|Collegium Announces FDA Advisory Committee Meeting for Xtampza ER; Intrexon and Synthetic Biologics Enter ECC to Develop Novel Biotherapeutics for Treatment of Phenylketonuria|
|By Josh Gee|
|Monday, 10 August 2015 21:27|
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 10, 2015.
Collegium Pharmaceutical, Inc. (NASDAQ: COLL) announced a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) is scheduled to review the Company's New Drug Application (NDA) for Xtampza™ ER (oxycodone extended-release capsules) on September 11, 2015.
Xtampza ER, Collegium's lead product candidate, is an abuse-deterrent, extended-release, oral formulation of oxycodone. Xtampza ER is being developed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The Company's NDA submission for Xtampza ER was accepted for review by the FDA on February 10, 2015. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of October 12, 2015 for completion of its review of the Xtampza ER NDA.
"The upcoming FDA advisory committee meeting represents progress toward our goal of obtaining approval of Xtampza ER. We look forward to discussing the efficacy, safety and abuse-deterrent data included in our NDA with the Advisory Committee and will continue to work with the FDA through the review period," stated Michael Heffernan, CEO of Collegium.
Intrexon Corporation (NYSE: XON), a leader in synthetic biology, and Synthetic Biologics, Inc. (NYSE MKT: SYN), a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases, today announced an Exclusive Channel Collaboration (ECC) to pursue the development and commercialization of novel biotherapeutics for the treatment of patients with phenylketonuria (PKU), a serious and debilitating metabolic disorder. Through the ECC, the companies plan to utilize Intrexon's ActoBiotics™ platform providing a proprietary method of delivering therapeutic protein and peptides to the gastrointestinal (GI) tract through food-grade microbes.
"We are excited to build on our existing relationship with Intrexon through this new collaboration," commented Jeffrey Riley, Chief Executive Officer, of Synthetic Biologics. "We believe a biotherapeutics-based approach has great potential to provide relief for patients managing this devastating disease and an opportunity to improve upon current therapies that rely on constant dietary monitoring and drugs to increase phenylalanine breakdown. The development of these biotherapeutics expands our pipeline of products targeted for release in the GI tract without adverse impact on the natural balance of the patient's gut microbiome."
PKU is a genetic disease that begins at birth characterized by a deficiency in the liver enzyme that breaks down the essential amino acid phenylalanine (Phe), a building block of proteins normally obtained through the foods we eat. As a result, Phe accumulates in the body, becoming toxic and leading to serious health consequences, including profound mental retardation, brain damage, mental illness, behavioral problems, seizures, tremors, limited cognitive ability and hyperactivity. If left untreated, the most severe form of PKU leads to permanent cognitive damage. PKU affects more than 14,000 people in the U.S. and an estimated 50,000 people across developed nations globally. There is no existing cure for PKU, requiring patients to maintain a life-long treatment program and carefully controlled diet.
Samuel Broder, M.D., Senior Vice President and Head of Intrexon's Health Sector, said, "The goal of our collaboration is for our ActoBiotics™ program to deliver a key enzyme to facilitate the breakdown of phenylalanine and thereby prevent the toxicity in these patients." Dr. Broder added, "We are very pleased that Intrexon's suite of complementary technologies and proprietary industrial processes will facilitate our ECC partner, Synthetic Biologics, in the development of new therapies for PKU."
Aduro Biotech, Inc. (NASDAQ:ADRO) today reported financial results for the second quarter ended June 30, 2015. Net loss was $26.3 million for the second quarter of 2015, or $0.50 per share, and $42.9 million, or $1.61 per share, for the six months ended June 30, 2015, compared to net loss of $3.6 million, or $12.27 per share, and $11.4 million, or $38.61 per share respectively, for the same periods in 2014.
Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) today announced financial results and an operational update for the second quarter ended June 30, 2015.
Argos Therapeutics Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of fully individualized immunotherapies for the treatment of cancer based on the Arcelis® technology platform, today announced the initiation of a single-center pilot clinical trial of AGS-003 as a neoadjuvant immunotherapy in patients with localized renal cell carcinoma.
Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, announced today its financial results for the second quarter ended June 30, 2015.
Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based cancer diagnostics, announced today that it has entered into an agreement in principle (the "Agreement") to act as a "stalking horse" and acquire substantially all the assets and operations of Los Angeles based Response Genetics, Inc. (OTCQB:RGDX).
CareDx, Inc. (Nasdaq:CDNA), a molecular diagnostics company focused on the development and commercialization of clinically differentiated, high value, non-invasive surveillance solutions for transplant recipients, today reported financial results for the second quarter ended June 30, 2015.
Cara Therapeutics, Inc. (NASDAQ:CARA), a biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors, today announced financial results for the second quarter ended June 30, 2015, and provided a corporate update.
Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported business and financial highlights for the second quarter ended June 30, 2015.
Coherus BioSciences, Inc. (Nasdaq:CHRS), a leading pure-play, global biosimilars company with late-stage clinical products, today reported financial results and reviewed corporate events for the second quarter ended June 30, 2015.
Entellus Medical, Inc. (NASDAQ:ENTL), a medical technology company focused on the design, development and commercialization of products for the minimally invasive treatment of chronic and recurrent sinusitis patients in the physician office setting or operating room, today announced a collaboration with Fiagon NA Corporation, a manufacturer of the latest generation in innovative surgical navigation systems.
Intuitive Surgical, Inc. (Nasdaq:ISRG) today reported that equity awards approved by the Compensation Committee of the Board of Directors, which consists entirely of Independent Directors, were made to 30 new employees.
ICU Medical, Inc., (Nasdaq:ICUI), a leader in the development, manufacture and sale of innovative medical devices used in infusion therapy, oncology and critical care applications, today announced financial results for the second quarter ended June 30, 2015.
Kite Pharma, Inc. (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products for the treatment of cancer, today reported financial results for the quarter ended June 30, 2015.
Lion Biotechnologies, Inc. (Nasdaq:LBIO), a biotechnology company that is developing novel cancer immunotherapies based on tumor-infiltrating lymphocytes (TIL), today reported financial results for the second quarter and six months ended June 30, 2015.
Nanosphere, Inc. (NASDAQ:NSPH), a company enhancing medicine through targeted molecular diagnostics, today reported financial and operating results for the second quarter ended June 30, 2015.
Nature's Sunshine Products, Inc. (NASDAQ:NATR), a leading natural health and wellness company engaged in the manufacture and direct selling of nutritional and personal care products, today reported its financial results for the second quarter ended June 30, 2015.
Novavax, Inc., (Nasdaq:NVAX) a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced its financial results for the second quarter and six months ended June 30, 2015.
Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), today reported financial results for the second quarter of 2015.
Relypsa, Inc. (NASDAQ:RLYP), a biopharmaceutical company, and Vifor Fresenius Medical Care Renal Pharma Ltd. (VFMCRP), a common company of Galenica and Fresenius Medical Care, today announced they have entered into an exclusive partnership to commercialize Patiromer for Oral Suspension (Patiromer FOS), Relypsa's investigational medicine for the treatment of hyperkalemia.
Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced financial results for the second quarter ended June 30, 2015.
SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the launch of its Ventura™ NanoMetalene® transforaminal intervertebral body fusion device.
Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical stage biopharmaceutical company developing novel oncology drugs that primarily target cancer stem cells (CSCs) and tumor bulk, today reported financial results for the quarter ended June 30, 2015.
Swisher Hygiene Inc. (NASDAQ:SWSH), a leading service provider of essential hygiene and sanitizing solutions, announced today results for the three and six months ended June 30, 2015.
Vitae Pharmaceuticals, Inc. (NASDAQ:VTAE), a clinical-stage biotechnology company, today announced that it has initiated a Phase 1 multiple ascending dose clinical trial of VTP-43742, its wholly owned and first-in-class RORγt inhibitor product candidate for the treatment of autoimmune disorders, including psoriasis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis and multiple sclerosis, as well as numerous orphan indications.
ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) today announced financial results for the second quarter ended June 30, 2015, and provided an update on the company's recent activities.
Zogenix, Inc. (NASDAQ:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of central nervous system (CNS) disorders, provided a corporate update, and announced financial results for the second quarter ended June 30, 2015.