Friday, September 28, 2018
Avadel Pharmaceuticals announces published Phase 3 Noctiva data
Avadel Pharmaceuticals announced that the Journal of Urology, official journal of the American Urological Association, recently published results from pivotal Phase 3 clinical trial data on Noctiva nasal spray, the lowest effective dose of desmopressin. These data showed that treatment with Noctiva resulted in significant reductions in nocturic episodes in patients with nocturia. Additionally, Noctiva showed improvements in patients’ quality of life and had a well-tolerated safety profile. These results demonstrate that Noctiva is an effective treatment for adults with nocturia due to nocturnal polyuria. In two double-blind, placebo controlled, Phase 3 trials, DB3 and DB4, 1,333 patients with a mean of 2.16 or more nocturic voids per night were randomized to Noctiva 1.66 or 0.83 mcg, or placebo, for a 12-week treatment period. Existing etiologies of nocturia included nocturnal polyuria, benign prostatic hyperplasia and overactive bladder. Co-primary end points were the mean reduction in nocturic episodes per night from baseline and the percent of patients with a 50% or greater reduction in mean nocturic episodes per night. Secondary end points were the validated INTU questionnaire, time to first nocturic void, the percent of nights with one or fewer nocturic voids and the reduction in volume of urine produced at night. The results showed that reduction in mean nocturic episodes per night from baseline were significantly greater with Noctiva compared to placebo in both DB3 and DB4. The percentage of patients who achieved a 50% reduction in mean nocturic episodes per night was significantly higher with the Noctiva 1.66 mcg dose compared with placebo in the DB3 and DB4 studies, as well as the pooled analysis of both studies. A significant difference was also observed with the 0.83 mcg dose compared with placebo in the pooled analysis. Both doses of Noctiva had an acceptable safety profile and were well tolerated. The most common adverse events of nasal discomfort and nasopharyngitis were mild to moderate in intensity and occurred with similar incidence in the placebo group. Incidence of hyponatremia, defined as serum sodium regardless of symptoms or less than 130 mmol/L with symptoms, was low and occurred in five patients (1.1 percent) at the higher dose and in one patient who received placebo. No patient receiving the 0.83 mcg dose developed hyponatremia. In secondary endpoints, patients receiving the 1.66 mcg dose had a statistically significant improvement in the overall impact score reported on the INTU indicating better quality of life and a clinically meaningful benefit. These results mark the first time a decrease in nocturic episodes was correlated with improvement in patients’ quality of life in terms of how they feel and function. Compared with placebo in DB3 and DB4 studies and in the pooled analysis, both strengths of Noctiva significantly increased the time from bedtime to the first nocturic void. There was also a significant increase in the percent of nights with one or fewer nocturic episodes after treatment with Noctiva 1.66 mcg dose compared with placebo; in the pooled analysis both 0.83 mcg and 1.66 mcg doses showed significant improvement compared to placebo.
https://thefly.com/landingPageNews.php?id=2797041
Lilly’s migraine treatment approval adds to Teva worries, says Wells Fargo
Wells Fargo analyst David Maris noted that Eli Lilly (LLY) received FDA approval of Emgality for the prevention of migraines and announced a U.S. list price of $6,900 annually, which is in line with Teva’s (TEVA) Ajovy and Aimovig from Amgen (AMGN) and Novartis (NVS). Lilly’s approval adds to Teva investor worries, said Maris, who sees migraines being a competitive market with similar drugs “where the competitors are marketing powerhouses…and Teva is undergoing a lot of organizational change.” He maintains a Market Perform rating on Teva shares.
https://thefly.com/landingPageNews.php?id=2797043
GW Pharmaceuticals price target raised to $240 from $197 at Morgan Stanley
Morgan Stanley analyst David Lebowitz raised his price target on GW Pharmaceuticals shares to $240 from $197 following the DEA’s assignment of Epidiolex to Schedule V, which he said was a better classification than he expected. Stating that the favorable scheduling should enable a strong launch, Lebowitz increased his Epidiolex estimates and maintains an Overweight rating on GW Pharmaceuticals.
https://thefly.com/landingPageNews.php?id=2797051
Immutep initiated at B. Riley FBR
Immutep initiated with a Buy at B. Riley FBR. B. Riley FBR analyst Dylan Dupuis started Immutep with a Buy rating and $7.75 price target. The analyst views the company as a leader in LAG-3 immunotheraphy.
Teladoc target raised to $88 after analyst day at Piper Jaffray
Piper Jaffray analyst Sean Wieland raised his price target for Teladoc to $88 from $84 following the company’s analyst day. Management committed to 20%-30% organic revenue growth, positive free cash flow in 2019, and inched up 2018 guidance on greater revenue per client, Wieland tells investors in a research note. He believes the Advance Medical acquisition should drive international share gains and reiterates an Overweight rating on Teladoc shares.
Qiagen receives FDA approval to expand use of EGFR test in lung cancer
Qiagen (QGEN) announced that the FDA has approved a PMA Supplement expanding the labelling claim of the therascreen EGFR RGQ PCR Kit to allow its use as a companion diagnostic with Pfizer’s VIZIMPRO for first-line treatment of patients with non-small cell lung cancer with epidermal growth factor receptor, or EGFR, exon 19 deletions or an exon 21 L858R mutation. The therascreen EGFR RGQ PCR kit is now approved as a companion diagnostic to guide the use of three FDA-approved therapies It is registered in more than 40 countries globally. This was a project governed under an agreement between QIAGEN and Pfizer (PFE).
PTC Therapeutics price target raised to $51 from $15 at JPMorgan
JPMorgan analyst Eric Joseph raised his price target for PTC Therapeutics to $51 heading into risdiplam clinical updates for both Type 1 and Type 2/3 spinal muscular atrophy at World Muscle next week. The analyst sees 15% share swings on definitively positive and negative data. Joseph believes the World Muscle conference creates incremental upside potential but that longer term appreciation is based on execution. He keeps a Neutral rating on PTC Therapeutics.
https://thefly.com/landingPageNews.php?id=2796905
Subscribe to:
Posts (Atom)