|Healthcare Review: EnteroMedics, Northwest Biotherapeutics, BioCryst Pharmaceuticals, Regeneron, Synthetic Biologics|
|By Staff and Wire Reports|
|Monday, 10 March 2014 14:29|
The FDA has postponed a meeting of an advisory committee to discuss whether or not to recommend approving EnteroMedics' ($ETRM) Maestro System therapy for treating morbid obesity. The meeting will take place on June 17 rather than on May 29. EnteroMedics said the delay is due to a scheduling conflict. Notwithstanding what seems to be a rather innocuous reason for the postponement
H.C. Wainwright begins coverage of BioCryst Pharmaceuticals ($BCRX) with a Buy rating and $21 price target. Friday's close was $11.46.Consensus revenue estimates for 2014 and 2015 are $11.9M and $71M, respectively.49 mutual funds have positions, down from 89 a year earlier.
Northwest Biotherapeutics ($NWBO) gets a "Hospital Exemption" early access program for DCVax-L from German regulators. This means that the company may provide the product to patients for the treatment of Glioblastoma multforme and lower grades of gliomas outside of its clinical trial and charge full price. The approval term is five years. The German reimbursement authority approves DCVax-L eligibility for reimbursement from the Sickness Funds (health insurers). The specific level of payment will be negotiated by the company, hospitals and insurers.
The FDA requests that Regeneron ($REGN) and Sanofi ($SNY) assess potential neurocognitive side effects of their late stage cholesterol drug alirocumab, a PCSK9 inhibitor. Memory loss, impaired concentration and paranoia, though rare, have been associated with the use of statins for lowering LDL cholesterol. Both firms disclosed in their regulatory filings that the appearance of these side effects could delay or stop the product's development.
Synthetic Biologics ($SYN) gets patent 8,658,627 entitled Pregnancy Hormone Combination for Treatment of Autoimmune Diseases. The patent includes claims to the use of Trimesta (oral estriol) in conjunction with gestagen for the treatment of MS and other autoimmune diseases. The company currently holds two other patents (8,372,826 and 6,936,599) covering the use of Trimesta.