Top Pick of the Day: FMI

Foundation Medicine Inc. (Nasdaq: FMI) announced inking a new deal with Kura Oncology for supporting enrollment in its its Phase 2 clinical trial evaluating farnesylation inhibitor tipifarnib in patients with treatment-resistant HRAS-mutant squamous cell carcinoma of the head and neck (SCCHN). Under the terms of the collaboration, Foundation Medicine’s SmartTrials Precision Enrollment program will contact physicians treating individuals across the U.S. diagnosed with SCCHN whose tumors harbor HRAS mutations as detected in the course of routine clinical care.
The company stock gained over 1 percent in its past trading session, taking its Year to Date gains to 125 percent. The stock’12 months gain stands at over 82 percent.

Focus Ticker: SGMO

Sangamo Therapeutics Inc. (SGMO) announced that the FDA has given the Fast Track review designation to its in vivo gene editing product candidates SB-318 and SB-913. These drugs are meant to treat rare metabolic disorders. The designation entails that the agency will communicate frequently with the company to help streamline the approval process. SB-318 is designed to treat Mucopolysaccharidosis Type I while SB-913 Mucopolysaccharidosis Type II. These genetic diseases occur then enzymes needed to break down large sugar chains in bodily tissues are not present and subsequently damage the tissue.
The news was taken positively by the company stock which has gained over 211 percent this year so far while its 12 months gain stands at 53 percent.

Sector News

Anthem (ANTM) reported filing a civil suit against Insys Therapeutics (INSY). The company alleged that the latter company undertook “fraudulent schemes” to secure reimbursement for its Subsys product. Anthem also said that it paid more than $19 million for Subsys prescriptions that should not have been reimbursed as a result of the fraud.

Holozyme (HALO) announced that Roche’s Genentech unit has started a Phase 1b/2 clinical trial assessing the combination of PEGPH20 and TECENTRIQ (atezolizumab) in patients with metastatic pancreatic ductal adenocarcinoma, the most common type of pancreatic cancer. Holozyme and Genentech are collaborating to test the combination in Roche's cancer immunotherapy development platform MORPHEUS.

Approvals

Mylan (MYL) announced that an FDA advisory committee has unanimously recommended the approval of the generic version of Roche’s Herceptin breast cancer drug. Mylan developed the proposed biosimilar trastuzumab in collaboration with its Indian partner Biocon. Trastuzumab is under review in several other countries including Europe, Canada and Australia.

Johnson & Johnson (JNJ) announced receiving the FDA approval for its TREMFYA (guselkumab) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Guselkumab is a human monoclonal antibody that binds to interleukin 23 (IL-23), a pro-inflammatory cytokine.

Deals and Collaborations

Teledyne (TDY) announced its new deal to acquire Scientific Systems. The companies did not disclose the financial terms of the deal. Scientific Systems is a manufacturer of precision components and specialized subassemblies used in analytical and diagnostic instrumentation.

Vertex Pharmaceuticals (VRTX) announced inking a new deal with the Italian Medicines Agency. Under this agreement, the Italian agency has agreed to reimburse ORKAMBI (lumacaftor/ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis in people ages 12 and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator gene.