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SteadyMed (STDY)

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Last Post: 12/8/2017 1:28:13 PM - Followers: 3 - Board type: Free - Posts Today: 0

This Undiscovered ultra low float stock could be a Once in a Lifetime Opportunity please do your own dd and realize the MEGA Potential here .
SteadyMed (STDY) is a undiscovered stock which is close to NDA & EMA filing (expected in 4Q 2016) for their Big Orphan Drug called Trevyent® for the treatment of pulmonary arterial hypertension (PAH) . SteadyMed is trading almost at Cash Level and lots of Insider & Institutions paid over $8 per Share now trading at just $2.50 more Infos below .I think this Stock really has MEGA upside Potential .GL
SteadyMed (Nasdaq: STDY)

Market Cap: $34.9 Million
Cash: $31.8 Million
Price: $2.57

Shares Out : 13.58 Million
Insiders & Institutions holding 10.8 Million Shares

Presentation Februar 2016

Trevyent® for pulmonary arterial hypertension (PAH)

• Combination of treprostinil and our PatchPump® platform technology
- Goal - to overcome the limitations of market leader Remodulin® (treprostinil)

- Expected NDA filing in Q3 2016
• Potential high revenue, high margin ~$180,000 per patient per year
• Potential >$4 Billion addressable market opportunity in U.S.

Bio-waiver confirmed – No clinical studies required for approval
• 505(b)(2) NDA in the U.S.
• Hybrid 10(3) Application in the E.U. - granted Centralized Review by EMA
NDA submission anticipated Q3 2016 and E.U. MAA H2 2016
Remodulin safety and efficacy data to be included in Trevyent prescribing
Example of FDA product approvals through bio-waiver
• Parenteral epoprostenol reformulation (Veletri®, Actelion) for PAH
Pipeline of two At-Home Patient Analgesia (AHPA) product candidates

• SMT – 201 (Ketorolac). Anticipate pivotal / registration trial H2 2016
• SMT – 301 (Bupivacaine.) Formulation development and technical feasibility ongoing

Mar 25, 2015 STARK BRIAN JAYDirector 1,288,112 Indirect Acquisition (Non Open Market) at $8.50 per share. 10,948,952
Mar 25, 2015 FLYNN JAMES EBeneficial Owner (10% or more) 737,555 Indirect Purchase at $8.50 per share. 6,269,217
Mar 25, 2015 GINOR RONDirector 1,075,102 Indirect Acquisition (Non Open Market) at $8.50 per share. 9,138,367
Mar 25, 2015 BANK KEITHDirector 2,294,283 Indirect Acquisition (Non Open Market) at $8.50 per share. 19,501,405
Top Shareholders
Total Number of Shares Held 10.8M

Some ‘cheap’ biotech stocks that could be buyout targets, RBC says
Shares of Arbutus Biopharma, SteadyMed and Endocyte are trading below cash value
Given that the drug is used to treat an orphan market, the profit margin for treatment in this arena is typically very high. Other orphan drugs markets can yield profit margins in the range of 20-40%. Given company estimates, the capital raised from the IPO would be enough to support approval and the final stages of development behind Trevyent. Using the conservative end of margins, 20%, and 10% market share, possible earnings would be $90 million. Then using the high growth 30x price-earnings ratio for the pharmaceutical industry, the resulting market valuation would be around $2.7 billion.

Trevyent could reach 10% market share very quickly. For example, leading competitor, Remodulin, manufactured by United Therapeutics (NASDAQ:UTHR) was approved for market in December 2013. It reached 10% share within 12 months. Given the advantages of SteadyMed's product, it should be able to at least replicate these results given the market is still largely untreated.

The Pipeline

SteadyMed's flagship drug, Trevyent, is currently in late-stage development and obtaining final approvals before going to market. The drug could treat up to 30,000 patients that suffer from PAH in the US annually. Currently, very few alternative treatments exist for PAH. The leading competitor currently only has an estimated market share of 10%. Most patients, about 80-90%, do not undergo treatment due to the difficult, cumbersome nature of the current treatment options. Trevyent and the proprietary PatchPump device promise to significantly reduce the burden of treatment, and increase accessibility. Finally, the Trevyent-PatchPump combo secures a larger share of revenue since SteadyMed sells both the drug and device. Treatment costs currently average $125k to $175k. If SteadyMed can even fetch the midpoint of this range, at a 10% market share Trevyent would be generating $450 million in sales. And, at 50% share, the drug could be a $2.3 billion drug.


Current Price
Bid Ask Day's Range
  • 1D
  • 1M
  • 2M
  • 3M
  • 6M
  • 1Y
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  • 5Y
STDY News: Termination of Registration of a Class of Security Under Section 12(b) (15-12b) 09/10/2018 01:59:59 PM
STDY News: Statement of Changes in Beneficial Ownership (4) 09/07/2018 05:13:15 PM
STDY News: Amended Statement of Beneficial Ownership (sc 13d/a) 09/07/2018 04:59:45 PM
STDY News: Notice of Effectiveness (effect) 09/07/2018 06:03:16 AM
STDY News: Notice of Effectiveness (effect) 09/07/2018 06:02:03 AM
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#16   hmm wonder will this climb back up a Tdash 12/08/17 01:28:13 PM
#15   Got me 3,50's Quiet a small float europtiger 12/08/17 09:57:40 AM
#14   SteadyMed Announces FDA Agreed Pathway to Trevyent NDA Resubmission crudeoil24 12/08/17 08:48:10 AM
#13   Adage Capital Partners GP LLC has filed a wiltonio 05/02/17 04:17:40 PM
#12   STDY bullish 6.20 stocktrademan 04/14/17 06:26:01 PM
#11   Rocket ship! Jess070283 04/03/17 09:34:01 AM
#10   Still going AH Awl416 03/31/17 04:57:32 PM
#9   nice !!!! schnitz 03/31/17 02:26:26 PM
#8   STDY news out schnitz 03/31/17 02:25:06 PM
#7   Buying. Seel 09/22/16 02:48:58 PM
#6   Interesting... ClearlyStocks 07/29/16 03:08:36 PM
#5   up she goes told you so but still BioSpecialist 04/06/16 11:25:33 AM
#4   Big move if it breaks the $3 mark . BioSpecialist 04/06/16 09:49:09 AM
#3   Steadymed’s (STDY) Buy Rating Reiterated at JMP Securities BioSpecialist 04/05/16 07:39:53 AM
#2   Most Insider & Institutions paid $8.50 per share BioSpecialist 04/04/16 01:41:24 PM
#1   This Undiscovered ultra low float stock could be BioSpecialist 04/04/16 10:11:33 AM