Regulatory Catalyst News: $ALKS, $AMLN, $LLY, $MNKD, $SVNT
March 15th, 2010
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Shares of Amylin Pharma (NASDAQ: AMLN) are rising by about 10% during early trading today on the issuance of a Complete Response Letter (CRL) from FDA for its once-weekly formulation of its diabetes drug Byetta (exenatide), which would be marketed as Bydureon. The issues raised in the CRL appear to be minor and related to labeling issues with expected resubmission in the next few weeks and likely Class I (60-day) review designation by the FDA upon resubmission by AMLN. Eli Lilly (NYSE: LLY) and Alkermes (NASDAQ: ALKS) also have stakes in the drug, with ALKS also trading up 10% and LLY up slightly during early trading.
Categories: Independent Equity Research
Access Pharma (OTC: ACCP.OB) is an emerging bio-pharmaceutical company which is focusing on the development of a late-stage, diversified oncology pipeline in addition to a treatment called MuGard that is cleared for marketing in the U.S., Europe, and other key global markets for a common side effect of some cancer treatments known as mucositis (painful sores in the mouth and GI mucosal lining). 
I had the opportunity last week to discuss the updated strategy and expected milestones for ImmunoCellular Therapeutics (OTC: IMUC.OB) in 2010 and beyond with CEO, Manish Singh, following the conclusion of the OneMed, JP Morgan, and other healthcare conferences in San Francisco. IMUC is an emerging cancer immunotherapy company that is developing therapeutic and diagnostic product candidates taking aim at the root cause of the disease, cancer stem cells, based on two technology platforms that include active (therapeutic cancer vaccines) and passive (monoclonal antibodies) approaches.
During the second week of January, Unilife Medical Solutions (ASX: UNI.AX) (OTC: UNIFF.PK) shareholders overwhelmingly voted in favor of the Company’s U.S. relocation. Unilife is now in the final stages of preparation for a NASDAQ: UNIS stock market trading debut, which is expected to occur by the end of February in conjunction with the Company’s re-domiciliation to Central Pennsylvania. Unilife is emerging as a leading innovator in the medical device manufacturing space with a focus on safety syringes and business segments that include pre-filled syringes for pharmaceutical companies to deliver injected medications, sharps safety devices for healthcare facilities, and contract manufacturing services.
Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) is an emerging, small-cap biopharma company that has a pair of lead compounds in late-stage, Phase 3 development for the treatment of cancer (perifosine) and renal disease (Zerenex) under Special Protocol Assessment (SPA) agreements with the FDA. 
Delcath Systems (NASDAQ: DCTH) is an emerging, small-cap medical device innovator that is developing a regional treatment system for cancer in the liver. Delcath’s Percutaneous Hepatic Perfusion (PHP) technology allows physicians to deliver significantly higher doses of existing chemotherapy drugs to the liver without exposing each patient’s entire body to the anti-cancer drugs, representing an elegant solution that promises to increase the effectiveness of approved anti-cancer drugs while reducing systemic side effects. 