eHealth initiated with an Outperform at Evercore ISI. Evercore ISI analyst Ross Muken initiated eHealth with an Outperform rating and $75 price target. In a research note to investors, Muken says that after a challenging period post-ACA, the company’s new management has successfully pivoted the strategy toward Medicare, positioning eHealth as a “unique ecommerce marketplace” and pricing transparency tools within healthcare. He sees eHealth as uniquely positioned to be a dominant player in the consumer centric healthcare revolution, and sees a path to $1B in revenue over the next decade.
Monday, February 4, 2019
Spero Therapeutics announces FDA acceptance of SPR994 IND application
Spero Therapeutics announced the acceptance by the FDA of its investigational new drug, or IND, application for SPR994, Spero’s lead product candidate designed to be the first oral carbapenem antibiotic, for the treatment of complicated urinary tract infections, or cUTI. This IND acceptance will enable Spero to initiate U.S. enrollment in its planned global, single pivotal Phase 3 clinical trial of SPR994 in cUTI. Spero’s planned pivotal Phase 3 clinical trial of SPR994, ADAPT-PO, is designed as a double-blind, double-dummy trial to compare oral SPR994 with an existing standard of care intravenous, or IV, antibiotic, ertapenem, in approximately 1,200 patients randomized 1:1 in each arm. The primary endpoint of the pivotal trial will be the combined clinical and microbiological response at the test of cure with a 10% non-inferiority margin versus IV ertapenem. The trial will incorporate a lead-in cohort of 70 patients with intensive pharmacokinetics assessment to confirm the dose and exposure in the cUTI patient population. Spero anticipates receiving interim pharmacokinetic data from the trial’s lead-in cohort in the second half of 2019. In addition, Spero will conduct routine ancillary clinical pharmacology studies in parallel with the ADAPT-PO clinical trial, including a renal insufficiency study, a thorough QT prolongation study and a drug-drug interaction study. Spero has begun start-up activities for the ADAPT-PO clinical trial and anticipates opening trial sites to support study enrollment in Q1.
Cantor reiterates $86 target on Aerie Pharmaceuticals after doctor survey
After surveying with 25 glaucoma specialists who have used Rhopressa in their clinical practice, Cantor Fitzgerald analyst Elemer Piros reiterates an Overweight rating on Aerie Pharmaceuticals with an $86 price target. In the survey, 84% of physicians indicated that the safety and efficacy of Rhopressa in their practices have either met or surpassed expectations, Piros tells investors in a research note. Further, physicians provided positive feedback from their experiences with prescribing Rhopressa, says the analyst. In addition, Piros says he was unable to identify any correlation with patient compliance or physician expectations with levels of hyperemia.
Biohaven achieves targeted therapeutic exposures of BHV-3500
Biohaven Pharmaceutical announced that administration of intranasal BHV-3500 in a Phase 1 clinical trial has achieved targeted therapeutic exposures and that the compound will advance into a Phase 2 trial to evaluate efficacy for the acute treatment of migraine. BHV-3500 is a novel, third generation calcitonin gene-related peptide receptor antagonist being developed by Biohaven.
AC Immune price target lowered to $8 from $18 at H.C. Wainwright
H.C. Wainwright analyst Andrew Fein lowered his price target for AC Immune to $8 to reflect the discontinuation of crenezumab in the valuation. However, despite this setback, the analyst still believes that the fundamental approach of AC Immune is “de-risking in itself” with multiple targets in multiple modalities. The company possesses one of the deepest pipelines in the neurodegenerative space, Fein tells investors in a research note. He reiterates a Buy rating on the shares.
https://thefly.com/landingPageNews.php?id=2858231
https://thefly.com/landingPageNews.php?id=2858231
Actinium Pharmaceuticals begins second dosing cohort of leukemia candidate
Actinium Pharmaceuticals announced that the Medical College of Wisconsin has started dosing patients in the second cohort of its novel trial of Actimab-A in combination with CLAG-M in patients with relapsed or refractory AML or Acute Myeloid Leukemia. This trial is evaluating the impact that the addition of targeted internalized radiation via Actimab-A to the salvage chemotherapy regimen CLAG-M will have on safety and tolerability, response rates, rates of BMT or bone marrow transplant, PFS or progression-free survival, and OS or overall survival. No dose limiting toxicities were reported in the first patient cohort. Assuming no DLTs are observed in the second cohort, three patients will be treated and the study will progress to the third and final cohort will study Actimab-A at a dose of 0.75 uCi/kg.
https://thefly.com/landingPageNews.php?id=2858277
https://thefly.com/landingPageNews.php?id=2858277
Genesis in real estate partnership with Next for 15 nursing homes
Genesis HealthCare announced that it has entered into a real estate partnership with Next Healthcare Capital involving 15 skilled nursing facilities previously leased from Welltower. Seven additional facilities historically leased from Welltower were sold to a third party. Genesis will no longer operate the seven facilities after the sale. Welltower sold the real estate of 15 facilities to the new partnership, of which Genesis acquired a 46% ownership interest. Genesis also acquired a fixed price purchase option to acquire the real estate beginning in 2026 at a 10% premium above the original acquisition cost. Genesis will continue to operate these facilities pursuant to a new lease with the partnership. The remaining interest is held by Next, a privately owned healthcare real estate investment firm. The 15 facilities had been included in the company’s master lease with Welltower and were subject to 2% annual rent escalators. Under the new lease, there are no rent escalators for the first five years. The seven facilities that Genesis will no longer operate had aggregate annual revenue of approximately $73M. As a result of the transaction, Genesis estimates its annual EBITDAR will decline $2.5M and annual cash lease obligations will be reduced approximately $3.2M. In year one, the transaction is accretive to EBITDA by $700,000.
https://thefly.com/landingPageNews.php?id=2858305
https://thefly.com/landingPageNews.php?id=2858305
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