Endo International (ENDP +0.9%) submits a proposal to Auxilium Pharmaceuticals (AUXL -1.6%) to acquire it for $28.10 per share in cash. The total value of the transaction would be $2.2B or a 31% premium to today's closing price.
AUXL is up 42% AH on robust volume. ENDP is up 5% AH on heavy volume.
Retrophin (RTRX +3.5%) board member Jeffrey Paley, M.D. steps down to devote more time to his medical practice. As a result, the BOD and the Audit Committee are no longer in compliance with the NASDAQ requirement of a majority of independent directors because only two of the four directors qualify as independent. The company intends to regain compliance in both areas prior to the expiration of the cure period. A search for a new independent board member is underway.
CFO Marc Panoff resigns to pursue other opportunities. He will stay on board until a replacement is hired. A search is underway.
Insulet Corp. (PODD +0.5%) appoints Patrick J. Sullivan as President and CEO replacing the retiring Duance DeSisto. Mr. Sullivan was the former CEO of Cytyc Corp. and the Executive Chairman of Hologic after it acquired Cytyc.
The company reiterates its revenue guidance: $73M - 77M for Q3 and $290M - 300M for 2014.
In a red flag development, PDL BioPharma (PDLI +0.4%) accountant Ernst & Young LLP resigns effective September 11, 2014. The auditor confirmed its resignation in a letter delivered to PDL on September 15.
The 12-month clinically-driven target lesion revascularization (CD-TLR) rate was 2.4% for the IN.PACT Admiral DCB compared to 20.6% for standard PTA. In other words, only 2.4% required another procedure within one year compared to one in five PTA patients.
In an economic analysis from the U.S. phase of the SFA trial, the follow-up target limb-related medical care costs from discharge to one year were $750/patient lower in the DCB group versus the PTA group, despite higher initial hospital costs. This translates into an incremental cost-effectiveness ratio (ICER) of about $2,900 per repeat revascularization avoided, which is similar to other cardiovascular therapies, including coronary drug-eluting stents.
Regenerative medicine firm Avita Medical (OTCQX:AVMXY +1.6%) secures FDA clearance for the expanded use of ReCell Spray-On Skin and broadened eligibility criteria for its clinical trial. The changes will make the trial more accessible and resolve the delays with patient recruitment.
The revised eligibility criteria will now allow for more extensive and severe (deeper) burn injuries and include participants as young as five years of age.
The trial will evaluate ReCell as a complementary treatment to expanded meshed skin grafting in a cohort of 25 patients. The company expects to begin enrolling the new cohort in early 2015 and complete enrollment by the end of 2015. Each patient will be followed for 12 months.
On Thursday, September 18, the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will jointly meet to discuss privately-held Clarus Therapeutics' New Drug Application for Rextoro, an orally-available testosterone for patients with hypogonadism.
Tomorrow, the two committees will jointly meet to discuss the appropriate population for testosterone therapy and the potential for adverse cardiovascular outcomes associated with testosterone replacement therapy.
The FDA approves NxStage Medical's (NXTM +0.7%) OneSite single needle technology. OneSite employs a dual lumen needle design that allows a dialysis patient to have only one needle inserted per treatment instead of two.
Thinly-traded nano cap MediciNova (MNOV -10.9%) is off on 5x higher volume as traders take some money off the table from the sharp run-up that began on August 26 when the firm announced the impending start of a clinical trial evaluating MN-166 as a treatment for patients with ALS.
Shares peaked yesterday at $3.38 which represented a 62.5% jump from August 25's close of $2.08.
Oculus Innovative Sciences (OCLS +0.7%) is awarded four new patents related to Microcyn, one in the U.S. for second- and third-degree burns; on in the U.S. and Canada for the treatment of peritonitis and one in China for the Microcyn solution and its method of use.
The company's IP estate now includes 41 issued and allowed patents with 92 pending applications.
PharmAthene (PIP -13.2%) goes south on increased volume albeit on turnover of only 550K. Investors appear to perceive that its potential award from (SIGA -22.2%) may be at risk or at least substantially delayed due to its Chapter 11 filing and appeal.