Monday, December 17, 2018
Taiwan Liposome initiated at Janney Montgomery Scott
Taiwan Liposome initiated with a Buy at Janney Montgomery Scott. Janney Montgomery Scott analyst Esther Hong initiated Taiwan Liposome with a Buy rating and $13 fair value estimate, noting that the company has developed two proprietary lipid technology platforms and four clinical stage compounds across pain management, ophthalmology, and oncology. He estimates TLC599, the furthest along in development, has the potential for U.S. sales of $720M in 2028 and believes Taiwan Liposome will be a commercial stage company within a few years.
https://thefly.com/landingPageNews.php?id=2837827
UroGen Pharma initiates rolling submission of NDA for UGN-101
UroGen Pharma announced that it has initiated the rolling submission with the U.S. Food and Drug Administration of the New Drug Application for UGN-101 for instillation as a treatment for patients with low-grade upper tract urothelial cancer. The company expects to complete its NDA submission by mid-2019, with potential approval in 2019. The NDA submission is supported by clinical data from the Phase 3 OLYMPUS clinical trial of UGN-101 for the non-surgical treatment of LG UTUC. Results from an interim analysis were presented at the American Urologic Association Annual Meeting in May 2018. UroGen plans to present topline data from the OLYMPUS study in January 2019. The FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to UGN-101 for the treatment of UTUC. If approved, UGN-101 would be the first drug approved for the non-surgical treatment of LG UTUC.
https://thefly.com/landingPageNews.php?id=2837833
Tiziana Therapeutics initiated at Laidlaw
Tiziana Therapeutics initiated with a Buy at Laidlaw. Laidlaw analyst Francois Brisebois initiated Tiziana Therapeutics with a Buy and $17 price target saying the main value driver consists of Foralumab in development as a potential treatment for large unmet medical needs such as NASH. While Foralumab remains in Phase 1, Brisebois sees their fully human oral anti-CD3 mAb as relatively de-risked as fully murine OKT3 showed encouraging immunological trends in a previous Phase 2 trial in NASH. The analyst said 2019 is setting up as a catalyst year with potential data readouts in both their oral and intranasal Foralumab trials as well as their Phase 2a monotherapy.
https://thefly.com/landingPageNews.php?id=2837835
Teva announces FOCUS study met primary, secondary endpoints
Teva Pharmaceutical Industries announced positive topline results from the Phase IIIb FOCUS study that evaluated the efficacy and safety of fremanezumab for the preventive treatment of migraine in adult patients who previously experienced inadequate responses to two to four classes of preventive treatments. In the study of 838 patients, including those who suffer from either chronic or episodic migraine, patients treated with fremanezumab experienced highly significant reduction in the monthly average number of migraine days versus placebo over the 12 week assessment period, for both monthly and quarterly dosing regimens. In addition, patients treated with fremanezumab experienced significant improvement compared to placebo on all secondary endpoints for both quarterly and monthly dosing regimens. There were no safety signals detected in the study. Teva plans to submit the full results for medical meetings in 2019, as well as peer-reviewed publication. The Phase IIIb FOCUS study is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study that evaluated the efficacy, safety, and tolerability of quarterly and monthly treatment with fremanezumab, compared to placebo. Adult patients with chronic migraine or episodic migraine who have responded inadequately to two to four classes of prior preventive treatments were enrolled in the study. Inadequate response is defined as: lack of efficacy after at least three months of therapy; or the patient cannot tolerate the drug; or the drug is contraindicated; or the drug is not suitable for the patient. The classes of medications include: beta-blockers, anticonvulsants, tricyclics, calcium channel blockers, angiotensin II receptor antagonists, onabotulinumtoxinA, and valproic acid. In the study, chronic migraine and episodic migraine patients were randomized in blinded-fashion 1:1:1 into one of three treatment groups – a quarterly dosing regimen, a monthly dosing regimen or matching placebo. An open-label extension of three months followed the placebo-controlled portion of the study.
https://thefly.com/landingPageNews.php?id=2837859
FDA to hold a joint committee meeting
The Anesthetic & Analgesic Drug Products Advisory Committee and the Drug Safety & Risk Management Advisory Committee provide input and advice on strategies to increase the availability of naloxone products intended for use in the community. Participants include President & CEO Kramer of Emergent Biosolutions and Medical Affairs Director Mariano of Insys Therapeutics in the meeting being held at the FDA Silver Spring, MD offices on December 17 at 8 am.
Centene: 2019 peak enrollment to exceed 2018 by 150,000-200,000 members
Centene has updated its estimates for health insurance marketplace enrollment for 2019. Based on enrollment reporting through December 16, 2018, the company expects its 2019 peak enrollment to exceed 2018 peak enrollment by 150,000 to 200,000 members. At its investor day on Friday, December 14, 2018, the company previously estimated its peak enrollment would be 50,000 to 150,000 higher than 2018. Both projections exclude approximately 80,000 Fidelis marketplace members. While the enrollment period for the Federal Exchange has concluded, the enrollment periods for several state-based exchanges continues beyond December 15, 2018. Final enrollment is determined after members make premium binder payments. The company will update its guidance for the final membership enrollment on its 2018 year end earnings call on Tuesday, February 5, 2019.
https://thefly.com/landingPageNews.php?id=2837885
Needham names Ionis a top 2019 pick, boosts target to $82
Needham analyst Chad Messer raised his price target for Ionis Pharmaceuticals to $82 from $67 and named the stock a top pick for 2019. Unlike most other biotech companies, Ionis has been executing on a “perennial innovative pipeline while generating sustainable and growing profits,” Messer tells investors in a research note. The company has already produced one blockbuster drug with Spinraza and is in the midst of launching a second potential blockbuster Tegsedim, says the analyst. Further, he points out that four additional programs of the company will reach pivotal trials in 2019. Messer keeps a Buy rating on Ionis Pharmaceuticals.
https://thefly.com/landingPageNews.php?id=2837927
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