Scholar Rock announces CEO Tony Kingsley departs company » 07:4808/0308/03/21
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Regeneron price target raised to $741 from $729 at H.C. Wainwright » 06:1108/0208/02/21
H.C. Wainwright analyst…
H.C. Wainwright analyst Michael King raised the firm's price target on Regeneron to $741 from $729 and reiterates a Buy rating on the shares after the FDA authorized REGEN-COV to be used as a post-Covid exposure therapy in individuals with high risk for severe Covid. The FDA's decision to expand REGEN-COV's use as a post-exposure proxylaxis therapy represents a significant step in preventing potentially exposed high-risk individuals from acquiring the infection and succumbing to its complications, King tells investors in a research note.
Ipsen, Exicure enter exclusive collaboration agreement to explore SNAs » 05:3908/0208/02/21
Ipsen (IPSEY) and Exicure…
Ipsen (IPSEY) and Exicure (XCUR) have signed an exclusive collaboration agreement to research, develop, and commercialize novel Spherical Nucleic Acids, or SNAs, as potential investigational treatments for Huntington's disease and Angelman syndrome. Oligonucleotides are synthetic structures of nucleic acids that can be used to modulate gene expression via a range of processes, including gene activation, inhibition, and splice-modulation. These molecules have demonstrated potential in many different therapeutic areas. Achieving efficient oligonucleotide delivery to target organs and tissues, including the brain, remains a major limitation to their use. Exicure's SNAs provide distinct chemical and biochemical properties to oligonucleotides. In preclinical models, SNAs have been shown to enhance the cell penetration, biodistribution and organ persistence properties of oligonucleotides, which may potentially enhance drug delivery to previously inaccessible target tissues, including deep brain regions. Under the agreement, Ipsen will receive exclusive options to license SNA-based therapeutics arising from two collaboration programs for Huntington's disease and Angelman syndrome. Ipsen will pay Exicure a cash upfront payment of $20M upon closing and Exicure will be responsible for discovery and certain pre-clinical development activities. In the event Ipsen exercises its option, Ipsen will be responsible for further development and commercialization of the licensed products. Exicure will receive a $20M upfront payment and is eligible to receive up to $1B in option exercise fees and milestone payments should Ipsen opt into both programs, as well as tiered royalties.
Regeneron reports FDA expands authorized use of REGEN-COV » 13:4607/3007/30/21
Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration updated the Emergency Use Authorization, or EUA, for the investigational COVID-19 antibody cocktail REGEN-COV. The authorization now includes post-exposure prophylaxis in people at high risk for progression to severe COVID-19, who are not fully vaccinated or are not expected to mount an adequate response to vaccination, and have been exposed to a SARS-CoV-2 infected individual, or who are at high risk of exposure to an infected individual because of infection occurring in the same institutional setting, such as in nursing homes or prisons. In those who require repeat dosing for ongoing exposure, REGEN-COV can also now be administered monthly. This new indication in people aged 12 and older is in addition to the previously granted authorization to treat non-hospitalized patients. REGEN-COV is not a substitute for vaccination against COVID-19, and is not authorized for pre-exposure prophylaxis to prevent COVID-19.
Regeneron price target raised to $729 from $703 at H.C. Wainwright » 12:5807/2907/29/21
H.C. Wainwright analyst…
H.C. Wainwright analyst Michael King raised the firm's price target on Regeneron Pharmaceuticals (REGN) to $729 from $703 and keeps a Buy rating on the shares after the company and Sanofi (SNY) announced Dupixent met all key primary and secondary endpoints in the Phase 3 trial for chronic spontaneous urticaria. The data continues to support Dupixent's "well-established" safety profile, King tells investors in a research note. The analyst updated his model to reflect the increased probability of success for Dupixent.
Regeneron, Sanofi announce Dupixent trial met primary and secondary endpoints » 05:5307/2907/29/21
Regeneron (REGN) and…
Regeneron (REGN) and Sanofi (SNY) announced a pivotal Phase 3 trial evaluating Dupixent in patients with moderate-to-severe chronic spontaneous urticaria, or CSU, met its primary and all key secondary endpoints at 24 weeks. Adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives for biologic-naive patients, compared to antihistamines alone in Study A, the first of two trials of the LIBERTY-CUPID clinical program. In the trial, adding Dupixent to standard-of-care antihistamines nearly doubled the reduction in itch and urticaria activity compared to standard-of-care alone (placebo) with continuous improvement out to 24 weeks. Patients experienced a 63% reduction in itch severity with Dupixent versus 35% with placebo, as measured by a 0-21 point itch severity scale, the primary endpoint in the U.S.; 65% reduction in urticaria activity severity with Dupixent versus 37% with placebo, as measured by a 0-42 point urticaria activity scale, the secondary endpoint in the U.S. The trial demonstrated safety results similar to the known safety profile of Dupixent in its approved indications. For the 24-week treatment period, the occurrence of treatment emergent adverse events were generally similar between the Dupixent and placebo groups. The most common adverse events were injection site reactions. The potential use of Dupixent in CSU and EoE is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.
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SpringsWorks Therapeutics appoints James Cassidy as CMO » 08:0907/2707/27/21
SpringWorks Therapeutics (SWTX) announced that James Cassidy, M.D., Ph.D., has been appointed Chief Medical Officer. Cassidy succeeds Jens Renstrup, M.D., MBA, who will be leaving the company. Dr. Cassidy joins SpringWorks from Regeneron Pharmaceuticals (REGN), where he was Vice President of Oncology Strategic Program Direction.
AstraZeneca Regeneron to commercialize new small molecule medicines for obesity » 07:0407/2707/27/21
AstraZeneca (AZN) announced it has entered into a collaboration with Regeneron (REGN) to research, develop and commercialize small molecule compounds directed against the GPR75 target with the potential to treat obesity and related co-morbidities. The companies will evenly split research and development costs and share equally in any future potential profits. Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: "We are pleased to announce this important collaboration with Regeneron to identify small molecule modulators against GPR75, a newly identified target with genetic validation in metabolic disorders. Obesity and insulin resistance remain key drivers in the development of type-2 diabetes and areas of significant unmet medical need." George Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron, added: "As experts on genetics and human biology, Regeneron is excited to join forces with the chemistry and small molecule leaders at AstraZeneca, as we seek to develop new medicines tackling the harmful and costly obesity epidemic."
Regeneron price target raised to $679 from $629 at RBC Capital » 06:4507/2307/23/21
RBC Capital analyst…
RBC Capital analyst Kennen MacKay raised the firm's price target on Regeneron to $679 from $629 and keeps a Sector Perform rating on the shares. The analyst updates his model to include both REGN3500 & NTLA-2001, stating that he views REGN3500 as one of the company's most underappreciated late-stage pipeline assets with the potential to quickly gain blockbuster status should the currently enrolling phase 3 AERIFY-1/2 trials in COPD demonstrate statistical benefit.. MacKay adds that he models a 2025 approval with the potential for REGN3500 to achieve $3B in global risk-unadjusted sales by 2035.