Leerink’s Geoffrey Porges and Assaf Vestin see continued dominance for Gilead Sciences (GILD) in hepatitis C after reviewing abstracts for the European Association for the Study of the Liver conference in April. They explain why:
We are positive onGilead with an Outperform rating, due in large part to success of its anti-viral programs including the significant cash generation of its HCV franchise. Every year, advances in the treatment and management of liver diseases are discussed at the European Association for the Study of the Liver (EASL) International Liver Conference (April 13-17). In anticipation of the meeting in Barcelona in two weeks, we reviewed the abstracts and discussed the communitys expectations for the meeting, with an eye on the potential impact on Gilead…
The main conclusions we draw from the abstracts (lacking information about late breakers) is that Gileads dominance of HCV seems secure for the immediate future, with sof/vel (sofosbuvir/velpatasvir) showing impressive efficacy in difficult-to-treat patient subsets. Competitors have early data for their new HCV development efforts (Merck (MRK) [MP], Johnson & Johnson (JNJ) [OP], AbbVie (ABBV)) but will not present new clinical data at this meeting.
Hot European Companies To Watch For 2017: Chiasma, Inc.(CHMA)
Chiasma, Inc., incorporated on April 12, 2001, is a biopharmaceutical company. The Company is engaged in developing and commercializing oral forms of therapies that are available only by injection. Using its Transient Permeability Enhancer (TPE) technology platform, the Company is developing oral therapies. The Company has completed a Phase III clinical trial of its TPE platform-based product candidate, oral octreotide capsules (trade named as MYCAPSSA) for the treatment of acromegaly, a condition that results in the body’s production of excess growth hormone. Octreotide is an analog of somatostatin, a natural inhibitor of growth hormone secretion.
The Company’s TPE technology enhances the absorption through the intestinal wall of drugs. Using its TPE technology, the Company can transiently and reversibly open the so-called tight junctions between the cells lining the inner intestinal wall, enabling drug molecules to be absorbed intact. Its TPE formulation is a suspension of water-soluble particles containing a precise combination of medium-chain fatty acid salts and drug substance in a fat-soluble medium. The Company is developing octreotide capsules as a liquid-filled solid gelatin capsule formulation, which is intended to be taken over twice a day. The Company has initiated a Phase III multi-center, open-label, baseline-controlled clinical trial to evaluate the safety and efficacy of octreotide capsules in patients with acromegaly who responded to and tolerated treatment with somatostatin analogs. The Company also focuses on developing CH2 for Orphan indication.
- [By Lisa Levin]
Chiasma Inc (NASDAQ: CHMA) was down, falling around 13 percent to $9.51 ahead of the U.S. Food and Drug Administration’s decision on Friday to approve or reject the company’s therapy. The status of its oral treatment for acromegaly, a capsule known as Mycapssa, will be in focus on Friday. The Street’s biotechnology expert Adam Feuerstein stated that an investor source believes the FDA will reject Chiasma’s capsules because data from a single-arm study failed to demonstrate a clinically meaningful benefit among patients.
Hot European Companies To Watch For 2017: Myriad Genetics, Inc.(MYGN)
Myriad Genetics, Inc. (Myriad), incorporated on November 6, 1992, is a molecular diagnostic company. The Company is engaged in the discovery, development and marketing of transformative molecular diagnostic tests. The Company operates through two segments: diagnostics and other. The diagnostics segment provides testing and collaborative development of testing that is designed to assess an individual’s risk for developing disease later in life, identify a patient’s likelihood of responding to drug therapy and guide a patient’s dosing to enable optimal treatment, or assess a patient’s risk of disease progression and disease recurrence. The other segment provides testing products and services to the pharmaceutical, biotechnology and medical research industries, research and development, and clinical services for patients, and also includes corporate services, such as finance, human resources, legal and information technology. Myriad offers diagnostic tests for a range of dise ases, such as Myriad myRisk Hereditary Cancer test for hereditary breast cancer, hereditary ovarian cancer, hereditary pancreatic cancer, hereditary uterine (endometrial) cancer and hereditary colon cancer; Myriad myPlan Lung Cancer test for lung cancer; Myriad myPath Melanoma test for melanoma; Prolaris test for prostate cancer, and Vectra DA for rheumatoid arthritis (RA).
Molecular Diagnostic Testing
The Company’s molecular diagnostic tests are designed to analyze genes, their expression levels and corresponding proteins. Myriad’s primary molecular diagnostic tests include myRisk Hereditary Cancer, a deoxyribonucleic acid (DNA) sequencing test for assessing the risks for hereditary cancers, such as breast cancer, ovarian cancer, colon cancer, uterine cancer, melanoma, pancreatic cancer, prostate cancer and gastric cancer; BRACAnalysis, a DNA sequencing test for assessing the risk of developing breast and ovarian cancer; BART, a DNA sequencing test for hereditary breast and ovarian cancer; BRACAnalysis CDx ! , a DNA sequencing test for use as a companion diagnostic with the poly (ADP-ribose) polymerase (PARP) inhibitor LynparzaTM (olaparib); Tumor BRACAnalysis CDx, a DNA sequencing test designed to be utilized to predict response to DNA damaging agents, such as platinum-based chemotherapy agents and PARP inhibitors; COLARIS, a DNA sequencing test for assessing the risk of colorectal and uterine cancer; COLARIS AP, a DNA sequencing test for assessing the risk of colorectal cancer; Vectra DA, a protein detection test for assessing the disease activity of rheumatoid arthritis; Prolaris, a ribonucleic acid (RNA) expression test for assessing the aggressiveness of prostate cancer; EndoPredict, an RNA expression test for assessing the aggressiveness of breast cancer; myPath Melanoma, an RNA expression test for diagnosing melanoma, and myPlan Lung Cancer, an RNA expression test for assessing the aggressiveness of lung cancer.
Pharmaceutical and Clinical Services
The Company provides a range of pharmaceutical and clinical services. Through its subsidiary, Myriad RBM, Inc., Myriad provides biomarker discovery and pharmaceutical and clinical services to the pharmaceutical, biotechnology and medical research industries utilizing its multiplexed immunoassay technology. The Company also owns Privatklinik Dr. Robert Schindlbeck GmbH & Co. KG, located approximately 15 miles from the Company’s European laboratories in Munich, Germany. The Company’s technology enables it to screen sets of well-characterized clinical samples from both diseased and non-diseased populations against its menu of biomarkers.
- [By Ben Levisohn]
We took in Walt Disney (DIS) earnings, Argus’ downgrade of Noble (NE), and Myriad Genetics’ (MYGN) freefall.
We looked at the speculation that International Paper (IP) could be a takeover target, and the progress made at Ralph Lauren (RL), and the slowing same-store sales at Shake Shack (SHAK).
5 Best Low Price Stocks To Invest In 2017: ZIOPHARM Oncology Inc(ZIOP)
ZIOPHARM Oncology, Inc., incorporated on May 16, 2005, is a biopharmaceutical company. The Company is seeking to acquire, develop and commercialize, on its own or with partners, a portfolio of cancer therapies through synthetic immuno-oncology. The Company’s clinical-stage product candidate, Ad-RTS-IL-12, is used with the oral activator veledimex. Its Ad-RTS-IL-12 + veledimex uses gene delivery system to produce interleukin-12 (IL-12), a potent, naturally occurring anti-cancer protein. The Company’s initial drug candidate being developed using the synthetic immuno-oncology platform is Ad-RTS-IL-12 + veledimex.
The Company in collaboration with Intrexon Corporation is focused on chimeric antigen receptor T cell (CAR+ T) products. The Company in collaboration with Intrexon plans to develop treatments for graft-versus-host disease (GvHD), a major complication of allogeneic hematopoietic stem-cell transplantation (HSCT), which impairs the quality of life and survi val of many recipients. Allogeneic HSCT is used for the treatment of various diseases, including hematological malignancies, immunological deficiencies, as well as non-malignant conditions. Approximately 40 to 60% of HSCT recipients develop GvHD, either acute or chronic, when immune (graft) cells in a transplant patient recognize their engrafted host as foreign and attack the patient’s (host) cells. Immunosuppressive agents and systemic steroids routinely used to treat GvHD have limited efficacy and toxicity. Human studies have shown that administration of low-dose subcutaneous IL-2 in patients with steroid-refractory GvHD acts through Tregs to ameliorate its manifestations.
Ad-RTS-IL-12 + veledimex
The Company’s Ad-RTS-IL-12 + veledimex has been evaluated in two Phase II studies, the first for the treatment of metastatic melanoma, and the second for the treatment of unresectable recurrent or metastatic breast cancer. The Company is evaluating Ad-RT S-IL-12 + veledimex, in brain cancer and breast cancer. It h! as developed an adenoviral vector, Ad-RTS-IL-12, administered intratumorally under the control of the RheoSwitch Therapeutic System (RTS) expression platform. Gene expression and subsequent IL-12 protein production is tightly controlled by the activator ligand veledimex.
Ad-RTS-IL-12 + veledimex for malignant glioma
The Company has initiated the Phase I study for malignant glioma. The Food and Drug Administration (FDA) granted orphan drug designation of Ad-RTS-IL-12 + veledimex for the treatment of malignant glioma.
Ad-RTS-IL-12 + veledimex for metastatic breast cancer and melanoma
The Company has completed the Phase II monotherapy studies in melanoma and breast cancer using Ad-RTS-IL-12 + veledimex. The Company has initiated a Phase Ib/II study of Ad-RTS-hIL-12 + veledimex following chemotherapy for the treatment of patients with locally metastatic breast cancer.
The Company competes with Novartis/University o f Pennsylvania, Bluebird bio/Celgene/Baylor College of Medicine, Kite Pharma/National Cancer Institute, Juno Therapeutics/Fred Hutchinson Cancer Research Center/Memorial Sloan-Kettering Cancer Center/Seattle Children’s Research Institute, Cellectis/Pfizer, Adaptimmune/GSK, Celgene, NantKwest, Amgen, AstraZeneca, Bristol-Myers, Incyte, Merck and Roche.
- [By Monica Gerson]
ZIOPHARM Oncology Inc. (NASDAQ: ZIOP) rose 10.43 percent to $7.73 in pre-market trading after the company offered data highlighting favorable interim survival results with Ad-RTS-hIL-12 in brain cancer.
Hot European Companies To Watch For 2017: Apollo Global Management, LLC(APO)
Apollo Global Management, LLC is a publicly owned investment manager. It primarily provides its services to endowment and sovereign wealth funds, as well as other institutional and individual investors. The firm manages client focused portfolios. It launches and manages hedge funds and mutual funds for its clients. The firm also manages real estate funds and private equity funds for its clients. The firm invests in the fixed income and alternative investment markets across the globe. Its alternative investments include investment in private equity and real estate markets. The firm’s private equity investments include traditional buyouts, recapitalization, distressed buyouts and debt investments in real estate, corporate partner buyouts, distressed asset, corporate carve-outs, turnaround, corporate restructuring, special situation, acquisition, and industry consolidation transactions. Its fixed income investments include income -oriented senior loan and bond, structured credit, opportunistic credit, non-performing loans and value oriented fixed income securities. The firm seeks to invest in chemicals; commodities; consumer and retail; oil and gas, metals, mining, agriculture, commodities, distribution and transportation; financial and business services; manufacturing and industrial; media distribution, cable, entertainment, and leisure; natural resources, energy, packaging and materials; and satellite and wireless. It seeks to invest in companies based in across North America with a focus on United States, and Europe. The firm also makes investments outside North America, primarily in Western Europe and Asia. The firm employs a combination of contrarian, value, and distressed strategies to make its investments. It conducts an in-house research to create its investment portfolio. The firm seeks to acquire minority positions in its portfolio companies. The firm seeks to make investments in the range of $200 million and $1.5 billion. Apollo Global Management, ! LLC was founded in 1990 and is headquartered in New York, New York with additional offices in Los Angeles, California; Purchase, New York; Houston, Texas; London, United Kingdom; Frankfurt, Germany; Luxembourg, Luxembourg; Hong Kong, Hong Kong; Singapore, Singapore; and Mumbai, India.
- [By Lisa Levin]
The Fresh Market Inc (NASDAQ: TFM) agreed be acquired by Apollo Global Management LLC (NYSE: APO) for $28.50 per share in cash.
In an approximately $1.4 billion in cash buyout, shareholders are set to receive $28.50 per share. This calculates to an approximately 53 percent premium over the February 10 closing price and an approximately 24 percent premium over last Friday’s closing price.
- [By Chad Tracy]
In 2008, Apollo Global Management (NYSE: APO) co-founder Joshua Harris was on a losing streak.
The firm's $430 million investment in big-box retailer Linens N' Things went south when the company filed for bankruptcy.
Hot European Companies To Watch For 2017: Calumet Specialty Products Partners L.P.(CLMT)
Calumet Specialty Products Partners, L.P. produces and sells specialty hydrocarbon products in North America. It operates in two segments, Specialty Products and Fuel Products. The Specialty Products segment processes crude oil and other feedstocks into various customized lubricating oils, white mineral oils, solvents, petrolatums, gelled hydrocarbons, cable fillers, natural petroleum sulfonates, waxes, and compressor lubricants. Its products are used in applications in a range of industries, such as industrial goods, including metal working fluids, belts, hoses, sealing systems, batteries, hot melt adhesives, pressure sensitive tapes, electrical transformers, refrigeration compressors, and drilling fluids; consumer goods, including candles, petroleum jelly, creams, tonics, lotions, coating on paper cups, chewing gum base, automotive aftermarket car-care products, lamp oils, charcoal lighter fluids, camping fuel, and various aerosol products; and automotive goods, such as motor oils, greases, transmission fluid, and tires. The Fuel Products segment processes crude oil into various fuel and fuel-related products, such as gasoline, diesel, jet fuel, and heavy fuel oils. This segment also offers fuel-related products, including fluid catalytic cracking feedstock, asphalt vacuum residuals, and mixed butanes. Calumet GP, LLC serves as the general partner for Calumet Specialty Products Partners, L.P. The company was founded in 1916 and is headquartered in Indianapolis, Indiana.
- [By Lisa Levin]
In trading on Friday, energy shares tumbled by 1.25 percent. Meanwhile, top losers in the sector included Southwestern Energy Company (NYSE: SWN), down 16 percent, and Calumet Specialty Products Partners, L.P (NASDAQ: CLMT), down 14 percent.