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July 24, 2017 By Alex Keown , BioSpace.com Breaking News Staff NEW YORK – As investors scour the internet for prognosticative information about which biotech stocks to back, one analyst is betting that two small cap oncology companies could demonstrate rallies that last until the end of the year . Writing in Seeking Alpha , Bret Jensen, the editor of the online publication’s Biotech and Insiders forums, pegged San Diego-based Ignyta ( RXDX ) and New York-based TG Therapeutics as two stocks to watch. Jensen said both companies are making progress with their respective pipelines and have both reported positive news in recent months. 1. Ignyta Since a May 3 low of $6.15, shares of Ignyta have climbed to a high of $11. Share prices have slipped a bit since that June 23 high to this morning’s price of $9.25 per share, as of 10:27 a.m. What sparked the growth of Ignyta’s stock was two bits of strong support from the U.S. Food and Drug Administration. In May, the FDA granted Ignyta’s cancer drug entrectinib a Breakthrough Therapy Designation. “for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumors in adult and pediatric patients who have either progressed following prior therapies or who have no acceptable standard therapies.” Entrectinib is the company’s investigational, orally available, CNS-active tyrosine kinase inhibitor targeting tumors that harbor NTRK1/2/3, ROS1, or ALK gene fusions, according to company data. The drug is currently in Phase II development. Earlier this month, the FDA also granted Orphan Drug designation to entrectinib or “ treatment of NTRK fusion-positive solid tumors .” NTRK fusions are molecular alterations that occur in a broad variety of adult and pediatric solid tumor types. In addition to entrectinib, Jensen also pointed to two other investigational drugs in Ignyta’s pipeline, RXDX-105 and Taledegib. RXDX-105, “an orally available, VEGF-sparing, potent RET inhibitor” is in a Phase Ib trial, Jensen said. Taledegib is a small molecule hedgehog/smoothened inhibitor, he added. Earlier this year, the company said it was exploring strategic options for Taledegib. In March, the company said it entered into an amended and restated license , development and commercialization agreement with Eli Lilly and Company for the Taledegib oncology program. 2. TG Therapeutics Since a March spike that saw share prices of TG Therapeutics leap from $5.60 per share to a high of $14.45 per share, company stock has been on a roller coaster ride. Shares of TG Therapeutics are trading at $12.45 as of 10:42 a.m. Since May, the company has had no shortage of positive data due to the strong results it has seen from its Phase III anti-CD20 monoclonal antibody TG-1101 and its triple combination treatment of TGR-1202, TG-1101 and ibrutinib (Imbruvia). In June, the company presented strong data for its Chronic Lymphocytic Leukemia treatment TG-1101 at the American Society of Clinical Oncology . At ASCO, TG Therapeutics said TG-1101 (ublituximab) combined with AbbVie ’s Imbruvica demonstrated an objective response rate of 78 percent in patients with high-risk CLL. TG-1101 works differently than other anti-CD-20 drugs, such as Rituxan. In the case of TG-1101, the drug is designed to target a unique CD-20 molecule that’s found on mature B-cells that makes it such a strong companion drug for Imbruvica. TG Therapeutics’ triple combination treatment has also seen positive results. Adding the company’s PI3K-delta inhibitor TGR-1202 to the combination of TG-1101 and Imbruvica, the company saw a 100 percent ORR by iwCLL criteria, as well as a high level of complete responses.

March 18, 2015 By Riley McDermid , BioSpace.com Breaking News Sr. Editor Israeli company Teva Pharmaceutical Industries Ltd. is once again rearranging its oncology portfolio, saying late Tuesday that it will sell four of its cancer assets to Ignyta in a deal valued at $41.6 million. As part of the switch, Ignyta will now own four of Teva ’s oncology assets: CEP-32496 (RXDX-105)--a Phase 1/2 small molecule inhibitor of BRAF, EGFR and RET; CEP-40783 (RXDX-106)--a preclinical pseudo-irreversible inhibitor of AXL and cMET; CEP-40125 (RXDX-107)--a preclinical nanoformulation of modified bendamustine and TEV-44229 (RXDX-108)--a preclinical selective inhibitor of the atypical kinase RKCiota plus next generation PKCiota inhibitors. “Acquiring these four development stage programs from Teva is truly transformational for Ignyta and well aligned with our strategic focus on developing first-in-class and best-in-class precision medicines to help cancer patients with unmet needs,” said Ignyta Chairman and Chief Executive Officer Jonathan Lim . Ignyta will pay for the group via a stock purchase agreement, which has Teva buying an additional 1.5 million shares of Ignyta at $10 per share. Other investors will buy an additional 2.7 million RXDX shares also at $10, valuing the total offering at $41.6 million. “These oncology programs add critical mass to our pipeline and further enable us to leverage our precision oncology platform, including our proprietary multiplex diagnostic assays and our CLIA certified, QSR compliant diagnostic laboratory,” said Lim. “Furthermore, these new assets complement our entrectinib development program and extend our ability to target the majority of known oncogenic drivers across multiple solid tumor indications,” he said. “For example, in non-small cell lung cancer alone, we believe that our product candidates have potential activity against many of the most frequent oncogenic drivers in this disease, and we plan to explore these opportunities through innovative clinical trial designs such as master protocols.” This is the second time this year Teva has switched around its cancer assets. On Feb. 17 Teva announced it has entered into a $120 million licensing agreement that will allow it to distribute and promote a competitor to its own cancer drug, Eagle Pharmaceuticals ‘s EP-3102. The news pushed Eagle ’s stock up over 13.8 percent in morning trading Tuesday. Eagle ’s non-Hodgkin’s lymphoma drug EP-3102 competes directly with Teva ’s Treanda, because both drugs target chronic lymphocytic leukemia. However, because EP-3102 is delivered via infusion, it is easier and faster to administer. The two companies said they will now settle a patent infringement lawsuit that had been brewing between them in U.S. District Court for the District of Delaware . Under the terms of the deal, Teva will shell out $30 million in cash, which will be followed by $90 million in additional milestone payments and double- digit royalties on sales. Teva will handle all regulatory approvals and both the costs and logistics associated with running clinical trials. “With a substantially shorter infusion time [than Treanda], Eagle ‘s rapid infusion bendamustine HCl represents an important and improved benefit to both patients and healthcare providers,” said Paul Rittman , vice president of oncology, in a statement. Teva also said Tuesday it will now waive its orphan-drug exclusivities for two diseases that EP-3102 also targets, a move which will put it in front of consumers much more quickly. Eagle already has submitted a new drug application for EP-3102, a rapid infusion bendamustine product for the treatment of patients with CLL and patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen, to the U.S. Food and Drug Administration (FDA) . Because of its efficacy in clinical trials, it had requested priority review, a nice boost for a product which has already received orphan-drug designation the seven years of patent exclusivity that go with that demarcation. Separately, the companies said they will settle a pending patent-infringement action between them in the U.S. District Court for the District of Delaware . “We are very pleased to partner with Teva for the commercialization of our rapid infusion bendamustine product,” said Scott Tarriff , president and CEO of Eagle Pharmaceuticals . “Given their strong presence and unsurpassed knowledge of this market, we believe there is no better company than Teva to optimize the market potential of this product.” BioSpace Temperature Poll After Amgen Inc. said last week that it will close its South San Francisco facility acquired during its $10 billion buyout of Onyx Pharmaceuticals and will lay off 300 of Oynx ’s 750 workers, BioSpace is wondering—will the number of mergers and acquisitions completed in 2014 mean a “streamlining” of biotech jobs in the Bay Area? 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