BioShares Biotechnology Clinical Trials (BBC): $22.01, -$0.83, -24.2% YTD
BioShares Biotechnology Products (BBP): $32.93, -$0.59, +6.8% YTD
U.S. stock index futures reversed course to trade higher after employment growth slowed for the third straight month in September, which could make the Federal Reserve more cautious about raising interest rates. Nonfarm payrolls rose 156,000, down from a revised gain of 167,000 jobs in August, the Labor Department said on Friday. Economists polled by Reuters had expected employers to add 175,000 jobs last month. Fed Chair Janet Yellen has said the economy needs to create less than 100,000 jobs a month to keep up with population growth. Average monthly job gains have been about 180,000 this year, which Yellen has described as "unsustainable." The unemployment rate ticked up a tenth of a percentage point to 5.0 percent last month, though the increase was driven by Americans rejoining the labor force.
Alcobra announced today that it has received the written full clinical hold notice from the Division of Psychiatry Products of the U.S. Food and Drug Administration (FDA) in follow up to their verbal communication on the matter. The FDA indicated in the letter that the clinical hold was placed due to electrophysiological neurologic findings in previously submitted long-term animal studies with Metadoxine. The FDA letter did not reference any clinical safety data observed in the MEASURE study or in previous human studies with MDX. The Division recommended that Alcobra schedule a meeting to discuss a plan to collect additional human safety data in its development program. Alcobra will continue to work rapidly and diligently with the FDA to seek the removal of the clinical hold and will provide an update following its meeting with the Agency.
Aradigm Corporation announced that it entered into an agreement with the University of Sydney to collaborate on a joint program on the development of advanced nanotechnologies for targeting bacterial and fungal biofilms that are often present with concomitant infections in chronic diseases such as cystic fibrosis (CF) and non-CF bronchiectasis (non-CF BE). This agreement provides for funding of AUD$420,000 over a three-year period from the Australian Research Council through the Australian Linkage Project program.
The Medicrea Group announced its sales for the 3rd quarter ending September 30, 2016. Sales reached a total of €6.8 million over the third quarter, down 3% compared to the same quarter of 2015, due to a temporary decrease in activity in Europe. Year-to-date 2016, Medicrea sales have increased by 3% thanks to its priority markets, the United States (+9%) and France (+13%) where the adoption of UNiD™ patient-specific technology is continuing with more than 100 surgeons utilizing this service and the significant 1,000 UNiD™ surgery milestone anticipated within the next month.
Clovis Oncology announced the oral presentation of the primary efficacy and safety data from its NDA dataset for rucaparib at the 2016 ESMO Congress in Copenhagen. Rucaparib is currently under priority review with FDA for the monotherapy treatment of advanced ovarian cancer in patients with BRCA-mutated tumors inclusive of both germline and somatic BRCA mutations who have been treated with two or more chemotherapies, and the submission has a PDUFA date of February 23, 2017.
Incyte announced that updated data from the Phase I portion of the ECHO-202 trial evaluating the safety and efficacy of epacadostat, Incyte’s selective IDO1 enzyme inhibitor, in combination with pembrolizumab (Keytruda), Merck’s anti-PD-1 therapy, have been published as a poster at the European Society for Medical Oncology (ESMO) Annual Congress 2016 in Copenhagen, Denmark.
Exelixis announced results from a Phase I trial of cabozantinib in combination with nivolumab in patients with previously treated genitourinary tumors. The findings will be presented during a poster discussion session (Abstract #774PD) on October 9 at the European Society for Medical Oncology (ESMO) 2016 Congress, which is being held in Copenhagen, October 7 – 11, 2016. Between July 2015 and September 2016, 24 patients were accrued with metastatic urothelial carcinoma (n=7), urachal adenocarcinoma (n=4), squamous cell carcinoma of the bladder or urethra (n=3), germ cell tumor (n=4), castration-resistant prostate cancer (n=4), renal cell carcinoma (n=1), or trophoblastic tumor (n=1) and were treated in Part I of the study, which evaluated the combination of cabozantinib and nivolumab at four dose levels. The median number of prior systemic therapies was 3, and 10 patients had received 4 or more prior therapies. The objective response rate was 43 percent among the 23 patients who were evaluable for response, with one complete response and nine partial responses. Four of six patients (67 percent) with urothelial cancer achieved a response. The recommended doses for the ongoing expansion cohorts were determined to be cabozantinib at 40 mg daily and nivolumab at 3 mg/kg once every 2 weeks. Part II of the phase I trial examining the use of the triplet combination of cabozantinib, nivolumab, and ipilimumab is also ongoing.
Exelixis announced that its collaborator Genentech, a member of the Roche Group, will present preliminary results from a phase Ib clinical trial evaluating the safety and clinical activity of the triple combination of cobimetinib, vemurafenib, and atezolizumab in patients with previously untreated BRAF V600 mutation-positive advanced melanoma. The results will be the subject of a poster discussion presentation (Abstract #1109PD) at the European Society of Medical Oncology (ESMO) 2016 Congress, which is being held October 7-11 in Copenhagen, Denmark. Patrick Hwu, M.D., chair of the Department of Melanoma Medical Oncology at the University of Texas M.D. Anderson Cancer Center, Houston, Texas, will present the results during a session on Monday, October 10, 2016, beginning at 11:00 a.m. CEST.
Celgene announced results from multiple sponsored and independent studies will be presented during the European Society of Medical Oncology (ESMO) 2016 Annual Meeting evaluating the use of ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) as a foundational treatment, either alone or in combination with novel agents and novel regimens, for patients with traditionally challenging cancers, including metastatic pancreatic cancer (mPAC), metastatic breast cancer (MBC) and advanced non-small cell lung cancer (NSCLC).
Seattle Genetics and Agensys, an affiliate of Astellas, presented updated clinical data for enfortumab vedotin (ASG-22ME) and ASG-15ME at the European Society for Medical Oncology (ESMO) Congress being held October 7-11, 2016 in Copenhagen, Denmark. Enfortumab vedotin and ASG-15ME are investigational antibody-drug conjugates (ADCs) that target the cell surface proteins Nectin-4 and SLITRK6, respectively. The clinical data for both agents continue to demonstrate overall response rates in patients with previously treated metastatic urothelial cancer, including those with prior checkpoint inhibitors. Safety and recommended Phase II doses were also presented for both programs. While both Phase I studies will continue to enroll patients, the companies plan to advance enfortumab vedotin and discuss next steps with regulatory agencies. Evaluation of next developmental steps for ASG-15ME is ongoing.
Coherus BioSciences announced results from two pharmacokinetic (PK) studies involving CHS-0214, a biosimilar candidate to etanercept (Enbrel®). CHS-0214-06 (‘06 Study) was a Phase I pharmacokinetic bioequivalence (PK BE) study comparing CHS-0214 vs. EU Enbrel. The ‘06 Study achieved the primary PK BE endpoint, as the 90% confidence intervals for the geometric mean ratio for the two groups was within 80% to 125% for all PK parameters. As planned, Coherus is moving forward with pre-submission meetings, now expected in the first quarter 2017, to review the complete CHS-0214 program prior to filing. The planned marketing authorizations submissions will occur directly thereafter.
Reuters reported that AstraZeneca announced that it has entered into an agreement with Cilag GmbH International, an affiliate of Johnson & Johnson, for the divestment of the rights to Rhinocort Aqua outside the US.
Alexion Pharmaceuticals announced that researchers presented new long-term data from an ongoing, open-label extension of the pivotal Phase III ARISE trial of Kanuma (sebelipase alfa) in children and adults with lysosomal acid lipase deficiency (LAL-D), a genetic and progressive ultra-rare metabolic disease. At 52 weeks of Kanuma treatment, nearly all patients (97 percent) who had received Kanuma from the start of the double-blind period had a rapid and sustained reduction in alanine aminotransferase (ALT), with a mean percent reduction of 53 percent, and an increase from 31 percent (11/36) to 45 percent of patients (15/33) achieving ALT normalization. Similarly, after 52 weeks of Kanuma treatment, nearly all patients (97 percent) who had initially received placebo during the double-blind period had a reduction in ALT, with a mean percent reduction of 52 percent, and 48 percent of patients (14/29) achieving ALT normalization. Sustained improvements were also observed in both groups in markers of lipid abnormalities (including LDL cholesterol, non-HDL cholesterol, triglycerides, and HDL cholesterol) through 52 weeks of Kanuma treatment. These data were reported in a poster presentation at the 5(th) World Congress of Pediatric Gastroenterology, Hepatology and Nutrition (WCPGHAN) in Montréal, Canada.
Rigel Pharmaceuticals announced the appointment of two company veterans to leadership roles that will impact Rigel’s newly refocused small molecule R&D effort targeting immunology and oncology diseases. Esteban Masuda, Ph.D., who has made significant contributions to Rigel’s research programs for 18 years, has been named Senior Vice President, Research. Joseph Lasaga, who formerly held roles in both research and business development at Rigel, rejoins the company as Vice President, Business Development and Alliance Management. The company recently restructured its research area to focus on immunology and oncology, with a team that maintains the full complement of capabilities necessary for productive drug discovery. From this effort, Rigel expects to file an IND with the FDA for its first IRAK inhibitor in 2017. IRAKs are key components in the signal transduction pathways associated with inflammation. Rigel has identified IRAK1/4 inhibitors that are potent regulators of the inflammatory signal mediated by the Toll-like receptors and Interleukin-1 family of cytokines. Rigel’s IRAK1/4 inhibitors may be valuable therapeutic tools to treat cytokine-driven autoimmune and inflammatory diseases such as gout or lupus, as well as various hematological malignancies.
Otonomy held an investor and analyst day which included an update on the commercial launch of OTIPRIO (ciprofloxacin otic suspension) for use during ear tube surgery, OTIPRIO label expansion activities, OTO-104 clinical program for Ménière’s disease and cisplatin-induced hearing loss prevention, OTO-311 clinical program for tinnitus, as well as providing an introduction to Otonomy’s Program 4 for the treatment of sensorineural hearing loss and a general corporate update.
Moleculin Biotech announced it has secured an agreement with Dermin Sp. Zo. O. ("Dermin") to utilize Dermin’s supply of Annamycin for its upcoming clinical trial, substantially reducing the expenditures required of Moleculin for drug product and shortening the time required to produce clinical supplies.
Valeant Pharmaceuticals announced that Louis W. Yu, Ph.D. has been appointed to the newly created position of Chief Quality Officer, Global Quality, effective October 3, 2016.
Osiris Therapeutics announced that it has appointed R. Alberto Avendano, M.D., as the Company’s Chief Medical Officer.
Soligenix announced that it has filed a Certificate of Amendment to its Second Amended and Restated Certificate of Incorporation to implement a one-for-ten (1:10) reverse split of its authorized, issued, and outstanding common stock, which took effect at 12:01 a.m. this morning. The reverse stock split was implemented by the Company in preparation for its proposed up-listing of the Company’s common stock to the NASDAQ Capital Market ("NASDAQ"). The NASDAQ listing is expected to facilitate greater liquidity in the stock as well as enable broader access to the investment community, many participants of which are unable to buy stock listed on the bulletin board. The reverse split was overwhelmingly approved by the Company’s stockholders on June 16, 2016 and recently unanimously authorized by its Board of Directors.
Cidara Therapeutics announced the pricing of an underwritten public offering of 2,475,248 shares of its common stock at a price to the public of $10.10 per share. The gross proceeds to Cidara from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be approximately $25.0 million. The offering is expected to close on or about October 12, 2016, subject to customary closing conditions. In addition, the underwriter has been granted a 30-day option to purchase up to an additional 371,287 shares of its common stock at the public offering price. Cantor Fitzgerald is acting as the sole book-running manager for the offering.
Heat Biologics announced that it has paid down $1.5 million on its commercial loan following the recent exercise of warrants, which have generated $2.8 million in cash proceeds last quarter.
Concordia International announced the pricing of its previously disclosed offering of 5 ½ year Senior Secured First Lien Notes. The Senior Notes will bear an interest rate of 9.00 per cent per annum and will be issued at 100.00 per cent of their face value. The principal amount of the Notes is $350 million. Concordia intends to use the net proceeds from the Offering for general corporate purposes, including funding of pipeline products and funding small regional product acquisitions.
Goldman Sachs analyst Salveen Richter upgraded her coverage view of Smid-cap Biotech to “attractive” from “neutral”, citing macro headwinds from drug pricing political rhetoric are likely to persist through YE16+, but this group is relatively better positioned under a new administration than those relying on repricing of branded drugs.
Goldman Sachs analyst Salveen Richter initiated coverage of GW Pharmaceuticals with a “buy” rating and $189 price target, citing GWPH’s lead asset is Epidiolex for Dravet Syndrome and Lennox-Gastaut Syndrome, two severe orphan epilepsies, which are de-risked post three positive Phase III studies.
Brean analyst Jason Wittes assumed coverage of Pacira Pharmaceuticals with a “hold” rating, citing a significant market opportunity ahead for Exparel, but it requires a significant amount of blocking and tackling.
Guggenheim analyst Tony Butler initiated coverage of Syndax Pharmaceuticals with a “buy” rating and $29 price target, citing developing combination therapeutic solutions in multiple cancer indications.
HC Wainwright analyst Corey Davis initiated coverage of the following companies: Lipocine with a “buy” rating and $25 price target; Zynerba with a “buy” rating and $22 price target.
Morgan analyst David Lebowitz downgraded Alnylam to “equal weight” from “overweight” and decreased his price target to $36 from $93, citing the announcement that they were discontinuing the revusiran program after the Data Monitoring Committee determined during an interim analysis that the benefit-risk profile of the therapy does not support further investigation.
Leerink analyst Jason Gerberry decreased his price target of Teva to $57 from $61, citing generic Copaxone 40mg launch in late 2H17 is a risk and near term headwinds.
HC Wainwright analyst Shaunak Deepak initiated coverage of Lexicon with a “buy” rating and $26 price target, citing strong partnerships, positive pivotal data, and over $400M in cash at 2Q.
Canaccord analyst Mark Massaro increased his price target of Illumina to $165 from $145, citing confidence that ILMN realizes its order backlog in 2H/16 predominantly driven by orders from China in the backdrop of the Chinese Precision Medicine Initiative.
HSBC analyst Steve McGarry increased his price target of Teva to $66 from $65, citing the partnering agreement with Celltrion and Teva is a credible marketing opponent against Roche.
BTIG analyst Dane Leone initiated coverage of Trillium Therapeutics with a “buy” rating and $21 price target, citing positive optionality for Trillium’s lead therapeutic program, TTI-621, targeting CD47 in hematological malignancies.