BioShares Biotechnology Clinical Trials (BBC): $19.59, -$0.12, -32.6% YTD

BioShares Biotechnology Products (BBP): $33.93, +$0.15, +10.1% YTD

 

 

MARKET COMMENTARY

 

Major U.S. stock index futures were mostly lower, while the dollar rose to its highest since February against the Japanese yen, ahead of the much awaited FOMC meeting this week. Federal Budget figures for November is on the economic calendar. European shares fell, pulled lower by weaker pharmaceutical stocks. Asian markets were also lower as Chinese stocks suffered their biggest fall in six months. Oil prices surged to their highest since mid 2015 after the world’s top crude producers agreed to cut output. Gold prices sank to their lowest in over 10 months.

 

 

MARKET HIGHLIGHTS

 

Advaxis announced that the company’s proprietary bacterial vector system, its Lm Technology™, was the focal point of a luncheon during the 1st Annual International Congress on Immunotherapies in Cancer: Focus on Practice-Changing Application on Dec. 10, 2016.  Advaxis Chief Scientific Officer Robert Petit, PhD, joined congress co-chairs Antoni Ribas, MD, PhD, Director of the Tumor Immunology Program, Jonsson Comprehensive Cancer Center and Naiyer Rizvi, MD, Director of Thoracic Oncology, to discuss Lm Technology and highlight the two newest applications of Advaxis’ Listeria monocytogenes bacterial vector system, ADXS-NEO and ADXS-HOT.

 

Eiger BioPharmaceuticals announced clinical and regulatory advances in the development of exendin 9-39 for the treatment of post-bariatric hypoglycemia (PBH).  Advances in the program included interim results of an ongoing Phase 2 multiple-ascending dose (MAD) study evaluating subcutaneous (SC) exendin 9-39 in post-bariatric surgical patients who experience dangerously low, postprandial blood glucose levels (hypoglycemia) known as PBH, plans to advance a newly developed novel liquid formulation of exendin 9-39, and granting of US orphan designation for exendin 9-39 in hyperinsulinemic hypoglycemia, a broad category of syndromes which includes PBH.  

 

BioTime announced that Co-Chief Executive Officer Michael D. West, Ph.D., is delivering a presentation at the Global Bioproduction Summit, December 12-13, at the Hilton San Diego Bayfront.  Dr. West’s presentation, “Methodologies for Human Cell Manufacturing from Pluripotent Stem Cells in the Application of Regenerative Medicine,” will be delivered on Tuesday, December 13, at 9:20 a.m. PST.

 

Achaogen announced that its lead product candidate, plazomicin, met the objective of non-inferiority compared to meropenem for the U.S. Food and Drug Administration (FDA) and achieved superiority for the European Medicines Agency (EMA) primary efficacy endpoints in the Phase 3 EPIC registration trial in patients with complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). In addition, in the Phase 3 CARE trial in patients with serious infections due to carbapenem-resistant Enterobacteriaceae (CRE) a lower rate of mortality or serious disease-related complications was observed for plazomicin compared with colistin therapy, one of the few remaining antibiotics for treatment of infections due to CRE.

 

Ignyta announced the appointment of Mr. Steven L. Hoerter to its board of directors, effective December 8, 2016. Mr. Hoerter will serve as an independent director, as well as a member of the nominating and corporate governance committee. The appointment increases the number of Ignyta directors from five to six.

 

Ophthotech Corporation announced that the pre-specified primary endpoint of mean change in visual acuity at 12 months was not achieved in its two pivotal Phase III clinical trials investigating the superiority of Fovista (pegpleranib) anti-PDGF therapy in combination with Lucentis (ranibizumab) anti-VEGF therapy compared to Lucentis monotherapy for the treatment of wet age-related macular degeneration (AMD). The addition of Fovista to a monthly Lucentis regimen did not result in benefit as measured by the mean change in visual acuity at the 12 month time point. Following the news, JP Morgan analyst Anupam Rama downgraded the stock to “neutral” from “overweight” and decreased his price target to $11 from $110; SunTrust analyst Yatin Suneja downgraded the stock to “hold” from “buy” and decreased his price target to $7 from $100; Chardan analyst Gbola Amusa downgraded the stock to “neutral” from “buy” and decreased his price target to $15 from $200.

 

The Board of Directors of Alexion Pharmaceuticals announced that it has named David Brennan as Interim CEO, effective immediately. Mr. Brennan is the former CEO and Executive Director of AstraZeneca PLC and has been a member of the Alexion Board of Directors since July 2014. Mr. Brennan succeeds David Hallal who has resigned for personal reasons, effective immediately. Mr. Hallal has also resigned from the Board. Spencer Stuart has been engaged to commence the search for a permanent CEO. In addition, the Board announced that David J. Anderson, the former Senior Vice President and CFO of Honeywell for 11 years, has joined the Company as CFO, effective immediately. Mr. Anderson succeeds Vikas Sinha, who has left Alexion to pursue other opportunities. The previously announced Audit and Finance Committee investigation is nearing completion. At this point in time, the Audit and Finance Committee’s investigation has not identified any facts that require the Company to update its previously reported historical results. The Company continues to assess these matters from an accounting, disclosure and internal controls perspective, and expects to file the Form 10-Q for the period ended September 30, 2016 in January 2017 or earlier.

 

Akorn announced that the FDA conducted a re-inspection of its Decatur, Illinois manufacturing facility from December 5, 2016 to December 9, 2016, with no Form 483 observations. The re-inspection was conducted to verify the implementation and effectiveness of Akorn’s responses to the observations from the June 2016 FDA inspection.

 

Immunomedics announced a novel immuno-oncology agent, (E1)-3s, that can direct a patient’s T cells, a type of white blood cells, to kill cancer cells with the cancer marker, the Trop-2 antigen, which can be enhanced by combining with an immune checkpoint inhibitor.

 

Emergent BioSolutions announced that Health Canada has approved the company’s NDS for its botulism antitoxin, BAT [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine)]. BAT is indicated for the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adults and pediatric patients. BAT was approved under the Extraordinary Use New Drug Regulations, which provide a regulatory pathway for products for which collecting clinical information for its intended use in humans is logistically or ethically not possible.

 

Axovant Sciences announced a new analysis of the data from a Phase IIb trial evaluating treatment with intepirdine (RVT-101), combined with standard of care donepezil, compared with donepezil plus placebo in people with mild-to-moderate Alzheimer’s disease. This analysis indicates that the addition of intepirdine to treatment was associated with reduced progression in dependence (as assessed by Dependence Level based on the Dependence Scale), suggesting that those in the study who received combination treatment spent more time in the earlier, less dependent stages of the disease. This analysis was presented in an oral session at the 2016 Clinical Trials in Alzheimer’s Disease (CTAD) Meeting in San Diego.

 

Seattle Genetics presented data from an ongoing Phase I clinical trial evaluating SGN-LIV1A for patients with metastatic breast cancer (MBC), with particular focus on triple-negative MBC (TN MBC), at the 39(th) San Antonio Breast Cancer Symposium (SABCS) taking place in San Antonio, Texas. SGN-LIV1A is an investigational antibody-drug conjugate (ADC) which consists of a LIV-1-targeted monoclonal antibody linked to the cell-killing agent monomethyl auristatin E (MMAE) by a protease-cleavable linker.

 

Corcept Therapeutics released efficacy data today from its Phase I/II trial of mifepristone to treat patients with metastatic (TNBC). The data were presented at the 2016 San Antonio Breast Cancer Symposium.

 

Reata Pharmaceuticals announced that, due to adverse market conditions, it has requested withdrawal of its Registration Statement on Form S-1 (File No. 333-214915) that was filed on December 6, 2016, with the SEC for a proposed underwritten public offering of shares of its Class A common stock. The Registration Statement has not been declared effective by the SEC, and no securities have been sold in connection with the offering described in the Registration Statement.

 

Inspyr Therapeutics announced that it has entered into definitive securities purchase agreements with institutional and accredited investors, led by a healthcare-dedicated fund, for the private placement of shares of convertible preferred stock and warrants to purchase shares of common stock resulting in gross proceeds of approximately $1.0 million. The offering is expected to close on or about December 14, 2016, subject to satisfaction of customary closing conditions.

 

Flexion Therapeutics announced it has submitted a NDA to the FDA for its lead investigational product candidate Zilretta (also known as FX006), which is being evaluated to treat patients with osteoarthritis (OA) of the knee. Zilretta has received Fast Track designation from the FDA, a designation granted to drugs intended to treat serious conditions with the potential to provide meaningful improvement over existing therapies. Since the Zilretta NDA is being submitted as a 505(b)(2) application, FDA has up to 74 days to inform Flexion if the submission has been deemed complete and permits a full review.

 

Soligenix announced SGX942 (dusquetide) has been granted Promising Innovative Medicine (PIM) designation in the United Kingdom (UK) by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of severe oral mucositis in head and neck cancer patients receiving chemoradiation therapy.

 

Calithera Biosciences announced that William D. Waddill has resigned as the company’s Senior Vice President and Chief Financial Officer due to his relocation outside Northern California. Mr. Waddill’s resignation will be effective on or about December 31, 2016 in order to facilitate a smooth transition.

 

Merck announced new interim data investigating Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in combination with Eisai’s microtubule dynamics inhibitor, HALAVEN (eribulin), in patients with metastatic triple-negative breast cancer (TNBC). Findings presented during the 2016 San Antonio Breast Cancer Symposium (SABCS) were based on interim data from 39 evaluable patients and showed an overall response rate (ORR) of 33.3% (n=13/39; 95% CI, 19.5-48.1), with one complete response and 12 partial responses (Abstract #: P5-15-02). ORR was similar between PD-L1-positive and -negative cohorts [PD-L1 positive=29.4% (n=5/17; 95% CI, 11.1-51.1); PD-L1 negative=33.3% (n=6/18; 95% CI, 14.1-54.6)]. HALAVEN and KEYTRUDA are not approved for use in combination.

 

Akebia Therapeutics announced that the Opposition Division (OD) of the European Patent Office (EPO) has revoked another of FibroGen‘s HIF-related patents. The patent, EP 1 633 333 (the ’333 patent), claimed various compounds that were purported to stabilize HIFα for treating or preventing various conditions, including iron deficiency and specific forms of anemia. This ruling follows Akebia’s challenge to FibroGen’s earlier European patent, EP 1 463 823, which was revoked in its entirety by the OD earlier this year.

 

Bayer AG and Versant Ventures announced the launch of BlueRock Therapeutics, a next-generation regenerative medicine company that plans to develop best-in-class induced pluripotent stem cell (iPSC) therapies to cure a range of diseases using an industry-leading platform. BlueRock Therapeutics will be led by a world-class team and has assembled its platform through a series of strategic partnerships with academia and industry.

 

Galena Biopharma announced that two posters were presented at the San Antonio Breast Cancer Symposium (SABCS).

 

KaloBios Pharmaceuticals announced that the company recently completed a face-to-face meeting with FDA to review its proposed development plans for benznidazole in the treatment of Chagas disease, a neglected tropical disease. With the meeting, FDA’s Division of Anti-Infective Products addressed the company’s questions and provided guidance on preparation of an acceptable package for benznidazole.

 

Endo International announced that one of its operating companies, Par Pharmaceutical, has begun shipping ezetimibe 10 mg tablets, the generic version of Merck‘s ZETIA. Par Pharmaceutical is the marketer and distributor of the product in the U.S., and is entitled to Hatch-Waxman generic marketing exclusivity based on the first-to-file ANDA status of its licensing partners, Glenmark Pharmaceuticals, Inc., USA, with whom Par will share profits.

 

Neuralstem announced the closing of Tianjin Pharmaceutical Group International Holdings Co., LTD.‘s $20 million strategic investment. Upon the close of the transaction, Tianjin receives 28,500,000 shares of common stock and 1,000,000 shares of Series A convertible preferred stock. The preferred stock is convertible into 50,551,383 shares of the company’s common stock subject to certain beneficial ownership limitations. The transaction was initially announced on September 12, 2016.

 

Atara Biotherapeutics announced that it has reached agreement with the FDA on the designs of two Phase III trials for ATA 129 intended to support approval in the treatment of rituximab-refractory EBV-Associated Post Transplant Lymphoproliferative Disorder (EBV-PTLD) after hematopoietic cell transplant (HCT) or solid organ transplant (SOT). These two Phase III trials will support potential approvals in two separate indications.

 

RedHill Biopharma announced the top-line final results from its CEASE-MS Phase IIa proof-of-concept (PoC) clinical study evaluating fixed oral-dose RHB-104 in patients treated for relapsing-remitting multiple sclerosis (RRMS).

 

Elite Pharmaceuticals announced that it has filed an ANDA with the FDA for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets, USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. Norco is a combination medication and is used to help relieve moderate to moderately severe pain.

 

Pediapharm announced Health Canada’s approval of Otixal (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) otic solution for the treatment of acute otitis media with tympanostomy tubes ("AOMT") in pediatric patients (aged 6 months and older).

 

Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., announced the presentation of two posters highlighting the latest data on elenbecestat (development code: E2609), its in-house discovered Beta Amyloid Cleaving Enzyme (BACE) inhibitor. The posters were presented at the 9th Clinical Trials on Alzheimer’s Disease (CTAD) meeting in San Diego, California.

 

BioMarin Pharmaceutical announced that the company has initiated a global Phase III study for vosoritide, an analog of C-type Natriuretic Peptide (CNP), in children with achondroplasia, the most common form of dwarfism. The first child enrolled in the study was at a site in Australia.

 

Kite Pharma announced that characterizations of T cell receptor candidates which it has licensed under the Cooperative Research and Development Agreement (CRADA) with the NIH have been published in the December 8, 2016 New England Journal of Medicine (NEJM).

 

Tyme Technologies announced that it had completed enrollment of the Phase Ib portion of its open-label Phase Ib/II trial of SM-88 in patients with prostate cancer with rising Prostate-Specific Antigen (PSA) non-metastatic disease. The trial is designed to confirm SM-88′s earlier reported activity in reducing PSA.

 

Cellectar Biosciences announced that the USPTO has granted patent number 9,480,754 covering the method of use for CLR 1603 to treat breast, lung, colorectal and prostate cancers as well as their associated cancer stem cells. CLR 1603 consists of Cellectar’s proprietary phospholipid drug conjugate ("PDC") delivery platform technology using a unique chemical linker, conjugated to the chemotherapeutic agent paclitaxel.

 

New clinical study results presented at the San Antonio Breast Cancer Symposium demonstrate that Biovica’s DiviTum biomarker assay can evaluate the efficacy of the novel breast cancer drug palbociclib (Ibrance, Pfizer). The US study, performed by Dr Cynthia Ma, St Louis, investigated 50 women with clinical stage II or III estrogen receptor positive, HER2 negative breast cancer, treated with anastrozole in combination with palbociclib prior to surgery. DiviTum was used to measure levels of thymidine kinase (TK) activity, an enzyme closely linked to cell proliferation rate, in blood samples collected before and after treatment. Results demonstrate a highly significant correlation between the anti-proliferative effect of palbociclib and the reduction in TK levels measured by DiviTum post 2 weeks of adding palbociclib and at the time of surgery. The assay may thus serve as an early indicator of treatment response by CDK 4/6 inhibitors like palbociclib.

 

Alvogen has launched the first generic equivalent to Tamiflu (oseltamivir phosphate) capsules in the United States. Alvogen expects the generic equivalent to Tamiflu capsules to deliver significant savings for patients and health providers of up to $500 million during this upcoming season. The product is available in three strengths (30 mg, 45 mg and 75 mg).

 

Almirall and Nuevolution entered into a Strategic Collaboration to Develop RORγt Inhibitors for Treatment of Dermatology Diseases & Psoriatic Arthritis.

 

Nexvet Biopharma announced it has initiated a pivotal field efficacy and safety study of frunevetmab, the Company’s anti-nerve growth factor (NGF) monoclonal antibody (mAb) therapy which is being developed as a monthly subcutaneous injectable for the control of pain associated with osteoarthritis in cats. Nexvet expects to report data from both this study and a currently running pivotal target animal safety study of frunevetmab in the fourth quarter of calendar 2017.

 

CytoDyn announced the first several patients have been treated in the Company’s Phase III clinical trial with PRO 140 as a single-agent maintenance therapy in virally suppressed subjects with HIV.  PRO 140 is the Company’s proprietary fully humanized monoclonal antibody targeting the CCR5 entry receptor.

 

Sun Pharma and Moebius Medical have entered into an exclusive worldwide licensing deal to further develop MM-II, a novel pharmaceutical candidate for the treatment of pain in osteoarthritis.  MM-II is a novel non-opioid product that leverages the physical properties of proprietary liposomes to lubricate arthritic knee joints, thereby reducing friction and wear, consequently leading to joint pain reduction.

 

Cempra announced that the company has appointed board member David Zaccardelli, Pharm.D., as acting CEO and has promoted David Moore to the newly created position of president and chief commercial officer, effective immediately.

 

Immune Therapeutics announced with immense sadness the passing of Christopher Pearce, one of the founders of Immune Therapeutics and its COO. Mr. Pearce passed away after a 10-year battle with cancer.

 

 

ANALYST RECOMMENDATIONS

 

Chardan analyst Gbola Amusa upgraded Regeneron Pharmaceuticals to “neutral” from “sell” and increased his price target to $350 from $300, citing the underperformance in shares this year, as well as reduced risk to Eylea franchise following the failure of OPHT’s Fovista in wet AMD announced earlier this morning.

 

Credit Suisse analyst Kennen MacKay downgraded Seattle Genetics to “neutral” from “outperform” and increased his price target to $70 from $53, citing a best-in-class oncology pipeline, though we view the stock as fairly valued on a standalone basis following its ~+30% run following the US presidential elections.

 

Janney analyst Debjit Chattopadhyay assumed coverage of Ionis with a “neutral” rating and $48 price target, citing Ionis has turned itself around from the disappointments that followed the Kynamrohype cycle and disclosure issues surrounding it.

 

Piper Jaffray analyst David Amsellem downgraded Depomed to “underweight” from “neutral” and decreased his price target to $14 from $17, citing prescription trends for the commercial portfolio that heightens concerns that management will not be able to drive significant growth from the business in 2017+.

 

Rodman & Renshaw analyst Raghuram Selvaraju downgraded Cerecor to “neutral” from  “buy” and decreased his price target to $1 from $4, citing negative top-line results from the Phase 2 Clin501-201 trial of its second pipeline candidate, CERC-501, a small molecule antagonist of the kappa (κ) opioid receptor (KOR), in smoking cessation.

 

HC Wainwright analyst Shaunak K. Deepak initiated coverage of Dicerna Pharmaceuticals with a “buy” rating and $7 price target, citing Dicerna recently announced its intention to shift development its RNA interference (RNAi) programs to use its proprietary GalXC delivery platform.

 

UBS analyst Matt Miksic initiated coverage of MiMedx with a “sell” rating and $9 price target, citing many conversations with clinicians, we expect the launch of IART‘s Omnigraft to put competitive pressure on MDXG’s EpiFix over time.

 

Northland dropped coverage of the following companies, citing changes in personnel, AMAG, DEPO, ENDP, EVOK, IPXL, JAZZ, JNP, MNK, PRGO, SCMP,SHPG, and SUPN.