Iovance announced that first patient has been dosed in Cohort 4, the pivotal cohort of the innovaTIL-01 study of lifileucel. Cohort 4 is designed to enroll 75 patients with advanced melanoma. InnovaTIL-01 is a pivotal phase 2 global multicenter study evaluating the safety and efficacy of Iovance’s autologous lifileucel TIL therapy for treatment of patients with metastatic melanoma.
Tuesday, April 2, 2019
ADMA Biologics reports FDA approves Asceniv intravenous immune globulin
ADMA Biologics announced that the U.S. Food and Drug Administration has approved Asceniv Immune Globulin Intravenous, Human – slra 10% Liquid, formerly referred to as RI-002. Asceniv is an Intravenous Immune Globulin drug product for the treatment of Primary Humoral Immunodeficiency Disease, or “PIDD,” in adults and adolescents. The company anticipates having the product available for commercial launch during the second half of 2019. “We are excited about this significant achievement in receiving FDA approval for Asceniv a novel, patented IVIG product that we feel is a necessary addition to existing available therapies for patients who suffer from PI. We hope availability of Asceniv will help ameliorate a portion of the current shortages facing U.S. IVIG supply,” stated Adam Grossman, President and CEO of ADMA Biologics. “With the receipt of Asceniv’s FDA approval, ADMA, at its sole option, can elect to access up to an additional $27.5M of available funding from Perceptive Advisors under ADMA’s existing credit facility. This option remains available to the company through June 2020, and such funds could be used to support the launch of Asceniv, procure plasma raw material inventory, and begin construction on potential new plasma centers, as well as for general corporate activities,” concluded Grossman.
https://thefly.com/landingPageNews.php?id=2887233
https://thefly.com/landingPageNews.php?id=2887233
Calithera Biosciences presents preclinical CB-708 data at AACR
Calithera Biosciences announced new data for the company’s CD73 inhibitor CB-708. The data will be presented at the American Association for Cancer Research, or AACR. CB-708 is a selective, oral inhibitor of CD73, an enzyme that synthesizes the immunosuppressive agent adenosine and is over-expressed in multiple tumor types. By blocking adenosine production in the tumor, CB-708 is designed to enhance T-cell activation leading to anti-tumor activity. Calithera plans to initiate clinical development of the compound in the second half of 2019. The preclinical data being presented demonstrates that CB-708 is a potent and selective inhibitor of CD73 that has immune-mediated, single agent activity in syngeneic mouse tumor models. In addition, in pre-clinical studies CB-708 is well-tolerated and shows enhanced anti-tumor activity when combined with either an anti-PD-L1 immunotherapy or with chemotherapeutic agents such as oxaliplatin or doxorubicin.
https://thefly.com/landingPageNews.php?id=2887239
https://thefly.com/landingPageNews.php?id=2887239
BioCryst price target raised to $8 from $6 at Barclays
Barclays analyst Gena Wang raised her price target for BioCryst Pharmaceuticals to $8 from $6 following a deep dive ahead of the BCX7353 APeX-2 Phase 3 readout in Q2 for the prevention of hereditary angioedema attacks. The analyst believes APeX-2 is “well powered to allow for statistical significance” with only greater than 25-30% attack reduction. However, she continues to see some risk in the trial outcome and a high bar for future commercial uptake. Wang keeps an Equal Weight rating on BioCryst.
Deutsche: ‘substantial’ growth runway for Intuitive Surgical, starts at Buy
Deutsche Bank analyst Imron Zafar last night initiated coverage of Intuitive Surgical with a Buy rating and $630 price target. Intuitive is the dominant global leader in robotic surgery and one of the premier medtech growth stories, Zafar tells investors in a research note. Further, the analyst believes a “still-underpenetrated” worldwide surgery market leaves “substantial runway for continued robust sales growth.”
BARDA decides not to advance Pfenex anthrax programs
Pfenex disclosed last night that it received notice from the Department of Health and Human Services, Biomedical Advanced Research and Development Authority, advising the company of its decision not to exercise development options for cGMP manufacturing and potential Phase 1/2b study readiness for the company’s novel anthrax vaccine candidates Px563L and RPA563, collectively, the anthrax programs. In the notice BARDA stated: “While technical risks were noted, this decision was more of a reflection of the programmatic strategy around [BARDA’s] vaccine portfolio as a whole, and a lack of products for other urgent threats.” Following the receipt of the notice from BARDA and pursuant to ongoing discussions with BARDA, the company “is assessing the priority of this program in its portfolio.”
Novartis announces Chinese approval of Cosentyx for psoriasis patients
Novartis announced that the China Health Authority NMPA approved Cosentyx, the first-in-class interleukin-17A inhibitor for moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. “Reimagining the management of psoriatic disease to provide patients with the ability to live their life free from the burden of psoriasis is a key focus for us,” said Paul Hudson, CEO Novartis Pharmaceuticals. “With Cosentyx, we are offering a new treatment to doctors and psoriasis patients in China which can act within 3 weeks, has demonstrated sustained safety in more than 200,000 patients worldwide and can deliver what doctors and patients are looking for.”
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