BioShares Biotechnology Clinical Trials (BBC): $22.65, +$0.45, -22.0% YTD
BioShares Biotechnology Products (BBP): $33.36, +$0.61, +8.2% YTD
U.S. stock futures pointed to a near-flat start for Wall Street ahead of key economic releases, including construction spending, ISM’s purchasing managers’ index data and auto sales figures. Investors will gauge strength of the economy to assess the likelihood of a December interest rate hike. European shares rose, buoyed by shares of fund management companies in the wake of a large merger in the sector. Asian markets were mostly stronger as easing concerns over the health of Deutsche Bank, triggering a relief bounce in financial sector shares. The sterling slumped as Britain set a March deadline to begin exit proceedings from the European Union. Gold edged up while the dollar held steady. Oil rose to its highest since August, above $50 a barrel, supported by a planned production cut by OPEC.
TRACON Pharmaceuticals announced the successful completion of an End-of-Phase 2 meeting with the United States Food and Drug Administration and a Protocol Assistance Meeting with the European Medicines Agency. TRACON reached agreement with both regulatory agencies regarding key elements of the Phase 3 program for TRC105 in angiosarcoma and expects to initiate enrollment in the Phase 3 study by year-end.
Advaxis announced that Christopher Duke has joined the Company as Senior Vice President and Chief Operating Officer effective today. Duke, a biotech veteran with more than 20 years of life sciences experience, will lead operations at Advaxis with a focus on overseeing the company’s clinical development programs as well as managing early commercial planning activities.
Prothena Corporation announced today that Gene Kinney, PhD has been appointed President and Chief Executive Officer of Prothena. Dr. Kinney has also been appointed to Prothena`s Board of Directors. The appointments come following the passing of Prothena`s Co-founder, President and CEO, Dr. Dale B. Schenk on September 30, 2016.
Albireo Limited announced positive top-line results from a pivotal Phase 3 clinical trial of its product candidate, elobixibat, in chronic constipation conducted in Japan. In the trial, elobixibat met the primary endpoint, change in the number of weekly spontaneous bowel movements (SBMs) from baseline to the first treatment week compared with placebo, with high statistical significance. The SBM endpoint is the endpoint required to support regulatory approval to treat chronic constipation in Japan.
Dynavax Technologies received anticipated requests for information from the FDA review team in connection with the pending BLA for HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)]. The review team’s questions are in line with the company’s expectations.
Merrimack Pharmaceuticals announced a major corporate restructuring with the objective of prioritizing its research and development on a focused set of systems biology-derived oncology products and strengthening its financial runway. As part of this move, Merrimack is immediately implementing a 22% reduction in headcount and eliminating more than $200 million in expected costs over the next two years. In line with this restructuring, the Board of Directors has accepted the resignation of President and CEO Robert Mulroy, effective immediately. In order to accelerate this change, the Board of Directors has appointed Chairman of the Board Gary Crocker as interim President and CEO.
Alkermes announced the initiation of a clinical study designed to evaluate the metabolic profile of ALKS 3831, an investigational, novel, oral atypical antipsychotic drug candidate, compared to olanzapine, an established atypical antipsychotic agent with proven efficacy but also metabolic liabilities, including significant weight gain. The randomized, double-blind, parallel-group study will characterize metabolic parameters, including insulin sensitivity and lipid metabolism, in response to treatment with ALKS 3831 and olanzapine. This exploratory metabolic study in healthy subjects is a supportive study in the ENLIGHTEN pivotal program of ALKS 3831 for the treatment of schizophrenia. The two key Phase III studies, ENLIGHTEN-1 and ENLIGHTEN-2, have been enrolling patients since December 2015 and February 2016, respectively.
Aralez Pharmaceuticals announced the availability of once-daily YOSPRALA, the only prescription fixed-dose combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI), in the U.S. YOSPRALA is indicated for patients who require aspirin for secondary prevention of cardiovascular (CV) and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers.
CTI BioPharma announced that James A. Bianco, M.D, CTI BioPharma’s President and Chief Executive Officer, has retired from the Company effective on October 2. At the request of the Board of Directors, Richard Love, a director of CTI BioPharma since 2007, has been appointed to serve as interim President and Chief Executive Officer.
Ironwood Pharmaceuticals announced that ZURAMPIC (lesinurad) is now available in pharmacies throughout the United States. ZURAMPIC is approved as a once-daily oral tablet to be taken in combination with a xanthine oxidase inhibitor (XOI) for the treatment of hyperuricemia – high serum uric acid (sUA) levels in the blood – associated with gout in patients who have not achieved target sUA levels with an XOI alone. ZURAMPIC is not recommended for the treatment of asymptomatic hyperuricemia and should not be used as monotherapy.
Exosome Diagnostics has entered into an agreement with Amgen to evaluate the potential to advance drug development with Exosome’s proprietary liquid biopsy diagnostics technology and platform. Under the terms of the agreement, the companies will collaborate to identify a potential liquid biopsy diagnostic. Financial terms of the agreement were not disclosed.
Rosetta Genomics announced that the company has added two new patent allowances to its intellectual property portfolio for its microRNA platform technology. With these new allowances, Rosetta Genomics has 64 granted or allowed patents and 33 patents pending.
Checkpoint Therapeutics, a Fortress Biotech company, announced that the first patient has been dosed in a Phase I/II clinical study of CK-101, its novel, oral, third-generation epidermal growth factor receptor ("EGFR") inhibitor product candidate.
Spectral Medical announced the top line results of its Phase III pivotal trial which enrolled a total of 450 patients, including a pre specified population of 243 patients with a high multiple organ dysfunction score ("MODS") either treated with two Toraymyxin columns or given two shams (the per protocol group). While the trial did not, with this sample size, statistically achieve its primary end point target of absolute reduction in mortality at 28 days, it did demonstrate beneficial treatment effects across multiple end points. The trial clearly showed that mortality benefit significantly increased as a function of the amount of endotoxin removed, as measured by the EAA(TM) assay. In addition, cardiovascular function improved and the use of vasopressors decreased. Based on these outcomes, the Company intends to consult with its clinical and regulatory advisors and then meet with the FDA to discuss its regulatory pathway going forward.
Eisai and Arena Pharmaceuticals announced the availability of BELVIQ XR (lorcaserin HCl) CIV extended-release 20 mg tablets, a new once-daily dosing option that may help some patients achieve and maintain weight loss.
Reuters reported that Ampliphi Biosciences is offering 5.3 million shares of common stock and warrants to purchase 1.3 million shares of common stock.
Neptune Technologies & Bioressources and Aker BioMarine jointly announced that they have entered into a broad patent cross-licensing agreement, thus ending all outstanding litigation between both companies.
VIVUS and Metuchen Pharmaceuticals announced an agreement providing Metuchen a fully-paid, perpetual license for exclusive rights to commercialize STENDRA (avanafil) in the U.S., Canada, South America and India. The parties simultaneously signed a commercial supply agreement pursuant to which VIVUS will be responsible for the manufacture and supply of STENDRA to Metuchen for a mutually agreed term. For a period of 180 days, Metuchen has the option to assume the manufacturing and supply rights of STENDRA for its territories. Under the license agreement, VIVUS received $70 million. Additionally, Metuchen will be responsible for royalties due to Mitsubishi Tanabe Pharma Corporation based on net sales.
Jazz Pharmaceuticals announced the initiation of a rolling submission of a NDA to the FDA on September 30, 2016, seeking marketing approval of Vyxeos (cytarabine and daunorubicin liposome injection), an investigational agent for the treatment of acute myeloid leukemia (AML). The company expects to complete the submission of the NDA by early 2017, and will request a priority review.
Hemostemix announcesdthat two new patents have been granted in 2016 in the United States and Canada. The USPTO granted patent US 9,404,084 titled "Regulating Stem Cells". It is the fourth Hemostemix patent issued in the United States. The patent covers a method for generating therapeutic cell products, including the company’s lead product ACP-01 and cardiomyocyte -like precursor cells. These precursor cells – which is isolated from a simple blood collection – are generated from a core population of cells named "Synergetic Cell Population" (SCP). The Hemostemix technology enables proprietary cells, grown from a patient’s blood, to be injected into that same patient’s diseased tissue in order to restore its function.
Collegium Pharmaceutical announced the submission of a New Drug Submission (NDS) to Health Canada seeking marketing approval of Xtampza ER (oxycodone extended-release), an abuse-deterrent, extended-release opioid, for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Morphotek, a subsidiary of Eisai, announced that it signed an exclusive licensing agreement with Eurofarma Laboratórios S.A. (Eurofarma) to develop and commercialize farletuzumab (MORAb-003) in Latin America. In exchange, Morphotek will receive an upfront payment, scheduled development and sales milestone payments, and other fees. Additionally, Morphotek will receive royalties from commercial sales of farletuzumab in Latin America. Morphotek will supply Eurofarma with clinical and commercial materials at an agreed-upon transfer price; Eurofarma has the option to assume responsibility for filling and labeling farletuzumab vials. Morphotek retains all rights to develop and commercialize farletuzumab in regions outside of Latin America.
AVEO Oncology announced that a settlement hearing will be held on December 19, 2016 at 3:00 p.m., before the Honorable Denise J. Casper, United States Courthouse, Courtroom No. 11 of the John Joseph Moakley U.S. Courthouse, 1 Courthouse Way, Boston, Massachusetts 02210 in the matter of Karen J. van Ingen v. AVEO Pharmaceuticals, Inc., et al., Civil Action No. 1:14-cv-11672-DJC (D. Mass.).
Chiasma announced that Mark J. Fitzpatrick has been appointed President and Chief Executive Officer and a member of the company’s Board of Directors, effective October 1, 2016. Mr. Fitzpatrick currently serves as Chiasma’s Chief Financial Officer.
Janssen Research & Development announced findings from the first of three pivotal Phase III studies evaluating guselkumab, a subcutaneously administered anti-interleukin (IL)-23 monoclonal antibody in late-stage development for the treatment of adults with moderate to severe plaque psoriasis. Data from the VOYAGE 1 trial showed significantly higher proportions of patients receiving guselkumab achieved cleared/minimal disease compared with patients receiving placebo, as defined by at least a 90 percent improvement in the Psoriasis Area Severity Index (PASI 90, near complete skin clearance) and an Investigator’s Global Assessment (IGA) score of cleared (0) or minimal disease (1) at week 16, the study co-primary endpoints. The VOYAGE 1 trial also included an active comparator arm evaluating guselkumab versus Humira (adalimumab), and showed the superiority of guselkumab across major study endpoints and through 48 weeks of treatment. These data were presented for the first time at the 25(th) European Academy of Dermatology and Venereology (EADV) Congress and mark the first-ever results from a head-to-head study of an IL-23–targeted biologic therapy (guselkumab) compared with an anti-TNF-alpha treatment (adalimumab).
Sanofi and Regeneron Pharmaceuticals announce that detailed results from LIBERTY AD SOLO 1 and SOLO 2, two placebo-controlled Phase III studies evaluating investigational Dupixent (dupilumab) in adult patients with inadequately controlled moderate-to-severe atopic dermatitis (AD), were published in The New England Journal of Medicine (NEJM). The studies met their primary endpoints evaluating extent and severity of the disease. In addition, both trials met key secondary endpoints measuring reduction in itch, improvement in patient-reported anxiety and depression symptoms, and certain quality of life measures. Dupixent inhibits signaling of IL-4 and IL-13, two key cytokines required for the type 2 (including Th2) immune response, which is believed to be a major driver in AD and in certain atopic or allergic diseases, includingasthma andnasal polyposis, where Dupixent is being evaluated in ongoing clinical trials.
Novartis announced new data showing Cosentyx (secukinumab) delivers efficacy in patients with moderate to severe plaque psoriasis out to four years of treatment. These late-breaking data come from the extension study of the Phase III SCULPTURE trial. Results were presented for the first time at the 25(th) European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria.
Eisai announces the initiation of a multicentre, global, randomised Phase III study that will evaluate the efficacy and safety of lenvatinib in combination with anti-PD-1 immunotherapy pembrolizumab and lenvatinib in combination with everolimus versus sunitinib in patients with advanced renal cell carcinoma (RCC) in a first-line setting. Pembrolizumab is marketed under the brand name Keytruda by Merck, Sharp & Dohme in the EU.
UCB and Dermira announced topline results from CIMPASI-2, a Phase III, multi-center, placebo-controlled clinical trial evaluating the efficacy and safety of CIMZIA (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis. In the CIMPASI-2 trial, CIMZIA demonstrated statistically significant improvements for both co-primary endpoints compared to placebo at both treatment doses. The CIMPASI-2 trial results are from the first of three Phase III clinical trials to be reported evaluating CIMZIA in this patient population.
Allergan announced that it has entered into a licensing agreement with MedImmune, AstraZeneca’s global biologics research and development arm, for the global rights to MEDI2070. MEDI2070 is an anti-IL-23 monoclonal antibody currently in Phase IIb clinical development for the treatment of patients with moderate-to-severe Crohn’s disease and is Phase II ready for ulcerative colitis and other related conditions. Under the terms of the agreement, Allergan will make an upfront payment to AstraZeneca of $250 million for the exclusive, worldwide license to develop and commercialize MEDI2070. In addition, Allergan may make potential payments to AstraZeneca of up to $1.27 billion, payable over a period of up to 15 years, including launch milestone payments of up to $435 million and sales-based milestone payments of $725 million, as well as tiered royalties on sales of the product.
Biohaven Pharmaceutical announced it has acquired the rights from Rutgers, The State University of New Jersey, to develop and commercialize certain glutamate modulating agents in the treatment of cancer.
Innovus Pharmaceuticals announced an exclusive licensing agreement with Seipel Group for the rights to market Urox Formulation using the Company’s Beyond Human Platform.
NovaBay Pharmaceuticals announced that during the third quarter it has received $7 million from the early exercise of 3,673,462 warrants issued as part of five previously completed financings. NovaBay issued 3,673,462 shares of its common stock for the redeemed warrants. In addition to the $7 million received, based upon commitments already received from other warrant holders, NovaBay expects to receive at least another $400,000 from exercises in October.
Sun BioPharma announced that the SEC has declared effective its registration statement on Form S-1, registering the sale of up to 3,331,500 shares of common stock issuable to investors in recent private placement transactions. The selling stockholders may, from time to time, sell any or all of their shares of common stock on any stock exchange, market or trading facility on which the shares are traded or quoted or in private transactions. These sales may be at fixed or negotiated prices. The Company also announced that, as of September 28, 2016, its common stock has begun trading on the OTCQB Venture Marketplace tier of the over-the-counter markets administered by the OTC Markets Group, Inc. The Company’s shares will continue trading under the symbol "SNBP." In addition, the company has secured DTC Eligibility, from The Depository Trust Company, for its shares to trade electronically.
Editas Medicine announced the appointment of Gerald Cox, M.D., Ph.D., as Chief Medical Officer.
Concordia International announced that it has exercised an option to defer half of the anticipated GBP144 million earn-out obligation due to Cinven and the other sellers of Concordia’s International segment, to February 1, 2017.
Merus Labs International announced that it has made the second of its regularly scheduled quarterly principal repayments under its new credit facility and achieved a 0.5% reduction in the annual interest rate under the credit facility.
Immunovaccine announced that CFO Kimberly Stephens is departing the company. The Immunovaccine management team, in conjunction with the company’s Board of Directors, has begun the process of hiring a new CFO. Ms. Stephens will continue to work with Immunovaccine through December 2016 while the company transitions her successor into the position. Ms. Stephens has accepted a new CFO role at Appili Therapeutics.
Lion Biotechnologies announced the appointment of Gregory T. Schiffman, MBA as CFO of the company, effective immediately.
Jefferies analyst Gena Wang increased her price target of Sarepta to $58 from $50, citing updated launch assumptions.
Following Depomed’s announcement of a favorable ruling on Nucynta, UBS analyst Ami Fadia increased her price target to $26 from $20, Janney analyst Ken Trbovich increased his price target to $31 from $28.
Leerink analyst Michael Schmidt increased his price target of Incyte to $98 from $95, citing greater comfort in INCY’s growth strategy focused on commercial execution on the Jakafi business, in-house innovation in oncology, and growth of the geographic footprint.