Cantor Fitzgerald analyst Eliana Merle views the first clinical data of an IL36R inhibitor in patients presented at EADV Congress as a positive read-through to AnaptysBio’s IL36R program. Anaptys’s second wholly owned clinical stage asset, ANB019, is an IL36R inhibitor in development for rare forms of psoriasis, Merle tells investors in a research note. She points out that data over the weekend from a competitor program, BI 655130, showed that IL36R inhibition can lead to clinically meaningful improvement in generalized pustular psoriasis. The analyst thinks this de-risks the IL36R mechanism ahead of initial patient data from ANB019 in GPP in early 2019. Merle keeps an Overweight rating on AnaptysBio with a $124 price target
Monday, September 17, 2018
KemPharm has topline results from abuse-potential trial of med
KemPharm announced topline results from its intranasal, or IN, human abuse potential, or HAP, clinical trial of serdexmethylphenidate, the major active pharmaceutical ingredient in KP415, KemPharm’s investigational product candidate for the treatment of ADHD. In the IN HAP trial, SDX produced significantly lower scores on the primary endpoint, maximal drug liking, and other abuse-related endpoints, compared to intranasal d-methylphenidate hydrochloride, indicating that SDX is not efficiently converted to active d-methylphenidate when snorted. KemPharm will present the data from all three HAP trials, as well as tampering study results, to the FDA as part of its human abuse potential assessment for SDX in the KP415 new drug application, or NDA. During the review process, the FDA will recommend a controlled substance schedule for SDX to the Drug Enforcement Agency, or DEA. If KP415 is approved, the DEA must subsequently confirm the schedule for SDX, and KemPharm believes that the entirety of the data may support a lower schedule compared to other currently available methylphenidate-based ADHD products. Furthermore, since the FDA has required KemPharm to conduct all three HAP trials, KemPharm anticipates that data from these trials may likely be included in the label.
NuVasive price target raised to $80 from $70 at Canaccord
Canaccord analyst Kyle Rose raised his price target on NuVasive to $80 from $70 following meetings with management. The analyst believes the shares offer a compelling risk/reward setup in medtech citing its conservative guidance, robust new product flow, stable U.S. spine market share, and improving investor sentiment. Rose reiterated his Buy rating on NuVasive shares.
Tenet hospitals in South Carolina fully operational after Hurricane Florence
Tenet Healthcare announced that its four hospitals in South Carolina are fully operational following Hurricane Florence and meeting the healthcare needs of the communities they serve. Coastal Carolina Hospital, East Cooper Medical Center and Hilton Head Hospital, which are all located in areas impacted by the storm, had no material damage. These hospitals resumed normal operations over the weekend, and it is noteworthy that they remained open during the storm. East Cooper Medical Center in Mt. Pleasant, S.C., received an exception to the mandatory evacuation order issued by the Governor of South Carolina and remained open with reduced census and an operational emergency room. Piedmont Medical Center was not directly impacted by the storm and remained fully operational. USPI has eight surgery centers in areas impacted by the storm. Those facilities are in the process of rescheduling cancelled cases, with plans in place to be operational as of today.
https://thefly.com/landingPageNews.php?id=2791207
Halozyme: Roche receives approval for subcutaneous formulation of trastuzumab
Halozyme (HALO) announced that Roche (RHHBY) has received approval from Health Canada for a subcutaneous formulation of trastuzumab for the treatment of patients with HER2-positive breast cancer. This is a co-formulation with Halozyme’s proprietary recombinant human hyaluronidase enzyme.
https://thefly.com/landingPageNews.php?id=2791215
Weight Watchers’ refresh could be ‘major’ positive catalyst: Craig-Hallum
Craig-Hallum analyst Alex Fuhrman reiterated a Buy rating and $120 price target on Weight Watchers. In a research note to investors, the analyst says he believes the upcoming Weight Watchers brand refresh, which is expected to be unveiled before the end of the year and possibly before the early-November Q3 report, could be a major positive catalyst for shares. Fuhrman says Weight Watchers’ brick and mortar locations could be rebranded as “WW Studio,” which he calls a “significant upgrade” from the current “meetings” offering and sees the likely renaming of the “OnlinePlus” offering and the corporate wellness offering. Additionally, Fuhrman expects that the company’s “underutilized” B&M locations may be put to more use, including possibly introducing regular operating hours for some of its higher-traffic locations.
https://thefly.com/landingPageNews.php?id=2791269
Theravance Biopharma, Mylan report data from Phase 3 studies of YUPELRI
Theravance Biopharma (TBPH) and Mylan (MYL) announced that positive new data from the companies’ Phase 3 clinical program for YUPELRI inhalation solution were featured in an oral presentation at the European Respiratory Society International Congress 2018, which is being held in Paris, France on September 15-19, 2018. Presented data showed reductions in the rates of chronic obstructive pulmonary disease exacerbations ranging from 15% to 18% in moderate to very severe COPD patients administered once-daily YUPELRI for up to 52 weeks as compared to placebo and tiotropium. While the YUPELRI Phase 3 program was not designed or powered to achieve statistical significance on differences in COPD exacerbation rates, researchers were interested in a post-hoc analysis of data from the studies to identify trends in this area. Researchers evaluated and presented data on COPD exacerbations that were collected from the three clinical trials comprising the Phase 3 YUPELRI program. Pooled data from the two replicate 12-week pivotal Phase 3 efficacy trials, which included a total of 1,229 patients with moderate to very severe COPD, demonstrated that the mean annualized rate of all COPD exacerbations was 0.47 for YUPELRI dosed at 175 mcg/day and 0.45 for YUPELRI dosed at 88 mcg/day. When compared to the mean annualized rate of exacerbations for placebo of 0.55, these results represent COPD exacerbation rate reductions in the range of 15% to 18%. Additionally, data from the 12-month Phase 3 safety trial, which included a total of 1,055 with moderate to very severe COPD, demonstrated that the estimated annualized rate of all COPD exacerbations was 0.38 for YUPELRI dosed at 175 mcg/day and 0.57 for YUPELRI dosed at 88 mcg/day, compared to 0.46 for tiotropium dosed at 18 mcg/day. These results for the 175 mcg/day YUPELRI dose represent a 17% reduction in COPD exacerbation rates as compared to tiotropium.
https://thefly.com/landingPageNews.php?id=2791285
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