Wednesday, June 12, 2019
Quorum Health discontinues hospital operations in Illinois
Quorum Health (NYSE:QHC) announces that MetroSouth Medical Center in Blue Island, Illinois filed an application to discontinue hospital operations.
If the Company is not able to divest the facility, it will discontinue all operations by the end Q4.
This decision is a result of mounting financial losses due to decreasing patient volumes, increasing market saturation, and reduced reimbursement from government and commercial payors.
Alkermes advancing ALKS 4230 in kidney cancer and melanoma
Alkermes plc (NASDAQ:ALKS) has initiated the monotherapy expansion stage of its Phase 1/2 ARTISTRY-1 trial evaluating ALKS 4230 in patients with renal cell carcinoma or melanoma. This portion of the study will assess ALKS 4230 administered intravenously for five consecutive days in up to 105 patients who have not responded to prior therapies.
ALKS 4230 is an engineered fusion protein designed to preferentially bind to and signal through the intermediate- affinity interleukin 2 (IL-2) receptor complex, thereby selectively activating and increasing the number of immunostimulatory tumor-killing immune cells while avoiding expanding immunosuppressive cells that interfere with the anti-tumor response.
Concert’s CTP-692 shows favorable safety profile in early-stage studies
Concert Pharmaceuticals (NASDAQ:CNCE) announces that results from single-dose and multiple-ascending-dose Phase 1 trials evaluating the safety, tolerability and pharmacokinetics of CTP-692 in healthy volunteers showed that it was well-tolerated across all dose ranges tested, including those to be assessed in Phase 2 studies. Analyses of blood and urine biomarkers did not indicate any signs of renal impairment.
A Phase 2 trial in schizophrenia should launch in Q4.
CTP-692 is a deuterium-modified form of an amino acid called D-serine. The company says it has the potential to restore NMDA receptor activity in key areas of the brain in schizophrenia sufferers, adding that it will be initially developed as an adjunctive therapy with standard antipsychotic medications.
Study supports use of Pfizer’s Xeljanz alone in rheumatoid arthritis
Results from a Phase 3b/4 clinical trial, ORAL Shift, evaluating the efficacy of Pfizer’s (NYSE:PFE) XELJANZ (tofacitinib) XR after the withdrawal of methotrexate in adults with moderately to severely active rheumatoid arthritis (RA) showed it to be non-inferior (no worse than) to XELJANZ XR + methotrexate at week 48. The data are being presented at EULAR in Madrid.
Metroplex Clinical Research Center’s Stanley Cohen, M.D. says, “The results of ORAL Shift provide important information on the use of XELJANZ XR as monotherapy after methotrexate withdrawal, which is significant as some people living with rheumatoid arthritis are unable or unwilling to use methotrexate.”
The FDA approved XELJANZ in November 2012 for RA.
Catalyst sues FDA over approval of Firdapse competitor
Citing violations of its own regulations, Catalyst Pharmaceuticals (NASDAQ:CPRX) is suing the FDA over its recent approval (May 6) of Jacobus Pharmaceutical Company’s Ruzurgi (amifampridine) for the treatment of children with an autoimmune disorder called Lambert-Eaton syndrome (LEMS).
The agency approved Catalyst’s Firdapse (amifampridine) for LEMS in November 2018 under Orphan Drug status which is supposed to provide a seven-year period of market exclusivity in the U.S. for the indication.
Shares are down 2% premarket on light volume.
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