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clearseeing1 23 posts  |  Last Activity: Mar 27, 2012 10:44 PM Member since: Mar 1, 2012
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  • Reply to

    CHTP is undervalued says Needham

    by clearseeing1 Mar 27, 2012 9:57 PM
    clearseeing1 clearseeing1 Mar 27, 2012 10:44 PM Flag

    this paragraph from tonight's Motley Fool is particularly telling: (esp the line on MULTIBAGGER RETURNS!!)

    Chelsea has a market cap of only $250 million, well below where it was before the advisory panel; clearly investors aren't very confident in approval. If the FDA issues a surprise endorsement, shares are going to take off like Larry King's high blood pressure. Who knows where they'll land, but multibagger returns aren't out of the question once Northera is on the market. Acorda Therapeutics (Nasdaq: ACOR ) , with one orphan drug that's expected to bring in less than $275 million this year, sports a $1 billion market cap.

  • Reply to

    CHTP is undervalued says Needham

    by clearseeing1 Mar 27, 2012 9:57 PM
    clearseeing1 clearseeing1 Mar 27, 2012 10:38 PM Flag

    you are right, I omitted that part but that goes without saying, I think. The stock price has so thoroughly discounted a rejection, that even if there is a delayed path to approval it will shoot up (look at MAPP with a CRL, the stock barely went down)

  • Reply to

    CHTP is undervalued says Needham

    by clearseeing1 Mar 27, 2012 9:57 PM
    clearseeing1 clearseeing1 Mar 27, 2012 10:02 PM Flag

    the rest of the story:

    March 27, 2012 4:42 PM EDT

    Biotech traders were toying with Chelsea Therapeutics (Nasdaq: CHTP) today ahead of tomorrow's PDUFA date for Northera.

    In February, and FDA AdCom voted 7-4 in favor of Northera approval.

    Recently analysts at Needham & Company commented on the upcoming decision.

    "In our opinion, the favorable AdCom vote is an important recognition of Northera’s utility in an indication with a serious unmet need," the analyst said. "However, we believe there are meaningful risks to approval in NOH by the PDUFA date. The vote should be viewed in the context of the negative briefing documents released prior to the meeting, which reflect substantial reservations by at least some members of the FDA."

    With or without approval tomorrow, the firm believes Northera approval is achievable in 2012 and the stock is undervalued.

  • With or without approval tomorrow, the firm believes Northera approval is achievable in 2012 and the stock is undervalued.
    (from Streetinsider)

  • Traders Eye Chelsea Therapeutics (CHTP) Ahead of Northera PDUFA Date

    March 27, 2012 4:42 PM EDT


    Biotech traders were toying with Chelsea Therapeutics (Nasdaq: CHTP) today ahead of tomorrow's PDUFA date for Northera.

    In February, and FDA AdCom voted 7-4 in favor of Northera approval.

    Recently analysts at Needham & Company commented on the upcoming decision.

    "In our opinion, the favorable AdCom vote is an important recognition of Northera’s utility in an indication with a serious unmet need," the analyst said. "However, we believe there are meaningful risks to approval in NOH by the PDUFA date. The vote should be viewed in the context of the negative briefing documents released prior to the meeting, which reflect substantial reservations by at least some members of the FDA."

    With or without approval tomorrow, the firm believes Northera approval is achievable in 2012 and the stock is undervalued.

  • Traders Eye Chelsea Therapeutics (CHTP) Ahead of Northera PDUFA Date



    March 27, 2012 4:42 PM EDT

    Biotech traders were toying with Chelsea Therapeutics (Nasdaq: CHTP) today ahead of tomorrow's PDUFA date for Northera.

    In February, and FDA AdCom voted 7-4 in favor of Northera approval.

    Recently analysts at Needham & Company commented on the upcoming decision.

    "In our opinion, the favorable AdCom vote is an important recognition of Northera’s utility in an indication with a serious unmet need," the analyst said. "However, we believe there are meaningful risks to approval in NOH by the PDUFA date. The vote should be viewed in the context of the negative briefing documents released prior to the meeting, which reflect substantial reservations by at least some members of the FDA."

    With or without approval tomorrow, the firm believes Northera approval is achievable in 2012 and the stock is undervalued.

    http://www.streetinsider.com/Trader+Talk/Traders+Eye+Chelsea+Therapeutics+%28CHTP%29+Ahead+of+Northera+PDUFA+Date/7300502.html

  • Reply to

    breaking Dow Jones story on CHTP

    by clearseeing1 Mar 14, 2012 11:08 AM
    clearseeing1 clearseeing1 Mar 14, 2012 11:09 AM Flag

    continued...

    Chelsea said annual sales of Northera could reach $300 million to $375 million within about five years of launch; it currently has no revenue.
    "It's only a question of when the drug is going to be approved," Chelsea Chief Executive Simon Pedder said in an interview Wednesday.
    "We continue to work with them toward the [March 28 decision] date and provide them the data which we hope will lead them to approve the drug," said Pedder, a former Roche Holding AG (RHHBY) executive.
    Northera has been available in Japan for more than 20 years, though at lower doses than those Chelsea is proposing for the U.S. Chelsea, which began life a decade ago and now has about 50 employees, licensed the drug in 2006 from Dainippon Sumitomo Pharma Co. (DNPUF:$10.65,00$0.30,002.90%) . Chelsea is in the process of recruiting about 85 sales representatives to market Northera.
    Chelsea, of Charlotte, N.C., is proposing to market Northera in the U.S. to treat symptomatic neurogenic orthostatic hypotension, or NOH. The condition can lead to sudden fainting in people with certain degenerative disorders like Parkinson's disease.
    There are few current therapeutic alternatives for NOH. The drug ProAmatine is approved to treat the condition, but the FDA has questioned whether it provides sufficient symptom relief.
    The clinical trials for Northera, however, have had mixed results. In one trial, Northera improved symptoms of NOH versus a placebo, and Chelsea said it was safe and well tolerated. However, in another trial, Northera didn't show a statistically significant improvement in the study's primary efficacy goal, though Chelsea said subsequent analysis suggested certain benefits.
    An FDA staff review released last month said the drug had safety issues, including reports of a life-threatening disorder, neuroleptic malignant syndrome, in Japanese users. The review also said there was no durable effect of Northera beyond four weeks of use, and recommended against agency approval at this time.
    Chelsea says the drug is safe and effective, and fills a significant unmet medical need. Chelsea said neuroleptic malignant syndrome has been documented to occur in patients with Parkinson's disease who abruptly stop certain medications.
    The FDA advisers who voted in favor of FDA approval cited the burden of the disease and dearth of current treatment options, while those voting against suggested another study should be conducted before approval.
    Pedder said Chelsea was able to provide additional information at the advisory committee meeting that he hopes will alleviate the concerns.
    Chelsea hasn't decided yet on Northera pricing, but Pedder said it would probably be higher than ProAmatine, which can cost up to $16 per day.
    Pedder said Chelsea has enough cash to support the company into 2013. The company has talked to potential partners to help market Northera outside the U.S., he said. Chelsea expects to handle U.S. marketing itself.


    (END) Dow Jones Newswires
    03-14-121100ET
    Copyright (c) 2012 Dow Jones & Company, Inc.

  • FOCUS: High-Pressure Moment Nears For Proposed Low Blood Pressure Drug 03/14 11:00 AM



    --U.S. FDA expected to act by March 28 on Chelsea's proposal to market Northera for a form of low blood pressure
    --FDA advisory committee recommended approval last month despite concerns about efficacy and safety
    --Chelsea predicts drug could generate annual sales of $300 million to $375 million within about five years
    By Peter Loftus
    Of DOW JONES NEWSWIRES
    Tiny drug developer Chelsea Therapeutics International Ltd. (CHTP:$3.35,00$0.03,000.90%) hopes to clear another tough hurdle in its bid to bring its first drug to market, a proposed treatment for low blood pressure.
    Already the company has surprised some observers by receiving the support of a U.S. regulatory advisory panel last month, despite mixed clinical results for the drug, Northera.
    The company argued that Northera would help an under-served patient population--those with certain neurological disorders who are prone to fainting or dizziness--and is relatively safe. Helping the company's case was the support of patient advocates.
    The Food and Drug Administration advisory committee's 7-4 vote last month overcame a recommendation against approval by the FDA's own staff reviewer, who raised safety and efficacy concerns. The surprise vote sent Chelsea shares surging 61% in one day.
    But, as the FDA's targeted March 28 decision date gets closer, some of the bullishness has waned. Some investors and analysts think FDA approval could be delayed to later this year or beyond. The agency might extend its review or decline to approve the drug and ask for more information.
    Chelsea shares are down about 14% since last month's bounce, trading recently around $3.32.
    However, if Chelsea does get FDA approval for Northera by March 28, the stock could surge to double-digits. Even if approval comes later this year, some analysts have price targets above $10, which also reflect positive expectations for another drug in development at Chelsea, a treatment for rheumatoid arthritis.

  • interesting...

  • Market Chatter: Human Genome Sciences Up 5%; Subject Of Renewed Takeover Rumors 03/08 02:30 PM



    02:30 PM EST, 03/08/2012 (MidnightTrader) -- Human Genome Sciences (HGSI:$7.84,00$0.39,005.23%) is moving more than 5% higher in afternoon trading on renewed buyout rumors.
    Theflyonthewall.com is the biopharmaceutical company could be a takeover target.
    In the past rumors have abounded that Human Genome Sciences (HGSI:$7.84,00$0.39,005.23%) could be bought out.
    Price: 7.84, Change: +0.40, Percent Change: +5.37

  • CW: Well, one that I think could perform really well this year is Human Genome Sciences Inc. The stock got down to $7 or $8 in December, but it was as high as $29 or $30 last year. So, basically it's been totally crushed. In March 2011 the company launched Benlysta (belimumab), the first new drug in 50 years for moderate to severe systemic lupus. It was a very poorly run launch by GlaxoSmithKline plc (GSK:NYSE), and it got a very slow start. One of the interesting things about Benlysta is that it takes two or three doses, these are IV infusions given once a month, before you see results. Also, the endpoint used in the pivotal trial was a composite endpoint that isn't exactly the way doctors look at their patients every day. So, the doctors need to talk to each other to figure out which patients might benefit and what to look for. In most cases the physician's goal is to reduce the amount of steroids the patient is receiving to a safer dose. So, it's a little bit of a challenge to find the right patient, and then you've got to wait several months after successive doses to see results. So, it's a different drug in the rheumatology world.

    TLSR: Your target price of $23 for Human Genome represents an implied upside of nearly 200% from current levels.

    CW: I'm very optimistic that it's going to be a good drug. The side effects of Benlysta have been very mild, and so that's just been great. And for most of the physicians I've spoken to, reimbursement hasn't been that much of a problem.

    http://www.investorideas.com/news/2012/main/03021.asp

  • The April 8 call volume just exploded to over 5500 contracts!!

  • Hearing GlaxoSmithKline to Acquire Human Genome Sciences

    The Rumor:
    GlaxoSmithKline (NYSE: GSK) to acquire Human Genome Sciences (NASDAQ: HGSI) for around $15 per share, according to sources.

    Representatives from GlaxoSmithKline and Human Genome Sciences refused comment on the rumor.

    Human Genome Sciences closed at $7.45 Wednesday, a loss of 1.32% on 1.7 times the average daily volume.

    http://www.benzinga.com/trading-ideas/long-ideas/12/03/2406373/benzingas-m-a-chatter-for-wednesday-march-7-2012

  • clearseeing1 by clearseeing1 Mar 7, 2012 2:30 PM Flag

    ...with Benlysta peak sales estimates of nearly $500 million by 2015 and an Enterprise Value of $1.5 billion, I’m thinking there’s something there . . .there.

    Read more: http://www.minyanville.com/business-news/markets/articles/bry-credit-default-swaps-bond-market/3/7/2012/id/39775#ixzz1oSe5AMbS

  • clearseeing1 by clearseeing1 Mar 7, 2012 12:25 PM Flag

    Human Genome calls active on renewed takeover chatter BY Fly On The Wall
    — 10:18 AM ET 03/07/2012
    Human Genome March 8 and April 9 calls are active on total call option volume of 10,100 contracts (270 puts) on renewed takeover chatter. March call option implied volatility is at 94, April is at 78; compared to its 26-week average of 72 according to Track Data. Active call volume suggests traders positioning for price movement.

  • Reply to

    Cariprazine may add sinificant value to FRX

    by clearseeing1 Mar 1, 2012 3:32 PM
    clearseeing1 clearseeing1 Mar 7, 2012 8:31 AM Flag

    and now Levomilnacipran !!!! Treatment with levomilnacipran significantly reduced depression symptoms in patients with MDD compared to placebo, as early as week one !

  • No surprises in the report, some investors had cashed out expecting a dilutive secondary, CHTP is all washed out and ready to go higher!!!

  • Reply to

    Increase in Jan Benlysta patients

    by clearseeing1 Mar 1, 2012 9:51 PM
    clearseeing1 clearseeing1 Mar 5, 2012 7:53 AM Flag

    the uptick in new patients may spark a new uptrend in the stock price. HGSI is a steal at $8 !!!

  • Source: IMS health, BofAML analysis (Feb 29, 2012)

    Jan Benlysta sales were $9.8M, tracking in line with our 1Q12 $32M US sales
    estimate. The data suggest an increase in an estimated new monthly patient adds
    to Benlysta in January from anemic 4Q adds.


    ( For perspective, here's a research note from January 9, 2012 :Benlysta 4Q misses lowered estimate
    HGSI pre announced 4Q Benlysta US sales of $25.7M, lower than our recently
    lowered 4Q estimate of $27.5M. Gross to net adjustments of 12% during the
    quarter were consistent with 3Q, suggesting that demand remains sluggish.
    Rolling four-week periods during 4Q of $2.3M, $2.1M and $2.5M show no sign of
    an inflection point in demand. HGSI emphasized in its press release that
    education remains a key barrier to adoption, and we suspect that patient
    identification also remains an issue. We see downside to consensus 2012 sales
    of $235M and we have made minor adjustments to our estimates.)

  • Reply to

    Cariprazine may add sinificant value to FRX

    by clearseeing1 Mar 1, 2012 3:32 PM
    clearseeing1 clearseeing1 Mar 1, 2012 9:25 PM Flag

    Discounted cash flow analysis
    We assessed a theoretical value for FRX’s shares using a sum-of-the-parts DCF
    analysis, in which we ascribed a value to each of the company’s products and
    product lines. We view DCF as a useful valuation tool for companies with patent
    cliffs because it takes into account potential product duration. Key DCF
    assumptions in our analysis include:
    􀂄 Sales are projected from F2013 (March) to F2023; terminal growth rate of
    1.5%.
    􀂄 Profits are discounted back to end-C2012 at 8.5%, which we assume is the
    company’s approximate weighted average cost of capital.
    This analysis, which we acknowledge has a lot of moving parts that could change,
    suggests a theoretical value of approximately $40 per share. Note that this
    analysis does not ascribe value to early-stage products or for the use of cash
    towards future pipeline building. Please refer to Pages 9-10 for details.
    Table 12 summarizes the theoretical DCF value for each of the cariprazine
    scenarios. The Base case would increase the DCF value by $4/share, while the
    Higher and Invega cases would increase the DCF value by roughly $8/share and
    $12/share, respectively.
    Table 12: DCF sensitivity to cariprazine scenarios
    DCF/share
    Base case $44.11
    Higher case $47.95
    Invega case $52.06
    No cariprazine (current model) $40.27
    Source: BofA Merrill Lynch Global Research

FRX
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