Monday, May 6, 2019
Mallinckrodt announces prelim results from Phase 4 registry for INOmax gas
Mallinckrodt announced preliminary results of a planned interim analysis from the company’s Phase 4 registry assessing the use of INOmax gas, for inhalation, for premature neonates versus term and near-term neonates with pulmonary hypertension, or PH. The primary outcome measure compares the incidence of mechanically ventilated subjects with PH who achieve at least a 25% improvement in Oxygenation Index, or OI, from baseline, or Surrogate Oxygenation Index, or SOI, for subjects who are not ventilated, between gestation age groups. OI is commonly used to evaluate the severity of hypoxic respiratory failur, or HRF, in neonates with PH. The planned interim analysis occurred at the approximate midway point of enrollment. The preliminary analysis found that, at this juncture in the study, approximately 86% of both cohorts showed a 25% or greater improvement in OI or SOI during the treatment period. The safety and efficacy of INOmax nitric oxide gas for treating HRF in premature neonates with PH has not been evaluated by the FDA.
Aclaris Therapeutics initiated at SVB Leerink
Aclaris Therapeutics initiated with an Outperform at SVB Leerink. SVB Leerink analyst Pasha Sarraf initiated Aclaris Therapeutics with an Outperform rating and $13 price target.
Bausch Health CEO says ‘off to a strong start in 2019’
“Bausch Health is off to a strong start in 2019 with the continued growth of XIFAXAN which grew 11% in the quarter, the launch of BRYHALI, the successful acquisition of TRULANCE, and the approval of DUOBRII and expected launch in June. We believe that our promising pipeline and focus on Project CORE has positioned the company to build on our growth in 2019 and beyond. Strong operational execution is leading us to raise our full-year 2019 revenue and adjusted EBITDA guidance,” said Joseph Papa, chairman and CEO, Bausch Health. “With nearly 60% of our revenues coming from a diversified mix of medical devices, OTC products and prescription and branded generic products that are not exposed to the U.S. branded prescription drug pricing environment, we believe that Bausch Health is uniquely positioned to grow in health care,” Papa continued.
Cytokinetics price target raised to $26 from $21 at H.C. Wainwright
H.C. Wainwright analyst Joseph Pantginis raised his price target for Cytokinetics to $26 from $21 and keeps a Buy rating on the shares. While the Phase 2 trial testing reldesemtiv in patients with amyotrophic lateral sclerosis missed its endpoint misses, reldesemtiv activity was “clear and broad,: setting up the next steps, Pantginis tells investors in a research note titled “Bad Headline, Impressive Data; Reldesemtiv Effects Consistent; Target Increased to $26.” The analyst believes the data show important characteristics of reldesemtiv, including comparable effects across all doses, consistent effects across all timepoints, and durability of the effects.
Adaptimmune announces clinical progress in ADP-A2M4 study
Adaptimmune announced clinical progress with partial responses in 4 out of 5 synovial sarcoma patients treated with 10B cells in the ADP-A2M4 pilot study and tumor shrinkage seen in nearly all assessed synovial sarcoma patients. Based on these data, the company will initiate the SPEARHEAD-1 trial in patients with synovial sarcoma and myxoid/round cell liposarcoma, or MRCLS, later this year. Beyond sarcoma, there is evidence of antitumor activity with ADP-A2M4 and ADP-A2M10 in other solid tumors. Based on these data and translational findings, the company is expanding its clinical trial program by initiating a radiation sub-study, as well as opening a next-generation ADP-A2M4CD8 study, for which the IND has been filed. Finally, the first patient with HCC was treated in Cohort 2 of the ADP-A2AFP study and showed tolerability to treatment and a transient decrease in serum AFP as well as tumor shrinkage at first scan. ADP-A2M4 SPEAR T-cells appear to show a favorable benefit:risk profile in patients with synovial sarcoma with “good” tolerability overall. Most adverse events are consistent with those typically experienced by cancer patients undergoing cytotoxic chemotherapy or other cancer immunotherapies. Tumor shrinkage seen in lung patients in ADP-A2M10 and melanoma and ovarian patients in ADP-A2M4. Adaptimmune is planning to start two new studies to transform currently observed activity in epithelial tumors into durable responses.
https://thefly.com/landingPageNews.php?id=2903577
https://thefly.com/landingPageNews.php?id=2903577
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