The Zacks Analyst Blog Highlights:MannKind, Cubist, Medicines Co., Amgen and Halozyme
CHICAGO, April 10, 2014 /PRNewswire/ -- Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include the MannKind (Nasdaq:MNKD-Free Report), Cubist (Nasdaq:CBST-Free Report), Medicines Co. (Nasdaq:MDCO-Free Report), Amgen (Nasdaq:AMGN-Free Report) and Halozyme (Nasdaq:HALO-Free Report).
Today, Zacks is promoting its ''Buy'' stock recommendations. Get #1Stock of the Day pick for free.
Here are highlights from Wednesday's Analyst Blog:
Biotech Stock Roundup
Last week's highlights include FDA panel meeting outcomes, court rulings, and regulatory updates. The clear winner was MannKind (Nasdaq:MNKD-Free Report) which saw its shares soar a whopping 73.9% on a positive panel recommendation for its experimental diabetes drug, Afrezza.
Third Time Lucky for MannKind's Afrezza? After a choppy start to the week when concerns regarding FDA briefing documents on Afrezza surfaced, MannKind investors had a lot to cheer about – an FDA advisory panel voted in favor of approving Afrezza for type I (13-1) and type II (14-0) diabetes.
Approval would make Afrezza the first ultra rapid-acting mealtime insulin therapy in the U.S. Although the FDA is not required to follow the panel's advice it usually does so. But the real test will be the launch and uptake of the product.
Considering the safety concerns raised in the briefing documents, we think the company will have to conduct post-marketing studies. Moreover, uptake could be slow as physicians need to be convinced about switching patients to Afrezza from currently available treatments.
FDA Panel in Favor of Cubist (Nasdaq:CBST-Free Report)Drug: Cubist investors had a good start to the week with the company receiving a favorable recommendation from an FDA advisory panel for its experimental anti-infective drug – Sivextro (tedizolid). The panel voted unanimously (14-0) in favor of approving the drug for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
This brings Sivextro a step closer to gaining approval; although the FDA is not required to follow the panel's advice, it usually does so. The FDA action date for Sivextro is Jun 20. Shares were up 4.4%.
Once approved, Sivextro will try to take share from Pfizer's Zyvox. Phase III data showing that Sivextro is non-inferior to Zyvox should help it capture share. Less frequent dosing and a shorter treatment period should also work in Sivextro's favor.
The Medicines Co.'s (Nasdaq:MDCO-Free Report)Shares Tumble: Last week was not so great for The Medicines Co. – the company's shares fell 16.5% on an unfavorable trial opinion in a patent infringement lawsuit regarding Angiomax. The company failed to prove that its patents have been infringed by Hospira. Angiomax is The Medicine's Co.'s lead product and accounted for almost 80% of total revenues in 2013. Needless to say, the earlier-than-expected entry of generics will be a major setback for the company.
Amgen's (Nasdaq:AMGN-Free Report)T-Vec Fails to Show Overall Survival: Amgen, which has of late been presenting a series of positive data on its PCSK9 inhibitor, faced some disappointment with its cancer candidate, talimogene laherparepvec (often referred to as T-Vec) failing to achieve the secondary endpoint of overall survival in a late-stage study.
Even though the primary endpoint of durable response rate was achieved, the failure to achieve overall survival is disappointing as it is an important factor for cancer treatments. Encouraging overall survival data would have boosted T-Vec's chances of gaining approval as well as its commercial potential, especially as a monotherapy.
Safety Concern Woes for Halozyme (Nasdaq:HALO-Free Report): Halozyme shares plunged 27.3% on a safety scare related to the development of PEGPH20 for pancreatic cancer. An independent Data Monitoring Committee (DMC) recommended that patient enrollment and dosing in an ongoing mid-stage study should be temporarily halted. The temporary halting of the phase II study due to safety signals is a matter of concern and creates uncertainty regarding the future of this program.
Today, Zacks is promoting its ''Buy'' stock recommendations. Get #1Stock of the Day pick for free.
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