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Wednesday, August 15, 2018

Amedisys, LHC Group expected to gain market share, says Jefferies


Jefferies analyst Brian Tanquilut said analysis of the firm’s CMS Home Health Stars data continues to indicate publicly traded home nursing providers continue to deliver above-average care quality, which should translate to bonus payments and share gains. Tanquilut expects Buy rated Amedisys (AMED) and LHC Group (LHCG) to gain market share, see accelerated growth, realize enhanced profitability, and drive earnings upside.

Jazz Pharmaceuticals price target raised to $195 from $182 at Wells Fargo


Wells Fargo analyst David Maris raised his price target for Jazz Pharmaceuticals to $195 from $182 as he believes it continues to execute well on the commercial side and on its pipeline-driven strategy. The analyst likes the conservative balance sheet, the current sales trends, and the focus on pipeline progress. He reiterates an Outperform rating on the shares.

ObsEva initiated at Leerink


ObsEva resumed with an Outperform at Leerink. Leerink analyst Ami Fadia resumed coverage of ObsEva with an Outperform rating and $25 price target. The analyst believes that at current levels the stock does not fully reflect the commercial potential of its lead product linzagolix, which she believes can reach over $1B in peak sales, its additional women’s health pipeline, and its more than $100M cash balance that can fund operation into 1H20, by which time she expects to get positive UF Phase 3 data readout for linzagolix.

ViiV Healthcare announces success for long-acting HIV treatment


ViiV Healthcare has announced positive headline results from its global, phase III ATLAS study of a long-acting, injectable two-drug regimen (2DR) for the treatment of HIV.
ATLAS (Antiretroviral Therapy as Long-Acting Suppression) was designed to establish if HIV-1-infected adult participants who had maintained viral suppression for at least six months, on a daily oral regimen comprised of two nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent, maintained similar rates of viral suppression upon switching to the investigational, two-drug, long-acting, injectable regimen of cabotegravir and rilpivirine, compared with continuing the three-drug oral regimen.
“This would give HIV patients one month between each dose of antiretroviral therapy, changing HIV treatment from 365 dosing days per year, to just 12.”
The study showed long-acting cabotegravir and rilpivirine, injected once a month, had similar efficacy to a standard of care, daily, oral three-drug regimen at Week 48. The injectable treatment regimen met the primary endpoint for non-inferiority (the proportion of participants with plasma HIV-1 RNA ≥50 copies per milliliter [c/mL] using the FDA Snapshot algorithm at Week 48). Overall safety, virologic response and drug resistance results for the injectable regimen were consistent with results from the phase II LATTE and LATTE-2 studies.
Detailed results from the study will be presented at an upcoming scientific meeting. Headline results from FLAIR, a second pivotal trial designed to evaluate a long-acting, injectable regimen of cabotegravir and rilpivirine in treatment-naïve individuals, are expected later this year.
This investigational, long-acting, injectable regimen is being co-developed as part of a collaboration with Janssen Sciences Ireland UC, it is currently not approved by regulatory authorities anywhere in the world.
John C. Pottage, Jr., MD, Chief Scientific and Medical Officer of ViiV Healthcare, said: “This novel approach is another step towards potentially reducing the treatment burden for people living with HIV. The data from ATLAS suggest a long-acting, injectable 2DR of cabotegravir and rilpivirine may offer an alternative to daily, oral three-drug therapy for people who have previously achieved viral suppression. If approved, this regimen would give people living with HIV one month between each dose of antiretroviral therapy, changing HIV treatment from 365 dosing days per year, to just 12.”

Corvus Pharmaceuticals upgraded to Outperform at Credit Suisse

Credit Suisse analyst Michael Morabito upgraded Corvus Pharmaceuticals to Outperform from Neutral and raised the stock’s price target to $15 from $11 after assuming coverage of the name. The analyst believes the company’s lead product, CPI-444, has a clear lead in the clinic compared to competitors, and looks like a compelling treatment for PD-1 refractory patients, a growing market with PD-1 therapy being used increasingly in first-line settings.

Natera, Fox Chase Cancer Center partner on kidney cancer study


Natera has partnered with Fox Chase Cancer Center, one of the leading cancer centers in the United States, to assess the company’s Signatera customized circulating tumor DNA assay for recurrence monitoring of kidney cancer. The study will analyze biological specimens collected and banked from 49 patients diagnosed with kidney cancer-including a group whose cancer recurred and a group that did not recur after three years or more. The study will use Natera’s proprietary customized assay and next-generation sequencing-based technology to determine whether Signatera can be used to distinguish between the recurring and non-recurring kidney cancer cases. The study will be led by Philip Abbosh, M.D., Ph.D., assistant professor, Molecular Therapeutics Program, Fox Chase Cancer Center.

CDC intends to purchase 9M doses of smallpox vaccine from Emergent


The Centers for Disease Control and Prevention intends to award a sole source firm fixed price contract to Emergent Biodefense Operations Lansing, a post to the Federal Business Opportunities website indicates. The Government intends to purchase 9 Million doses of Food And Drug Administration licensed ACAM2000 Smallpox Vaccine, at the time of award with the option to purchase 66 additional doses. This contract will have a 12 month base period and four 12 month option periods. “Emergent is the only FDA licensed provider of ACAM2000 Smallpox Vaccine and therefore is the only source capable to provide this requirement to the Government,” the post states.