AUPHPDUFA positivo, aprobado tras cierre post market. Tema Lupus. La llevo desde hace un mes, veremos subida grande parece:https://www.multivu.com/players/English/8811951-aurinia-pharmaceuticals-lupkynis-voclosporin/
A título informativo, ARCT ha presentado resultados fase I/II hoy. De lo que leo parece q no son malos datos pero no tanto como los de pfizer o moderna. Cae un 30% en AH, y eso que no solo se dedica a tema covid. Estaba bien inflada. Pego comentario:I don't know. We'll see. I need to analyze the data and listen to the investor call again. But at the moment, not too excited to buy more based on today's update.They did talk about the T cell response (which can be interpreted as pivoting away from low neutralizing antibody levels), and how it could actually be the main driver of protection against the virus (and the mouse model with depleted B-cells and T-cells confirms that, at least preclinically), and how early T-cell response may lead to lower neutralizing antibody production and low response to a subsequent boost. Separately, they pointed out the data point from the PFE/BNTX and MRNA studies where the first dose was significantly protective after 12 days or so and antibody titers were still quite low at the time. And lastly, animal challenge models, including non-human primates look good. This vaccine should work, but the problem is the very high bar set by PFE/BNTX and MRNA. Not just for ARCT but for other vaccine manufacturers. Need to review more, but ARCT profile to date looks similar to better than CVAC vaccine profile. And CVAC is ahead and should provide some read-through. If it works as well as PFE/BNTX and MRNA, should be positive for ARCT.And lastly, they talked about trial timelines. They initially planned a phase 2/3 study and just decided to split it up to separate phase 2 and phase 3 because of some regulatory uncertainty due to emergency authorizations for PFE/BNTX and MRNA vaccines and how they could change the design of phase 3 part of the study. Not related to today's results, but sentiment for vaccine players has turned quite negative lately. That won't help ARCT tomorrow (and isn't helping in AH trading either, though I'd say the AH decline is all about the data they reported).
Hola Framus,Efectivamente, la tengo desde hace tiempo, pero reduje posiciones cuando rebalanceé la cartera y diversifiqué más, porque esta demasiado cargado. Ese fue el motivo principal. Respecto a mi confianza en HZNP sigue al 100% no tanto por lo que yo pueda saber que es nada, sino porque leo mucho al respecto sobre todo de un servicio de pago de SA, de un experto con portfoliio en growth stocks especializado en farmas. Respecto a este tema del otro día, de hecho sigue confiando al 100% y la propia empresa no ha modificado la guidance, por lo que parece algo temporal de algún elemento del suministro de tepezza. Si te interesa más información te la paso sin problema, te pego aquí parte del artículo y/o chat al respecto, copiado literal del 17 de diciembre donde dio señal de entrada (buy at close en este caso):Horizon Therapeutics (HZNP) dropped today because of a short-term disruption in the supply of Tepezza. The U.S. government ordered manufacturer Catalent to prioritize COVID-19 vaccine production and Tepezza was the victim of the order. There is minimal disruption this year, and the company maintained its guidance for the year, including Tepezza’s full year sales guidance of more than $800 million. Most (and probably all) of the disruption will happen in Q1 2021, and the company has a solution but needs to work with the FDA to get the approval before it can proceed. Catalent will provide one production slot per month to Horizon but several slots are needed at current specifications. That slot can be scaled but the FDA needs to review the data and approve the new process.The FDA has agreed to a rolling submission of the data and Horizon expects to submit the data in January. If successful, Tepezza sales could resume sometime in February. The worst-case scenario appears to be a full quarter of disruption as Catalent’s manufacturing facility for the COVID-19 vaccine is coming online in April.This is a temporary setback that doesn’t impact the thesis on Horizon or the long-term outlook for Tepezza. Horizon will ensure that all patients who discontinue therapy can resume as fast as possible and for new patients to start treatment. Some patients may not even have to wait because it takes up to 90 days from the patient enrollment form to the first infusion.
