BioShares Biotechnology Clinical Trials (BBC): $20.78, -$0.80, -28.5% YTD
BioShares Biotechnology Products (BBP): $31.59, -$1.27, +2.5% YTD
Tracking movement in global markets, U.S. stock index futures pointed towards a lower start, after disappointing trade data from China. Initial claims, import and export prices are on the economic calendar. Risk aversion pushed safe haven gold and the yen higher, while the dollar weakened broadly. Oil edged up.
Eiger BioPharmaceuticals announced that abstracts from its LOWR HDV (LOnafarnib With Ritonavir in Hepatitis Delta Virus) Program will be presented at the American Association for the Study of Liver Diseases (AASLD) meeting in Boston, Massachusetts, November 11 to 15, 2016. Twenty-four-week data from the phase 2 LOWR HDV Program will be presented.
Advaxis has received preliminary approval for a $2.7 million tax credit from the New Jersey Economic Development Authority’s (NJEDA) New Jersey Technology Business Tax Certificate Transfer (NOL) program. The company anticipates it will be able to transfer this credit and receive more than $2.5 million in cash by the end of 2016.
Onconova Therapeutics will present a company update at the 2016 BIO Investor Forum on Wednesday, October 19th at 10:30am Pacific Time.
BioTime will be presenting at the BIO Investor Forum on Wednesday, October 19, 2016, at 2:00 p.m. Pacific Time.
Innate Pharma SA announced that preliminary safety and clinical activity results for the Phase I study testing IPH4102 in patients with relapsed/refractory cutaneous T-cell lymphomas (“CTCL”) will be presented by Professor Martine Bagot, Head of the Dermatology Department at the Saint-Louis Hospital, Paris, at the Third World Congress of Cutaneous Lymphomas “3WCCL”, being held October 26-28, 2016, in New-York City.
OncoSec Medical announced that new clinical data from the Phase II Investigator Sponsored Trial led by the University of California, San Francisco (UCSF) to assess the combination of OncoSec’s investigational intratumoral therapy, ImmunoPulse® IL-12, and Merck’s KEYTRUDA® (pembrolizumab) in patients with unresectable metastatic melanoma and a low likelihood of response to an anti-PD1 alone will be presented at an oral poster presentation at the upcoming Society for Immunotherapy of Cancer ("SITC") Annual Meeting to be held on November 11-13, 2016, in National Harbor, MD.
Pernix Therapeutics Holdings announced that its Board of Directors unanimously approved a reverse split of its common stock at a ratio of 1-for-10 and a majority voting standard for the election of directors in uncontested elections.
VBL Therapeutics announced that it has engaged in a long-term lease contract of a new stand-alone facility in Modiin, Israel. The site will house VBL’s local biological drugs manufacturing facility, as the company plans ahead for potential commercialization of VB-111.
ContraVir Pharmaceuticals reported positive interim data for CMX157, the Company’s highly potent prodrug of tenofovir, from its ongoing Phase IIa multiple ascending dose clinical study. The head-to-head study is the first evaluation of CMX157 in HBV patients, and directly compares CMX157 to tenofovir disoproxil fumarate (TDF, Gilead‘s Viread) in chronically infected hepatitis B (HBV) patients.
Ocular Therapeutix announced that it has entered into a strategic collaboration, option and license agreement with Regeneron Pharmaceuticals. Ocular and Regeneron will collaborate on the development of a sustained release formulation of the vascular endothelial growth factor (VEGF) trap aflibercept for the treatment of wet age-related macular degeneration (wet AMD) and other serious retinal diseases. This formulation is currently in preclinical development. Regeneron’s aflibercept is currently approved by the FDA for certain indications under the brand name EYLEA.
TG Therapeutics announced that it has filed with the FDA an amended protocol for the GENUINE Phase III trial. Prior to the amendments, the GENUINE study consisted of two parts: Part I to evaluate the effect of the addition of TG-1101 to ibrutinib on overall response rate (ORR) in approximately the first 200 patients enrolled, to support a filing for accelerated approval of TG-1101 and Part II to evaluate the effect of the addition of TG-1101 to ibrutinib on progression-free survival (PFS) in all study patients (approximately 330), to support a filing for full approval of TG-1101. The amended protocol contains the following substantive changes: Part II of the study has been eliminated, and accordingly, the study’s sole primary endpoint will be ORR as originally contemplated in Part I and target enrollment has been reduced to approximately 120 randomized patients.
OncoGenex Pharmaceuticals announced results from the final analysis of the Phase III ENSPIRIT trial of custirsen in patients whose non-small cell lung cancer (NSCLC) has progressed following initial treatments. The trial did not meet the primary endpoint of demonstrating a statistically significant improvement in overall survival for patients treated with custirsen in combination with docetaxel compared to docetaxel alone. The median overall survival for the custirsen arm was 9.0 months versus 7.9 months for the control arm with a hazard ratio of 0.915 (one-sided p=0.178). Safety results were consistent with those observed in previous trials of custirsen in combination with chemotherapy.
Dow Jones reported that Pfizer ‘s attempt to stop generic drug manufacturer Actavis from producing Pfizer’s Lyrica drug was foiled by the U.K.’s appeal court. In September 2015, a U.K. High Court judge ruled against Pfizer in a patent case involving its blockbuster drug Lyrica, leaving generic-drug makers free to sell cheap copycats of the drug. Pfizer had hoped for a ruling that would protect the exclusive use of Lyrica for pain, even though the patents for two other uses–general anxiety disorder and epilepsy–have already expired. Pfizer had said it maintained its "strong belief in the validity, and importance, of the second medical-use patent for the use of Lyrica in pain" and planned to appeal the ruling. Following the appeal, the U.K. Court of Appeal has upheld the High Court’s decision that the patent claims asserted by Pfizer are invalid and not infringed by Actavis. In its judgment, the Court of Appeal gives guidance on what would amount to infringement of second medical use patents by a generic manufacturer. Although infringement may occur when it is known or can be foreseen that some of the generic manufacturer’s product will be used to fulfill prescriptions for the patented condition, infringement can be avoided where the generic manufacturer takes all reasonable steps within its power to prevent this from occurring. Pfizer’s original patent expired in 2014, but the secondary patent is intact until 2017. Generic-drug makers, including Actavis, now Allergan, and Mylan, launched copycat versions of Lyrica when the first patent expired but sought approval only for use in general anxiety disorder and epilepsy.
Heat Biologics announced that it continues to remain on track to report topline data this quarter from its Phase II trials evaluating HS-410 and HS-110 for the treatment of non-muscle invasive bladder cancer (NMIBC) and non-small cell lung cancer (NSCLC), respectively, as well as its Phase Ib trial evaluating HS-110 in combination with Bristol-Myers Squibb‘s anti-PD-1 checkpoint inhibitor, Opdivo, for the treatment of NSCLC.
Can-Fite BioPharma announced it has submitted the clinical trial protocol for its Phase II study of CF102 in the treatment of non-alcoholic fatty liver disease (NAFLD), the precursor to non-alcoholic steatohepatitis (NASH), to a leading Institutional Review Board (IRB) in Israel. Top medical centers in Israel, including Hadassah Medical Center and Rabin Medical Center are expected to participate in the planned study by enrolling and treating patients.
CLINUVEL PHARMACEUTICALS announced that it will meet with the FDA on 7 November to formally discuss lodging its NDA for the novel drug SCENESSE (afamelanotide 16mg). The pre-NDA meeting will focus on finalizing requirements for filing SCENESSE with the FDA for the treatment of adult patients with the rare genetic disorder erythropoietic protoporphyria (EPP).
Results from Phase I, Phase IIa and preclinical studies of CVT-301, an inhaled form of levodopa, have been featured in the current edition of Science Translational Medicine. Acorda Therapeutics is developing CVT-301 for the treatment of OFF periods in people with Parkinson’s disease (PD).
Aptose Biosciences announced that it received a response from the FDA regarding the clinical hold of Aptose’s Phase Ib clinical trial of APTO-253 in patients with hematologic cancers requesting additional information and informing Aptose that the hold would not be removed until this information is submitted and reviewed. The FDA response to Aptose focused exclusively on the request to provide the FDA with complete Chemistry, Manufacturing and Control (CMC) information on the final GMP drug substance and drug product intended for the clinic.
Allergan announced that Sweden has received the Marketing Authorization for BELKYRA (deoxycholic acid) after being granted approval by the Swedish Medical Products Agency (MPA). BELKYRA is a prescription medicine for the treatment of moderate-to-severe convexity or fullness associated with submental fat (often called double chin) in adults when the presence of submental fat has a psychological impact for the patient. Fullness under the chin can impact how a person feels about themselves and, for both women and men, can lead to feelings of negative self-impression.
Immunovaccine announced positive topline results from its Phase I trial evaluating the safety and immunogenicity of DPX-RSV, its DepoVax-based, small B cell epitope peptide vaccine candidate for respiratory syncytial virus (RSV). The results six months or more after vaccination confirmed earlier-reported interim data on the ability of DepoVax- formulated antigens to generate a relevant, durable immune response.
Ocular Therapeutix provided an update on the Company’s development strategy for its sustained release intravitreal depot technology for the treatment of serious retinal diseases.
Corbus Pharmaceuticals Holdings announced that it has completed the Phase II study evaluating Resunab for the treatment of diffuse cutaneous systemic sclerosis ("systemic sclerosis"). Corbus expects to report topline data from this study in the fourth quarter of 2016.
Esperion Therapeutics announced the bempedoic acid global pivotal Phase III LDL-C lowering clinical development program will include patients with hypercholesterolemia on any statin at any dose based on positive top-line results from its Phase II pharmacokinetics and pharmacodynamics (PK/PD) study of bempedoic acid added to atorvastatin 80 mg (1002-035), and the previously completed Phase I and Phase II studies. Top-line results from 1002-035 demonstrated the eight-week study met its primary endpoint of greater LDL-C lowering from baseline of 22 percent (p=0.0028) with bempedoic acid 180 mg compared with placebo with all patients on a background of atorvastatin 80 mg. Bempedoic acid also demonstrated an incremental reduction of 35 percent (p=0.0020) in high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease. Bempedoic acid added to atorvastatin 80 mg produced no clinically relevant effects on atorvastatin PK, and appeared to be safe and well-tolerated, with no serious adverse events reported.
Horizon Pharma announced that Horizon Pharma, Inc. and Horizon Pharma USA, Inc., its wholly owned subsidiaries, intend, subject to market and other considerations, to offer $300 million aggregate principal amount of senior notes due 2024, and to borrow $375 million aggregate principal amount of incremental term loans under Horizon’s existing senior secured credit facility. Horizon currently expects to use the net proceeds from the offering of notes and the incremental term loans to fund a portion of Horizon’s planned acquisition of Raptor Pharmaceutical, repay Raptor’s outstanding debt, and pay any prepayment premiums, fees and expenses in connection with the foregoing.
bluebird bio will outline key activities underway intended to advance the company’s LentiGlobin programs in transfusion-dependent β-thalassemia (TDT) and severe sickle cell disease (SCD). The presentation will focus on three key aspects of these activities: 1) potential improvements in transduction efficiency and manufacturing; 2) updates to the protocol for the company’s ongoing HGB-206 clinical trial in SCD; and 3) regulatory plans for the company’s LentiGlobin drug product candidate in TDT.
Clarus Therapeutics reported that its patent infringement lawsuit against Lipocine that had been filed in U.S. District Court in Delaware has been dismissed. The court found that there was not an immediate reason to hear the case given Lipocine’s failure to receive FDA market approval for LPCN-1021. Importantly, the decision was made without ruling on the validity of Clarus’s U.S. Patent 8,828,428 and other merits of the case. While Clarus disagrees with the court’s ruling, no further action will be taken unless LPCN-1021 is approved by the FDA, at which time Clarus will have the option to refile its patent infringement lawsuit.
Aptuit announced that it has relocated its recently acquired subsidiary Kuecept to its Oxford UK site, and added further formulation and safety assessment capacity to meet sustained customer demand for IND de-risking and enabling packages.
Flex Pharma provided a nocturnal leg cramp (NLC) regulatory and clinical update for FLX-787, a topically-acting, selective transient receptor potential (TRP) ion channel agonist, which the Company is evaluating for the treatment of nocturnal leg cramps (NLC), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), and other disorders.
Insys Therapeutics announced that its preliminary estimated revenues from Subsys (fentanyl sublingual spray) for the third quarter of 2016 will be in the range of $54 million to $55 million. The Company believes it will be cash-flow positive at this level of sales and will be able to meet its overall objectives of new product development and future growth.
Dr. Reddy’s Laboratories announced that it has launched Aripiprazole tablets, USP, in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg, a therapeutic equivalent generic version of Abilify (aripiprazole) tablets in the United States market approved by the FDA.
Cerus announced that The Community Blood Center (CBC) of Appleton, Wisconsin has submitted the first BLA to the FDA requesting allowance for interstate distribution of platelets that have been pathogen-reduced via the INTERCEPT Blood System.
Reuters reported that Dicerna Pharmaceuticals filed for a mixed shelf offering of up to $150 million.
Allergan announced a collaboration with SonarMD, a leader in population health management, on the development of clinical decision support (CDS) and patient engagement tools which can be used to facilitate physician identification of patients suffering from Irritable Bowel Syndrome with Diarrhea (IBS-D) in clinical practice and monitor their treatment outcomes. Moreover, the companies will establish a patient engagement platform which can be used to evaluate symptoms and health outcomes among patients with IBS-D in a real-world clinical setting.
Chromocell Corporation and Astellas Pharma announced that the FDA has granted Fast Track designation to the development program of the drug candidate CC8464/ASP1807, for the management of neuropathic pain associated with idiopathic small fiber neuropathy (iSFN). In 2015, Chromocell and Astellas entered into a license and collaboration agreement for the development and commercialization of CC8464/ASP1807 for the management of neuropathic and other pain indications. Chromocell submitted the IND for CC8464/ASP1807 in July, 2016, and recently dosed the first subject in a Phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetics of the oral formulation of CC8464/ ASP1807.
Eisai Co. announced that a presentation on the results of a Phase Ib clinical study of its in-house developed multiple receptor tyrosine kinase inhibitor lenvatinib mesylate (lenvatinib) in combination with the anti-PD-1 antibody pembrolizumab developed by Merck in patients with selected solid tumors was given at the ESMO Congress held from October 7 to 11. Development of this combination regimen is being conducted jointly under the cooperation of both companies.
Jefferies analyst Jeffrey Holford revised his price target and rating of the following companies: Pfizer downgraded to “hold” from “buy” and decreased his price target to $36 from $39; Abbott increased to $49.50 from $48; AstraZeneca increased to 6,000p from 5,800p; Bayer decreased to €99 from €104; Bristol-Myers decreased to $54 from $57; GlaxoSmithKline increased to 1,950p from 1,900p; Merck increased to $65 from $56; Novartis decreased CHF97 from CHF102; Novo Nordisk decreased to DKK285 form DKK 315; Roche decreased to CHF275 from CHF280; Sanofi decreased to €74 from €76; Zoetis increased to $63 from $60.
Leerink analyst Jonathan Chang resumed coverage Kura Oncology with an “outperform” rating and $15 price target, citing KURA’s lead pipeline program, tipifarnib as a safe and active drug.
HC Wainwright analyst Corey Davis initiated coverage of Cara Therapeutics with a $20 price target, citing Cara now has shown impressive proof of concept data, but the real clincher should come from the readout of three ongoing Phase 2/3 studies expected in the 1H 2017.
Cowen analyst Chris Shibutani increased his price target of Ariad Pharmaceuticals to $16 from $10, citing positive view on Brigatinib, ARIA’s wholly owned drug for ALK+ Non-small cell lung cancer.
Goldman analyst Jami Rubin removed Bristol-Myers from the “Conviction Buy List” and decreased her price to $67 from $75, citing disappointing CM-26 data adds a greater level of uncertainty to future trials.