Nota de Piper:
Revance risk/reward attractive into RT002 launch, says Piper Jaffray Revance Therapeutics has enough cash to commercialize RT002 in the aesthetics setting following last week's capital raise, Piper Jaffray analyst David Amsellem tells investors in a research note. The company will be launching RT002 into a "consumer-focused, promotion-intensive landscape where it will be up against a well-entrenched competitor," adds the analyst. However, Amsellem continues to believe that the body of data surrounding RT002 in glabellar lines points to the product gaining a "significant foothold." He believes peak sales for RT002 could be well in excess of $1B, making for an attractive risk/reward profile on shares of Revance. The analyst reiterates an Overweight rating on the stock with a $50 price target.
Y nota de Jefferies sobre como afectará el shutdown a la FDA:
In the near term, operations/timelines are still generally ongoing (ie. over the next month), but if the shutdown continues (and drug user fees dry up in weeks), we will head into uncharted territory where reviews could come to a halt, resulting in a growing backlog.
Our expert cited the FDA is currently able to still partially work because they have user-fee money to work off of. While this is not a "huge amount," it has helped continue regulatory reviews and other workloads. A few important points: (1) Our experts estimate the agency would have roughly another month of runway; (2) Any items or submissions for which user fees have been paid prior to the shutdown (ie. prior to 12/22) can continue (hence near-term PDUFA dates are still active), and if any advisory committee meetings have been scheduled those will continue; (3) Submissions after 12/22 are in a queue (which is good) but generally would not be worked on until shutdown is resolved; (4) If shutdown continues beyond the foreseeable future, ie. ~1 month, then essentially many reviews will stop; (5) In that case only essential matters will continue to be worked on such as leadership oversight of FDA, food safety matters, product/manufacturing safety issues, or BTD, or Priority Review, etc., but these could still be impacted due to required CMC or other reviews that need to happen and limited by personnel.
Companies will want to get their filings in as soon as possible and in the queue. In the worst case scenario, if the shutdown continues and the agency has to halt all review processes and focus only on "essential matters," then we end up in "murky waters" as we will end up building a queue of submissions. According to our experts, the agency will have some algorithm of how they go through the queue with drugs/agents with priority review and/or other high need taking priority. It was clear in this case, companies with submissions later in the queue could get delayed. Our estimate is a PDUFA could get delayed by perhaps the length of time from when funds dry up (next month) to when the government is back open.
Companies that have made submissions prior to 12/22 will be earlier in the queue.
We highlight a few selected tickers that come to mind in terms of near-term filings that
can happen but PDUFAs would be riskier given the above info: SAGE (PDUFA 3/19), KPTI
(PDUFA 4/19), AMAG (PDUFA 6/23), DOVA (PDUFA 6/30), VRTX (triple pill filing soon),
AMRN (Vascepa sNDA filing March), ESPR (BA filing Q1), EPZM (Taz filing soon), IMMU
('132 re-submission), NVS (Mayzent), SNY (Cablivi), SNY/REGN (Dupi for Paeds), ROG
(Tecentriq for ES-SCLC).
Amarin Corporation plc (NASDAQ:AMRN) announced that new data showing the reduction in total major adverse cardiovascular (i.e., ischemic) events shown in the landmark REDUCE-IT™ cardiovascular outcomes trial has been accepted for presentation as late breaking clinical trial data at the American College of Cardiology’s (ACC) 68th Annual Scientific Session on March 18, 2019 in New Orleans, LA.
La repentina shooting star en VIX me fuerza a ser precavido y tomar profits. Cierro shorts en RDUS y EXEL (practicamente en tablas esta ultima ). 100% cash ahora y mañana vere si considero algun largo.
veo ahora que en EXEL creo que hice bien. Cuña descendente y esa vela en el 38,20% de retroceso fibo … quita, quita, me da igual lo que diga MACD y Estocastico. Mejor me curo en salud.
Viendo RDUS no tengo tan claro que haya hecho bien cerrando el corto, para mi el patrón de double top me resulta muy viable y por eso hice short … ya revisare el asunto mañana … no descarto un retest al canal roto …
El caso es que esta vela VIX, shooting star, menudo primer rechazo de la MM20 diaria y en peldaño fibo … ha sido verlo con el móvil y he cerrado shorts sin miramientos ...
… Porque ya es la segunda sesión en la que la MM50 hace su trabajo en SPY … y mañana podría ser dia de toros ...
Por cierto, las NVAX … pese a lo bearish que apunta su MACD y estocástico … cuña descendente y tercera sesión que la MM50 aguanta como una campeona cuando hubiera tenido a huevo tirar cuesta abajo … interesante para seguir el asunto mañana ...
Los fundamentales van por un lado y el ruido short term por otro.
Confío que a nadie que lleve el stock le siente mal que comente mi operativa short. Trato de argumentarla del modo mas aséptico posible.