Friday, January 4, 2019
Generex plans breast cancer vaccine spinout and dividend
Generex President & CEO Joe Moscato stated, “NuGenerex Immuno-Oncology is being established to not only advance the NuGenerex Immuno-Oncology core technology, but also to expand the Company’s portfolio in the field of immunotherapy and personalized medicine through partnerships and acquisitions. As part of our strategy, we are exploring opportunities to spin-out NuGenerex Immuno-Oncology as a separate DTC-eligible SEC registered company.” Moscato stated that following the spin-out, NuGenerex Immuno-Oncology is expected to seek to list its common stock on a national stock exchange. “The spin-out of NuGenerex Immuno-Oncology into a separate, publicly traded entity has been the focus of the Generex strategic development plan in cancer drug development,” Moscato indicated. “The Ii-Key technology has been underappreciated for too long, as we have advanced the immunotherapy field with the largest breast cancer vaccine study ever conducted, and now the results of that trial have led to an exciting combination Phase II trial with AE37 plus Ketruda in triple negative breast cancer. We believe this spin-out will help to unlock the true value of the Ii-Key technology for our stockholders as it creates a pure play in immunotherapy, which will foster investment and collaboration.” The spin-out will be accomplished by the issuance of one or more dividends of NuGenerex Immuno-Oncology stock to Generex stockholders. Following the issuance of stock dividends, Generex expects to retain a controlling interest in NuGenerex Immuno-Oncology, but the exact proportion of the shares to be held by Generex has not yet been determined. Subject to market conditions and the satisfaction of regulatory requirements, it is expected that the NuGenerex Immuno-Oncology spin-out will occur sometime following the upcoming Annual Meeting of the Generex stockholders.
https://thefly.com/landingPageNews.php?id=2843985
Infinity Pharmaceuticals initiated at B. Riley FBR
Infinity Pharmaceuticals initiated with a Buy at B. Riley FBR. B. Riley FBR George Zavoico started Infinity Pharmaceuticals with a Buy rating and $3 price target. The company could “hold the key” to improving checkpoint inhibitors in cancer, Zavoico tells investors in a research note.
Piper insulin delivery survey shows Tandem gaining market share
Piper Jaffray conducted an insulin delivery survey in November consisting of 140 patients, physicians and certified diabetes educators, analysts led by JP McKim tell investors in a research note. The firm’s top three takeaways from the survey are that the introduction of automated insulin delivery systems will increase pump penetration from ~30% today up into the 40%-45% range, Tandem Diabetes (TNDM) is gaining market share from Medtronic (MDT) though both are going to benefit from the Animas exit, and smart pens are more attractive to current multiple daily injection users compared to those already on a pump. Piper keeps Overweight ratings on both Insulet (PODD) and Tandem given this backdrop. It believes near term upside remains the highest for Tandem.
Evelo Biosciences: First patient dosed in Phase 1/2 trial of EDP1503
Evelo Biosciences (EVLO) announced that it has dosed the first patient in its Phase 1/2 clinical trial of EDP1503 in combination with KEYTRUDA, Merck’s (MRK)anti-PD-1 therapy. EDP1503 is an orally delivered monoclonal microbial product candidate being developed for the treatment of cancer. This open-label clinical trial will evaluate the safety, tolerability, immune response markers, and overall response rates achieved with EDP1503 in combination with KEYTRUDA in up to 120 patients across three groups: microsatellite stable colorectal cancer; triple-negative breast cancer; and patients across multiple tumor types who have relapsed on prior PD-1/L1 inhibitor treatment. Patients will receive daily EDP1503 monotherapy for two weeks followed by treatment with daily EDP1503 in combination with KEYTRUDA. The study will evaluate biomarkers identified from paired biopsies taken before and after the two-week run-in, as well as clinical outcomes observed over the course of the trial. Evelo expects to report initial clinical data from the trial in the first half of 2020.
Piper sees ‘significant share appreciation’ potential for Ocular Therapeutix
Ocular Therapeutix expects top-line data from OTX-TP’s first Phase III glaucoma study in the first half of 2019, Piper Jaffray analyst Joseph Catanzaro tells investors in a research note. The analyst believes investors have discounted this program based on mixed Phase I/II data that utilized different formulations and study designs. However, he thinks the Phase III design gives OTX-TP the best chance at demonstrating clinical efficacy in this setting. A successful outcome will be statistically significant IOP-reductions over placebo at all time points and importantly, at least a 5 mm Hg reduction in IOP from baseline at 6 of the 9 time points, Catanzaro contends, citing his review of literature and a survey of ophthalmologists. He believes such an outcome would represent “another successful application of the hydrogel platform and drive significant share appreciation.” The analyst has an Overweight rating on Ocular Therapeutix with a $14 price target.
Regeneron upgraded to Buy from Neutral at Guggenheim
https://thefly.com/landingPageNews.php?id=2843583
Pacific Biosciences cut to Market Perform from Outperform at Cowen
https://thefly.com/landingPageNews.php?id=2843625
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