Fly Intel: After-Hours Movers » 18:0807/0207/02/20
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Regeneron falls 3.5% after ph.3 data on Kevzara in Covid patients 16:3307/0207/02/20
Regeneron/Sanofi's ph3 trial of Kevzara in COVID did not meet endpoints » 16:3207/0207/02/20
Regeneron (REGN) and…
Regeneron (REGN) and Sanofi (SNY) announced that the U.S. Phase 3 trial of Kevzara or sarilumab, 400 mg in COVID-19 patients requiring mechanical ventilation did not meet its primary and key secondary endpoints when Kevzara was added to best supportive care compared to best supportive care alone. Minor positive trends were observed in the primary pre-specified analysis group that did not reach statistical significance, and these were countered by negative trends in a subgroup of critical patients who were not mechanically ventilated at baseline. In the primary analysis group, adverse events were experienced by 80% of Kevzara patients and 77% of placebo patients. Serious adverse events that occurred in at least 3% of patients and more frequently among Kevzara patients were multi-organ dysfunction syndrome and hypotension. Based on the results, the U.S.-based trial has been stopped, including in a second cohort of patients who received a higher dose of Kevzara of 800 mg.
Applied Genetic may attract Sanofi takeover interest, says Roth Capital » 13:0607/0107/01/20
Applied Genetic Technologies (AGTC) recently announced significant advancements to its proprietary AAV gene therapy manufacturing platform, which "exceeds the performance and economics of many others," Roth Capital analyst Zegbeh Jallah tells investors in a research note. Further, Investigational New Drug enabling studies for more indications beyond rare genetic retinal diseases are expected to begin during the second half of 2020 and could put Applied Genetic "into the running for M&A interest" from Sanofi (SNY), adds the analyst. Jallah believes the company's manufacturing advancements position it to potentially attract takeover or partnering interest from large pharma. The analyst keeps a Buy rating on Applied Genetic Technologies with a $25 price target. The stock is up 6% to $5.88 in afternoon trading following the analyst note.
Regeneron price target raised to $675 from $625 at Oppenheimer » 08:1107/0107/01/20
Oppenheimer analyst Hartaj Singh raised the firm's price target on Regeneron to $675 from $625 and keeps an Outperform rating on the shares. The analyst continues to highlight Regeneron as one of his top biotech names. However, with the stock up about 67% year-to-date, he acknowledges that performance in the second half of 2020 could be accompanied by greater volatility. Singh would argue that, with potential Eylea competition receding, and Dupixent revenues continuing to grow, mid/long-term sales/earnings momentum should continue.
Kiniksa says Phase 3 trial of rilonacept meets efficacy endpoints » 07:2206/2906/29/20
Kiniksa Pharmaceuticals (KNSA) reported data from RHAPSODY, a pivotal Phase 3 trial of rilonacept, a weekly, subcutaneously-injected, recombinant fusion protein that blocks interleukin-1 alpha and interleukin-1 beta signaling, in recurrent pericarditis. RHAPSODY met its prespecified primary and all major secondary efficacy endpoints, showing that rilonacept improved clinically meaningful outcomes associated with the unmet medical need in recurrent pericarditis, a painful and debilitating autoinflammatory disease. The U.S. Food and Drug Administration granted Breakthrough Therapy designation to rilonacept for the treatment of recurrent pericarditis in 2019, and Kiniksa expects to submit a Supplemental Biologics License Application later this year. RHAPSODY is a global, randomized withdrawal design, pivotal Phase 3 clinical trial of rilonacept in recurrent pericarditis. The trial's primary analysis population included 61 actively symptomatic recurrent pericarditis patients who were failing standard of care treatment, including nonsteroidal anti-inflammatory drugs, colchicine, or corticosteroids, initiated rilonacept treatment during a run-in period, discontinued background medications, and achieved and maintained clinical response on rilonacept monotherapy. Clinical responders were randomized 1:1 to receive continued weekly rilonacept or placebo in a blinded manner in the randomized withdrawal period. The primary efficacy endpoint of time-to-first adjudicated pericarditis recurrence in the randomized withdrawal period was highly statistically significant. Median time to pericarditis recurrence for rilonacept recipients in the randomized withdrawal period could not be estimated due to the low number of recurrences in the rilonacept treatment arm. The median time-to-recurrence for placebo recipients was 8.6 weeks. Rilonacept recipients experienced a 96% reduction in risk of recurrent pericarditis events. All major secondary efficacy endpoints in the randomized withdrawal period were also highly statistically significant. 81% of rilonacept recipients maintained clinical response at Week 16 of the randomized withdrawal period, compared to 20% of placebo recipients. Consistent results were observed at Week 8 and Week 24 and were also highly statistically significant. The proportion of rilonacept recipients with absent or minimal pericarditis symptoms at Week 16 of the randomized withdrawal period was 81% compared to 25% for placebo recipients. Consistent results were observed at Week 8 and Week 24 and were also highly statistically significant. Rilonacept was well-tolerated in the study, with adverse events consistent with the FDA-approved label for the treatment of Cryopyrin-Associated Periodic Syndromes. The most common adverse events were injection site reactions. Additional analyses of the RHAPSODY trial results are ongoing, and Kiniksa plans to present the data at a future medical meeting or in a publication. Rilonacept was discovered and developed by Regeneron Pharmaceuticals (REGN) and is approved by the FDA under the brand name ARCALYST for the treatment of CAPS. Kiniksa licensed rilonacept from Regeneron in 2017 for evaluation in diseases believed to be mediated by both IL-1alpha and IL-1beta, including recurrent pericarditis. The FDA granted Breakthrough Therapy designation to rilonacept for recurrent pericarditis in 2019. Based on the Phase 3 RHAPSODY data announced today, the Biologic License Application (BLA) for CAPS will transfer to Kiniksa, and the company plans to submit an sBLA with the FDA in recurrent pericarditis later this year. Upon receipt of FDA approval for rilonacept in recurrent pericarditis, Kiniksa would assume the sales and distribution of rilonacept for the approved indications in the United States and will evenly split profits on sales with Regeneron.
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Translate Bio initiated with a Buy at SunTrust » 07:2706/2606/26/20
SunTrust analyst Joon Lee…
SunTrust analyst Joon Lee initiated coverage of Translate Bio (TBIO) with a Buy rating and $40 price target. The analyst notes that the mRNA is an "emerging therapeutic modality that could rival RNA silencing therapeutics", and he is positive on the company's early MRT5005 data in cystic fibrosis, which significantly de-risks three additional follow-on lung indications. Lee adds that Translate Bio's recent collaboration deal with Sanofi (SNY) is validating.
Sanofi mulls eliminating hundreds of jobs, Reuters reports » 10:2706/2506/25/20
Sanofi is mulling the…
Sanofi is mulling the elimination of hundreds of jobs and will discuss possible steps with staff representatives on Friday and Monday to develop a restructuring plan, Reuters' Matthias Blamont reports, citing four sources familiar with the matter. The move comes as the French drugmaker's CEO Paul Hudson has been looking to reduce costs. Reference Link
Sanofi considers jobs cuts, will discuss with reps in coming days, Reuters says 10:1506/2506/25/20
Markets and Markets to hold a virtual event » 09:4606/2506/25/20
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Next-Gen 3rd Annual…
Next-Gen 3rd Annual Immuno-Oncology Virtual Congress will be held on June 25-26. Webcast Link