Novartis ends Wet AMD trial for Beovu citing safety concerns

  • Novartis (NYSE:NVS) announced the termination of its Phase 3 MERLIN study that was designed to evaluate Beovu (brolucizumab) 6 mg versus Regeneron's EYLEA (Aflibercept) 2 mg in patients with wet age-related macular degeneration (AMD).
  • Announcing year one results of the study where Beovu was given in four-week dosing intervals following the loading phase, the company said that the trial met its primary endpoint compared to aflibercept.
  • However, intraocular inflammation (IOI) including RV, and RO were more frequent in the Beovu arm compared to aflibercept 2 mg. (IOI: 9.3% vs 4.5% of which RV: 0.8% vs 0.0%; RO: 2.0% vs 0.0%.) while the overall rate of vision loss was 4.8% in Beovu arm vs 1.7% in the aflibercept arm.
  • 'In the interest of patient safety, Novartis has decided to terminate the MERLIN study," the company said adding that it has also ended RAPTOR and RAVEN studies which evaluated brolucizumab with six initial monthly injections in retinal vein occlusion.
  • Other relevant trial protocols will also be amended to discontinue the four-week dosing intervals after the loading phase.
  • In 2019, the FDA approved BEOVU for wet AMD.

    For this year the company, based in Basel revenue will be around 51.97 billion CHF. This is according to the average of the analysts' estimates. This is slightly more than 2020's revenue of 49.9 billion CHF.

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    The analysts expect for 2021 a net profit of 14.18 billion CHF. For this year the majority of the analysts, consulted by press agency Thomson Reuters, expects a profit per share of 6.31 CHF. Based on this the price/earnings-ratio is 12.84.

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    For this year the analysts expect a dividend of 3.31 CHF per share. The dividend yield is then 4.09 percent. The average dividend yield of the pharmaceutical companies equals a limited 1.39 percent.

    Most recent target prices around 96 CHF

    Jefferies & Co., UBS and Oddo BHF recently provided recommendations for the stock.

    Based on the current number of outstanding shares Novartis 's market capitalization 183.51 billion CHF. The Novartis stock was the past 12 months quite volatile. Since last June the stock is 1 percent higher. This year the stock price moved between 70 and 87 CHF.

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    On Friday the stock closed at 81.02 CHF.

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