Novartis announces REACH3 trial of Jakavi reaches primary endpoint » 12:4712/0412/04/20
Detailed results from the…
Detailed results from the pivotal Phase III REACH3 study demonstrate Jakavi significantly improved outcomes across a range of efficacy measures in patients with steroid-refractory/dependent chronic graft-versus-host disease, or GvHD, compared to best available therapy, Novartis (NVS) announced. The results of REACH3, which the company calls "the first successful, randomized Phase III trial in chronic GvHD," were presented today during the 62nd American Society of Hematology Annual Meeting & Exposition, or ASH. REACH3 is jointly sponsored by Novartis and Incyte (INCY). In REACH3, patients treated with Jakavi achieved significantly greater overall response rate compared to BAT at Week 24, the primary endpoint of the study. Jakavi also demonstrated statistically significant and clinically meaningful improvements in key secondary endpoints, the company said. David Feltquate, Head Hematology Development Unit, Novartis, added: "Jakavi is the first treatment to demonstrate efficacy in a large-scale randomized clinical trial in steroid-refractory/dependent chronic GvHD, and with these meaningful data we look forward to advancing discussions with regulatory authorities."
Incyte: Jakafi improved outcomes in patients in REACH3 trial » 12:3212/0412/04/20
Incyte (INCY) announced…
Incyte (INCY) announced that detailed results from the pivotal Phase 3 REACH3 study demonstrate Jakafi significantly improved outcomes across a range of efficacy measures in patients with steroid-refractory or steroid-dependent chronic graft-versus-host disease compared to best available therapy. The results of REACH3, the first successful, randomized Phase 3 trial in chronic GVHD, were highlighted in a press briefing today and will be presented during the 62nd American Society of Hematology Annual Meeting & Exposition. REACH3 is jointly sponsored by Incyte and Novartis (NVS). "The results from this large, randomized study further emphasize the role Jakafi can play as a meaningful option for patients with chronic GVHD, for whom new treatments are urgently needed," said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte. "These data are important for patients living with GVHD and their physicians as they represent the continued success of Jakafi in the chronic form of the disease, a historically difficult-to-treat condition." In REACH3, patients treated with Jakafi achieved significantly greater overall response rate compared to BAT at Week 24, the primary endpoint of the study6. Jakafi also demonstrated statistically significant and clinically meaningful improvements in key secondary endpoints: Patients receiving Jakafi had a significant improvement in failure-free survival versus patients receiving BAT. Patients treated with Jakafi also had greater improvements in patient-reported symptoms than those treated with BAT, as measured by the rate of responders who achieved a reduction of greater than or equal to 7 points of total symptom score from baseline of the modified Lee Symptom Score. Additionally, best overall response rate, defined as any response up to week 24, was achieved in 76.4% of patients in the Jakafi arm compared to 60.4% in the BAT arm. The median duration of response was 6.2 months in the BAT arm, but was not yet reached in the Jakafi arm. No new safety signals were observed in REACH3, and adverse events attributable to treatment were consistent with the known safety profile of Jakafi.
Dicerna participates in a conference call with Truist » 10:2912/0412/04/20
Conference call with…
Conference call with management will be held on December 10 at 11 am hosted by Truist.
Cowen calls Aurinia a best idea for 2021 into FDA action date » 10:2112/0412/04/20
Aurinia Pharmaceuticals is positioned for a "meaningful inflection" into the January 22 FDA action date for voclosporin in lupus nephritis, Cowen analyst Ken Cacciatore tells investors in a research note. Citing voclosporin's efficacy and safety, combined with clinician enthusiasm and an unmet clinical need, the analyst has "strong conviction" that voclosporin should be "rapidly incorporated" into the standard of care and has $1B-plus sales potential. He calls Aurinia a best for 2021 and recommends adding to positions at current levels. Cacciatore keeps an Outperform rating on the shares with a $30 price target.
Omeros price target raised to $25 from $20 at Maxim » 07:5912/0412/04/20
Maxim analyst Jason…
Maxim analyst Jason McCarthy raised the firm's price target on Omeros to $25 from $20 and keeps a Buy rating on the shares. The analyst is citing the recent CMS guidelines, which confirm that Omidria will qualify for separate payment under the ambulatory surgical center payment system as a non-opioid pain management drug. McCarthy adds that this decision marks a significant event for Omeros, as Omidria is the cash engine for the company.
CureVac names Antony Blanc chief business officer, chief commercial officer » 07:2512/0412/04/20
CureVac (CVAC) announced…
CureVac (CVAC) announced that Antony Blanc was appointed chief business officer and chief commercial officer of CureVac. In this role, he will be responsible for building the network of partnerships that will support the growth of CureVac, for developing the competitiveness and commercial relevance of the company's programs in development and for building the commercial organization. Antony Blanc previously served biotech clients in Europe as an associate partner with McKinsey & Company. Between 2009 and 2017, he developed deep and broad cross-functional expertise in vaccines by serving in several senior roles at GSK Vaccines (GSK), including leading strategic marketing, strategic pricing, joint ventures and the integration of the Novartis Vaccines business unit.
McKesson, Amgen sign strategic agreement to help improve cancer care » 07:2112/0412/04/20
McKesson (MCK) and Amgen…
McKesson (MCK) and Amgen (AMGN) have signed a strategic agreement to help improve cancer care in community oncology settings. One in five cancer patients receives an Amgen medicine, while McKesson reaches 20% of U.S. cancer patients. This multi-year agreement bridges the two companies and will focus on reducing gaps in care by optimizing access to innovative precision medicine and immuno-oncology in the community setting. This partnership will be led by Ontada, McKesson's new oncology technology and insights business. Ontada is focused on helping life sciences companies like Amgen improve patient outcomes for cancer care, from early clinical development to drug commercialization and post-launch activation of insights. Amgen and Ontada will launch various programs over the course of the partnership and build on projects that have already begun, such as those focusing on reducing gaps in molecular testing and understanding treatment patterns in the community setting. For example, Amgen and McKesson recently conducted real-world research to better understand patterns of molecular testing in advanced/metastatic non-small cell lung cancer with community oncologists with plans to publish the findings in early 2021. Through the strategic partnership, McKesson and Amgen hope to: elevate awareness on molecular testing in order to optimize care in patients that benefit from targeted therapy; uncover insights on unmet need and treatment outcomes by enriching data and insight capabilities; leverage real-world evidence to better understand and optimize the deployment of biosimilars to offer providers and their patients greater choice of therapies relative to value; co-develop new approaches to deliver immuno-oncology therapies in the community setting and optimize therapy sequencing to improve patient outcomes including supportive care.
Clover announces data for COVID-19 S-Trimer vaccine candidates » 05:1412/0412/04/20
Clover Biopharmaceuticals announced clinical data from its Phase 1 trial demonstrating that its protein-based COVID-19 S-Trimer vaccine candidates in combination with adjuvants from either GlaxoSmithKline (GSK) or Dynavax (DVAX) induces strong immune responses, including neutralizing antibodies and cell-mediated immunity, as well as favorable safety and tolerability profiles in 150 adult and elderly participants. The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. No serious adverse events related to the vaccine candidates studied were reported. The majority of adverse events were mild and transient. S-Trimer adjuvanted with GSK's pandemic adjuvant system induced neutralizing antibody titers in 100% of participants at the selected 9 microgram S-Trimer dose in both adult and elderly groups, with geometric mean titers, or GMT, greater than 1:1,800. CpG-1018/alum-adjuvanted S-Trimer induced neutralizing antibodies in 100% of adult participants at the selected 30 microgram S-Trimer dose with GMT greater than 1:1,000, and seroconversion was observed in 88% in elderly. Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant. Preliminary results from stability studies have demonstrated that S-Trimer is stable at 2-8 degrees Celsius for at least six months and stable at room temperature and 40 degrees Celsius for at least one month, in line with the adjuvants tested. Thus, the ability of Clover's COVID-19 vaccine candidates to be stored in standard refrigeration temperatures makes them suitable for broad global distribution based on current results. Based on the Phase 1 results reported and the unprecedented need for COVID-19 vaccines, Clover and its partners said they are confident to enter late-stage clinical development for both adjuvanted vaccines. A global Phase 2/3 efficacy study of the S-Trimer vaccine candidate in combination with GSK's pandemic adjuvant system is expected to begin in December. Clover intends to initiate a separate pivotal clinical trial of the S-Trimer vaccine candidate in combination with Dynavax's advanced CpG 1018 adjuvant plus alum in the first half of 2021.
Nasdaq, in association with Morgan Stanley to hold a virtual conference » 04:5512/0412/04/20
AKAM, ZG, YNDX, TSCO, SRCL, QLYS, PTC, POOL, PODD, PFPT, ZI, OLED, ALNY, ANSS, DOX, EBAY, EQIX, HBAN, HSIC, INTU, LITE, ON
Nasdaq 43rd Virtual…
Nasdaq 43rd Virtual Investor Conference will be held on December 1-4.
Alnylam selects PANTHERx Rare Pharmacy as Oxlumo partner » 13:5512/0312/03/20
PANTHERx Rare Pharmacy…
PANTHERx Rare Pharmacy announces that it has been selected by Alnylam Pharmaceuticals as a "very limited distribution pharmacy partner" for new drug Oxlumo, or lumasiran. The drug has been approved by the U.S. Food and Drug Administration for the treatment of primary hyperoxaluria type 1 to lower urinary oxalate levels in pediatric and adult patients.