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.
Friday, April 5, 2019
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”.
Celgene, Acceleron announce BLA submission for luspatercept to FDA
Celgene (CELG) and Acceleron Pharma (XLRN) announced that Celgene has submitted a Biologics License Application, or BLA, for luspatercept, an erythroid maturation agent, for the treatment of adult patients with very low to intermediate risk myelodysplastic syndromes-associated anemia who have ring sideroblasts and require red blood cell, or RBC, transfusions and for the treatment of adult patients with beta-thalassemia-associated anemia who require RBC transfusions. The submission is based on the safety and efficacy results of the pivotal phase 3 studies MEDALIST and BELIEVE, both recently presented at the American Society of Hematology annual meeting, where MEDALIST was included in the plenary session.
https://thefly.com/landingPageNews.php?id=2889187
https://thefly.com/landingPageNews.php?id=2889187
Endo Begins Shipment of Authorized Generic Version of PROVENTIL
Endo International plc (NASDAQ: ENDP) announced today that one of its operating companies, Par Pharmaceutical (Par), has begun shipping an authorized generic version of Merck’s PROVENTIL® (albuterol sulfate) HFA Inhalation Aerosol, 120mcg. Endo’s subsidiary, Endo Procurement Operations Limited, recently entered into an exclusive U.S. supply and distribution agreement with a subsidiary of Merck & Co., Inc., of Kenilworth, N.J. allowing Par to launch and distribute an authorized generic of the product.
“We are very pleased to add albuterol sulfate to Par’s portfolio and to be able to offer the authorized generic of the product to patients,” said Tony Pera, President of Par Pharmaceutical. “Par has partnered with Merck several times to bring an authorized generic product to market and we are proud to be a reliable, quality supplier.”
PROVENTIL® is a registered trademark of Merck Sharp & Dohme Corp.
Arcturus Therapeutics initiated at H.C . Wainwright
Arcturus Therapeutics initiated with a Buy at H.C. Wainwright. H.C. Wainwright analyst Ed Arce started Arcturus Therapeutics with a Buy rating and $15 price target. The company is well positioned to realize the potential of mRNA therapeutics, Arce tells investors in a research note. The analyst believes Arcturus may initiate the first ever trial of an mRNA therapeutic dosed chronically via IV injection and views its “broad” RNA platform as “highly competitive and differentiated.”
https://thefly.com/landingPageNews.php?id=2889055
https://thefly.com/landingPageNews.php?id=2889055
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