Last week, it was all about Martin Shkreli who made headlines thanks to his arrest on fraud charges. The saga continued with Shkreli being released on bail and then being fired from the position of CEO of two companies.
Recap of the Week’s Most Important Stories
- Martin Shkreli found himself being removed from the position of CEO of two companies – Turing and KaloBios KBIO. Shkreli, who has been in the news mainly due to his price gouging tactics, was arrested last week not due to pricing issues but due to fraudulent practices committed during a 5-year period when he was also working as a hedge-fund manager.
- Meanwhile, quite a few companies tasted success on the regulatory front. While Actelion ALIOF gained FDA approval for its pulmonary arterial hypertension treatment, Uptravi, Amgen AMGN got EU approval for its melanoma treatment, Imlygic. The approval of Uptravi boosts Actelion’s PAH portfolio which includes drugs like Opsumit and Veletri. Actelion will position Uptravi as an option to delay disease progression once therapy has been started with a baseline treatment like Opsumit and well before the use of Veletri for the late-stage disease. Meanwhile, Imlygic is the first oncolytic immunotherapy to demonstrate therapeutic benefit in patients with metastatic melanoma in a phase III study.
- Isis Pharmaceuticals has finally changed its name and will now be known as Ionis Pharmaceuticals, Inc. and will trade under the symbol IONS instead of ISIS. The company decided to change its name so that people associate them with life-saving medicines. The name change will ensure that Isis is no longer associated with global terrorism.
- Gilead GILD has signed up with Galapagos for the development and commercialization of filgotinib, a JAK1-selective inhibitor for inflammatory disease indications in a deal which could see Gilead paying out at least $2.075 billion including an upfront payment of $725 million. Earlier this month, Galapagos had reported encouraging mid-stage data on filgotinib in patients with Crohn’s disease. We note that the Gilead agreement comes around three months after AbbVie ABBV terminated its deal with Galapagos for filgotinib (Read more: Gilead Collaborates with Galapagos for Filgotinib).
- BioMarin BMRN will have to wait a bit longer before the FDA announces its decision regarding the approval status of the company’s experimental Duchenne muscular dystrophy treatment, Kyndrisa. The FDA has informed the company that they are yet to complete their review process, which means a response will not be available by the FDA action date of Dec 27. The agency said that it expects to take action in early Jan 2016 (Read more: BioMarin's Kyndrisa Review Period Extended by FDA).
Another company facing a delay is Intercept ICPT. Intercept’s obeticholic acid (OCA) is currently under FDA review for primary biliary cholangitis (PBC). The agency, which was supposed to respond on the approval status of the candidate by Feb 29, 2016, has now extended the review period by 3 months to May 29, 2016. Moreover, OCA will be reviewed by an FDA advisory panel on Apr 7, 2016 (Read more: Intercept Down on Delay in FDA's Verdict on Lead Drug).
In response to an information request from the FDA, additional clinical data analyses have been submitted. To provide time for a full review of the submission, the original PDUFA date of February 29, 2016 has been extended by three months, resulting in a new PDUFA date of May 29, 2016. The FDA has also notified Intercept of a planned advisory committee meeting date of April 7, 2016.
Performance
Vertex VRTX was the highest gainer (4.66%) among major biotech stocks over the last five trading days while Regeneron declined 5.05% during this period. Meanwhile, Biogen lost 27.74% over the last six months with Regeneron being the highest gainer (1.40%) during this period.
The NASDAQ Biotechnology Index was up 0.83% over the last five trading days (See the last biotech stock roundup here: Amgen Hikes First Quarter Dividend, ARIAD Lowers Iclusig Outlook).
What's Next in the Biotech World?
Watch out for the usual pipeline updates and data presentations from biotech companies.
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