Analyst Offers Insight on Favorable FDA Ruling for Teva; Shares of MannKind Plummet Prior to Drug Advisory Meeting Print E-mail
By Staff and Wire Reports   
Monday, 31 March 2014 22:04
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 31, 2014.
Shares of Teva Pharmaceutical (NYSE: TEVA) are up 6.66 percent to $52.74 on news that the company has received a U.S. Supreme Court hearing on generic Copaxone delay.

The news will “bolster investor confidence that a generic will not be on the market in May 2014,” BMO Capital analyst David Maris said.

There is also the possibility that generic drug makers may not risk a debut in May, which would be positive for Teva. Each week the company is able to keep “generics away is good news, as Teva continues to rapidly move patients to the new 3x/week formulation,” according to Maris.

Conversion rate to new 3x per week formulation is trending up from 22 percent last week to 27 percent for existing patients.


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Shares of MannKind Corp. (NASDAQ: MNKD) fall as much as 27.105% prior to Tuesday's Endocrinologic and Metabolic Drugs Advisory Committee Meeting.

Piper Jaffray analyst Joshua Schimmer noted that MannKind faces a "number of obstacles" in the U.S. Food and Drug Administration's (FDA) review of the Afrezza Dreamboat insulin inhaler. Schimmer reported that it is "doubtful" for the company to gain positive recommendation from the advisory panel. The analyst commented that a closer read of the FDA staff briefing documents suggest that the agency "has enough concerns that only a cleanly positive vote will enable approval without additional requirements."

Schimmer downgraded MannKind from Underweight to Neutral and drastically lowered the price target from $5.00 to $1.50. Piper sees a 20% chance of clear positive vote, 60% chance of negative vote, 20% of split vote with “wide range of possible stock implications." The analyst added that the timeline with a two-year delay to the partner/ drug introduction "may still be presumptuous."

On Thursday, Summer Street analyst Bart Classen reported on potential problems regarding the Affinity 1 studies. On Monday, Classen continued to voice his concern, noting that the FDA panel will likely recommend against approval.

In addition to the poor glucose control potentially leading to increased complications, the Summer Street analyst highlighted the elevated cost of goods for Afrezza. Classen commented that 2.5 units of injected insulin are the same as 10 units of Afrezza, making the costs unnecessarily high. The analyst concluded that the Afrezza insulin inhaler "offers no real advantage to injectable insulin and is inferior in the control of blood sugar."

Shares of MannKind were down 9.7% in pre-market trading and fell as much as 27.105% to $3.80 Monday morning. The stock is currently down 19.259% at $4.05.



Also Monday:



Air Methods Corporation (Nasdaq:AIRM)
, the global leader in air medical transportation, today announced the appointment of two key executives, Kevin Campbell and Allison Farish.

Alliqua, Inc. (Nasdaq:ALQA)
, a provider of advanced wound care products, has hired a 20-member direct sales force to further strengthen the Company's brand awareness, increase brand adoption and drive greater market penetration in the United States.

Amarantus Bioscience Holdings, Inc. (OTCQB: AMBS)
, a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to neurodegeneration and apoptosis, today appointed Dr. Louis Kirby to the Board of Advisors to assist the Company in the development and commercialization of the LymPro Test® for Alzheimer's disease.

Anavex Life Sciences Corp. (OTCQB:AVXL)
, a clinical stage biopharmaceutical company developing novel drug candidates to treat Alzheimer's, diseases of the central nervous system (CNS) and various types of cancer, announced today that it has strengthened its Alzheimer's pipeline by obtaining exclusive rights to worldwide patents and patent applications covering methods and compositions for AF710B and other related, preclinical stage compounds from Life Science Research Israel Ltd. (LSRI).

athenahealth, Inc.(Nasdaq:ATHN)
, a leading provider of cloud-based services for electronic health record (EHR), practice management, and care coordination, today issued the following statement in reaction to the House vote, and pending vote from the Senate, to patch the Sustainable Growth Rate ("SGR" or "Doc Fix") and delay ICD-10 for another year to October 2015.

athenahealth, Inc. (Nasdaq:ATHN)
, a leading provider of cloud-based services for electronic health record (EHR), practice management, and care coordination, today announced that it will hold a conference call for investors on Friday, April 18, 2014, at 8:00 a.m. ET.

Curis, Inc. (Nasdaq:CRIS)
, an oncology-focused company developing novel, targeted drug candidates for the treatment of human cancers, today announced that Curis scientists and collaborators will present data from three programs at the Annual Meeting of American Association for Cancer Research (AACR) to be held from April 5th to 9th in San Diego, CA.

Curis, Inc. (Nasdaq:CRIS)
, an oncology-focused company developing novel, targeted drug candidates for the treatment of human cancers, today reported that the U.S. Food and Drug Administration (FDA) has notified the Company that its complete response submission to the November 2013 partial clinical hold on CUDC-427 has been reviewed and that the FDA has determined that it is safe to proceed under the IND.

Egalet Corporation (Nasdaq:EGLT)
today announced positive results of the first phase of the category 1 abuse deterrence studies for Egalet-001, an abuse-deterrent, extended-release, oral morphine product in development for the treatment of moderate to severe chronic pain.

Immunomedics, Inc. (Nasdaq:IMMU)
, a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that four posters will be presented at the 2014 Annual Meeting of the American Association for Cancer Research to be held in San Diego, CA, from April 5 – 9, 2014.

IPC The Hospitalist Company, Inc. (Nasdaq:IPCM)
, a leading national hospitalist physician group practice company, announced today that it has acquired Preferred Hospitalists of Michigan, PLLC (PHM), based in Warren, Michigan.

MacroGenics, Inc. (Nasdaq:MGNX)
, a clinical-stage biopharmaceutical company focused on discovering and identifying innovative monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases, today announced that pre-clinical data on its colorectal cancer product candidate, MGD007, will be presented at the 2014 American Association for Cancer Research (AACR) Annual Meeting in San Diego, CA.

Medical Marijuana Inc. (OTC Pink:MJNA)
is pleased to announce that due to the exponential growth of its subsidiary company, HempMedsPX™, the Company has outgrown the current headquarters location in San Diego, California.

Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK)
today announced that it will present at the 2014 AACR Annual Meeting.

NeoStem, Inc. (Nasdaq:NBS)
, a leader in the emerging cellular therapy industry, announced today that Lee Clough, RN, HP (ASCP), Director of Clinical Affairs & Apheresis for Progenitor Cell Therapy (PCT), a wholly-owned subsidiary of NeoStem, has been awarded the SHS Award from the American Society for Apheresis (ASFA).

Pacific Biosciences of California, Inc., (Nasdaq:PACB)
provider of the PacBio® RS II, today announced the release of a software upgrade for its Single Molecule, Real-Time (SMRT®) DNA Sequencing platform.

Sagent Pharmaceuticals, Inc. (Nasdaq:SGNT)
will join the Chicago Innovation Awards, the Chicago region's foremost annual celebration of innovation, in New York City on Monday, March 31, to close the NASDAQ Stock Market, the premier exchange for technology companies.

Stereotaxis, Inc. (Nasdaq:STXS)
announced today that it has entered into an amended credit agreement with Silicon Valley Bank (SVB) that replaces its existing $3 million revolving facility with a $10 million revolving facility scheduled to mature on March 31, 2015.

Symmetry Medical Inc. (NYSE:SMA)
, a leading global source of innovative medical device solutions, including surgical instruments, orthopedic implants, and sterilization cases and trays, announced today that its subsidiary, Symmetry Surgical, is launching the Symmetry® Sharp Kerrison at the Association of periOperative Registered Nurses (AORN) Surgical Conference and Expo in Chicago, March 30 – April 2, 2014.

Tauriga Sciences Inc. (OTCQB:TAUG)
, a diversified life sciences company with key assets that include active license agreements, interests in a topical medicinal cannabis company, and a proprietary microbial fuel cell technology, has today announced the completion of a $800,000 USD equity private placement at a price of 6 cents per share ("$0.06") to various accredited investors.

TetraLogic Pharmaceuticals Corporation (Nasdaq:TLOG)
today announced that J. Kevin Buchi, President and Chief Executive Officer, will present at the 13th Annual Needham Healthcare Conference on Tuesday, April 8, 2014 at 10:40 a.m. Eastern Time in New York, NY.



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