TG Therapeutics announced the presentation of long-term follow-up data from the Phase 2 and open label extension, or OLE, trial of ublituximab, the company’s novel glycoengineered anti-CD20 monoclonal antibody, in relapsing forms of Multiple Sclerosis, or RMS. The data are being presented at the American Academy of Neurology. Ublituximab continues to be well tolerated, with a median duration of follow-up of 97.5 weeks. No subjects discontinued due to an adverse event, or AE, related to ublituximab on the Phase 2 or during the OLE. AEs deemed at least possibly related to ublituximab were infrequent during the OLE with all patients dosed 450mg of ublituximab administered in a one-hour infusion. Infusion related reactions, or IRRs, were rare during the OLE, occurring in only 4 patients, all Grade 1 or 2. These long-term safety data, and the Phase 2 efficacy data support the ongoing, fully enrolled, international Phase 3 program evaluating ublituximab for the treatment of RMS. The Phase 3 trials, entitled ULTIMATE I and ULTIMATE II, are being conducted under special protocol assessment, or SPA, agreement with the FDA.
Tuesday, May 7, 2019
Nautilus price target lowered to $5 from $8 at DA Davidson
DA Davidson analyst Michael Kawamoto lowered his price target on Nautilus to $5 and kept his Neutral rating after its Q1 earnings miss, saying the company continued to experience pressure from the weaker demand in its Direct product offering amid the “rapidly changing” exercise industry landscape. The analyst notes however that Nautilus management is untertaking several internal initiatives to improve trends, adding that he awaits signs of progress from these efforts before reconsidering his rating.
https://thefly.com/landingPageNews.php?id=2904831
https://thefly.com/landingPageNews.php?id=2904831
uniQure price target raised to $76 from $64 at SunTrust
SunTrust analyst Edward Nash raised his price target on uniQure to $76 after the company disclosed plans last week to present 24-week data from its ongoing Phase IIb study of AMT-061 in hemophilia B on May 10th . The analyst believes that the pre-clinical data should provide “additional validation” to uniQure’s “technology platform and research engine,” keeping his Buy rating on the shares.
Tactile Systems analyst commentary at Guggenheim
Tactile Systems price target raised to $100 from $95 at Guggenheim. Guggenheim analyst Chris Pasquale raised his price target for Tactile Systems Technology to $100 from $95 saying the company reported “strong” Q1 results. Even absent the revenue recognition change, sales would have still beaten by $1.6M and top line growth would have still topped 30% for the fourth time in the past five quarters, Pasquale tells investors in a research note. The analyst sees the quarter as further evidence that Tactile Systems is “still in the early stages of addressing a large market opportunity.” He believes this is not fully reflected in the stock at current levels and reiterates a Buy rating on Tactile Systems.
Health Insurance Innovations target lowered to $50 from $80 at Lake Street
Lake Street analyst Mark Argento lowered his price target for Health Insurance Innovations to $50 from $80 following the company’s Q1 results while keeping a Buy rating on the shares. Strong policy duration growth has been offset by lower new policy adds and higher duration and expenses in the last two quarters, which is likely to persist in Q2 given management’s updated quarterly guidance, Argento tells investors in a research note. The analyst points out that Health Insurance’s fiscal 2019 guidance is now increasingly back-end loaded.
Eidos Therapeutics raised to $51 from $28 at Roth Capital
Roth Capital analyst Yasmeen Rahimi raised her price target for Eidos Therapeutics (EIDX) to $51 from $28 driven by an increase in AG10’s annual price from $150,000 to $225,000 and Probability of Success adjustment from 70% to 80% after Pfizer’s (PFE) tafamadis received U.S. approval with a high sticker price of $225,000, two months ahead of schedule. The analyst believes this makes life easier for Eidos Therapeutics to maintain and even expedite enrollment into its Phase 3 ATTRibute-CM trial. Rahimi reiterates a Buy rating on Eidos Therapeutics shares.
https://thefly.com/landingPageNews.php?id=2904755
https://thefly.com/landingPageNews.php?id=2904755
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