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  • Trevena's Q4 2014 Results Conference Call - What We Learned
    Mon, Mar. 23 TRVN 8 Comments

    Summary

    • In print, CEO Maxine Gowen prefers to go by the abbreviated Max. The likely reasons for this are unfortunately obvious.
    • As indicated in my article opening coverage on the equity, Trevena has a strong balance sheet with $106.9M in cash, cash equivalents and investments.
    • I did not know that Actavis PLC, then through the auspices of Forest Labs whom it later acquired, had previously paid $30M towards the development of TRV027. Now I do.
    • There's evidence that Wall Street analysts are paying attention to my thoughts, and so it appears is Trevena management. How it responds will be critical to share price appreciation.
  • Nektar-102 Will Be An Approved Treatment In Metastatic Breast Cancer
    Mon, Mar. 23 NKTR 8 Comments

    Summary

    • There are those who will tell you that the FDA will no longer approve a drug for commercial use that doesn't demonstrate statistical significance. This time, they're wrong.
    • Nektar-102 will be approved in metastatic breast cancer, in part because this is a gender issue. Women will not be denied the one drug that proved better than all others.
    • It is better by virtue of months survived, better by virtue of fewer side effects, and better by virtue of investigator opinion. Nektar-102 will be approved by the FDA.
  • Trevena Inc: Profitable To You And Disruptive To Everyone Else
     • Mon, Mar. 16 TRVN 27 Comments

    Summary

    • Trevena presents a unique opportunity to invest in a new technology platform displaying consistent signs of clinical activity in two distinct treatment populations.
    • With one compound in Acute Heart Failure and three more in pain relief, Trevena's market opportunities are unusually large for such an early stage venture.
    • A recent update to the large Phase 2 BLAST-AHF trial validates not only the efficacy and safety of TRV027 but the leadership skills of President and CEO Maxine Gowen PhD.
    • It was Gowen who deftly negotiated a partnership option with Actavis PLC providing for complete clinical funding of TRV027, $365M in milestones, a $65M upfront payment and 20% sales royalties.
    • Surfing the data wave of BLAST-AHF just as TRV130 sets out on its pivotal Phase 3 quest in early 2016 will be rewarding to investors willing to mount up early.
  • Where Celldex Is Concerned, Patience Will Be Required
    Mon, Mar. 9 CLDX 6 Comments

    Summary

    • You know an equity has momentum when a large public financing of nearly $200M is met with little or no drop in the share price.
    • The timing of that offering is indicative of a unique problem the company has moving forward - the absolute necessity of forging an autonomous path to commercialization of the pipeline.
    • Talks with regulators in both the U.S. and Europe won't occur until later this year when REACT data has matured delaying any commercialization of Rintega® until well into 2016.
  • Prospective New Investors Have To Wake Up To See Amarin Now
    Fri, Feb. 27 AMRN 36 Comments

    Summary

    • Amarin's depressing history has kept many investors from understanding its present potential.
    • I'll identify the only two risks associated with this equity at the present time and contrast them with the disproportionate reward.
    • There are lots of outstanding buys in biotech today that have low risk profiles - Celldex and Seattle Genetics are but two of them. Amarin is a third.
  • Nektar CEO Howard Robin Walks Along His Own Path
    Wed, Feb. 25 NKTR 13 Comments

    Summary

    • President and CEO Howard Robin is breaking ranks with his executive peers and becoming extraordinarily accessible to retail shareholders.
    • This openness should engender not only your respect, but infuse his words with a greater degree of credibility.
    • I'll enumerate the reasons why NKTR-102 may survive a BEACON miss.
    • And a strike-while-the-iron-is-hot buy-out scenario immediately following positive BEACON data is remotely possible.
  • CellDex Leaves Them All Behind
    Mon, Feb. 23 CLDX 11 Comments

    Summary

    • Celldex will win the race to glioblastoma multiforme commercialization leaving all current competing therapies in the clinic far behind.
    • Breakthrough Designation is the FDA's clear and unequivocal statement of support for this.
    • Celldex has an air of professionalism surrounding the company's entire presentation of itself that lends to a validation of increasing investor expectations.
  • Seattle Genetics: Zen And Resolve
       • Thu, Feb. 19 SGEN 8 Comments

    Summary

    • Adcetris is now clinically indispensable to Hodgkin Lymphoma patients.
    • Adcetris will remain the focal point of Hodgkin Lymphoma treatment because it targets CD-30 which is the primary marker of expression there.
    • Adcetris use and revenues are both rising.
    • Check point inhibitors such as Bristol-Myers Squibb's Nivolumab will compliment rather than challenge Adcetris domination in CD-30 malignancies.
    • Adcetris will become a front-line therapy in Hodgkin Lymphoma sooner than you think.
  • What The Chances Are Of BEACON's Success And What That Will Mean To Nektar
    Mon, Feb. 9 NKTR 22 Comments

    Summary

    • A major catalyst is now in play - publication of top-line data in the pivotal Phase III BEACON trial set to occur in March.
    • We'll take a closer look at etirinotecan pegol (NKTR-102) and assess the chances of attaining statistically significant data worthy of regulatory approval.
    • Marketing NKTR-102 in this 1st indication will provide a proprietary revenue stream worth up to $300M, but the actual impact will be operationally transformational to Nektar's current business model.
  • Synergy's Constipated Share Price Is Headed For A Cure
       • Wed, Feb. 4 SGYP 19 Comments

    Summary

    • The long suffering Synergy shareholder is soon to be rewarded when the first of two Plecanatide registration trials reads topline data in Q2 of 2015.
    • Synergy's painful slip towards oblivion can be explained by looking at the bigger picture surrounding the constipation treatment landscape.
    • Synergy's share price could double in Q2 of 2015 when a series of dominoes fall surrounding statistically significant data leading to talk of regulatory approval and a commercial partnership.
    • SP-333 is the first and only once daily oral therapeutic GC-C agonist to demonstrate efficacy in treating OIC patients and could be the first real commercial threat to AstraZeneca's Movantik.
  • The Butterfly Effect: Advanced Cell Technology Becomes Ocata Therapeutics (OCAT)
    Dec. 8, 2014 OCAT 301 Comments

    Summary

    • Ocata Therapeutics has entered an optimal moment in its developmental life cycle to initiate a long position.
    • Prior to the as yet unknown date of up-list to the NASDAQ, which will occur with an accompanying equity raise, there is reason to believe the stock price will rise.
    • Following dilution, the company will likely do everything possible to stabilize and enhance shareholder value although the door will be open to market manipulation.
  • Amarin: The Silence Of The Lamb
    Dec. 2, 2014 AMRN 39 Comments

    Summary

    • On November 2nd, Amarin management threw in the towel on further ANCHOR SPA rescission appeals.
    • Questions about the company's ability to finance its operations through the pivotal REDUCE-IT study results abound.
    • Biotechnology investment is speculative by nature, and Amarin's sudden shift from Brad Pitt's "first rule of fight club" to Mathew Mcconoughey's "Alright, alright, alright" should have your speculative ears piqued.
  • Nektar 181 Could Dominate A $13B Chronic Pain Market
    Editors' Pick • Aug. 26, 2014 NKTR 21 Comments

    Summary

    • The deliberate approach taken to bringing NKTR-181 into a registration trial built for success is reflective of how important the drug is to the FDA, Nektar and Nektar stakeholders.
    • Dr. Ivan Gergel was brought to the company for one reason only - to ensure that NKTR-181 meets its primary endpoint in Phase III and is commercially approved in 2016.
    • My graphical illustration of Nektar's Catalyst Calendar is too full to squeeze in yet another money-making event, but initiation of NKTR-181's IRB approval process takes place by year-end.
    • Beyond chronic pain, I'll show you an expansive secondary market for temporary pain relief that no one has yet talked about.
  • Celldex Offers A Broad Portfolio Of Oncology Solutions
    Editors' Pick • Aug. 25, 2014 CLDX 30 Comments

    Summary

    • Celldex's ACT-IV pivotal Phase III trial is fast approaching complete enrollment and will now read out in advance of Northwest Biotherapeutics' DCVax-L registration study.
    • Though Celldex offers a deep pipeline of oncology candidates, investors should expect volatility until REACT data is available in Q4.
    • Celldex stock could rebound toward rapid growth if REACT is positive.
  • The FDA Gives Itself Room To Move On Amarin's Appeal
    Aug. 11, 2014 AMRN 27 Comments

    Summary

    • This is no ordinary review process based entirely upon scientific considerations, but rather an upper level deliberation based upon the legal implications of agency decision making thus far.
    • The latest FDA responses to citizen petitions and to Amarin's official appeal indicate that the agency might be struggling to give itself a little wiggle room to make concessions.
    • Whilst only a few days ago I was deeply skeptical of John Jenkins' ANCHOR appeal response, I'm now cautiously optimistic that things might indeed move a bit in Amarin's favor.
    • As a middle income, month-to-month investor, I'm loading up on Amarin shares because one day Vascepa will be approved in the ANCHOR indication and will be a multi-billion dollar drug.
  • Nektar Therapeutics Harnesses The Power Of AstraZeneca To Move Movantik
    Aug. 7, 2014 NKTR 8 Comments

    Summary

    • Nektar, and Nektar shareholder excitement surrounding FDA approval of Movantik on the fast-approaching date of September 16th might only be exceeded by that of partner AstraZeneca.
    • I told you back in January that AstraZeneca would flex its political influence at the OIC advisory committee meeting to effect a positive outcome. It's even better at product launches.
    • Nektar president, Howard Robin was his usual understated self on the recently aired Q2 earnings call, reminding investors to be patient for a Movantik rollout following routine opioid antagonist de-scheduling.
  • Nektar President Howard Robin Is Listening To You
    Aug. 4, 2014 NKTR 4 Comments

    Summary

    • Nektar will morph into a self-commercializing biopharmaceutical company within the next few years.
    • Over the next six months, Nektar has more catalysts for stock price appreciation than any other biotechnology company.
    • Of these value drivers: Movantik approval, BAX-855 phase 3 data and NKTR-102 (BEACON) data, an announcement by the company to market NKTR-102 themselves may be the biggest mover of all.
  • Nektar: Reason Will Rarely Fail You
    Jul. 28, 2014 NKTR 8 Comments

    Summary

    • It's a stock with institutional ownership in excess of 93.5%, how then has Nektar lost 18.4% of its value since July 1st - especially given the positive OIC adcom vote?
    • Rather than speculate about market manipulation or unreported news events, we'll take a logical approach to assess what has happened.
    • Regado's halted REGULATE-PCI trial on July 2nd; Relistor label expansion into the opioid induced constipation population and Synergy's July 17th Phase 2 clinical trial enrollment completion factored into that equation.
    • Regardless, this debris field of negativity will be washed away by a tidal wave of 2nd half catalysts that make Nektar one of the best long-term holds in biotech.
  • Amarin: Will The Lamb Of Ireland Bleat Or The Lion Of The People Roar?
    Jul. 21, 2014 AMRN 95 Comments

    Summary

    • Amarin president, John Thero is hinting at mounting a 1st Amendment challenge to the FDA's off-label regulatory laws as a last resort, when he should be exercising free speech now.
    • I'll show you how the FDA unjustly deprived Amarin of Vascepa expansion into the $40B high triglyceride indication and why everyone should care enough to do something about it.
    • If Thero acts boldly, Vascepa could reach blockbuster status swiftly - paying for the completion of REDUCE-IT, financing all legal fees and rallying the stock to new heights.
    • The FDA is counting on Thero's timidity and ignorance to complete the hobbling of the company by denying the ANCHOR appeal and rescinding the REDUCE-IT SPA when the time comes.
  • Regado's Revolixys Revolution Meets With Resistance
    Jul. 7, 2014 RGDO 25 Comments

    Summary

    • Regado took a heavy hit to its reputation this past Wednesday evening. And Thursday morning's press conference was less hit than run.
    • The stock was slaughtered on a half day of heavy trading, as investors misinterpreted what had really happened.
    • If you bought the dip, you're now on an 8-week countdown to a return to fight or a technical knockout.
  • Placing Northwest Biotherapeutics In The Figure-4 Deadfall Trap
    Jun. 26, 2014 NWBO 134 Comments

    Summary

    • The Figure-4 Deadfall Trap metaphor is useful in examining the flimsy sticks we use to prop up our investment thesis in any biotechnology stock, but especially those engulfed in controversy.
    • There was a hidden sales message in the cascade of recent DCVax-Direct press releases, and investors bought it hook, line and sinker.
    • Northwest Biotherapeutics has postponed DCVax-L trial completion dates, expanded and contracted estimated enrollment numbers, avoided updating actual patient participation statistics, and hinted at trial expansion.
    • Instead of fighting progression-free survival (PFS) as a primary endpoint in the DCVax-L trial, I'll get you to see how it's an investment advantage, at least up until approval.
  • Regado Biosciences: The Revolixys Revolution Has Begun
    Jun. 17, 2014 RGDO 27 Comments

    Summary

    • Regado Biosciences offers a paradigm-changing approach to acute cardiovascular care in the hospital environment tied to a multi-billion dollar commercial setting.
    • On offer is an excellent short-term appreciative trade or long-term investment opportunity.
    • Regado's late-stage product candidate, Revolixys Kit, is an advanced therapy that intends to standardize emergent catheter intervention procedures.
  • A Nektar Victory
       • Jun. 14, 2014 NKTR 8 Comments

    Summary

    • The now concluded FDA Advisory Committee Meeting on opioid induced constipation has Nektar positioned for rapid appreciation in the second half of this year.
    • The September 16th Movantik PDUFA date is one of 5 major near-term catalysts. BAX-855 Topline Data; NKTR-181 P3 Trial Initiation; BAX-855 NDA Filing & NKTR-102 Topline Data being the rest.
    • Movantik's $2B market opportunity will be the driving force behind the rebirth of AstraZeneca which may choose to forgo the $545M in future milestone payments by buying Nektar outright.
  • Cyclacel Shapes Sapacitabine's Phase IIb Study For Regulatory Success
    Jun. 10, 2014 CYCC 5 Comments

    Summary

    • Cyclacel Pharmaceuticals is in the home stretch of a pivotal Phase III oncology trial that will serve to catalyze investor interest moving forward.
    • Sapacitabine's safety profile and the passage of two DSMB reviews diminishes risk against what is already a disproportionately higher reward opportunity.
    • A promising Phase IIb trial in R-MDS will enroll and read-out swiftly, providing new and rapid share price catalysts.
  • Cyclacel Pharmaceuticals: The Devil's Advocate Be Damned
    Jun. 4, 2014 CYCC 25 Comments

    Summary

    • Cyclacel's big event to unveil the pathway forward for sapacitabine in R-MDS was disastrous to shareholder equity.
    • Was any thought given to the consequences of engendering enormous expectations that would be met with underwhelming news? I hope not!
    • Cyclacel's honored guest speaker at this invitation-only fiasco was Hagop Kantarjian, M.D., who was feisty, candid, bewildered and refreshing.
  • Celldex: The Race Leader In Glioblastoma Multiforme
       • May. 29, 2014 CLDX 59 Comments

    Summary

    • The best hope for a viable Glioblastoma Multiforme therapeutic improvement rests in the hands of these four teams: Celldex; CytRx; Nektar Therapeutics and Northwest Biotherapeutics.
    • The two compounds with the best chance of winning the race to FDA approval are owned by companies with contrasting public images.
    • Two remedies are targeted chemotherapeutics and two are immunotherapeutic.
  • The Incredible Cyclacel Pharmaceuticals
       • May. 6, 2014 CYCC 21 Comments

    Summary

    • An oncology company in phase 3, with orphan drug status, a Special Protocol Assessment agreement, and a market cap of $69m - Incredible!
    • A confounding compound whose efficacy works in inverse proportion to the age of the patient benefiting from it - Incredible!
    • A CEO twice diluting near 52-week lows, within days of hearing his CFO explaining why it wasn't necessary at the same 2 press conferences he's pontificating from - Not Credible!
  • Nektar Fortifies Its Position In Advance Of The Rescheduled FDA Panel On OIC
       • Apr. 19, 2014 NKTR 14 Comments

    Summary

    • Nektar's big event - the FDA panel on Opioid Induced Constipation, or OIC has been rescheduled for June 11th and 12th.
    • An interim catalyst involving the readout of NKTR-171 Phase 1 data should keep shares solidly between $10 and $14 until naloxegol's future has been better defined.
    • A small capital raise to hedge against the lesser possibility of FDA panel disappointment, and the strengthening of yet another partner's financial position, are positive developments since my last report.
  • The Stalled State Of MannKind
    Apr. 11, 2014 MNKD 87 Comments

    Summary

    • The FDA has postponed MannKind's Afrezza PDUFA date until July 15, 2014.
    • While regulatory assent seems likely, questions abound as to what form that approval will take.
    • MannKind stock peaked in the wee hours of pre-market trading the day following a near unanimous adcom victory, but might not equal that fondly remembered price for years to come.
    • Though talk of a buyout, or commercial partnership may satisfy the need to divert focus from the harsh reality of the present moment, neither is likely to occur soon.
  • MannKind's Latest Critic: The FDA Has Joined The Chorus Of Missing Data Concerns
    Mar. 31, 2014 MNKD 178 Comments

    Summary

    • The historical foundation of the Afrezza application is made up of multiple identified deficiencies.
    • Missing data is now a black box concern of the FDA as well.
    • The seal of MannKind's fate will be broken on Tuesday, April 1, 2014.
  • MannKind: The Gambler's Creed - Let It Ride
    Mar. 14, 2014 MNKD 165 Comments

    Summary

    • In my previous article, we examined the obstacles to approval that Mannkind faces at its upcoming FDA advisory committee meeting by expanding our definition of what an adcom is.
    • In this article, we'll suss out the risks for long-term investors that attend to holding through this or any other high-profile event in the absence of using options.
    • Are adcoms really approved 82% of the time as MannKind's fervent supporters suggest? I'll demonstrate why it's better to read a document with quiet discernment than with partisan zeal.
    • And finally, we'll address the role that bloggers play in clarifying important issues surrounding investment in the sector, especially as this applies to binary events and to adcoms in particular.
  • Sunshine Heart: An Elementary Question Reveals A Profound Problem
       • Mar. 11, 2014 SSH 139 Comments

    Summary

    • Sunshine Heart's Counter-HF pivotal phase 3 trial of their remarkable C-Pulse Heart assist system for Class III and IV heart failure patients is enrolling sluggishly at best.
    • Investors should ignore the noise and laser focus on enrollment numbers moving forward.
    • Criteria for enrollment might be too rigid, competition for patients too stiff and the device might work too well for patients to stay on the required 12 months of participation.
    • The share price has been in steady downfall since a news release in mid-January of this year and short interest has been steadily rising.
    • Most troubling of all, the stated goal of 4 years to completion of the Counter-HF trial may be flawed by design.