BioShares Biotechnology Clinical Trials (BBC): $22.44, +$0.71, -22.8% YTD
BioShares Biotechnology Products (BBP): $33.66, +$0.83, +9.2% YTD
U.S. stock index futures edged lower, reflecting nervousness as investors await Wednesday’s release of minutes of the latest Federal Reserve Open Market Committee meeting. Alcoa kick starts the third-quarter earnings season. European stock markets were steady as gains in the shares of major luxury goods companies, offset the impact of weaker bank stocks. Asian bourses closed mixed. The dollar touched an 11-week high while the sterling plunged. Oil slipped as doubts lingered about OPEC plans to cut production. Gold edged lower.
VBI Vaccines announced that it has completed a pre-IND meeting with the U.S. Food and Drug Administration to discuss the development plan for VBI-1901, VBI’s glioblastoma multiforme immunotherapy candidate. The FDA addressed VBI’s questions related to preclinical data and planned clinical trial design and provided greater clarity on the requirements needed to file an IND to initiate a Phase I/IIa clinical trial in patients with GBM. VBI anticipates filing this IND in the first half of 2017. The FDA will consider a Fast Track designation for VBI-1901 at the time of the IND submission.
Aurinia Pharmaceuticals will provide a corporate overview at the 2016 BIO Investor Forum on Tuesday, October 18.
Aimmune Therapeutics will present Phase 2 clinical data on AR101, its investigational biologic oral immunotherapy for desensitization of patients with peanut allergy, and host corporate forums at The European Academy of Allergy and Clinical Immunology’s 4th Food Allergy and Anaphylaxis Meeting, October 13-15, 2016, in Rome; and, the 2016 Annual Scientific Meeting of the American College of Asthma, Allergy & Immunology (ACAAI), November 10-14, 2016, in San Francisco.
CymaBay Therapeutics announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 9,381,181. This patent provides coverage to at least 2035 and claims methods of treating NAFLD and NASH comprised of orally administering a therapeutically effective amount of MBX-8025.
Advaxis announced that the company will host a Research Reception during the Society for Immunotherapy of Cancer’s (SITC) 31st Annual Meeting & Associated Programs. The Advaxis Research Reception at SITC 2016 will be held at 6:30 p.m. ET on Thursday, November 10, in the Baltimore Ballroom 3 at the Gaylord National Hotel & Convention Center in National Harbor, Maryland.
Paratek Pharmaceuticals has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) to study omadacycline against pathogenic agents causing infectious diseases of public health and biodefense importance. These studies are designed to confirm humanized dosing regimens of omadacycline in order to study the efficacy of omadacycline against biodefense pathogens, including Yersinia pestis (plague) and Bacillus anthracis (anthrax). Funding support for the trial has been made available through the Defense Threat Reduction Agency (DTRA)/Joint Science and Technology Office (JSTO) and Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD)/Joint Project Manager Medical Countermeasure Systems (JPM-MCS)/BioDefense Therapuetics (BDTX).
Ohr Pharmaceutical announced that the company has been selected to present at the 2016 Ophthalmology Innovation Summit (OIS) at the American Academy of Ophthalmology (AAO) Annual Meeting being held in Chicago, Illinois, on Thursday, October 13, 2016.
Ocera Therapeutics announced that Linda Grais, M.D., Chief Executive Officer, will be presenting at the upcoming 2016 BIO Investor Forum being held October 18-19, 2016.
BIOPHYTIS announced the implementation of a proprietary e-Health platform, SARA-data, to process patient data from its SARA clinical studies. By combining highly standardized clinical outcomes with everyday-life health observations, SARA-data platform will allow a comprehensive assessment of the efficacy of Sarconeos in preventing physical disability in sarcopenia.
Addex Therapeutics announced today it has initiated a new study with ADX88178, a metabotropic subtype 4 (mGlu4) receptor positive allosteric modulator (PAM), in a non-human primate model of cocaine self-administration. The study is being conducted through the Company’s ongoing research collaboration with the US National Institute of Drug Abuse (NIDA).
Illumina announced estimated third quarter revenue of approximately $607 million, a 10% increase compared to $550 million in the third quarter of 2015. This unaudited estimate, based on management’s preliminary financial analysis, is lower than the third quarter revenue guidance of $625 million to $630 million. The shortfall in quarterly revenue was driven by a larger than anticipated year-over-year decline in high throughput sequencing instruments. As a result, the company expects fourth quarter revenue will be flat to slightly up sequentially. Following the news, Janney analyst Paul Knight downgraded the stock to “sell” from “neutral;” Cantor Fitzgerald analyst Bryan Brokmeier decreased his price target to $155 from $165; Cowen analyst Doug Schenkel decreased his price target to $160 from $180; Piper Jaffray analyst William Quirk decreased his price target to $150 from $163; Goldman analyst Isaac Ro decreased his price target to $127 from $141; Canaccord analyst Mark Massaro decreased his price target to $135 from $165; Barclays analyst Jack Meehan decreased his price target to $142 from $150; Wells Fargo analyst Tim Evans decreased his valuation range to $135-$140 from $145-$155; First Analysis analyst Joseph Munda decreased his price target to $130 from $143.
KemPharm announced that its IND application for KP415 has been accepted by the FDA. KP415, KemPharm’s co-lead product candidate, is an extended release (ER) d-threo-methylphenidate (d-MPH) prodrug for the treatment of ADHD. KemPharm expects to commence and complete proof of concept human trials prior to the end of 2016, with additional human clinical trials initiating during the first half of 2017.
Merrimack Pharmaceuticals announced final results from the pivotal Phase III NAPOLI-1 study validating the use of ONIVYDE (irinotecan liposome injection) in combination with fluorouracil (5-FU) and leucovorin, which represents a new standard of care for patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) following treatment with gemcitabine-based therapy. The final NAPOLI-1 results were presented in a poster discussion session and a separate analysis of NAPOLI-1 safety-over-time data was presented in a poster session at the European Society for Medical Oncology 2016 Congress in Copenhagen.
Supernus Pharmaceuticals announced positive topline results from its Phase IIb dose-ranging clinical trial of SPN-812 in children for the treatment of ADHD.
Alexza Pharmaceuticals, a wholly-owned subsidiary of Ferrer Therapeutics, announced that its sNDA seeking certain changes in the product label and modifications to the Risk Evaluation Mitigation Strategy (REMS) Program for ADASUVE (loxapine) inhalation powder (10mg) has been approved by the FDA. ADASUVE is the first and only orally inhaled medicine for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
Amgen announced results from new retrospective analyses of key studies with Vectibix (panitumumab) in metastatic colorectal cancer (mCRC) patients. The retrospective analysis of the PEAK study in mCRC patients with RAS wild-type primary tumors of left-sided origin showed that patients receiving Vectibix plus FOLFOX6 as first-line treatment achieved 43.4 months median overall survival (OS), an increase of 11.4 months when compared to FOLFOX6 plus bevacizumab. Additionally, for this patient population, the retrospective analysis of the PRIME study showed Vectibix plus FOLFOX4 increased OS by 6.7 months when compared to FOLFOX4 alone. These data were presented at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen (Abstract #89P).
Genentech, a member of the Roche Group, announced that the FDA has accepted a sBLA and granted Priority Review for Lucentis (ranibizumab injection) for the treatment of myopic choroidal neovascularization (mCNV), a complication of severe near-sightedness that can lead to blindness. The sBLA is based on results from the Phase III RADIANCE study that demonstrated treatment with Lucentis provided superior visual acuity gains in people with mCNV compared to verteporfin photodynamic therapy, the only treatment currently approved by the FDA for mCNV.
Allergan announced the FDA has accepted for filing the company’s sNDA for AVYCAZ (ceftazidime and avibactam), seeking the addition of new Phase III clinical trial data evaluating AVYCAZ in patients with complicated urinary tract infections (cUTI), including pyelonephritis, due to designated susceptible pathogens to the current product label. The FDA granted priority review status to this application based on the previous Qualified Infectious Disease Product (QIDP) designation for AVYCAZ and is expected to take action on the filing in the first quarter of 2017.
Horizon Pharma is providing estimates of certain third-quarter 2016 results, confirming expected net sales on a non-GAAP adjusted basis at the low end of its previously announced full-year net sales guidance range and revising its full-year 2016 adjusted EBITDA guidance range, reflecting higher fourth-quarter investment spending. The additional operating expenses reflect strategic investments the Company is making to support future growth opportunities, particularly as it transitions its business mix toward orphan disease medicines and builds a more durable primary care business. The Company’s full-year 2016 guidance does not include the previously announced expected acquisition of Raptor Pharmaceutical.
Neurocrine Biosciences announced that the FDA has accepted for Priority Review the NDA for INGREZZA (valbenazine) for the treatment of tardive dyskinesia. The INGREZZA application has been given a PDUFA target action date of April 11, 2017.
Atara Biotherapeutics announced that the EMA issued a positive opinion for orphan drug designation for the Company’s CMV-CTL product candidate for the treatment of CMV infection in patients with impaired cell-mediated immunity.
Syros Pharmaceuticals announced that the FDA has approved an investigational device exemption (IDE) for a laboratory-based blood test to detect proprietary biomarkers discovered using the Company’s gene control platform to select patients for enrollment in the ongoing Phase II clinical trial of Syros’ lead drug candidate, SY-1425, a selective retinoic acid receptor alpha agonist.
China Biologic Products announced that Shandong Taibang Biological Products Co. Ltd., the Company’s majority-owned subsidiary, recently obtained approval from the China Food and Drug Administration to begin human clinical trials on its Human Antithrombin III ("ATIII") product.
Curis announced the expansion of its pipeline with CA-327, an oral, small molecule immune checkpoint antagonist targeting programmed death ligand-1 (PD-L1) and T-cell immunoglobulin and mucin domain containing protein-3 (TIM-3).
Sirtex Medical announced that the European Society of Medical Oncology (ESMO) has indicated the use of SIRT using yttrium-90 (Y-90) microspheres as an option in for the treatment of intrahepatic cholangiocarcinoma (iCCA), a form of primary liver cancer that starts in the bile duct, the branching network of thin tubes that deliver fat-digesting bile from the liver to the small intestine.
Gamida Cell announced that the FDA has granted Breakthrough Therapy Designation to the Company’s lead product candidate, NiCord, in development as a novel graft modality for bone marrow transplantation in patients with high risk hematological malignancies (blood cancers) such as leukemia and lymphoma. The international, multi-center Phase III registration study of NiCord is planned to begin before the end of the year.
Applied DNA Sciences announced it is expanding the use of its proprietary, SigNature T DNA technology to cotton gins in Arkansas, California and Texas, with the launch of its fully automated DNA Transfer Systems. The new systems are equipped with real-time monitoring, security and data capture, ensuring efficient and consistent DNA tagging of cotton fibers during ginning.
Provectus Biopharmaceuticals announced that the poster presented at the European Society of Medical Oncology 2016 Congress is now available online.
Cleveland BioLabs announced that the Department of Defense (DoD) has modified its Joint Warfighter Medical Research Program (JWMRP) contract award number W81XWH-15-C-0101 with CBLI valued at up to $9.2 million which supports further development of entolimod as a medical radiation countermeasure.
EffRx Pharmaceuticals SA announced that the Company has made some changes and additions to its management team. Lorenzo Bosisio has been appointed as Chief Executive Officer effective July 1st, 2016. Prior to his promotion to CEO, Mr. Bosisio served as Chief Commercial Officer since 2013. During his tenure in EffRx, he has built the commercial infrastructure from the ground, successfully launched the Company’s lead product, Binosto, enabling the transformation of EffRx from a drug development company to an integrated biopharmaceutical company with an international footprint.
Auris Medical Holding AG announced additional clinical data as well as updates to its development plan for Keyzilen (AM-101) in acute inner ear tinnitus. Based on insights from the recently completed TACTT2 trial, the Company is submitting a protocol amendment to regulatory agencies in Europe for TACTT3, the ongoing second Phase III clinical trial. In the amended trial protocol, the change in Tinnitus Functional Index (TFI) score will be elevated from a key secondary endpoint to an alternate primary efficacy endpoint. Certain patient subgroups will be included in confirmatory statistical testing, and the trial size will be increased to enhance statistical sensitivity to the effects of treatment. Top-line results from the expanded TACTT3 trial are now expected in early 2018. The outcomes from TACTT2 and the regulatory path forward will be reviewed with the FDA in early December 2016.
VolitionRx Limited announced that research presented at the European Society for Medical Oncology Congress (ESMO) shows that Volition’s novel blood test for colorectal cancer combined with the conventional faecal immunochemical screening test has the potential to offer up to a 25% reduction in colonoscopies while maintaining almost 97% detection of colorectal cancer when combined with the faecal immunochemical test (FIT) score.
Daiichi Sankyo Company, Limited announced that the first patient has been enrolled in the global Phase III QuANTUM-First study evaluating the oral FLT3-ITD inhibitor quizartinib in patients with newly-diagnosed FLT3-ITD-positive (+) acute myeloid leukemia (AML).
Charles River Laboratories International announced that it has extended its longstanding integrated drug discovery alliance with Genentech, a member of the Roche Group.
Heat Biologics announced that they have advanced their biomarker discovery collaboration with Adaptive Biotechnologies. Adaptive will use its patented immune profiling assay, immunoSEQ, to enable an in-depth characterization of the immune response to Heat’s ImPACT and ComPACT-based immunotherapies, including HS-410, Heat’s Phase II product candidate for non-muscle invasive bladder cancer. The immunoSEQ Assay, when used to evaluate the mechanism of action of the ImPACT platform, provides a significant biomarker identification opportunity to better select patients and accelerate future enrollment based on immune status.
OWC Pharmaceutical Research announced it is starting the final phase for testing the efficacy of its own developed topical crème compound for the treatment of psoriasis and related skin conditions.
NanoViricides reported that it has filed its financial year end annual report with the SEC on Friday, September 16, 2016 in a timely manner. The company said it has sufficient cash to advance into clinical trials.
Immunovaccine announced that renowned malarial researcher J. Alexandra Rowe, D Phil, of The University of Edinburgh, presented topline preclinical data for Immunovaccine’s DepoVax-based malarial vaccine at the World Vaccine Congress Europe in Barcelona, Spain on October 10, 2016. Results from studies in mice, conducted in collaboration with the University of Edinburgh’s Centre for Immunity, Infection and Evolution (CIIE), indicated that the novel CIIE-identified targets, when formulated in the DepoVax targeting platform, generated strong, sustained, antibody responses that could prevent, after a single injection, a process in severe malaria known as ‘rosetting.’
Genomic Health announced results from its successfully completed analytical validation study of Oncotype SEQ Liquid Select, which demonstrated that this liquid biopsy mutation panel is highly sensitive, specific and reproducible. To provide transparent and clinically meaningful performance standards, the analytical performance for Oncotype SEQ is reported on a per-sample basis rather than a per-DNA base measure. The data were presented at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen, Denmark.
CureVac AG announced the appointment of Pierre Kemula as CFO. Mr. Kemula will join CureVac’s management board and will be responsible for leading the company’s financial and capital markets activities.
XBiotech announced that the U.S. District Court for the Western District of Texas granted the Company’s motion to dismiss in the 2015 securities class action lawsuit brought against the Company and certain of its directors. In a final judgment issued on October 7th, 2016, the Honorable Judge Sam Sparks dismissed the lawsuit with prejudice, meaning the plaintiff is barred from refiling the claim.
BONE THERAPEUTICS announced that Enrico Bastianelli has informed the Board of his intention to stand down as CEO after 10 years in the role for personal reasons. Thomas Lienard, the current Chief Business Officer, will become Interim CEO of the Company, working closely with Wim Goemaere, CFO, and the rest of the management team. Mr Bastianelli will continue to support the Company through a period of transition.
Patheon N.V. announced that its EVP and CFO, Stuart Grant, plans to retire in 2017. Grant will remain in his current role until a successor has been appointed and a transition has been completed. The company has initiated a search to identify a replacement for Grant.
Barclays upgraded the Health Care sector to “overweight” from “market weight,” citing the growth in payouts to be significantly slower in 2017, as non-financial companies curtail a rapid increase in leverage ratios, which in turn should create more demand for sectors that have the capacity to continue growing payouts.
Following Exelixis’ CABOSUN Presentation at ESMO, Stifel analyst Stephen Willey increased his price target to $17 from $15; Leerink analyst Michael Schmidt increased his price to $16 from $15.
Barclays analyst Douglas Tsao upgraded Momenta Pharmaceuticals to “overweight” from “equal-weight” and increased his price target to $19 from $13, citing low risk of MNTA being blocked from the 40mg opportunity past 2018.
Canaccord analyst John Newman increased his price target of Lipocine to $15 from $6, citing a more optimistic forecast on the company’s oral testosterone product.
Mizuho analyst Irina Koffler decreased her price target of Allergan to $299 from $305, citing uncertainty regarding the trajectory of the cosmetic business after a strong 2Q:16.
Credit Suisse analyst Alethia Young increased her price target of PTC Therapeutics to $15 from $6, citing doc checks around Translarna launch confirm EU/ROW are on track.