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On Friday, BioMarin Pharmaceutical received a positive CHMP opinion in Europe for ValRox for Hemophilia type A treatment. According to the last report, the core portfolio looks solid. Vozxogo remains the main driver of revenue growth this year. If approved in Europe, the start...
Results from the phase 3 RESPONSE study, which is using Seladelpar for the treatment of patients with primary biliary Cholangitis, are expected in 2023. PBC patients treated with Seladelpar over a 2-year period saw a decrease in GLOBE PBC Score and improved transplant-free survival. ...
Repare Therapeutics is working in synthetic lethality, where big pharma has shown interest. They have some early data. While things look good, I will wait for more conclusive data before I jump in. For further details see: Repare Therapeutics: Interesting Gene Editing Co...
BioCryst Pharmaceuticals shares have been clobbered due to both the bear market and the uncertainty relating to its lead developing drug (BCX9930). I believe that the FDA would remove the partial clinical hold on BCX9930 by either year-end or next year. The lead drug (Orladeyo) is...
Allogene's leadership position in allogeneic CAR-T can be rewarding for early investors. However, being a pioneer has its pitfalls. The company has a decent amount of cash. For further details see: Allogene Therapeutics: Multibagger Potential, But Terribly Risky
In the latest 1Q2022 earnings report, the lead medicine Oxbryta continues to generate highly aggressive growth. You can expect even stronger growth due to the recent Oxbryta launch for kids in the EU. There are also adult campaigns in other countries outside of the USA. Two promis...
Mirati will probably not get accelerated approval for adagrasib in 2nd line NSCLC. This will delay their program for two years. However, much of their data is stronger than Amgen's lumakras. For further details see: Mirati: Not Looking Good In 2022, But Stronger Prospect...
AVDL's FT218 is going to get delayed further over a patent issue. However, there's a goalpost in sight now, and the date is June 2023. The company is cash-strapped. For further details see: Avadel: Further Delay, But Some Light At The End Of The Tunnel
In the last 12 months, I count four Ionis programs that failed. This series of failures does not generate confidence. So, despite some catalysts up ahead, I will stay away. For further details see: Ionis Pharma: Too Many Programs Have Failed To Produce Confidence
Two ongoing studies for use of paltusotine for treatment of patients with Acromegaly are PATHFNDR-1 and PATHFNDR-2; Results from both studies expected 2023. Paltusotine is also being explored for the treatment of patients with neuroendocrine tumors in a phase 2 study. Phase 1 proo...
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