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Acadia Remains On Track With Pimavanserin Program
- NDA for pimavanserin in PDP expected to be filed late 2014. This would put a PDUFA late 2015.
- Phase 2 program in ADP, a significant value-driver in our opinion, continues on plan, with data expected late 2015.
- Our DCF model pegs fair-value between $25-30 per share, making the stock attractive for long-term investors at today's price of $17.
Nuvo Research Offers Low-Risk With Big Upside
- Nuvo Research, Inc. is a specialty pharmaceutical company with a diverse portfolio of marketed products (Pennsaid®, Pennsaid® 2%, Synera®, Pliaglis®).
- Beside the marketed products, the company also has an immunotherapy treatment (WF10) for allergic rhinitis in Phase 2 testing.
- We feel that Nuvo has tremendous upside. We believe investor should ‘Buy’ the shares today, and our target is $7.50 per share.
AntriaBio Looks To Corner The Long-Acting Insulin Market
- Long-acting insulin is currently dominated by Sanofi's Lantus. Thanks to once daily dosing, Lantus sales totaled nearly $8 billion in 2013.
- AntriaBio is taking a unique approach to developing the world's first once weekly insulin therapy.
- Moving from once daily to once weekly dosing has the potential to capture 30-40% of the $10 billion long-acting insulin market.
- We believe AntriaBio shares are attractive today based on the potential for AB101.
Durect Shares Should Double In The Next Year
- Pfizer is progressing nicely with Remoxy. Remoxy alone is worth $1.50 per share.
- Other assets such as POSIDUR, ELADUR, Relday, and ALZET and LACTLE are significantly under-appreciated by investors.
- DURECT has enough cash to fund operations into 2015.
- We believe the stock is worth $3.00 per share.
Omni Bio Raises Cash, Wastes No Time Getting Back To Work
- Raise financing of up to $3M allows company to move forward with pipeline.
- Investigator and outside sponsored studies could help generate revenue for Omni Bio.
- Fc-AAT looks like a potential blockbuster drug..
InVivo's Day Has Arrived
- Initiation of the pilot study is very good news for InVivo investors.
- We see the Neuro-Spinal Scaffolding as a $500 million device.
- Some of our previous concerns, such as starting the trial, manufacturing delays, and IP have been eased.
- Our primary existing concern is on long-term funding, as the cash position is down to less than six months.
- We are clearly warming back up to the InVivo story. Recent conversations with new CEO, Mark Perrin have certainly helped raise visibility.
Neuralstem's Cell Therapy Is Working, And This Is Just The Beginning
- Recently published data on NSI-566 from a Phase 1 study demonstrates clear signs of efficacy in a select patient population.
- Patient blogs from the ongoing Phase 2 study provide additional anecdotal evidence of efficacy.
- We believe NSI-566 is a $2+ billion drug in ALS.
- Neuralstem recently initiated a Phase 1 trial with NSI-566 in spinal cord injury. We view this as an incremental $2+ billion opportunity.
- We believe the shares will be above $6 by the end of the year 2014.
Expecting A Breakout Year For OxySure
- Revenue growth in 2013 was up 567%.
- CE Mark in Europe could double sales in 2014.
- Expect strong military orders later this year.
- Stock trading at less than 5x our 2016 EPS estimate.
Analyst Interview: Cynapsus Therapeutics Still A Top Pick
- The following is a transcript of an interview with Zacks' Sr. Biotech analyst Jason Napodano.
- The recent financing pulled in $23+ million in cash and looks to be enough to fund operations and development of APL-130277 through the NDA filing.
- Jason continues to believe Cynapsus shares represent a compelling value for investors.
- Target price is $2.15 per share, or 250% upside from today.
Immune Pharma Tackling Orphan Disease Bullous Pemphigoid
- Bertilimumab is a first-in-class fully human monoclonal antibody that is directed against eotaxin-1, a potent chemoattractant and activator of eosinophils.
- Eosinophils are implicated in the inflammatory changes seen in various inflammatory disorders such as inflammatory bowel disease (IBD), asthma, and dermatological diseases such as bullous pemphigoid (BP).
- BP is an orphan dermatological disease that affects approximately 12,000 people in the U.S. each year.
- Eotaxin-1 plays a role in the recruitment of inflammatory cells to skin lesions in patients with BP and represents a novel therapeutic target for this disease.
Still Several Reasons To Remain Long Amarantus
- Balance sheet and cash position significantly improved over the past six months.
- Management dramatically enhanced with several new hires.
- Guidance continues to be LymPro CLIA launch late 2014.
- Eltoprazine Phase 2b studies in LID and ADHD being planned.
- Stock worth 20-25c.
Plenty Of Upside Remains In ULURU, Inc.
- Below we provide a detailed review of the fourth quarter results and future business prospects for ULURU, Inc.
- We believe Altrazeal has the right combination of cost-benefit in the treatment of chronic wounds to be a $100 million drug by 2020.
- ULURU, Inc. pulled in $2.3 million in cash between January and April 2014.
- The shares are attractively valued and we see meaningful upside left in the story.
Time To Back Up The Truck On Cytomedix?
- We believe AutoloGel has peak sales in the area of $150 million.
- Angel has peak sales in the area of $75 million.
- Data on ALD-401 in the RECOVER-Stroke trial is coming in early May 2014.
- The shares are highly attractive for long-term investors.
A Nice Buying Opportunity In Tonix Pharma
- We strongly disagree with conclusions from a negative article on Tonix published on Seeking Alpha last week.
- Our own valuation modeling pegs Tonix's fair value between $16 and $18 per share.
- Below we provide a counterpoint to the three key assumptions from the negative article and outline our belief as to why TNX-102SL will be a commercial success.
Positive Clinical And Commercial Updates From Avita Medical
- Revenue growth was up 35% in the previous quarter, driven by revised and refocused marketing effort.
- Compassionate use of ReCell in burns/scalds is enormous opportunity - IDE approval coming soon.
- Potential for non-dilutive cash in the next few months from selling the respiratory businesses.
- Data from RESTORE and vitiligo clinical studies coming in 2015.
- Incredible cheap valuation - modeling yields potential for 100% upside.
Checking In On ARCA Biopharma
- The company's Phase 2b/3 Clinical Trial, GENETIC-AF, should start very soon.
- ARCA has cash to make it into early 2016.
- The development strategy for Gencaro makes sense based on our analysis of the previous data.
- The shares are attractive for long-term investors.
Weighing The Pros And Cons Of InVivo Therapeutics
- InVivo is guiding to starting the IDE trial in the second quarter 2014.
- Manufacturing issues have been a reason for the delay until now.
- Investors are looking for answers on this issue, right now visibility is low.
- Valuation looks expensive, but our model assumes no upside contribution given the low visibility.
4 Reasons Aastrom Looks Good Right Now
- Valuation is extremely attractive for long-term position.
- The company has cash (and access to more cash).
- Near-term catalysts include P3 REVIVE data in June 2014, ixCELL data in mid-2015.
Tonix TNX-201 Ready For Clinical Development
- Recent Pre-IND meeting paves the way for P1 study to start Q3-2014.
- TNX-201 has unique profile that could allow peak sales of $300 million.
- TNX-201 provides nice diversification and upside to the Tonix story.
CAPTURE Data Should Help Drive Soltamox Sales At DARA Bio
- Analysis of CAPTURE Poster presented below.
- Results are consistent with our financial model.
- Growing sales of Soltamox should have positive effect on the other five products at DARA.
Put This Specialty Pharma In Your Portfolio
- Management has done a fantastic job of building a specialty pharma business.
- Revenue growth in 2014 should be over 50%.
- On a peer-valuation, the stock is attractively valued. Target is $16.
Bertilimumab Is A Potential Blockbuster Drug For Immune Pharma
- Bertilimumab has significant scientific merit in IBD and BP.
- We see potential blockbuster sales for the drug.
- Immune Pharma shares are vastly under-valued, our target is $9 per share.
- Company just raised $11.6M and will seek NASDAQ uplisting shortly.
What The Market Is Missing About LabStyle Innovations
- Dario should be launched in the next few weeks.
- The market is missing an enormous potential revenue stream with software and data.
- We see the stock fairly-valued at $4.00, which is over 100% upside.
Pozen Looking Very Attractive As FDA Decision Nears
- FDA decision on PA325 is on April 25, 2014.
- Vimovo looks positioned for growth.
- Stock is extremely cheap based on future cash flows.
- Potentially additional cash distributions in 2015.
Titan Looking Attractive After Positive FDA Meeting
- Braeburn pays for necessary clinical work prior to re-filing in 2015.
- Clinical study should be a slam-dunk to hit.
- Titan stock offers 125% upside to my DCF target.
- Encouraging Recent Developments At OxySure Systems
- An Update On Acadia Pharmaceuticals
- Buy Cipher Pharma Before Someone Else Buys Them
- DARA: Next Steps After Awarding Of Orphan Designation For KRN5500
- Ico Therapeutics: Near-Term Catalyst Presents Enormous Upside
- Can GlassesOff Make You A Better Ballplayer?
- Neuralstem Phase 1 Data Gives Hope In ALS