patients experienced a complete response. The estimated two-year overall survival rate (secondary objective) was 30% with Opdivo plus Yervoy and was 17% with Opdivo alone. In this updated analysis, no new safety signals were observed. Grade 3/4 treatment-related discontinuation rates were 10% in the Opdivo plus Yervoy group and 4% in the Opdivo group.
Novartis announced results from its Phase III open-label, randomized, active-controlled, multi-center ASCEND-4 study, which found that patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) treated with first-line Zykadia (ceritinib) had a median progression-free survival (PFS) of 16.6 months (95% confidence interval [CI]: 12.6, 27.2), compared to 8.1 months (95% CI: 5.8, 11.1) in patients treated with standard first-line chemotherapy with maintenance. This equated to a 45% reduction in the risk of disease progression (hazard ratio
= 0.55, P<0.001)1. Results were presented during the Presidential Symposium at the 17th World Conference on Lung Cancer (WCLC), hosted by the International Association for the Study of Lung Cancer (IASLC), in Vienna. These late-breaking results were also featured in an official conference press briefing.
AstraZeneca presented data from the AURA3 trial that is supportive of TAGRISSO (osimertinib) potentially becoming the new standard of care for second-line treatment of patients with epidermal growth factor receptor (EGFR) T790M mutation-positive metastatic non-small cell lung cancer (NSCLC). The first randomized Phase III data showed that TAGRISSO second-line therapy improved progression-free survival (PFS) by 5.7 months compared with standard platinum-based doublet chemotherapy. The results were presented at the 17th World Conference on Lung Cancer (WCLC) in Vienna, Austria, hosted by the International Association for the Study of Lung Cancer, and published simultaneously online in The New England Journal of Medicine.
Pluristem Therapeutics announced a milestone in its development program for PLX-R18, which is being evaluated as a medical countermeasure in the treatment of the hematologic components of Acute Radiation Syndrome (ARS) by the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH). ARS is caused by exposure to very high levels of radiation, such as could occur in a nuclear catastrophe. The syndrome can cause severe illness or death. The FDA previously advised Pluristem to conduct a pilot study in large animals to determine the optimal dosage of PLX-R18 as a treatment for the component of ARS that affects bone marrow function. The NIAID has now completed the dosing of the first cohort and is preparing to initiate dosing of the second and final cohort. Data from the completed study are expected in the first half of 2017. Based on these data the optimal treatment dose will be chosen for a pivotal large animal study designed to meet the requirements for a BLA submission under the FDA’s Animal Rule regulatory pathway.
AcelRx Pharmaceuticals held an Analyst & Investor Event on December 1, 2016 during which members of AcelRx management and key opinion leaders reviewed market expectations and commercial plans for ARX-04 (sufentanil sublingual tablet, 30 mcg) as well as the current landscape for opioid treatment in the emergency medicine setting. During this event, AcelRx provided an updated U.S. commercial peak sales expectation for ARX-04 of $1.1 billion.
Karyopharm Therapeutics announced updated results from the Phase Ib dose-escalation portion of its ongoing STOMP study showing high response rates when selinexor (KPT-330) is combined with the proteasome inhibitor bortezomib (Velcade), including in patients with multiple myeloma (MM) that was previously refractory to proteasome inhibitors, at the ASH 2016 annual meeting held December 3-6, 2016 in San Diego. Other key presentations at the meeting described clinical data demonstrating the activity of selinexor in combination with carfilzomib (Kyprolis) and pomalidomide (Pomalyst) in MM, as well as selinexor with dexamethasone in quad- and penta-refractory MM in the STORM trial. Selinexor is the Company’s lead, novel, oral Selective Inhibitor of Nuclear Export (SINE) compound, in development for the treatment of a variety of malignancies, including MM and acute myeloid leukemia (AML).
Kadmon Holdings announced that it has submitted an ANDA for KD034, to the FDA. This is the first application submitted to the FDA by any company for a generic trientine hydrochloride product for the treatment of Wilson’s disease in patients who are intolerant of penicillamine.
Lexicon Pharmaceuticals announced top-line results from a Phase II clinical study of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, conducted by Lexicon in collaboration with JDRF, the leading global organization funding Type I diabetes research. The purpose of this Phase II clinical trial, which randomized a total of 87 patients, was to assess the effects of a once-daily 400 mg dose of sotagliflozin compared to a placebo control in insulin-treated young adults with Type I diabetes, aged 18-30 years, and particularly high baseline A1C levels of greater than or equal to 9.0%, representative of an at-risk population in which glycemic control and adherence to therapy are substantial challenges. The study promoted adherence and encouraged insulin adjustment as needed to achieve glucose control targets.
Bellicum Pharmaceuticals presented a review of results to date from its multicenter BP-004 clinical trial of BPX-501 in the pediatric setting, and provided an update on the regulatory pathway for product registration in Europe at an investor and analyst event held today. Clinical results on BPX-501 in children with hematological malignancies were also presented in a poster presentation at the ASH annual meeting.
Reuters reported that Sanofi is considering a bid for Actelion, rivaling an offer made by Johnson & Johnson, Bloomberg reported, citing people familiar with the matter. J&J said last month it was in preliminary talks with Actelion about a potential takeover of Europe’s largest biotech firm, which was then valued at about $20 billion.
Neurocrine Biosciences announced that two abstracts representing additional data from several clinical trials of the investigational drug INGREZZA (valbenazine) were being presented at the Annual Meeting of the American College of Neuropsychopharmacology in Hollywood, Florida. The posters include an evaluation of the safety and effectiveness of long-term dosing of INGREZZA in the treatment of tardive dyskinesia.
Acasti Pharma announced that it has received a receipt for a preliminary short form prospectus in connection with a proposed offering of units of Acasti for minimum gross proceeds of CAD$6,500,000 and maximum gross proceeds of CAD$10,000,000. The Offering will be conducted on a "commercially reasonable best efforts" basis through an agency syndicate led by Echelon Wealth Partners.
Acceleron Pharma and Celgene announced Phase II results from an open-label three-month base study and the ongoing long-term safety extension study with luspatercept in patients with beta-thalassemia during an oral presentation at the 58(th) Annual Meeting of the American Society of Hematology (ASH) in San Diego, California. Luspatercept is being developed as part of the global collaboration between Acceleron and Celgene.
Sunesis Pharmaceuticals announced the presentation of updated results from the VALOR trial examining overall survival in patients age 60 years and older with relapsed/refractory AML.
Seattle Genetics and Bristol-Myers Squibb highlighted the first reported data from an ongoing Phase I/II clinical trial evaluating ADCETRIS (brentuximab vedotin) in combination with Opdivo (nivolumab) in relapsed or refractory classical Hodgkin lymphoma (HL) at the 58(th) ASH Annual Meeting and Exposition. The data reported from 42 patients, including 29 evaluable for response, were featured in an oral presentation and selected to be included in the 2017 Highlights of ASH post-meeting program.
Celgene announced results from an analysis of three Phase I/II studies evaluating CC-486 in patients with myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute myeloid leukemia (AML) who had received prior hypomethylating agents (HMA) were presented at the 58(th) ASH Annual Meeting in San Diego, Calif.
Agios Pharmaceuticals presented new clinical data from the ongoing Phase I study evaluating single agent AG-120 in advanced hematologic malignancies at the 2016 ASH Annual Meeting and Exposition. AG-120 is a first-in-class, oral, selective, potent inhibitor of mutant isocitrate dehydrogenase-1 (IDH1).
Janssen Research & Development announced new data from two post-hoc analyses of the pivotal Phase III POLLUX and CASTOR clinical studies, demonstrating that daratumumab (DARZALEX) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, significantly improved progression-free survival (PFS) and overall response rates (ORRs) for previously-treated patients with multiple myeloma, regardless of prior treatment exposure or cytogenetic risk. Data from the CASTOR study will be featured in an oral presentation at the 58(th) ASH Annual Meeting.
Actinium Pharmaceuticals announced that results from its Phase I trial of Actimab-A were presented at the 58(th) ASH Annual Meeting that is currently ongoing in San Diego, CA. Data from the previously conducted Phase I study pertaining to safety, efficacy and PB burden were highlighted during the poster session.
AbbVie announced efficacy and safety findings from a Phase II study demonstrating that nearly half (48%) of patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) had a complete or partial response with single-agent ibrutinib (IMBRUVICA), as assessed by Independent Review Committee (IRC) investigators. The median duration of response was not reached. These data will be presented in an oral presentation at the 58(th) ASH Annual Meeting and Exposition.
Celyad presented new data from the Phase I trial of NKR-2 in patients with acute myeloid leukemia (AML) and multiple myeloma (MM) at the 2016 ASH Annual Meeting. NKR-2 is a CAR-T product candidate using NKG2D, an NK Cell activating receptor transduced on T lymphocytes.
Teva Pharmaceutical announced that it has received a positive outcome through the variation procedure to remove the pregnancy contraindication from the European label for COPAXONE (glatiramer acetate injection) 20 mg/mL. The product was originally authorized through a decentralized procedure in Europe. The removal of the pregnancy contraindication follows a Positive Variation Assessment Report issued by the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA; Reference Member State), and agreed by all Concerned Member States (CMS) in Europe, that were involved in the procedure.
Revive Therapeutics announced positive final study results of REV-003 (Tianeptine) from its research collaboration with Rettsyndrome.org for the potential treatment of Rett syndrome.
Auris Medical Holding confirmed that the TACTT3 Phase III trial with Keyzilen (AM-101) will resume enrollment in early 2017 as per previous guidance. This announcement follows receipt of key approvals from regulatory agencies and ethics committees in Europe on the recently submitted TACTT3 protocol amendment.
Bio-Path Holdings announced that a review of BP1001 data as a treatment for chronic myelogenous leukemia (CML) was presented in a poster at the 58(th) Annual American Society of Hematology (ASH) Annual Meeting taking place from December 3-6, 2016 in San Diego, CA.
Immunomedics announced that IMMU-140, the Company’s latest investigational product from its award-winning antibody-drug conjugate (ADC) program, demonstrated a significant antitumor effect without any undue toxicity in four hematopoietic tumors in preclinical studies.
TG Therapeutics announced that the target enrollment of 120 patients in the GENUINE Phase III study has been met and enrollment will be closed shortly. The GENUINE Phase III study is a randomized study of TG-1101, the Company’s novel, glycoengineered anti-CD20 monoclonal antibody in combination with ibrutinib, the oral Bruton’s tyrosine kinase (BTK), versus ibrutinib alone in approximately 120 patients with high-risk relapsed or refractory Chronic Lymphocytic Leukemia (CLL). In October, the study was modified to convert the primary endpoint solely to Overall Response Rate (ORR). If the study results are positive, and subject to a positive outcome of pre-BLA meeting with the FDA, the Company plans to utilize the results to file for accelerated approval. The Company expects to release top-line data from the GENUINE Phase III study in the first half of 2017.
Spectrum Pharmaceuticals announced the presentation of data from a case match control analysis of the PROPEL Study in a poster presentation session at the 58th American Society of Hematology (ASH).
Endo International announced that one of its operating companies, Par Pharmaceutical, has begun shipping mycophenolate mofetil hydrochloride (HCl) for injection following final approval from the FDA for its ANDA. Par’s mycophenolate mofetil hydrochloride (HCl) for injection is the generic version of Roche‘s CellCept and is the first and currently the only generic injectable available.
TG Therapeutics announced the presentation of data from three combination studies involving the Company’s lead compounds, TGR-1202, the Company’s once-daily PI3K delta inhibitor, and TG-1101 (ublituximab), the Company’s novel glycoengineered anti-CD20 monoclonal antibody at the 58(th) American Society of Hematology (ASH) Annual Meeting, in San Diego, California.
ARIAD Pharmaceuticals announced the results of clinical and translational studies on Iclusig (ponatinib), its approved BCR-ABL inhibitor, in heavily pretreated patients with resistant or intolerant chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). These data were featured in an oral and two poster presentations at the 57th Annual Meeting of the American Society of Hematology (ASH) taking place in San Diego.
Inovio Pharmaceuticals announced that the International Vaccine Institute (IVI) will provide new funding and support to further advance GLS-5300, Inovio’s vaccine to prevent Middle East Respiratory Syndrome (MERS) virus infection. Inovio is co-developing this vaccine with GeneOne Life Science. IVI will add technical, laboratory and financial support for GLS-5300 clinical trials in Korea.
XBiotech announced that enrollment has been completed in its randomized, placebo-controlled Phase I/II study evaluating dosing, safety and efficacy of the Company’s novel antibody therapy, 514G3. This proprietary antibody therapy has received Fast Track Designation by the FDA for the treatment of all forms of Staphylococcus aureus infections, including Methicillin-resistant S. aureus (MRSA). The Company reports that top-line findings from the 514G3 study should be reported in first quarter 2017.
Theravance Biopharma announced that the FDA has granted Fast Track designation to velusetrag (TD-5108) for the treatment of symptoms associated with idiopathic and diabetic gastroparesis. Velusetrag is an oral investigational drug in development for the treatment of patients with gastroparesis, and is currently being studied in a large, multinational Phase IIb study in patients with confirmed gastroparesis of either diabetic or idiopathic origin.
Helix BioPharma announced that it presented topline data from its Phase I/II dose escalation study of immunoconjugate L-DOS47 as a monotherapy in non-squamous non-small cell lung cancer patients at the 17(th) IASCLC World Conference on Lung Cancer ("WCLC") held in Vienna, Austria.
Cellectar Biosciences announced that it presented a poster at the 58(th) Annual Meeting of the American Society of Hematology in San Diego, which provides highlights of the company’s ongoing Phase I dose escalation clinical study of CLR 131 to assess safety and tolerability of the compound in patients with relapsed or refractory multiple myeloma. The poster provided detailed data related to the first two study cohorts.
Kadmon Holdings announced encouraging data from its ongoing Phase II clinical study of tesevatinib, the Company’s blood-brain barrier penetrant oral tyrosine kinase inhibitor, for the treatment of epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) that has metastasized to the brain and/or the leptomeninges (membranes lining the brain and spinal cord). The data were presented in a poster session at the International Association for the Study of Lung Cancer 17th World Conference on Lung Cancer in Vienna, Austria.
Calithera Biosciences announced that clinical data from its lead product candidate CB-839, a first-in-class glutaminase inhibitor, will be presented at the 2016 San Antonio Breast Cancer Symposium, December 6-10, 2016 in San Antonio, Texas. The data demonstrate the clinical activity, tolerability and unique mechanism of action of CB-839 in patients with advanced/metastatic triple negative breast cancer (TNBC).
Mast Therapeutics reported that the first patient has been enrolled in an investigator-sponsored Phase II study of the Company’s lead product candidate, AIR001, for the treatment of heart failure with preserved ejection fraction (HFpEF). The Inorganic Nitrite to Amplify the Benefits and Tolerability of Exercise Training (INABLE-TRAINING) in HFpEF study will evaluate AIR001′s potential to improve the clinical responses to exercise training in individuals with HFpEF. The INABLE-TRAINING study is expected to enroll approximately 68 patients who will undergo 12 weeks of cardiac rehabilitation, including exercise training, and will be randomized to receive either AIR001 or placebo inhalation solution through the training period. The primary endpoint of the study will be the change in exercise capacity as measured by peak oxygen consumption.
Inogen announced that its Board of Directors has appointed Scott Wilkinson as Inogen’s President and Chief Executive Officer, effective March 1, 2017. Mr. Wilkinson will also join the Board of Directors on January 1, 2017. Mr. Wilkinson will succeed Raymond Huggenberger, who is retiring as Chief Executive Officer, effective March 1, 2017. Mr. Huggenberger will continue to serve on Inogen’s Board of Directors following his retirement as Chief Executive Officer.
Aduro Biotech announced that Hans van Eenennaam, Ph.D., chief operational officer and executive director of Aduro Biotech Europe, and John Dulos, Ph.D., principal scientist, will be honored tonight by the Intellectual Property Owners Education Foundation (IPOEF) as winners of the 43rd Inventor of the Year Award for their work relating to the discovery of KEYTRUDA (pembrolizumab). KEYTRUDA is marketed by Merck and is the first FDA-approved PD-1 inhibitor for the treatment of select cancers.
Affimed announced the presentation of preclinical data from three studies at the 58th American Society of Hematology (ASH) Annual Meeting and Exposition 2016 in San Diego, California.
Reata Pharmaceuticals announced that it has filed a registration statement on Form S-1 with the SEC for a proposed underwritten public offering of shares of its Class A common stock. This offering will be subject to the registration statement on Form S-1 becoming effective and subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed. Reata intends to use the net proceeds from the offering to advance the development of its lead product candidate, bardoxolone methyl, through a Phase II/III trial and additional Phase II programs, to advance the development of its additional lead product candidate omaveloxolone, and to provide funds for working capital and other general purposes, including clinical trials and preclinical studies.
InMed Pharmaceuticals, announced progress on its R&D program in the use of cannabinoids for the treatment of chronic obstructive pulmonary disease (COPD). In June, 2015 InMed initiated its COPD program using its bioinformatics analysis tool to identify the targets and potential active compounds that can be useful for the treatment of COPD. Subsequently, with in vitro assays using human lung fibroblasts (HFL-1 cell line), InMed has demonstrated that certain cannabinoid compounds are capable of affecting a specific protein in the biochemical pathway relevant to healing and fibrosis in the lung.
Egalet announced the USPTO has issued patent number 9,498,446 covering Egalet’s proprietary Guardian Technology abuse-deterrent products which contain a matrix and an exterior shell including Phase 3 product candidate, Egalet-002. The patent offers protection through February 2030 for Egalet-002 and other products developed with a shell using Guardian Technology.
Oncolytics Biotech announced that Dr. Kevin Kelly and colleagues made a poster presentation at the 58th American Society of Hematology ("ASH") Annual Meeting. The poster presentation, titled "Oncolytic Reovirus Immune Priming: A Phase Ib Study of REOLYSIN with Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma," provides initial findings from the Company’s REO 019 Phase Ib trial.
HC Wainwright analyst Carol Ann Werther initiated coverage of Medgenics with a “buy” rating and $14 price target, citing the likelihood of positive results with NFC-1 is high and based on three supportive trials.
Janney analyst Debjit Chattopadhyay assumed coverage of Clovis Oncology with a “neutral” rating and $34 fair value estimate, citing the excitement surrounding PARP inhibitors across multiple, large, commercially important, oncology indications including potential synergies with checkpoints has yet to play out conclusively.
Following Juno’s updated results from the JCAR017 NHL study as well as the recent clinical hold on JCAR015, Cowen analyst Chris Shibutani decreased his price target to $41 from $51; Raymond James analyst Reni Benjamin downgraded the stock to “market perform” from “outperform” and removed his price target.
Jefferies analyst Biren Amin reinstated Zynerba with a “buy” rating and $32 price target, citing ZYNE presented safety data from PI studies for ZYN002 CBD gel in healthy volunteers and patients with epilepsy.
RBC analyst Adnan Butt increased his price target of Seattle Genetics to $72 from $62 to reflect a rollover of the valuation year to 2017 and the inclusion of a greater probability of success for SGN33A along with some other adjustments.