Piper says Alnylam making transition to commercial play on orphan diseases

After Alnylam announced an NDA filing on Onpattro for hATTR Amyloidosis in Japan, Piper Jaffray analyst Edward Tenthoff said the company is transitioning toward being a commercial play on orphan diseases. The analyst, who forecasts 2018 Onpattro sales of $10.7M growing to $81M in 2019, keeps an Overweight and $160 price target on Alnylam shares.
https://thefly.com/landingPageNews.php?id=2797205

Opiant Pharmaceuticals price target raised to $42 from $32 at Cantor

Cantor Fitzgerald analyst Brandon raised his price target for Opiant Pharmaceuticals to $42 citing upwards earnings revisions for Narcan and a revised share count post the recently completed equity financing. The company is developing treatments focused on multiple addictions including a next-generation, improved Narcan, OPNT003, which has a longer half-life, offering better reversal outcomes in fentanyl-related overdoses, Folkes tells investors in a research note. He believes Emergent BioSolutions’ recent acquisition of Adapt Pharma for $735M underscores the value of the opioid overdose market. As Opiant advances its pipeline, investors to begin to appreciate the market potential of its candidates, which should drive the stock higher, the analyst contends. Folkes reiterates an Overweight rating on the shares.
https://thefly.com/landingPageNews.php?id=2796975

AMN Healthcare’s recent headwinds have stabilized, says Jefferies

After spending time with management, Jefferies analyst Jason Plagman has greater confidence that AMN Healthcare Services’ recent headwinds have stabilized in Q3. The company’s organic growth is poised to accelerate back to positive mid-single-digits in 2019, which should drive greater than 10% earnings growth, Plagman tells investors in a research note. He keeps a Buy rating on AMN Healthcare with a $68 price target.
https://thefly.com/landingPageNews.php?id=2797021

Endo issues voluntary recall of two lots of Robaxin 750mg Tablets

Endo announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as “two to four tablets four times daily” rather than the correct dosage of “two tablets three times daily.” Patients who follow the directions on the bottle may experience significant drowsiness or dizziness which would put them at risk of falls or an overdose which could result in seizures, coma, or death. To date, Endo Pharmaceuticals Inc. has not received any reports of adverse events related to this recall.
https://thefly.com/landingPageNews.php?id=2797037

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