BioShares Biotechnology Clinical Trials (BBC): $22.63, -$0.22, +22.9% YTD

BioShares Biotechnology Products (BBP): $38.04, +$0.28, +16.2% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures were higher after U.S. Congress negotiators hammered out a federal funding deal late on Sunday, averting a government shutdown later this week. The dollar shrugged off early modest losses in holiday-thinned Asian trading, while gold fell. On the economic front, investors will look forward to data on personal income and consumer spending. ISM and Markit will also release its latest reading on manufacturing activity. Weakness in China’s manufacturing activity weighed on Asian markets, while upbeat earnings supported Nikkei. Many markets in Asia and Europe were closed for Labor Day. In commodities, crude oil prices slipped amid lingering concerns that an OPEC-led production cut has failed to significantly tighten an oversupplied market.

 

 

MARKET HIGHLIGHTS

 

Onconova Therapeutics announced one oral and one poster presentation at the 14th International Symposium on Myelodysplastic Syndromes taking place May 3-6, 2017 at the Palacios de Congresos de Valencia in Valencia, Spain.  These presentations will be made by the Company`s collaborators from the Mount Sinai School of Medicine and the Cleveland Clinic.

 

Achaogen announced that it will report its first quarter 2017 financial results on Monday, May 8, 2017 after the close of the U.S. financial markets.

 

Bellerophon Therapeutics announced that it will present new clinical data from its Phase 2 study evaluating the use of INOpulse® in idiopathic pulmonary fibrosis patients with pulmonary hypertension (PH-IPF) at the American Thoracic Society (ATS) 113th International Conference, on Sunday, May 21st in Washington DC.

 

Pernix Therapeutics Holdings announced that, due to a manufacturing issue with its supplier, the Company expects that the 20mg strength of Zohydro® ER with BeadTek™ will be on back order until at least the first quarter of 2018. Importantly, Pernix continues to market and distribute the other strengths of Zohydro ER with BeadTek, including the 10mg, 15mg, 30mg, 40mg, and 50mg strengths. The available dosage forms offer prescribers and patients a wide range of dosage options, most of which are consistent with the morphine milligram equivalents that are recommended in the recent Centers for Disease Control and Prevention guidelines for prescribing opioids for Chronic Pain.

 

iCAD, Inc. announced the first early-stage breast cancer patient was treated in Australia with intraoperative radiation therapy (IORT) using the Xoft® Axxent® Electronic Brachytherapy (eBx®) System®. The patient was treated at Monash Cancer Centre, a partnership between Peter MacCallum Cancer Centre and Monash Health, in Melbourne, Australia.

 

BrainStorm Cell Therapeutics will present data from its Phase 2 clinical study of NurOwn® in amyotrophic lateral sclerosis (ALS) at the International Society for Cellular Therapy (ISCT) annual conference in London, England on May 4th, and the World Advanced Therapy and Regenerative Medicine Congress in London, England on May 18th.

 

MediWound will release financial results for the three months ended March 31, 2017 at 7:00 a.m. Eastern time on May 8, 2017.

 

Gemphire Therapeutics announced that it will present a poster on gemcabene’s mechanism of action based on recent preclinical findings at the Arteriosclerosis, Thrombosis and Vascular Biology | Peripheral Vascular Disease (ATVB|PVD) 2017 Scientific Sessions, taking place in Minneapolis May 4-6, 2017.   The company also plans to release its financial results for the quarter ending March 31, 2017 on May 9, 2017.

 

Keryx Biopharmaceuticals announced that an additional large Medicare Part D plan sponsor has added Auryxia to its Medicare Part D plan formularies, effective June 1, 2017. Auryxia is currently indicated in the U.S. for the control of serum phosphorus levels in people with chronic kidney disease (CKD) on dialysis. Auryxia’s formulary status at this new Part D plan sponsor is effective for the remainder of 2017 and the full year 2018. The broad formulary status across Part D and commercial plans will support continuing growth of Auryxia in dialysis and provide access to Auryxia for people with iron deficiency anemia (IDA) and non-dialysis dependent (NDD) CKD, pending approval of this indication later this year.

 

Neurotrope announced positive top-line results from its Phase II study (-202 Study) of Bryostatin-1 in patients with moderate to severe Alzheimer’s disease (AD), a population not commonly targeted in AD clinical trials. Bryostatin-1, a Protein Kinase C epsilon activator that works through synaptic growth factors, as well as anti-amyloid and anti-tangle signaling pathways in the brain, has been shown, in non-clinical efficacy studies, to induce the growth of mature synapses in the brain and prevent neuronal death. Thus, Bryostatin-1 has a fundamentally different biological mechanism of action with the potential for longer lasting effects than the other currently marketed drugs for AD (e.g., donepezil (Aricept) and memantine (Namenda)).

 

Intra-Cellular Therapies provided a corporate update. “As part of our ongoing dialogue with the FDA regarding our lumateperone (also known as ITI-007) development program in schizophrenia, we requested guidance from the FDA on the acceptability of the two positive well controlled clinical trials we have conducted (Study ITI-007-005 and Study ITI-007-301), with supportive evidence from Study ITI-007-302, as the basis for the submission of a new drug application (NDA) for the treatment of schizophrenia.  In connection with this request we provided extensive information and data analyses to the FDA relating to the three studies.  The FDA has confirmed that the results of Study ITI-007-302 do not preclude us from submitting an NDA based on the efficacy studies we have conducted to date.  We are pleased with this response from the FDA and we believe our schizophrenia clinical development program collectively provides evidence of the efficacy and safety of lumateperone for the treatment of schizophrenia.”

 

Anthera Pharmaceuticals announced that it has filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation to effect a 1-for-8 reverse stock split of its common stock, effective as of April 28, 2017 at 5:00 p.m. Eastern Time. A Certificate of Amendment to effect a reverse stock split was approved by the Company’s stockholders at its Annual Meeting of Stockholders held on April 27, 2017, and the specific 1-for-8 ratio was subsequently approved by the Company’s Board of Directors.

 

Alkermes announced completion of patient enrollment in ENLIGHTEN-1, the first of two key phase III studies in the ENLIGHTEN clinical development program for ALKS 3831, an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of schizophrenia. The multinational, randomized, double-blind phase 3 study is designed to evaluate the antipsychotic efficacy of ALKS 3831 compared to placebo over four weeks in patients experiencing an acute exacerbation of schizophrenia. The study also includes a comparator arm of olanzapine, an established atypical antipsychotic agent with proven efficacy but also metabolic liabilities, including significant weight gain. Topline results from the study are expected in mid-2017. ALKS 3831 is designed to provide the strong antipsychotic efficacy of olanzapine with favorable weight and metabolic properties.

 

Revance Therapeutics announced that it is expanding the Company’s Phase II program investigating the use of DaxibotulinumtoxinA for Injection (RT002) for the management of plantar fasciitis from a single center to a multi-center study with protocol updates. Revance expects to report topline results from the Phase II study in the fourth quarter of 2017.

 

Janssen Research & Development announced it has submitted a sNDA to the FDA to update the prescribing information for XARELTO (rivaroxaban) to add a 10 mg dose to reduce patients’ risk of recurrent venous thromboembolism (VTE) after at least six months of standard anticoagulation therapy. This application is based on data from the EINSTEIN CHOICE study.

 

Takeda Pharmaceutical announced that ALUNBRIG (brigatinib) has received Accelerated Approval from the FDA for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under Accelerated Approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ALUNBRIG, which previously received Breakthrough Therapy Designation from the FDA, is a once-daily oral therapy that may be taken with or without food.

 

Summit Therapeutics announced the online publication of results from the Company’s Phase II clinical trial, called CoDIFy, in The Lancet Infectious Diseases. CoDIFy evaluated the Company’s novel antibiotic for the treatment of CDI, ridinilazole, against standard of care, vancomycin. The results showed ridinilazole demonstrated substantial clinical benefit over vancomycin. This included ridinilazole achieving statistical superiority over vancomycin in sustained clinical response (‘SCR’), a composite endpoint of cure at the end of treatment and no recurrence 30 days after treatment, a result which was driven by a large numerical reduction in infection recurrence.

 

Microbix Biosystems announced that it has consulted with the FDA regarding the Company’s plans to return its thrombolytic biologic drug, Kinlytic Urokinase, to the U.S. market.

 

AntriaBio announced that it has formally engaged Prosciento to conduct AntriaBio’s first-in-human clinical study of AB101, a once-weekly basal insulin for patients with diabetes mellitus. Prosciento, formerly known as Profil Institute for Clinical Research, is a clinical research organization (CRO) specializing in diabetes mellitus and other metabolic diseases. AntriaBio plans to file an IND application for AB101 with the FDA in June 2017 and subsequently initiate a Phase I clinical study that will assess the safety, pharmacokinetics and pharmacology of sequential single doses of AB101 in subjects with type 1 diabetes mellitus.

 

ImmunoGen announced that the results from a Phase I dose-escalation study evaluating mirvetuximab soravtansine (IMGN853) in patients with folate receptor alpha (FR?)-positive solid tumors were published in the journal Cancer. The previously disclosed data demonstrated encouraging clinical activity and a manageable safety profile for mirvetuximab soravtansine (IMGN853), and informed the dose that was used in Phase I expansion cohorts and the ongoing Phase III FORWARD I trial of patients with platinum-resistant ovarian cancer.

 

Cytokinetics announced that results from the dose escalation phase of COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), a Phase II trial evaluating omecamtiv mecarbil in patients with chronic heart failure, were presented at Heart Failure 2017, the annual congress of the Heart Failure Association of the European Society of Cardiology, held in Paris, April 29-May 2, 2017. The results were presented in a Rapid Fire Abstracts session by John Teerlink, M.D., professor of Clinical Medicine at the University of California San Francisco and director of Heart Failure at the San Francisco Veterans Affairs Medical Center. Omecamtiv mecarbil, a novel investigational cardiac myosin activator that increases cardiac contractility, is being developed by Amgen in collaboration with Cytokinetics for the potential treatment of heart failure.

 

Aeterna Zentaris announced that the ZoptEC Phase III clinical study of Zoptrex (zoptarelin doxorubicin) in women with locally advanced, recurrent or metastatic endometrial cancer did not achieve its primary endpoint of demonstrating a statistically significant increase in the median period of overall survival of patients treated with Zoptrex as compared to patients treated with doxorubicin.

 

Ampio Pharmaceuticals announced initiation of a single injection study to meet the "unmet medical need" of treating the severe pain and loss of function associated with Kellgren-Lawrence (KL) grade 4 osteoarthritis of the knee (OAK) with a primary endpoint that follows the Osteoarthritis Research Society International (OARSI) guidance, utilizing the Outcome Measures in Rheumatology Clinical Trials (OMERACT) OMERACT-OARSI responder rate.

 

Cerecor announced topline clinical results from a small, proof-of-concept clinical trial sponsored by the National Institute of Mental Health ("NIMH") of the National Institutes of Health. This was a Phase II trial of CERC-501, a potent and selective oral kappa opioid receptor ("KOR") antagonist, in treatment resistant depression ("TRD") conducted under the leadership of Dr. Maurizio Fava of Massachusetts General Hospital ("MGH").

 

Xenetic Biosciences announced that it is presenting a case study highlighting the Company’s proprietary drug development platform technology, PolyXen, at the 13(th) Annual PEGS Boston conference being held May 1 – 5, 2017 in Boston, MA.

 

TESARO announced the submission of an IND Application for TSR-033 to the FDA. TSR-033 is a monoclonal antibody targeting LAG-3.

 

DiaMedica Therapeutics announced that the USPTO has issued U.S. Patent No. 9,616,015, entitiled "Formulation of Human Tissue Kallikrein-1 for Parenteral Delivery and Related Methods" for DM199. The patent protects the methods of parenterally administrating DM199 to patients in need where absorption into the circulation via methods such as intravenous ("IV") or subcutaneous administration improves systemic pharmacokinetics ("PK"), bioavailability, safety, and/or convenience related to IV or other forms of administration. The patent has an expiration date of 2035, which does not include any potential patent term extension.

 

AmerisourceBergen announced that it has signed a new five-year agreement to supply pharmaceuticals to Express Scripts. The agreement extends through September 30, 2022. AmerisourceBergen and Express Scripts’ most recent supply agreement began in October 2012 and was set to expire in September 2017. The fiscal year 2016 revenue contribution from that agreement was approximately $23 billion.

 

Valeant Pharmaceuticals International announced that, following the earlier-than-expected closing of the sale of three skincare brands to L’Oréal and the closing of the divestiture of a manufacturing facility in Brazil, it has reduced its senior secured terms loans by approximately an additional $220 million as of Monday May 1, 2017.  In aggregate, the company has now reduced approximately $3.6 billion of debt from the end of first quarter 2016.

 

AmpliPhi Biosciences announced a new strategic emphasis on precisely targeted and personalized medicines designed to address the surging global threat posed by bacteria that have become resistant to antibiotics. Under existing compassionate-use guidelines, AmpliPhi expects to provide personalized phage therapies to patients suffering from severe, multidrug-resistant (MDR) infections who have failed prior therapies. In addition to offering hope to patients and families in dire need, the clinical data from these compassionate-use cases are expected to support the potential validation of the clinical utility of phage therapy and inform discussions with the FDA on defining a potential path to market approval.

 

22nd Century Group announced that the FDA has granted 22nd Century authorization to conduct a clinical trial studying the Company’s BRAND B, low tar-to-nicotine ratio cigarettes. This trial is designed to confirm that as smokers make the adjustment to a higher nicotine cigarette, they take in less smoke because the nicotine is more readily available. 22nd Century has engaged a Contract Research Organization with extensive experience in combustible cigarette exposure studies to conduct the BRAND B trial this summer.

 

Shire and Parion Sciences announced they have entered into an agreement granting Shire exclusive worldwide rights to develop and commercialize P-321. Shire will lead development of P-321, an investigational epithelial sodium channel (ENaC) inhibitor for the potential treatment of dry eye disease in adults, with the opportunity for Parion to co-fund.

 

VistaGen Therapeutics announced that its largest institutional stockholder, holding both common stock and substantially all (99.3%) of the Company’s outstanding preferred stock, entered into a 6-month lock-up agreement. Under the agreement, the stockholder and its affiliates agreed to not enter into any transaction involving the Company’s securities during the term of the agreement, which runs through late-October 2017 and covers approximately 36% of the Company’s issued and outstanding equity securities on an as converted basis.

 

CEL-SCI announced it has entered into a definitive agreement with one institutional investor for an offering of shares of common stock with gross proceeds of approximately $1.51 million in a registered direct offering. The closing of the offering is expected to take place on or about May 3, 2017, subject to the satisfaction of customary closing conditions. In connection with the offering, the CEL-SCI will issue approximately 13,199,000 registered shares of common stock at a purchase price of $0.115 per share. Concurrently in a private placement, the Company will issue warrants to purchase up to 9,899,250 shares of its common stock. For each share of common stock purchased in the registered direct offering, such investor in the private placement will receive from the CEL-SCI an unregistered warrant to purchase 0.75 share of common stock. The warrants have an exercise price of $0.1214 per share, will be exercisable upon the 6 month anniversary of the issue date, and will expire five and a half years from the issue date. Rodman & Renshaw, a unit of H.C. Wainwright & Co., LLC, is acting as the exclusive placement agent in connection with the offering.

 

Agios Pharmaceuticals announced that it has issued an additional 757,575 shares of common stock at the public offering price of $49.50 per share, for total gross proceeds of approximately $37 million, pursuant to the exercise in full of the underwriters’ over-allotment option in connection with the company’s previously announced public offering of common stock. After giving effect to the full exercise of the over-allotment option, the total number of shares sold by Agios in the public offering was 5,808,080 shares and gross proceeds were approximately $287 million. J.P. Morgan Securities and Goldman Sachs & Co. acted as joint book-running managers for the offering. Cowen and Company served as lead manager.

 

 

ANALYST RECOMMENDATIONS

 

Credit Suisse analyst Vamil Divan downgraded Corvus to “underperform” from “neutral” and decreased his price target to $10 from $17, citing limited near-term upside and recent underwhelming efficacy data.

 

Jefferies analyst Biren Amin increased his price target of Neurocrine to $67 from $65, citing encouraging Doc survey on Ingrezza across entire TD patient population.

 

Leerink analyst Joseph Schwartz initiated coverage of Audentes Therapeutics with an “outperform” rating and $22 price target, citing catalysts over the next 12 months have the potential to generate enthusiasm for the company’s approach, which appears derisked by strong preclinical animal model data.

 

BMO analyst Gary Nachman initiated coverage of Lannett with a “market perform” rating and $29 price target, citing LCI has a differentiated generics business that can offer better durability than some of its peers, as well as a solid pipeline that is not really factored in the stock.

 

Rodman & Renshaw analyst Joseph Pantginis initiated coverage of Aduro with a “buy” rating and $18 price target, citing Aduro is building a broad portfolio of immuno-oncology assets based on three platforms, LADD cancer vaccines; CDN "STING" platform; and B-select antibody platform.

 

BMO analyst Gary Nachman initiated coverage of Mylan with an “outperform” rating and $50 price target, citing despite significant headwinds with generics leading to a sector very much out of favor, longer term we see MYL as one of the best positioned generic companies to navigate through a challenging time and come out on top.

 

Credit Suisse analyst Vamil Divan decreased his price target of Alkermes to $70 from $78, citing an updated model after earnings. 

 

Following Exact Sciences’ earnings, Goldman Sachs analyst Isaac Ro increased his price target to $33 from $21; Stephens analyst Andrew Jones increased his price target to $28 from $24. 

 

Stifel analyst Adam Walsh increased his price target of Insmed to $27 from $23, citing bullish feedback from 3 KOLs.

 

Following MiMedx’s earnings, Craig Hallum analyst Matthew Hewitt increased his price target to $15 from $13; First Analysis analyst Joseph Munda increased his price target to $11 from $9.