BioShares Biotechnology Clinical Trials (BBC): $18.48, +$0.13, -36.4% YTD

BioShares Biotechnology Products (BBP): $29.19, -$0.09, -5.3% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures rose ahead of the economic data releases later in the day, including consumer spending and consumption, Core PCE price index, Dallas Fed manufacturing business index and Chicago PMI. Anadarko Petroleum Corp and Tenet Healthcare are amongst several others scheduled to report quarterly results after the closing bell. European equities fell for a sixth straight session, with energy shares tracking weaker crude oil prices. Asian stocks closed lower. The dollar pared earlier losses attributed to news that the FBI was investigating fresh e-mails linked to U.S presidential candidate Hillary Clinton’s private computer server. Gold prices edged down.  

 

 

MARKET HIGHLIGHTS

 

Rexahn Pharmaceuticals announced that it has received a notice of allowance from the United States Patent and Trademark Office (USPTO) for a patent for claims related to the synthesis of its novel anti-cancer investigational drug candidate, RX-3117. RX-3117 is currently in stage 2 of a Phase Ib/IIa clinical trial in patients with metastatic pancreatic cancer.

 

Mateon Therapeutics announced two poster presentations at the 16th Biennial Meeting of the International Gynecologic Cancer Society, held October 29-31 in Lisbon, Portugal. The poster presentations highlighted previously presented data demonstrating results from the treatment of recurrent ovarian cancer with CA4P, and also provided an overview of Mateon’s Phase 2/3 FOCUS Study evaluating the addition of CA4P to current standard of care in patients with platinum-resistant ovarian cancer.

 

Aimmune Therapeutics announced that Stephen G. Dilly, M.B.B.S., Ph.D., Chief Executive Officer of Aimmune, will present a company overview at the 25th Annual Credit Suisse Healthcare Conference on Monday, November 7, and the 28th Annual Piper Jaffray Healthcare Conference on Tuesday, November 29.

 

Zogenix will report its financial results for the third quarter ended September 30, 2016 after the market close, and will host a corporate update conference call and webcast on Monday, November 7.

 

BioTime has appointed Jim Knight as Senior Vice President, Head of Corporate Development. He reports to Adi Mohanty, Co-Chief Executive Officer.  Mr. Knight will oversee business development, portfolio strategy and strategic marketing.

 

Gemphire Therapeutics announced that the European Patent Office has granted European Patent No. 2658536 “Gemcabene and Derivatives for Treating Pancreatitis” covering the use of gemcabene for decreasing the risk of developing pancreatitis in patients having a blood triglyceride level of 500 mg/dL or higher.

 

MediciNova announced that an abstract regarding MediciNova’s ongoing clinical trial of MN-166 (ibudilast) in ALS has been accepted for oral presentation at the 27th International Symposium on ALS/MND (amyotrophic lateral sclerosis/motor neurone disease) to be held December 7-9, 2016 in Dublin, Ireland.

 

Catalyst Pharmaceuticals announced that it has reached an agreement with the FDA under a SPA for the protocol design, clinical endpoints, and statistical analysis approach to be taken in Catalyst’s upcoming Phase III study evaluating Firdapse (amifampridine phosphate) for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS).

 

Bio-Techne reported fiscal 1Q17 non-GAAP EPS of $0.84, which compares to $0.79 for the same period a year ago. The company beat the First Call non-GAAP EPS mean estimate of $0.79. Total revenue for fiscal 1Q16 was $130.6, which compares to $112.4 million for the same period a year ago. This compares to a mean estimate of $127.5 million.

 

INC Research Holdings reported 3Q16 non-GAAP EPS of $0.64, which compares to $0.58 for the same period a year ago. The company beat the First Call non-GAAP EPS mean estimate of $0.63. Total revenue for 3Q16 was $259.6 million, which compares to $234.5 million for the same period a year ago. This compares to a mean estimate of $259.9 million.

 

Omeros announced that it has requested fast track designation from the FDA for the development of OMS721 for the treatment of patients with immunoglobulin A (IgA) nephropathy (also known as Berger’s disease). The company recently reported positive data (p = 0.017) from the company’s Phase II clinical trial of OMS721 for the treatment of kidney disorders, including IgA nephropathy, none of which currently have an approved treatment and all of which frequently lead to end-stage renal disease and dialysis. OMS721 significantly improved key endpoints of renal function and patients achieved partial remission with just 12 weeks of dosing. With similar outcomes in additional patients, the company plans to pursue accelerated approval. OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system.

 

OncoGenex Pharmaceuticals committed to a restructuring of a portion of the Company’s workforce in order to preserve the Company’s resources as it determines future strategic plans. As part of this restructuring, the Company will eliminate 16 positions, representing approximately 55% of the Company’s workforce. The Company expects the restructuring to be substantially complete in the first quarter of 2017. The Company currently anticipates incurring total restructuring costs of approximately $1.4 million, which includes severance, benefits and related costs of approximately $1.2 million and potential fixed asset impairments of approximately $0.2 million. The Company is continuing to review the potential impact of the restructuring, and is unable to estimate any additional restructuring costs or charges at this time.

 

Merck and Pfizer announced that the EMA has validated for review Merck’s MAA for avelumab, for the proposed indication of metastatic Merkel cell carcinoma (MCC), a rare and aggressive skin cancer, which impacts approximately 2,500 Europeans a year. Validation of the MAA confirms that submission is complete and begins the EMA’s centralized review process. If approved, avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, could be the first approved treatment indicated for metastatic MCC in the EU.

 

Regeneron Pharmaceuticals and Sanofi announced the FDA issued a CRL regarding the BLA for sarilumab, an investigational interleukin-6 receptor (IL-6R) antibody for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). The CRL refers to certain deficiencies identified during a routine good manufacturing practice inspection of the Sanofi Le Trait facility in France where sarilumab is filled and finished, one of the last steps in the manufacturing process. Satisfactory resolution of these deficiencies is required before the BLA can be approved. Sanofi submitted a comprehensive corrective action plan to the FDA and is implementing the corrective actions specified in that plan. Sanofi is working closely with the FDA towards a timely resolution that addresses these concerns. The CRL does not identify any concerns relating to the safety or efficacy of sarilumab. 

 

Merrimack Pharmaceuticals announced that the FDA has accepted for review the ANDA for generic doxorubicin hydrochloride (HCI) liposome injection submitted by its partner Actavis. This is the first product developed by Merrimack under a partnership agreement with Actavis pursuant to which Merrimack is responsible for the development and commercial supply of bulk drug product and Actavis is responsible for fill/finish activities, regulatory approvals and commercialization in the United States.

 

Caladrius Biosciences announced that the independent Data Safety Monitoring Board for its Phase II, The Sanford Project: T-Rex Study recommended that the trial proceed with the enrollment of the prescribed second cohort of subjects in the study to meet the target of 111 total participants. The Company’s decision to resume enrollment ahead of the original timeline represents an acceleration of the program. The decision was made in consultation with external clinical advisors based on a favorable safety profile for the first cohort of 19 subjects who reached their 28-day post-treatment follow-up. Sanford Research, the Company’s collaborator for the study, has agreed to extend operational support at its participating clinical sites for the remainder of the Study. The study is evaluating CLBS03 (the Company’s product candidate consisting of autologous expanded regulatory T cells, or Tregs) as a treatment for recent-onset Type I diabetes (T1D).

 

Ophthotech announced that the Phase IIb study results of Fovista (pegpleranib), the Company’s anti-PDGF agent administered in combination with Lucentis (ranibizumab) anti-VEGF therapy for the treatment of wet age-related macular degeneration (AMD), have been published online in Ophthalmology, the journal of the American Academy of Ophthalmology. The article in Ophthalmology from this prospective, randomized, controlled Phase IIb clinical trial of 449 patients with wet AMD, indicates that Ophthotech’s Fovista (1.5 mg), administered in combination with Lucentis, met the pre-specified primary efficacy endpoint of mean change in visual acuity. Patients receiving the combination of Fovista (1.5 mg) and Lucentis (0.5 mg) gained a mean of 10.6 letters of vision on the ETDRS standardized chart at 24 weeks, compared to 6.5 letters for patients receiving Lucentis monotherapy (p=0.019). This represents a 62% additional benefit from baseline. No significant safety issues were observed for either treatment group in the trial.

 

ARIAD Pharmaceuticals announced that the FDA has accepted for review the NDA for ARIAD’s investigational oral anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, in patients with metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC) who have progressed on crizotinib. The FDA granted ARIAD’s request for Priority Review and has set an action date of April 29, 2017 under the PDUFA.

 

Eagle Pharmaceuticals announced initial results from the preclinical study conducted by Eagle at the National Institute on Drug Abuse ("NIDA")/National Institutes of Health ("NIH") exploring the use of Ryanodex in the treatment of hyperthermia related to MDMA ("Ecstasy") intoxication. The study was conducted in the summer of 2016 utilizing a well-characterized animal model.

 

NanoViricides announced that it has entered into an agreement with SUNY Upstate Medical University for the testing of its nanoviricides drug candidates against varicella zoster virus, i.e. the shingles virus.

 

vTv Therapeutics Inc. and vTv Therapeutics LLC entered into a venture loan and security agreement with Horizon Technology Finance Corporation and Silicon Valley Bank under which the Company and vTv LLC may borrow up to $25.0 million in three tranches of $12.5 million, $7.5 million and $5.0 million, respectively.

 

Memorial Sloan Kettering Cancer Center, The Rockefeller University and Weill Cornell Medicine announced that they have established a new drug discovery company called Bridge Medicines. Launched in partnership with Takeda Pharmaceutical Company Ltd. and healthcare investment firms Bay City Capital and Deerfield Management, Bridge Medicines is a groundbreaking initiative that completes a seamless, fully funded and professionally staffed path from concept to drug candidate to efficiently and rapidly develop innovative therapeutics for treating human diseases.

 

Aclaris Therapeutics announced that it has submitted an IND to the FDA for its drug candidate ATI-50001 for the treatment of alopecia universalis and alopecia totalis. Aclaris plans to conduct a human pharmacokinetic/pharmacodynamic (pK/pD) study to evaluate the safety of ATI-50001 in healthy volunteers.

 

FibroGen reported completion of enrollment in its Phase III clinical trials in China for roxadustat (FG-4592) in chronic kidney disease (CKD) patients suffering from anemia. The program includes trials in both CKD patients on dialysis and CKD patients not on dialysis.

 

Bio-Techne announced that its Board of Directors has decided to pay a dividend of $0.32 per share for the quarter ended September 30, 2016. The quarterly dividend will be payable November 28, 2016 to all common shareholders of record on November 14, 2016. Future cash dividends will be considered by the Board of Directors on a quarterly basis.

 

Selecta Biosciences announced that results from preclinical studies involving SVP-Rapamycin, the company’s novel immunotherapeutic, were presented by its collaborators Ira Pastan, MD, Chief of the Laboratory of Molecular Biology, and Ronit Mazor, Ph.D., Postdoctoral Fellow at Center for Cancer Research at the National Cancer Institute (NCI), part of the National Institutes of Health.

 

Intec Pharma announced that the State Intellectual Property Office of the People’s Republic of China (SIPO) has granted a Chinese patent for an Accordion Pill containing certain drugs, including the combination of Carbidopa and Levodopa. The patent, granted under No. ZL 200980120103.9, is titled "Carbidopa/Levodopa Gastroretentive Drug Delivery" and is currently scheduled to remain in force until April 2029. The patent belongs to the Company’s IN-7 patent family, which already includes patents granted in the U.S., Europe and Israel.

 

Intra-Cellular Therapies announced presentation (in oral and poster forms) of results from its clinical development program in schizophrenia that has replicated the efficacy of ITI-007 60 mg in two studies and found it to be safe and well tolerated in three large, well-controlled clinical trials: ITI-007-005, ITI-007-301 and ITI-007-302. Results from these trials were presented at the CNS Summit 2016 Annual Conference, held in Boca Raton, Florida October 27-30.

 

Eisai announced that enrollment has begun in the U.S. for MISSIONAD, a Phase III clinical program for E2609, a Beta-secretase Cleaving Enzyme (BACE) inhibitor for patients with early Alzheimer’s disease. E2609 was discovered by Eisai and is being jointly developed by Eisai and Biogen as a potential Alzheimer’s disease (AD) modifying treatment.

 

Eisai and Purdue Pharma L.P. announced the initiation of a multi-center, randomized Phase II clinical study (Study 202) to evaluate Eisai’s internally-discovered oral dual orexin receptor antagonist lemborexant (E2006) in patients with mild to moderate Alzheimer’s disease dementia (AD) who suffer from Irregular Sleep-Wake Rhythm Disorder (ISWRD). Lemborexant is being jointly developed by Eisai and Purdue Pharma L.P.

 

Regen BioPharma announced its strategy for developing its novel NR2F6 small molecule modulators. Regen has recently filed a composition of matter patent application covering these novel NR2F6 small molecule modulators.

 

Lattice Biologics announced it has formed a new strategic alignment with AllianceMed. As a third-party revenue cycle management company, AllianceMed serves as an advocate for physicians, medical professionals, and surgery facilities to increase the profitability of providing out-of-network benefits to patients. This partnership will help make Lattice’s all natural AmnioVisc amnio viscosupplement available to a greater number of osteoarthritis joint pain sufferers while increasing reimbursement potential for providers.

 

Hemispherx Biopharma announced that a retrospective analysis of the AMP-516 Phase III trial of Ampligen in patients with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), segmented primarily by disease duration, showed that 51% of Ampligen treated patients in a cohort with a disease duration of two to eight years vs. 18% of placebo patients demonstrated at least 25% improvement in placebo-adjusted exercise tolerance whereas the patient subset with less than two years or greater than eight years of disease duration failed to show a clinically-significant response. The data analysis was presented at the 12th International IACFS/ME Research and Clinical Conference: Emerging Science and Clinical Care in Fort Lauderdale, FL, October 27-30, 2016.

 

Theravance Biopharma announced the presentation of interim data from the Company’s ongoing Telavancin Observational Use Registry (TOUR) study. TOUR is designed to assess how VIBATIV (telavancin) is being used by healthcare practitioners to treat patients in real-world settings. An initial review of data from the first 200 patients enrolled in TOUR demonstrate clinical response rates of 74% in a range of difficult-to-treat infection types including the drug’s approved indications of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) and complicated skin & skin structure infections (cSSSI). Other serious infections reported to the TOUR database included bone and joint infections and bacteremia. Results show 17% of all patients were considered non-evaluable with 9% deemed to have failed treatment. Clinical response was defined as cure or improvement leading to step-down oral therapy. In addition to clinical response, reported data also provide an overview of the types of patients that are receiving VIBATIV treatment in real-world clinical settings. Findings show that the most frequent primary infections being treated with the drug are cSSSI (44%), bone and joint infections (30%), bacteremia (13%) and pneumonia (6%). For these infections, the underlying pathogen was most often identified as methicillin-resistant Staphylococcus aureus (S. aureus) or MRSA (51%), methicillin-susceptible S. aureus or MSSA (15%) and coagulase negative staphylococci (10%). VIBATIV was generally well tolerated. Of the 199 patients with safety data, there were 47 adverse events (AE) reported in 34 patients.

 

ACADIA Pharmaceuticals announced the initiation of SERENE, a Phase II study with pimavanserin for the treatment of agitation in patients with Alzheimer’s disease (AD Agitation). There is currently no drug approved by the FDA for the treatment of AD Agitation. Pimavanserin is a selective serotonin inverse agonist (SSIA) preferentially targeting 5-HT(2A) receptors, with a distinct mechanism of action compared to other currently available medicines used off-label to treat AD Agitation.

 

Capricor Therapeutics announced detailed results from its DYNAMIC clinical trial of CAP-1002 in patients with advanced heart failure. The results were featured at a poster session held on Saturday, October 29th at the 28th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, in Washington, D.C. Capricor had announced top-line 12-month data from DYNAMIC in June. CAP-1002 is Capricor’s investigational allogeneic cardiosphere-derived cell (CDC) therapy.

 

Telesta Therapeutics announced the closing of its previously announced plan of arrangement with ProMetic Life Sciences, pursuant to which ProMetic has acquired all of the issued and outstanding common shares of Telesta.

 

Novogen announced that it has entered into a worldwide licensing agreement with Genentech, a member of the Roche Group, to develop and commercialize GDC-0084, a small molecule inhibitor of the phosphoinositide-3-kinase (PI3K) pathway. The lead indication for GDC-0084 is glioblastoma multiform (GBM), which is the most aggressive form of brain cancer, accounting for approximately 15% of primary brain tumors. In other company news, Novogen announced that it has fully-acquired Glioblast Pty. The transaction includes an upfront payment of AU$ 2.1 million, comprising AU$600,000 in cash and ordinary fully-paid shares valued at AU$ 1.5 million, with the actual number of shares determined on the basis of the volume-weighted average price of Novogen shares on the ASX in the seven days prior to this announcement. The shareholders of Glioblast will be eligible for further payments in cash or equity on the achievement of performance-related milestones. The first two of these milestones provide for the issue of ordinary fully-paid shares valued at AU$ 1.25 million respectively on commencement and successful completion of a Phase II clinical trial of GDC-0084, with the actual number of shares determined on the basis of the volume-weighted average price of Novogen shares on the ASX in the seven days prior to satisfaction of the relevant milestone being announced. A further two milestones may trigger payments in cash or equity at Novogen’s sole discretion. Any issue of equity in Novogen will be subject to a minimum six-month escrow period.

 

Xbrane has received advice from BfArM, the German Federal Institute for Drugs and Medical Devices, with regards to the clinical and regulatory aspects of the Company’s planned submission of a MAA for Spherotide 1-month formulation for the European Union. A Market Authorization in EU would enable Xbrane to sell and market Spherotide in Europe and would serve as a base and facilitator for the approval process in other regions.

 

Third Rock Ventures announced the closing of Third Rock Ventures IV, LP, raising $616 million in an oversubscribed fund. With Fund IV, the firm will continue to execute on its strategy of creating innovative healthcare companies to make a meaningful difference in the lives of patients and their families. Since launching in 2007, Third Rock has raised $1.9 billion – including Fund IV – for building transformative companies with a particular emphasis in areas such as oncology, immunology, neurological disorders, cardiovascular disease and rare genetic diseases.

 

Foundation Medicine and Sarah Cannon Research Institute announced a collaboration focused on advancing personalized medicine utilizing molecular information for patients across Sarah Cannon’s cancer programs in the United States. The organizations will gather results from Foundation Medicine’s full suite of comprehensive genomic profiling (CGP) assays to personalize treatment options for patients and to ultimately support improved outcomes.

 

Epizyme announced that it has entered into two Cooperative Research and Development Agreements (CRADAs) with the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI). The CRADAs will evaluate tazemetostat, Epizyme’s first-in-class EZH2 inhibitor, and pinometostat, the Company’s first-in-class DOT1L inhibitor. Both investigational medicines target proteins implicated in the development and regulation of cancer.

 

 

ANALYST RECOMMENDATIONS

 

Credit Suisse analyst Vamil Divan upgraded Teva Pharmaceuticals to “outperform” from “neutral” and decreased his price target to $52 from $59, citing most of the risk around Copaxone and the US generics market is now priced into the shares.  

 

Piper Jaffray analyst Charles Duncan initiated coverage of Alder Biopharmaceuticals with an “overweight” rating and $47 price target, citing the anti-CGRP class could usher in a paradigm shift for migraine prophylaxis and there are multiple ways to win in this large and underserved market.

 

Cowen analyst Tyler Van Buren upgraded Innoviva to “outperform” from “market perform” and increased his price target to $15 from $13, citing the commercial prospects for Breo and Anoro remain stronger than ever heading into next year.

 

Following Sanofi’s earnings, Leerink analyst Seamus Fernandez increased his price target to €91 from €87; Alliance Bernstein analyst Tim Anderson increased his price target to $43 from $42.

 

Mizuho analyst Irina Koffler decreased her price target of Horizon Pharma to $29 from $33, citing a more price sensitive environment and increased rebates.

 

Following AbbVie’s earnings, Credit Suisse analyst Vamil Divan downgraded the stock to “neutral” from “outperform” and decreased his price target to $60 from $70; Goldman analyst Jami Rubin decreased her price target to $74 from $78; Leerink analyst Geoffrey Porges decreased his price target to $69 from $70; Deutsche Bank analyst decreased his price target to $60 from $66; BMO analyst Alex Arfaei decreased his price target to $63 from $67; JP Morgan analyst Chris Schott decreased his price target to $70 from $73.