BioShares Biotechnology Clinical Trials (BBC): $19.91, +$0.28, -31.5% YTD
BioShares Biotechnology Products (BBP): $30.48, +$0.15, -1.1% YTD
U.S. stock index futures were little changed after closing higher in the previous session, on the heels of solid earnings reports. American Express, eBay and Kinder Morgan are expected to report results after the closing bell. Building permits for September is on the economic calendar. European markets were in the red following weak updates from British companies, including Reckitt Benckiser, whose results were hit by a weaker pound. Asian stocks closed mixed. The dollar fell from a seven-month peak, lifting gold prices. Oil prices were supported by a drop in U.S. inventories.
Eiger BioPharmaceuticals announced that the first patient was dosed in the Phase 2 LIMT HDV (Lambda Interferon MonoTherapy in HDV) study, a monotherapy trial of pegylated interferon lambda 1a ("Lambda") as a potential treatment for chronic hepatitis D virus (HDV) infection. LIMT HDV is a 30-patient study designed to evaluate the safety, tolerability and efficacy of two dose levels of Lambda after 48 weeks of treatment. LIMT HDV is an international study currently enrolling at University of Auckland in New Zealand with additional sites planned in Israel and Pakistan.
Moberg Pharma announced the European Patent Office has issued Patent No. 2701681 which protects BUPI, currently in development for oral mucositis. The new patent covers pharmaceutical compositions comprising a local anesthetic, such as bupivacaine, for local administration to the mouth, protects lozenge formulations of a local anesthetic for use in the treatment of oral mucositis in cancer patients. The patent is expected to provide coverage through at least 2031. Additonal patent applications are pending in the United States and Canada.
Rockwell Medical will present data on the toxicology of Triferic administered intraperitoneally to rats at the ASN Kidney Week 2016 Annual Meeting, November 15-20 at the McCormick Place in Chicago, IL. Triferic is the Company’s iron-replacement drug for the treatment of iron deficiency in chronic kidney disease patients receiving dialysis.
Vermillion announced that CEO, Valerie Palmieri, will present at the Women in Bio – New York Chapter meeting at the PRIDE Global Event Space in New York, NY on October 20, 2016 at 6:00PM EST. The presentation, titled "Ovarian Cancer: Changing the Early Detection Paradigm and Controlling Your Destiny" will describe the who, what, why and how of the country’s most deadly gynecologic malignancy. The discussion will include a review of the disease symptoms, and how women can "listen" to their bodies and understand how modern diagnostics help identify cancer early, when it is still highly treatable. Ms. Palmieri will be joined by Sherry Pollex, life partner of NASCAR Sprint Cup driver Martin Truex, Jr and an ovarian cancer thriver. Sherry will review her journey and will highlight how awareness can "truly" make a difference!
InVivo Therapeutics Holdings announced that the Foothills Medical Centre in Calgary, Alberta has been added as a Canadian clinical site for The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury. The Foothills Medical Centre is the largest hospital in Alberta and is one of the most recognized medical facilities in Canada, providing advanced healthcare services to over two million people from Calgary and southern Alberta, the northwestern United States, southeastern British Columbia, and southern Saskatchewan.
Cerulean Pharma announced that the Company has entered into a strategic collaboration with Novartis to develop NDC product candidates combining Cerulean’s proprietary Dynamic Tumor Targeting technology with Novartis’ proprietary compounds directed at up to five targets. Cerulean will create NDC candidates, and Novartis is responsible for further development and commercialization of NDC products resulting from the collaboration. Under terms of the agreement, Cerulean will receive an upfront payment of $5 million plus funding for five full-time equivalents. Cerulean is also eligible to receive preclinical, clinical, regulatory, and sales milestones for each target. In addition, following regulatory approval of NDC products, Cerulean can earn single-digit to low double-digit tiered royalties on net sales for each NDC product.
Marinus Pharmaceuticals announced that in its Phase I dose-escalation study, ganaxolone intravenous (IV) achieved dose levels targeted for efficacy in patients with status epilepticus (SE) and other indications. Status epilepticus is a life-threatening medical emergency associated with high mortality and limited treatments. Typically, single or combination IV antiepileptic drugs are used in an attempt to break the seizures, however there are approximately 45,000 patients in the U.S. who do not respond to first-line treatment.
Omeros announced positive results from a Phase II clinical trial evaluating the effects of a peroxisome proliferator-activated receptor (PPAR)-gamma agonist in patients with cocaine use disorder (CUD). The trial, designed and conducted by Joy M. Schmitz, Ph.D. and her colleagues at the Center for Neurobehavioral Research on Addiction, University of Texas Health Science Center — Houston, demonstrates that the PPAR-gamma agonist reduces craving and improves the integrity of brain white matter in patients with CUD. There currently are no approved medications to treat cocaine addiction. Omeros’ issued and pending patents in its OMS405 program cover the use of any PPAR-gamma agonist, alone or in combination with other addiction therapies, to treat all forms of addiction, including cocaine, nicotine, opioids, alcohol and other substances of abuse as well as addictive or compulsive behaviors.
Immunomedics announced the issuance of U.S. Patent 9,458,242 for additional claims under the patent family "Dosages of immunoconjugates of antibodies and SN-38 for improved efficacy and decreased toxicity." This new patent, which will expire in July 2033, covers the use of labetuzumab govitecan (IMMU-130), the Company’s second investigational antibody-drug conjugate (ADC) for solid cancer therapy.
AbbVie in cooperation with Neurocrine Biosciences, announced detailed results from two replicate pivotal Phase III clinical trials evaluating the efficacy and safety of Elagolix in premenopausal women who suffer from endometriosis. The data demonstrate that, compared to placebo at month three and month six, patients treated with Elagolix reported statistically significant reductions in scores for menstrual pain (dysmenorrhea, DYS) and non-menstrual pelvic pain (NMPP) associated with endometriosis as measured by the Daily Assessment of Endometriosis Pain scale. The results were presented at the 72(nd) American Society for Reproductive Medicine Scientific Congress & Expo (ASRM) in Salt Lake City, as well as additional abstracts.
Merck announced that the pivotal Phase III clinical study of letermovir, an investigational antiviral medicine, met its primary endpoint. The global, multicenter, randomized, placebo-controlled study evaluated the efficacy and safety of letermovir for the prevention of clinically-significant cytomegalovirus (CMV) infection in adult (18 years and older) CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT). Merck will submit results from the study for presentation at a future scientific conference.
XOMA announced the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted in principle the Company’s proposal to initiate a multi-dose Phase II clinical study of XOMA 358 in children two years and older diagnosed with Congenital Hyperinsulinism (CHI).
Ardelyx announced the presentation of positive global endpoint data from its Phase IIb trial, completed in September 2014, which evaluated tenapanor for the treatment of patients with irritable bowel syndrome with constipation (IBS-C). These pre-specified analyses build off of positive efficacy findings on the study’s primary and key secondary endpoints in the same patient population, as previously announced in October 2014 and presented at Digestive Disease Week in 2015. They also further validate the 50 milligram (mg), twice-daily dose of tenapanor chosen for the two ongoing Phase III studies, T3MPO-1 and T3MPO-2, in patients with IBS-C, which are expected to have data readouts in mid- and late-2017, respectively. The company is also evaluating tenapanor in a Phase III study for the treatment of hyperphosphatemia in end-stage renal disease (ESRD) patients on dialysis, with data expected to be reported in the first quarter of 2017.
Merus N.V. announced that the company received an undisclosed milestone payment from Ono Pharmaceutical, under the ongoing collaboration between the two companies. The milestone was triggered as a result of pre-clinical confirmatory studies using the selected lead bispecific antibody candidate that Ono intends to advance into clinical testing. Ono and Merus have also extended their collaboration by signing an additional agreement for CMC activities to be carried out by Merus.
Swedish Orphan Biovitrum AB has been granted orphan designation by the European Commission (EC) for the company’s development product candidate SOBI003, a chemically modified human recombinant sulfamidase for the treatment of mucopolysaccharidosis type IIIA (Sanfilippo A syndrome). SOBI003 will be included in the EU Community Register of Orphan Medicinal Products.
Allergan and Tobira Therapeutics announced that the FTC has granted early termination of the waiting period under the Hart-Scott Rodino Antitrust Improvements Act of 1976, as amended ("HSR"), with respect to Allergan’s pending acquisition of Tobira. The early termination of the HSR waiting period satisfies one of the conditions to the closing of the pending acquisition, which remains subject to other customary closing conditions. Both companies expect the transaction to be completed by the end of 2016.
Advanced Proteome Therapeutics announced that it has entered into an exclusive option agreement with the Toronto Recombinant Antibody Centre (TRAC) at the University of Toronto (UT). APC acquired an option to license validated antibody candidates suited for development of antibody-drug conjugates (ADCs) as potential treatments for cancer.
Pfizer announced an award of a grant from the Bill & Melinda Gates Foundation to conduct a Phase I/II clinical trial of Pfizer’s vaccine candidate against group B Streptococcus (group B strep or GBS) infection, a leading cause of neonatal sepsis, a serious life-threatening blood infection. The investigational vaccine is designed to protect newborns via maternal immunization.
Hemispherx Biopharma announced that it has completed its technology transfer of the Ampligen manufacturing processes to Avrio Biopharmaceuticals. The transfer consists of providing Avrio with all information that is relevant to the manufacturing process of Ampligen and associated assays. This includes performing a test engineering run to identify any potential issues before moving forward with the first cGMP lot and confirming that the information exchange was successful. This will enable Avrio to begin manufacturing current Good Manufacturing Practice ("cGMP") lots of Ampligen. The first cGMP lot is expected to be compounded, filled and finished in November and released in December, 2016, for use in the Company’s Early Access Program in Europe and Turkey.
Relmada Therapeutics announced that the USPTO has issued U.S. Patent 9,468,611 for "d-Methadone for the Treatment of Psychiatric Symptoms." The patent contains claims that provide broad coverage for d-Methadone (dextromethadone, REL-1017), an N-methyl-D-aspartate (NMDA) receptor antagonist, as a treatment for psychological and psychiatric disorders, comprising depression, anxiety, fatigue, and mood instability including pseudo-bulbar affect (PBA) for which there is currently only one FDA approved treatment.
Kite Pharma presented updates on its advancing pipeline of chimeric antigen receptor (CAR) and T cell receptor (TCR) product candidates and KTE-C19 launch readiness at its Investor Day in New York on October 18, 2016.
Spotlight Innovation announced that it has obtained an exclusive, worldwide license from Indiana University Research and Technology Corp. to commercialize STL-182, an orally-available small molecule that may have therapeutic potential for treating Spinal Muscular Atrophy (SMA).
Norgine B.V. announced that the European DAYB study that compares PLENVU (NER1006) to a magnesium salt solution (CITRAFLEET) using a day before only dosing regimen met both primary endpoints and all secondary endpoints. In the study, PLENVU demonstrated non-inferiority in overall bowel cleansing success and achieved an ‘Excellent plus Good’ cleansing rate in the ascending colon. These data were presented at United European Gastroenterology Week (UEGW) 2016
CollPlant announced that it has achieved a significant milestone with the receipt of the CE Mark for VergenixSTR, a soft tissue repair matrix for the treatment of tendinopathy. Sales in Europe are expected to commence in the coming months.
Tetracore announced the successful completion of an extensive study of its Anthrax BioThreat Alert Lateral Flow Assay (LFA) and the BioThreat Alert Reader by the Department of Homeland Security (DHS). The results of the evaluation were recently published in a peer-reviewed scientific article in the September/October 2016 issue of Health Security, Volume 14, Issue 5, pp 351-365.
Nohla Therapeutics announced the signing of an exclusive supply agreement with LifeSouth Community Blood Centers in Gainesville, Florida. The agreement is specific to LifeSouth’s cord blood banking program and will provide Nohla with fully qualified clinical grade cord blood units that will become the starting material for the Company’s expanded hematopoietic stem and progenitor cell products.
Bracket announced a new study partnership with researchers at Massachusetts General Hospital (MGH) on the ‘Assessment of Brain Insulin Resistance in Alzheimer’s Disease Using an Insulin Clamp’. The researchers will utilize its proprietary CDR System in the study, which is both a product of the Bracket eCOA product line and the industry standard for automated assessment of cognitive function in clinical trials.
Ascendis Pharma announced the pricing of its underwritten public offering of 6,315,789 American Depositary Shares ("ADSs"), each of which represents one ordinary share of Ascendis, at a price to the public of $19.00 per ADS. All of the ADSs are being offered by Ascendis. The offering is expected to close on or about October 24, 2016 subject to customary closing conditions. In addition, Ascendis has granted the underwriters a 30-day option to purchase up to an additional 947,368 ADSs at the public offering price, less the underwriting commissions.
Lannett Company received a notice from the FDA that it will seek to withdraw approval of the Company’s ANDA for Methylphenidate Hydrochloride (HCl) Extended-Release (ER) Tablets. FDA’s proposal includes an opportunity for Lannett to request a hearing on this matter.
Aclaris Therapeutics announced results from an observational study that found patients with asymptomatic seborrheic keratosis (SK) are bothered by their highly visible skin lesions and very interested in treatment options to improve their appearance, even if a cost were associated with treatment. The study was conducted in dermatology practices by Burke, Inc. on behalf of Aclaris.
Genentech, a member of the Roche Group, announced that the FDA approved TECENTRIQ (atezolizumab) for the treatment of people with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities. This approval is based on results from the randomized Phase III OAK and Phase II POPLAR studies. The largest study, OAK, showed that TECENTRIQ helped people in the overall study population live a median of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy (median overall survival [OS]: 13.8 vs. 9.6 months; HR = 0.74, 95% CI: 0.63, 0.87). The study enrolled people regardless of their PD-L1 status and included both squamous and non-squamous disease types.
Puma Biotechnology announced that it is commencing an underwritten public offering of $150 million of shares of its common stock. Puma Biotechnology intends to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of shares of its common stock. All of the shares are being offered by Puma Biotechnology. Citigroup and J.P. Morgan are acting as lead book-running managers for the offering.
Voyager Therapeutics announced a transition process for Jeff Goater, Voyager’s chief financial officer, who has advised the Company of his plans to pursue other career opportunities. As the Company initiates a search for this role, Jeff will remain in his current position until January 2017, after which time he has agreed to serve as a consultant to the Company.
Nektar Therapeutics announced the pricing of its previously announced underwritten public offering of $175.5 million in aggregate gross proceeds, or 13,000,000 shares of its common stock at a public offering price of $13.50 per share. In connection with this offering, Nektar has also granted to the underwriters a 30-day option to purchase up to an additional 1,950,000 shares of common stock at the offering price. J.P. Morgan is acting as lead book-running manager in the offering. Jefferies and Piper Jaffray are acting as book-running managers. William Blair is acting as lead manager for the offering, and Brean Capital, BTIG, Janney Montgomery Scott, Ladenburg Thalmann and ROTH Capital Partners are acting as co-managers for the offering. Nektar intends to use the net proceeds from this offering for general corporate purposes including research and development funding and working capital.
Cerulean Pharma announced that it has entered into a $20 million common stock purchase agreement (Purchase Agreement) and a registration rights agreement (Registration Rights Agreement) with Aspire Capital Fund. These agreements constitute a firm commitment at-the-market equity facility. Immediately following the execution of the Purchase Agreement, Aspire purchased 800,000 shares of common stock for $1.25 per share. Cerulean has the right to sell up to the remaining $19.0 million of its common stock to Aspire over a 24-month period, at prices based on a formula linked to current market prices at the time of each sale. Aspire has the obligation to purchase common stock from Cerulean in amounts and timing determined by Cerulean in its sole discretion, subject to certain limits. The Purchase Agreement does not contain any restrictions on the use of any of the proceeds, financial or business covenants, restrictions on future financings, rights of first refusal, participation rights, penalties or liquidated damages. In connection with entering into the Purchase Agreement, Cerulean issued 700,000 commitment shares to Aspire. There are no warrants associated with this transaction. The Purchase Agreement may be terminated by Cerulean at any time, at its discretion, without any cost.
On October 12, 2016, Geoffrey Nichol, M.B., Ch.B., notified Sangamo BioSciences of his resignation as Executive Vice President, Research and Development effective October 25, 2016.
Sunesis Pharmaceuticals announced the pricing of underwritten offerings of (i) 4,935,500 shares of its common stock at a price of $3.85 per share, and (ii) 1,558 shares of its non-voting Series C Convertible Preferred Stock ("Series C Stock") at a price of $3,850.00 per share. Sunesis expects to receive combined gross proceeds of approximately $25 million from these offerings, before deducting the underwriting discount and other estimated offering expenses. Sunesis has granted the underwriters a 30-day option to purchase up to an additional 740,325 shares of common stock to cover over-allotments, if any. These offerings are expected to close on or about October 24, 2016, subject to customary closing conditions. Each share of non-voting Series C Stock is convertible into 1,000 shares of Sunesis common stock, provided that conversion will be prohibited if, as a result, the holder and its affiliates would own more than 9.98% of the total number of shares of Sunesis common stock then outstanding. Sunesis anticipates using the net proceeds from the offerings for clinical development of SNS-062, regulatory development of vosaroxin in Europe and other general corporate purposes. Cowen and Company and Wells Fargo Securities are acting as joint book-running managers.
Baird analyst Michael Ulz initiated coverage of Coherus BioSciences with an “outperform” rating and $40 price target, citing a potential leader in the biosimilar space with an experienced management team and differentiated legal strategy.
Following Johnson & Johnson’s earnings, Piper Jaffray analyst Richard Purkiss decreased his price target to $104 from $106; Societe Generale analyst Florent Cespedes increased his price target to $116 from $113; UBS analyst Matt Miksic increased his price target to $144 from $137; Wells Fargo analyst Larry Biegelsen decreased his valuation range to $127-$129 from $133-$135; Goldman analyst Jami Rubin decreased her price target to $120 from $125; Raymond James analyst Jayson Bedford decreased his price target to $125 from $132.
Goldman analyst Terence Flynn increased his price target of the following companies: Regeneron to $533 from $521; Ariad Pharmaceuticals to $11 from $8; Clovis Oncology to $32 from $12.
Wedbush analyst Liana Moussatos decreased her price target of Pacira Pharmaceuticals to $93 from $109, citing Q3 tends to be seasonally slow as elective procedures are put off into Q4 due to vacations.
Cowen analyst Boris Peaker initiated coverage of Proteon Therapeutics with an “outperform” rating, citing Proteon is close to its first Phase III readout, and the Phase II data is significantly better than investors currently assume.
Roth analyst Sa’ar Yaniv reinitiated coverage of Can-Fite Biopharma with a “buy” rating and $4 price target, citing Can-Fite’s diversified pipeline, including piclidenoson for Rheumatoid Arthritis and psoriasis; CF102 for Liver Cancer and NASH; and, CF602 for of Erectile Dysfunction, offers multiple shots on goal and is relatively undervalued.
Roth Capital analyst Michael Higgins resumed coverage of Acadia Pharmaceuticals with a “neutral” rating and $25 price target, citing it is too early to recommend the shares, given the risk of the launch is tilted away from consensus estimates and the potential for post-approval serious adverse events and mortality risk.
Citi analyst Joel Beatty initiated coverage of Amarin with a “buy” rating and $5 price target, citing outcomes trial results will be major binary event.
Brean Capital dropped coverage of the following companies, citing departure of Jonathan Aschoff: Alexion, Celldex, Neuralstem, Incyte, Inovio, Keryx, Merrimack, Medivation, Ohr, Pacira, Progenics, and Regeneron