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  • The FDA Gives Itself Room To Move On Amarin's Appeal
    Mon, Aug. 11 AMRN 15 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
    Thu, Aug. 7 AZN, NKTR 7 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
    Mon, Aug. 4 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
    Mon, Jul. 28 AZN, BAX, RGDO 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?
    Mon, Jul. 21 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
    Mon, Jul. 7 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
    Thu, Jun. 26 NWBO 133 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
    Tue, Jun. 17 NKTR, 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
       • Sat, Jun. 14 BAX, 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
    Tue, Jun. 10 CYCC 4 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
    Wed, Jun. 4 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
       • Thu, May. 29 CYTR, NKTR, NWBO 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
       • Tue, May. 6 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
       • Sat, Apr. 19 RGDO, 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
    Fri, Apr. 11 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
    Mon, Mar. 31 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
    Fri, Mar. 14 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
       • Tue, Mar. 11 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.
  • Thank You For Riding The MannKind Catalyst Train - Please Exit Safely At The Next Available Station
       • Thu, Feb. 27 MNKD 276 Comments
  • MediciNova: Gestation Is Slow And Uncomfortable - Birth Is Sudden And Unexpected
       • Tue, Feb. 25 MNOV 6 Comments
  • Nektar Therapeutics Is The Seattle Genetics Of San Francisco But It Could Be More
       • Tue, Jan. 21 AZN, NKTR 11 Comments
  • Cyclacel Rising
       • Dec. 1, 2013 CYCC 76 Comments
  • Cyclacel Pharmaceuticals Preferred Shares: An Investigative Report
    Sep. 27, 2013 CYCC 44 Comments
  • The Captain Of Amarin's Listless Ship Makes Ready For The Storm
    Sep. 20, 2013 AMRN 105 Comments
  • With Or Without You Cyclacel Is Going To Rise
       • Sep. 7, 2013 CYCC 87 Comments
  • Novavax: Big Pharma Wants RSV Bad
    Aug. 18, 2013 NVAX 18 Comments
  • The Explosive Biotech Calendar Catalyst Play: Novavax's 1st Analyst Day
    Aug. 13, 2013 NVAX 12 Comments
  • Synergy Pharmaceuticals: There's Strength In Safety
       • Aug. 8, 2013 SGYP 4 Comments
  • Is Novavax On The Fast Track To Profits?
       • Jul. 8, 2013 NVAX 11 Comments
  • Novavax Elevating To The Power Of 2
    Editors' Pick • Jun. 28, 2013 NVAX 14 Comments
  • Amarin's Anchor Will Hold As Vascepa's Sails Unfurl
    Jun. 21, 2013 ARNA, AZN, GSK 71 Comments
  • Hodgkin Lymphoma: The Top Secret Strategy Of Seattle Genetics Revealed
    Editors' Pick • May. 22, 2013 SGEN 10 Comments