Monday, September 17, 2018
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
CVS Health price target raised to $101 from $90 at RBC Capital
RBC Capital analyst George Hill raised his price target on CVS Health (CVS) to $101 and kept his Outperform rating, citing the increased visibility of the company’s merger with Aetna (AET) after its recent comments that it expects the deal to close in early Q4. The analyst also points to “de-risked” CVS investment thesis as it pertains to pharmacy benefit managers rebates and the much higher relative multiples for managed care companies, even though he warns that investors may still be spooked by any potential steps that the White House takes to drive prescription drug prices lower. Hill notes however that the latest government funding bill pulled the text that required drug companies to disclose prices in their ads, implying that the political will to change status quo may be limited.
https://thefly.com/landingPageNews.php?id=2791327
Roivant launches Respivant Sciences
Roivant Sciences announced the launch of Respivant Sciences, a biopharmaceutical company focused on improving the lives of patients suffering from serious respiratory diseases. Respivant will be led by CEO Bill Gerhart, Executive Vice President for Clinical and Regulatory Ahmet Tutuncu, MD, PhD, and Executive Vice President for Development and Manufacturing Pravin Soni, PhD. Respivant’s pipeline is anchored by RVT-1601, an inhaled therapeutic being developed for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis. RVT-1601 is a mast cell stabilizer with pleotropic immune modulating properties delivered directly to the lungs via a handheld aerosol device that produces a soft mist for patients to conveniently inhale. In a Phase 2a clinical trial, RVT-1601 demonstrated a statistically significant reduction in cough frequency among IPF patients after 14 days of treatment. Respivant plans to initiate a Phase 2b study for RVT-1601 in the first quarter of 2019.
https://thefly.com/landingPageNews.php?id=2791347
Anthem initiated at Cowen
Anthem initiated with an Outperform at Cowen. Cowen analyst Charles Ryhee initiated Anthem with an Outperform rating citing its unique dominant position in most of its markets because of the Blue Cross/Blue Shield brand. This affords it flexibility to build out its own PBM and pursue a more partnership-based provider strategy, said Ryhee, who has a $318 price target on Anthem shares.
https://thefly.com/landingPageNews.php?id=2791349
AstraZeneca : Three-Drug Combination Meets 8 out of 9 Objectives in COPD Trial
AstraZeneca PLC (AZN.LN) said Monday that a phase 3 trial of a three-drug combination for the treatment of chronic obstructive pulmonary disease met eight out of its main objectives.
The Anglo-Swedish pharmaceutical company said that the results of the Kronos trial, which compared a combination of budesonide, glycopyrronium and formoterol with a number of rival therapies, was published in the journal The Lancet Respiratory Medicine.
The three-drug cocktail called PT010 showed a significant reduction of exacerbations in patients with the disease compared with rival therapy, the company said.
AstraZeneca said it plans on making a first regulatory submission for the drug in the second half of the year.
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