The Medicines Co. (MDCO – Analyst Report) was in the news for different reasons last week – while the company reported disappointing preliminary top-line results for the first quarter, later on the company received some good news with the FDA issuing positive briefing documents for Kengreal ahead of an advisory panel meeting. Other companies making it to the headlines over the last five trading days include Tekmira (TKMR – Snapshot Report) and GW Pharmaceuticals (GWPH – Snapshot Report).
Recap of the Week’s Most Important Stories
1. The Medicines Co. has been in the news frequently this past week with the company providing preliminary top-line results. Moreover, the FDA released briefing documents ahead of an advisory panel meeting for Kengreal (Cangrelor). The company’s preliminary first quarter revenue expectations of $125 million – $130 million were disappointing (Read more: The Medicines Co. Posts Disappointing Preliminary Results) with Angiomax expected to record a significant decline in revenues from the year-ago period.
Meanwhile, an FDA advisory panel is meeting today to discuss the company’s new drug application for blood thinner Kengreal. Based on the positive tone of the briefing documents, the company may very well get a positive recommendation which could be followed by FDA approval by Jun 23. Kengreal gained EU approval in late March (Read more: The Medicines Co.’s Kengreal Briefing Documents Positive).
2. Tekmira received some encouraging news with the FDA informing the company that it has modified the partial clinical hold on the company’s Investigational New Drug application (IND) for TKM-Ebola. As a result, repeat dosing of healthy volunteers at a dose of 0.24 mg/kg/day will be allowed. However, the partial clinical hold with regard to doses above 0.24 mg/kg/day in healthy volunteers will remain in place. Tekmira is now looking to resume the phase I study shortly (Read more: Tekmira Up on Ebola Candidate Update from the FDA).
3. Biogen (BIIB – Analyst Report) provided detailed phase II results on anti-LINGO-1 for acute optic neuritis. The company, which had provided top-line results earlier this year, reported a statistically significant improvement in recovery of optic nerve conduction latency as compared to placebo. The data will be presented at the upcoming annual meeting of the American Academy of Neurology (AAN).
4. GW Pharmaceuticals also had a positive update on the pipeline front with the company reporting the release of encouraging data by the American Academy of Neurology. The data, from an open-label study on the company’s medicinal liquid form of marijuana – Epidiolex – showed a reduction in the rate of seizures in people with epilepsy. Shares were up 13.1% on the news. Epidiolex is currently in a phase III study for Dravet syndrome with phase III studies for Lennox-Gastaut syndrome expected to commence in the second quarter of 2015.
5. Alexion’s (ALXN – Analyst Report) label for Soliris has been updated in the EU – the paroxysmal nocturnal haemoglobinuria (PNH) indication now includes patients without a history of transfusion. Meanwhile, the atypical hemolytic uremic syndrome (aHUS) section of the label has been updated to include new efficacy data stating that longer-term treatment with Soliris was linked to a higher proportion of patients achieving clinically significant benefits (Read more: Alexion Up as Soliris Gains EU Nod for Label Updates).
Last 6 Weeks
The NASDAQ Biotechnology Index was up 4.47% over the last five trading days (See the last biotech stock roundup here: Alkermes Drug Fares Well, Targacept Slides on Deal Termination).
What’s Next in the Biotech World?
The FDA advisory panel’s decision regarding The Medicines Co.’s Kengreal will be out today. Meanwhile, several companies like Amgen (AMGN – Analyst Report) and Biogen will be reporting first quarter results next week.
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