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Fly News Breaks for March 16, 2016
SNY, AMGN, REGN
Mar 16, 2016 | 13:59 EDT
Piper Jaffray analyst Edward Tenthoff said that the jury ruling that two Amgen (AMGN) patents are valid, meaning that Regeneron (REGN) and Sanofi's (SNY) Praluent infringes, is not surprising to him. Tenthoff noted that he has expected Regeneron and Amgen to settle for a royalty payment, so a permanent injunction, if imposed, would be a worse than expected outcome. While this is not a big near-term negative for Regeneron, since Praluent's sales are still low, the patent fight is a potential risk, said Tenthoff, who keeps a Neutral rating on Regeneron shares.
News For REGN;AMGN;SNY From the Last 2 Days
AMGN
Apr 26, 2024 | 09:02 EDT
Amgen announced the imminent submission of a Marketing Authorization Application, or MAA, to the European Medicines Agency, or EMA, for teprotumumab, a fully human monoclonal antibody and targeted inhibitor of the insulin-like growth factor-1 receptor, or IGF-1R, for the treatment of moderate to severe Thyroid Eye Disease, or TED, in adults. TED is a serious, progressive, debilitating and potentially vision-threatening autoimmune disease that can cause proptosis, diplopia, eye pain, redness and swelling.1 If approved, teprotumumab would be the first and only medicine approved for TED in the European Union. The MAA is supported by multiple well-controlled clinical studies - a Phase 2 clinical study NCT01868997, Phase 3 confirmatory clinical study OPTIC NCT03298867, a Phase 4 study NCT04583735, and a Phase 3 clinical trial in Japan OPTIC-J, jRCT2031210453 - providing statistically significant and clinically meaningful improvements across multiple facets of TED, including in proptosis and diplopia, among the 287 total patients studied. Additionally, the studies assessed TED signs and symptoms such as pain, inflammation, redness and functional vision. Clinical improvements were seen in proptosis as early as six weeks, with continued improvement across the 24-week treatment period.2 Teprotumumab has a well-established safety profile.
REGN
Apr 26, 2024 | 08:41 EDT
Oppenheimer analyst Hartaj Singh raised the firm's price target on Regeneron to $1,175 from $1,125 and keeps an Outperform rating on the shares ahead of the Q1 earnings report on May 2. Oppenheimer believes the areas of focus will be the status and dynamics of the Eylea High Dose launch, questions around the impending Dupixent COPD PDUFA, the status of the two oncology approvals expected in 2024, updates on various pipeline projects in immunology and oncology, and comments on capital allocation and financial planning by the new CFO at the company.
SNY
Apr 25, 2024 | 06:17 EDT
Reports business EPS of EUR 1.78, down 17.6% reported and 7.4% at CER. Reports Q1 IRFS net sales EUR 10.464B, up 2.4%. Paul Hudson, Chief Executive Officer, commented: "We are off to an excellent start in 2024, delivering on our strategic priorities and a transformation of our portfolio of medicines and vaccines to become a development-driven, tech-powered biopharma company committed to serving patients and accelerating growth. Continued strong performance by Dupixent and our new launches drove sales growth of seven percent. In parallel, we are delivering on our promise of increased investments in our late-stage pipeline to fully realize its value for patients and Sanofi. We are awaiting regulatory decisions for Dupixent in COPD, a progressive disease with limited effective treatment options. If approved, Dupixent will be the first biologic treatment in COPD. With the robust progress in our portfolio transformation, we reaffirm our financial guidance for 2024."