Seeking Alpha
  • Today - Thursday, September 18, 2014

  • 5:16 PM
    • The FDA designates Navidea Biopharmaceuticals' (NAVB +14%) Lymphoseek (technetium Tc 99m tilmanocept) an Orphan Drug for use in sentinel lymph node detection in patients with cancer of the head and neck.
    • Orphan Drug status provides for a seven-year period of exclusivity, SPA assistance, tax credits and qualifies the company to request a refund of previously-paid filing fees up to $1.1M.
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  • 4:54 PM
    • Pro-Dex (PDEX +0.9%) financial results:
    • Fiscal Q4: Revenues: $3.2M (+18.5%); Gross Profit: $0.9M (+64.8%); Operating Expenses: $1.0M (-26.3%); Operating Income: $27K (+104.0%); Net Income: $23K (+103.4%); EPS: $0.01 (+105.0%); Quick Assets: $3.2M (+89.8%).
    • Fiscal 2014: Revenues: $10.8M (-11.5%); Gross Profit: $3.0M (-20.2%); Operating Expenses: $3.8M (-32.6%); Operating Loss: ($0.8M) (+57.0%); Net Loss: ($0.5M) (+72.6%); Loss Per Share: ($0.14) (+74.1%); Cash Burn: ($0.3M) (+74.1%).
    • No financial guidance given.
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  • 4:11 PM
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  • 4:03 PM
    • The FDA approves Eli Lilly's (LLY +1.1%) Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
    • Trulicity is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels.
    • Related tickers: (NVS +0.1%) (MRK +0.7%) (SNY +0.7%)(AZN +1.3%)(GSK +0.4%)
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  • 3:22 PM
    • Echo Therapeutics (ECTE -26.4%) SVP, General Counsel and Chief Compliance Officer Kimberly A. Burke plans to resign, as soon as an effective transition can occur, to pursue other opportunities.
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  • 1:31 PM
    • In a joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee today, members vote 18-3 against approval for privately-held Clarus Therapeutics' oral testosterone Rextoro.
    • The committees voted yesterday 20-1 in favor of revising who should be prescribe testosterone replacement therapies (TRT) and the need to conduct further studies to assess the cardiovascular risks. The revised population of patients appropriate for TRT will be much smaller as a result.
    • Related tickers: (LLY +0.9%) (ABBV -0.5%) (RPRX -25.4%) (LPCN -25.3%) (AUXL -0.5%) (TEVA +0.3%)
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  • 1:18 PM
    • TriVascular Technologies (TRIV -0.1%) initiates a voluntary field safety corrective action related to certain of its 29 mm Ovation Prime aortic stent grafts. The action pertains to 30 devices, all of which are held by distributors ex. U.S.
    • In a letter to be sent to international distributors, the company reports an increase in complaints about incomplete polymer fill of the 29 mm stent graft body during the implant procedure. This failure could lead to transient hypotension, prolonged procedure time and/or failure to exclude the aneurysm.
    • This is no associated risk to patients with existing implanted Ovation Prime stent grafts. The complaint rate is only 0.3% but the company is responding to a trend in complaints pertaining to the devices made within a certain time frame. It has implemented manufacturing process improvements in response to the complaints.
    | Comment!
  • 12:15 PM
    • Two new biotechs open with strong up moves today:
    • Foamix Pharmaceuticals (NASDAQ:FOMX) is up 16% from its $6 offer price on turnover of 13M shares.
    • ProQR Therapeutics (NASDAQ:PRQR) is up 32% from its $13 offer price on turnover of 5.5M shares.
    | Comment!
  • 11:55 AM
    • Thinly-traded nano cap Echo Therapeutics (ECTE -26.4%) plummets on a 5x surge in volume albeit on turnover of only 152K shares.
    • Platinum Management, the firm's largest shareholder, delivered a letter to the BOD disclosing its intention to seek the return of its $5M investment associated with the December 10, 2013 Securities Purchase Agreement. It believes Echo entered into the contract in bad faith with no intention of performing its obligations or using the funds for the intended purposes.
    • Platinum and its affiliates control ~30% of ECTE shares.
    | 1 Comment
  • 11:32 AM
    • Demonstrating a superb example of recent-IPO volatility, ReWalk Robotics (RWLK -15.3%) retreats on relatively light turnover of 1.6M. The stock debuted on Friday at $12 then exploded to a high of $43.71 on Tuesday before correcting.
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  • 11:22 AM
    • Repros Therapeutics (RPRX -24.7%) gets smacked down on almost 7x higher volume in response to yesterday's Ad Comm meeting on testosterone therapy.
    | 1 Comment
  • 10:54 AM
    • Thinly-traded nano cap Liposine (LPCN -25.9%) gyrated wildly after trading resumed this morning. The current price of $6.04 is near the bottom of high - low range of $11.33 - 5.90. Turnover is light at 54.5K shares.
    • NASDAQ halted trading yesterday pending news from the Ad Comm meeting on testosterone therapy.
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  • 10:39 AM
    • The FDA approves Siemens Healthcare's lower-priced Somatom Scope CT scanner. The 16-slice scanner is designed use in private radiology practices, community hospitals and other specialty practices by virtue of its light weight and low (130.2 sq. ft.) space requirement.
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  • 10:24 AM
    • Providence Service Corp. (PRSC +2.5%) acquires Matrix Medical Network in a cash-and-stock transaction valued at $400M ($360M in cash plus 946,722 shares of PRSC common stock) from private equity firm Welsh, Carson, Anderson and Stowe.
    • The Scottsdale, AZ-based Matrix provides in-home health assessment and care management services across 33 states. It posted $187M in revenue in the 12-month period ended June 30, 2014.
    • The transaction is expected to close in Q4 2014 and will be accretive to earnings in 2015.
    | Comment!
  • 10:10 AM
    • Merck Animal Health signs up to market Neogen's (NEOG +1.1%) Igenity Dairy Heifer Program, a panel of genomic tests that help dairy farmers in their breeding and heifer selection. The tests can be performed soon after a calf is born.
    • The tests enable a dairy farmer to avoid the financial risk that a heifer does not have the genetic merit to produce a superior calf when it reaches breeding age, usually two years.
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  • 9:42 AM
    • Baxano Surgical (BAXS +2.8%) hires Houlihan Lokey to advise it on potential strategic alternatives for its business.
    • The firm's market cap is $15M. In the quarter ended June 30, it posted $4.7M in revenues and consumed almost $17M in cash leaving a cash balance of only $2.3M.
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  • 9:29 AM
    • OvaScience (NASDAQ:OVAS) appoints Jeffrey Young as CFO. He joins the firm from Transmedics where he was CFO and Treasurer.
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  • 9:25 AM
    • The FDA approves Intuitive Surgical's (NASDAQ:ISRG) da Vinci S and da Vinci Si Surgical Systems for use in benign base of tongue resection procedures. The systems were previously approved for use in transoral otolaryngology procedures for the resection of early-stage benign or malignant tumors classified as T1 and T2.
    • The da Vinci Xi System is not approved for transoral otolaryngologic surgical procedures.
    | Comment!
  • 9:07 AM
    • Oncothyreon (NASDAQ:ONTY) prices its public offering of 10M shares of common stock at $2 per share and a concurrent offering of 10K shares of Series A Convertible Preferred Stock at $2,000 per share for total expected gross proceeds of $40M.
    • Underwriters over-allotment is 1.5M shares of common stock. Closing date is September 23, 2014.
    | Comment!
  • 8:59 AM
    • Tokai Pharmaceuticals (NASDAQ:TKAI) is set to continue its strong debut. Shares are up 6% premarket on healthy volume.
    • The company debuted yesterday closing at $23.76 (+58.4%) on turnover of 10.8M shares.
    | 1 Comment
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