Immunomedics initiated with an Overweight at Morgan Stanley
Monday, November 5, 2018
Nektar price target lowered to $47 from $54 at H.C. Wainwright
H.C. Wainwright analyst Debjit Chattopadhyay lowered his price target for Nektar Therapeuticsless than (NKTR) to $47 and keeps a Neutral rating on the shares. While the Phase 3 trial of Opdivo plus NKTR-214 is welcome news, the company faces a crowded frontline renal cell carcinoma treatment landscape and stiff commercial hurdles, Chattopadhyay tells investors in a research note. He believes that unless the NKTR-214 plus Opdivo combination is meaningfully superior to the Opdivo and Yervoy combination, Bristol-Myers (BMY) “may not be willing to muscle the commercial launch, given the cannibalization of its existing franchise.”
https://thefly.com/landingPageNews.php?id=2817187
Trevena downgraded to Neutral from Buy at H.C. Wainwright
H.C. Wainwright analyst Ed Arce downgraded Trevena to Neutral and lowered his price target for the shares to 75c from $3.00. Following the Complete Response Letter from the FDA on the new drug application for oliceridin, a second-pass PDUFA date is unlikely until early 2020, Arce tells investors in a research note. He believes the CRL “leaves several open questions.”
https://thefly.com/landingPageNews.php?id=2817191
https://thefly.com/landingPageNews.php?id=2817191
Argenx price target raised to $130 from $125 at Wedbush
Wedbush analyst David Nierengarten raised his price target for Argenx to $130 from $125 as the ASH abstract for its Phase 1/2 study of cusatuzumab in newly diagnosed AML patients unfit for intensive chemo impressed with a reported ORR of 92%, an MRD-negativity rate of 42% and a safety profile comparable to SOC azacitidine. The analyst also decreased his discount rate on the program to 30% from 40% while pushing back his commercial launch estimate a year to Q1 of 2022 to account for the development time needed for a confirmatory AML study in newly-diagnosed patients. He reiterates an Outperform rating on the shares.
https://thefly.com/landingPageNews.php?id=2817193
Ziopharm to present new data from Ad-RTS-hIL-12 plus veledimex trial at SNO
Ziopharm announced it will update data from its Phase 1 trial of Ad-RTS-hIL-12 plus veledimex, a gene therapy designed to control the expression of interleukin 12, or IL-12, a powerful cytokine that has demonstrated a targeted, anti-tumor immune response for the treatment of recurrent glioblastoma, or rGBM, at the meeting for Society for Neuro-Oncology, or SNO. Ziopharm’s presentation at SNO will include updated survival data for a group of 15 patients who received Ad-RTS-hIL-12 during surgical resection and the 20mg dose of veledimex, as well as the group of patients who received stereotactic administration of Ad-RTS-hIL-12. Additionally, the company will present further analysis of the effect of dexamethasone, as data suggests that lower versus higher dose of steroids improves overall survival. Ziopharm’s Ad-RTS-hIL-12 plus veledimex construct is designed to express human interleukin 12, or hIL-12, under the control of an orally administered activator ligand, veledimex through a proprietary RheoSwitch therapeutic system gene switch. Data from this Phase 1 trial previously revealed a median overall survival, or mOS, of 12.7 months for patients treated with Ad-RTS-hIL-12 plus 20mg of veledimex at a mean follow-up time of 12.9 months as of May 4. The mOS of 12.7 months compares favorably to the five to eight months survival established in historical controls for patients with rGBM. At SNO 2017, biopsy data from this study showed consistent, dose-dependent production of recombinant IL-12 leading to production of interferon gamma, an influx of CD3+ CD8+ cytotoxic T cells, and upregulation of PD-1 and PD-L1. The evaluation of Ad-RTS-hIL-12 plus veledimex as a monotherapy to treat patients with rGBM continues as the company is expanding the number of adult patients treated with 20mg of veledimex from 15 patients to up to 40, and a trial evaluating this treatment for pediatric patients with brain cancer is ongoing. Ziopharm also is conducting a Phase 1 trial to evaluate Ad-RTS-hIL-12 plus veledimex in combination with Opdivo, an immune checkpoint, or PD-1, inhibitor, in adult patients with rGBM.
https://thefly.com/landingPageNews.php?id=2817211
Clearside Biomedical to host conference call
Conference call to discuss the 8-week topline data from the SAPPHIRE trial will be held on November 5 at 8:30 am.
Webcast: http://ir.clearsidebio.com/events-and-presentations
https://thefly.com/landingPageNews.php?id=2817233
https://thefly.com/landingPageNews.php?id=2817233
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