Medtronic announced the results of an analysis on the impact of stroke severity in patients receiving its HeartWare HVAD System as destination therapy, showing that targeted blood pressure management helped reduce serious strokes. The HVAD System is a left ventricular assist device that helps increase the amount of blood that circulates through the body in patients with advanced heart failure; the destination therapy indication refers to patients who are not candidates for heart transplants. The retrospective analysis, presented at the 2019 International Society for Heart and Lung Transplantation Scientific Sessions, used data from both the ENDURANCE and ENDURANCE Supplemental randomized trials, the company said.
https://thefly.com/landingPageNews.php?id=2889211
Friday, April 5, 2019
LivaNova ‘currently reviewing’ 2019 guidance
LivaNova is currently reviewing its 2019 guidance and will provide updates and report its full financial results for first quarter 2019 in connection with its earnings call on Wednesday, May 1
Oklahoma AG dismisses all but one claim against Teva, J&J in opiod case
Oklahoma Attorney General Mike Hunter dismissed without prejudice several claims filed against opioid manufacturers, including Purdue Pharma, Teva (TEVA) and Johnson & Johnson (JNJ), saying he is “refocusing the case on its central claim, abating the public nuisance caused by the companies’ decades-long fraudulent marketing campaigns.” The public nuisance claim provides the state with a comprehensive plan to address and remediate the effects the opioid crisis continues to have across the state, the AG said. Dismissing the claims without prejudice does not limit the state’s ability to reassert these claims in the future if necessary. Nor does it reduce the amount of damages the state is seeking from the defendants in the lawsuit. The trial remains set to begin May 28. Attorney General Hunter said: “Moving forward with the state’s public nuisance claim moots most of the issues raised by the defendants in discovery, allowing the parties and the judge to focus on preparing for this trial, set to begin in less than eight weeks.”
Centene, Molina could be ‘compelling’ targets for Humana, says Cowen
Cowen analyst Charles Rhyee said he believes Centene’s (CNC) planned takeover of WellCare (WCG) could potentially accelerate Humana’s (HUM) timeline to acquire a scaled Medicaid asset, noting that it currently has the second smallest Medicaid book among managed care organizations. His analysis suggests Centene and Molina Healthcare (MOH) could both be “compelling acquisition targets” for Humana and believes the company has the financial capacity to make a bid for either, though Rhyee added that he does not believe Humana needs to rush a decision. Rhyee sees about a one year window in which Humana “can dictate the Medicaid M&A market” before Cigna (CI) and/or CVS Health (CVS) can get involved, he tells investors. While the analyst believes Centene makes the most sense as a potential target for Humana if the latter does not win the Texas STAR+PLUS contract, he suspects Centene is not willing to sell and believes Humana would have to offer a significant premium. If Humana does win the Texas STAR+PLUS contract it does not need to pursue large scale M&A, but a deal could be attractive anyway, Rhyee said.
Trovagene provides update to Phase 1b/2 AML trial data
Trovagene announced updated data following its presentation at the American Association for Cancer Research. Additional data from its ongoing Phase 1b/2 study evaluating onvansertib in combination with standard-of-care chemotherapy in Acute Myeloid Leukemia demonstrates response to treatment in patients in the dose-escalation phase of the trial who received onvansertib at 27mg/m2 and 40mg/m2. The trial is now enrolling patients at the dose level of 60mg/m2 (approximately a 50% increase) in combination with either LDAC or decitabine. The greatest anti-leukemic activity, to-date, has been observed in the onvansertib + decitabine arm, now with 3 of 6 evaluable patients treated at the two highest dose levels tested to-date (27mg/m2 and 40mg/m2) achieving a complete response (2CR and 1CRi). The first patient in the onvansertib + LDAC arm has achieved a complete response at the highest dose level of 40mg/m2 of onvansertib.
Gilead submits supplemental NDA for once-daily Descovy for HIV PrEP
Gilead Sciences announced that the company has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for Descovy for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection among individuals who are HIV-negative and at risk for HIV. A Priority Review voucher was submitted with the filing, leading to an anticipated review time of six months. The filing is based on the results of the Phase 3 DISCOVER trial which evaluated the safety and efficacy of Descovy compared to Truvada in men and transgender women who have sex with men at high-risk for sexually acquired HIV infection. Truvada for PrEP is currently the only FDA approved product indicated to reduce the risk of sexually acquired HIV-1 in individuals who are HIV-negative and at risk for HIV. Results from the DISCOVER trial demonstrated that Descovy achieved non-inferiority to Truvada in study participants who were at substantial and sustained risk of HIV acquisition. Additionally, statistically significant improvements in renal and bone laboratory parameters were observed for participants receiving Descovy versus those receiving Truvada. In the United States, Descovy is approved in combination with other antiretroviral agents for the treatment of HIV infection in patients weighing greater than or equal to25 kg and is not indicated for PrEP. Truvada is indicated in combination with safer sex practices for HIV PrEP to reduce the risk of sexually acquired HIV in at-risk individuals who are HIV-negative and weigh greater than or equal to35 kg. Descovy and Truvada each have a Boxed Warning in their respective product labels regarding the risk of post-treatment acute exacerbation of hepatitis B; the Truvada label also carries a Boxed Warning for the risk of drug resistance with PrEP in undiagnosed early HIV infection. Among DISCOVER trial participants, Descovy and Truvada were well tolerated and had low discontinuation rates due to adverse events of 1.3 percent and 1.8 percent, respectively. The most common drug-related adverse event was diarrhea. The use of Descovy for the prevention of HIV is investigational and has not been determined to be safe or efficacious and is not approved anywhere globally.
https://thefly.com/landingPageNews.php?id=2889147
https://thefly.com/landingPageNews.php?id=2889147
Joint Corp price target raised to $20 from $15 at DA Davidson
DA Davidson analyst Michael Kawamoto raised his price target on Joint Corp to $20 and kept his Buy rating after hosting the company’s CEO and CFO for investor meetings. The analyst says the discussions added to his confidence in the company’s “ability to execute its growth strategy and continue to build brand awareness. ” Kawamoto also points to Joint Corp’s 3-year stacked comps growth of 72% thanks to its “significant first mover advantage” and he expects those trends to continue, with added scale translating into “significant margin expansion and earnings growth”.
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