Goldman Sachs analyst Isaac Ro upgraded Varian Medical Systems to Buy and raised his price target for the shares to $129 from $107. The company’s guidance looks conservative given the new China quota, Ro tells investors in a research note. The new, larger quota in China has the ability to grant approximately 1,400 licenses by 2020, about a 50% increase on a per annum basis from the prior quota, says the analyst. He calls Varian an “out of consensus Buy idea” with China driving upside over the next two years.
Friday, January 4, 2019
Aerie: ‘Positive’ results from Phase 2 study of netarsudil ophthalmic solution
Aerie Pharmaceuticals announced the topline results of its pilot Phase 2 study of netarsudil ophthalmic solution in a Japanese-American population. The study was designed in accordance with the requirements of Japan’s PMDA to support the potential regulatory submission of netarsudil ophthalmic solution in Japan. Netarsudil ophthalmic solution 0.02% is known by the name Rhopressa in the United States, where it is currently marketed. This pilot study was initially designed as a larger Phase 2 trial to be conducted in the United States, enrolling Japanese subjects and Japanese-American subjects that are within second generation. Due to scarcity of qualified subjects in the United States, the enrollment of this study was limited to approximately 40 subjects across three study arms. The primary objectives of the study were to evaluate (1) the ocular hypotensive activity of two different dose concentrations of netarsudil ophthalmic solution (0.02% and 0.04%) relative to placebo over a 28-day period, for a total of three arms all dosed in the evening, and (2) the ocular and systemic safety of netarsudil ophthalmic solution relative to placebo over that period. The ranges of unmedicated baseline IOP at 8am in the study were greater than or equal to 15 mmHg to less than 35 mmHg for subjects with open-angle glaucoma, and greater than or equal to 22 mmHg to less than 35 mmHg for subjects with ocular hypertension. The results, which are outlined in the supporting slide presentation to this press release, demonstrated that netarsudil ophthalmic solution 0.02% lowered IOP in mean diurnal IOP by a range of 5.0 to 5.3 mmHg for subjects with an average baseline IOP of 18.3 mmHg. The netarsudil ophthalmic solution 0.04% arm lowered IOP in mean diurnal IOP by a range of 5.2 mmHg to 6.6 mmHg for subjects with average baseline IOP of 20.2 mmHg. The placebo arm lowered IOP in mean diurnal IOP by a range of 2.0 to 2.5 mmHg for subjects with an average baseline pressure of 19.6 mmHg. Both netarsudil arms showed higher levels of IOP reduction as compared to placebo to a statistically significant degree at Day 28. The safety findings were consistent with previous netarsudil trials. Aerie expects to initiate a Phase 2 clinical trial in Japan in the first quarter of 2019 structured, as agreed with the PMDA, consistently with this pilot study with the addition of a 0.01% concentration of netarsudil.
OraSure to acquire CoreBiome, Novosanis
OraSure announced that it has entered into definitive agreements to acquire two companies. CoreBiome is a privately-held, early-stage microbiome services provider that accelerates discovery for customers in the pharmaceutical, agricultural and research communities. CoreBiome’s proprietary genomics pipeline and algorithms deliver speed and scalability in the lab as well as precise analytics. Novosanis is a privately-held, Belgian company founded as a spinoff company from the University of Antwerp, Belgium, in 2013. Novosanis is an early commercial-stage producer and distributor of urine sample collection devices targeted primarily at the liquid biopsy, sexually transmitted infection screening and urological cancer markets. Novosanis’ primary product technology is Colli-Pee, a device designed for the standardized collection of first-void urine in the privacy of the user’s home or at a clinic. The transactions are structured with an upfront payment and potential additional payments based on future performance. The company expects that the acquisitions will together contribute from $4M-$7M in net revenues in 2019, with 3c-5c per share of dilution to non-GAAP earnings excluding transaction costs and required acquisition accounting adjustments.
Boehringer Ingelheim exercises option in research collaboration with Dicerna
Boehringer Ingelheim and Dicerna Pharmaceuticals announced that Boehringer Ingelheim has exercised an option to receive exclusive rights to a second hepatic disease target emerging from its research collaboration and license agreement with Dicerna. The collaboration, established in October 2017, aims to discover and develop novel GalXC RNAi therapeutics for the treatment of chronic liver diseases, with an initial focus on nonalcoholic steatohepatitis, a devastating disease for which there is no approved treatment. The option is the second target under the two companies’ research collaboration and license agreement. Under the terms of the agreement, Boehringer Ingelheim will be responsible for future clinical development and commercialization of the therapeutic target. Dicerna is eligible to receive development and commercial milestone payments, and royalties on worldwide net sales. Dicerna and Boehringer Ingelheim selected the target based on its ability to be drugged using Dicerna’s proprietary GalXC technology platform. The GalXC platform uses RNAi to inhibit the expression of disease-causing genes by destroying the messenger RNAs of those genes. The approach has the potential to treat diseases by silencing previously inaccessible drug targets.
Acorda Therapeutics price target raised to $33 from $30 at H.C. Wainwright
H.C. Wainwright analyst Raghuram Selvaraju raised his price target for Acorda Therapeutics to $33 saying FDA approval for the company’s lead clinical candidate Inbrija bodes well for 2019. The label does not appear to contain any overly onerous restrictions, Selvaraju tells investors in a research note. He reiterates a Buy rating on Acorda.
Chembio Diagnostics initiated at Canaccord
Chembio Diagnostics initiated with a Buy at Canaccord. Canaccord analyst Mark Massaro initiated Chembio Diagnostics with a Buy rating as he believes it is an underappreciated player in the very attractive point-of-care diagnostics space. The analyst said Chembio has best-in-class test accuracy and he likes its third party partnerships model. He also believes it can increase U.S. market share and make an even greater impact outside of the United States. Massaro has a $9 price target on Chembio Diagnostics shares.
Herbalife Nutrition initiated at Argus
Herbalife Nutrition resumed with a Buy at Argus. Argus analyst John Staszak resumed Herbalife Nutrition with a Buy rating and a price target of $72, saying the company stands to benefit from “increased consumer interest in overall health and fitness, rather than just weight-loss products.” The analyst is positive on the company’s efforts to expand its product portfolio in capitalizing on that trend and relying more on coaching and educational programs to boost sales. Staszak further states that Herbalife’s 2016 settlement with the FTC has likely resolved most of its legal and regulatory hurdles.
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