The main short term catalyst for Incyte Pharmaceuticals (Nasdaq: INCY) is a PDUFA date of Dec 3 for its JAK1/JAK2 inhibitor ruxolinitib -ruxo for short. This drug met its primary and secondary endpoints in two pivotal Phase III trials named COMFORT I and COMFORT II. In both trials patients treated in the ruxo arm experienced significant spleen reduction as well as clinically meaningful improvements of symptoms and quality of life. These trials were conducted under a Special Protocol Assessment with the FDA.
(As published on Seeking Alpha on Nov 3 2011, click here to read the post and additional comments)
Ariad Pharmaceuticals’ $1.5bn market cap is mainly driven by two drugs in advanced clinical stages: ridaforolimus for soft tissue and bone sarcoma and ponatinib for chronic myeloid leukemia (CML) and Philadelphia positive acute lymphoblastic leukemia (Ph+ ALL). The former is partnered with Merck and presented top-line results of the phase III SUCCEED trial early this year. Merck is now on track to file an NDA later this year. Ariad also announced on August 18 that the EMA had accepted the MAA of the drug.
Vectura’s shares (LSE:VEC) took a hit on October 25 after its partner Novartis (NYSE:NVS; SIX:NOVN) said it’d delay regulatory filings of two of their respiratory drugs: NVA237 and QVA149.
The stock tumbled 20% that day and has been under selling pressure since then. It’s trading now at 52-week lows.
On the one hand, NVA237 (also named Seebri Breezhaler) will require additional data in the US hence delaying not only its NDA submission, but also affecting QVA149’s. On the other hand, on Sept 28, Novartis announced it had submitted a Marketing Authorisation Application (MAA) for NVA237 to the European Medicines Agency (EMA) triggering a $5m milestone payment under [Read more...]
Exelixis (Nasdaq: EXEL) plunged 40% last week after the company informed investors it’ll go ahead with its intention to run pivotal Phase III trials of cabozantinib (cabo) for castration-resistant prostate cancer (CRPC) despite not getting an agreement on a Special Protocol Assesment with the FDA. Exelixis announced very positive results from a Phase III clinical trial of cabo in medullary thyroid cancer the week before. Although it’s a small indication from a commercial standpoint, it provides a clinical validation of Exelixis’ main drug and sets it for a potential approval in 2012. Exelixis plans to initiate a rolling NDA submission for this indication this quarter. The filing will be completed in 1H 2012.