This week is going to be particularly heavy on the earnings updates and FDA actions. Below are some of our views on potential updates and major events at biopharmaceutical companies this week. Additionally, the 12th Annual Needham Healthcare Conference takes place this week from 4/30-5/1. Monday, April 29th Main story for Dynavax will be the potential […]
DCTH – Soaring Ahead of The Upcoming Advisory Committee
Delcath Systems, Inc. (DCTH) -Nasdaq DCTH has been on our watch list for a while, looking for an entry point. we kept following out the stock performance at the forum and stated a position at $1.63 just after the price found a support around the 200-day Moving Average, also added more shares to the position at […]
DCTH – Our take on Delcath’s upcoming advisory committee
The FDA’s Oncologic Drugs Advisory Committee (ODAC) is slated to review Melblez (previously known as Chemosat) on May 2nd. An FDA decision is expected on June 15th. Melblez is a chemosaturation system that isolates the liver in order to allow the administration of high doses of melphalan for the treatment of liver metastases from other […]
DCTH – Commercial prospects and valuation
In our previous note, we discussed why we thought that a drug with orphan status, fast-track that tackles metastatic disease would receive a 6-month priority review. However, the FDA didn’t think Chemosat was elegible to get it and granted a 10 month review with a PDUFA date on June 15, 2013. The agency will convene […]
An October full of data and decisions
With October underway, we felt the need to highlight some of the most important upcoming data readouts and regulatory decisions. This month is particularly busy on the regulatory side of things with 5 PDUFAs, 4 Advisory Committees, 6 FDA actions, and multiple potential European Medicines Agency(EMA) decisions. The events are listed in chronological order. Eli […]
DCTH – Flash note on Delcath’s NDA acceptance
Delcath (NASDAQ: DCTH) is approaching a key catalyst related to its technology Chemosat. The company is slated to hear from the FDA with regards to the acceptance of its NDA for the Chemosat technology and we’ll know whether it’s granted priority review (expected announcement on October 14), or standard review (expected Oct 28). Depending on the […]
