SteadyMed (STDY)

[Tdash]

hmm wonder will this climb back up a bit b4 closee.. news was pretty good

[europtiger]

Got me 3,50's

Quiet a small float

[crudeoil24]

SteadyMed Announces FDA Agreed Pathway to Trevyent NDA Resubmission
1 hour 48 minutes ago - DJNF
SteadyMed Announces FDA Agreed Pathway to Trevyent NDA Resubmission
No clinical trials required for NDA resubmission

SAN RAMON, Calif., Dec. 08, 2017 (GLOBE NEWSWIRE) -- SteadyMed Ltd. (Nasdaq:STDY), a specialty pharmaceutical company focused on the development of drug product candidates to treat orphan and high-value diseases with unmet parenteral delivery needs, today announced it has received final minutes from the US Food and Drug Administration (FDA) on the work necessary to resubmit its New Drug Application (NDA) for Trevyent(R) for the treatment of Pulmonary Arterial Hypertension (PAH).

The minutes followed a positive and collaborative Type A meeting with the FDA on November 1, 2017. The FDA is not requiring SteadyMed to conduct any clinical trials to prove the safety or efficacy of Trevyent and has agreed that a repeat of in vitro Design Verification (DV) testing on the final to-be-marketed Trevyent product, supported by pharmacokinetic modelling and Process Validation, should be adequate for the resubmission and acceptance of the 505(b)(2) New Drug Application (NDA).

[wiltonio]

Adage Capital Partners GP LLC has filed a new 13G, reporting 9.61% ownership in $STDY - https://fintel.io/so/us/stdy

[stocktrademan]

STDY bullish 6.20









normal chart




log chart

[Jess070283]

Rocket ship!

[Awl416]

Still going AH

[schnitz]

nice !!!!

[schnitz]

STDY news out

[Seel]

Buying.

[ClearlyStocks]

Interesting...

[BioSpecialist]

up she goes told you so but still brutally undervaued stock here

[BioSpecialist]

Big move if it breaks the $3 mark .

[BioSpecialist]

Steadymed’s (STDY) Buy Rating Reiterated at JMP Securities
http://www.iramarketreport.com/steadymeds-stdy-buy-rating-reiterated-at-jmp-securities/49753/

JMP Securities reiterated their buy rating on shares of Steadymed Ltd (NASDAQ:STDY) in a report issued on Wednesday morning, AnalystRatingsNetwork.com reports. JMP Securities currently has a $9.00 price target on the stock.

An institutional investor recently raised its position in Steadymed stock. Jennison Associates raised its position in Steadymed Ltd (NASDAQ:STDY) by 0.3% during the third quarter, Holdings Channel reports. The firm owned 432,255 shares of the company’s stock after buying an additional 1,159 shares during the period. Jennison Associates owned about 3.18% of Steadymed worth $1,535,000 at the end of the most recent reporting period.

Separately, RBC Capital reaffirmed a buy rating on shares of Steadymed in a research note on Monday, March 28th.

[BioSpecialist]

Most Insider & Institutions paid $8.50 per share you can have it at $2.70 which is a fantastic entry point near ATL . The Biotech Selloffin last weeks created this unbelievable opportunity because this stock is still unknown to most investors .


http://finance.yahoo.com/q/it?s=STDY+Insider+Transactions

Mar 25, 2015 STARK BRIAN JAY Director 1,288,112 Indirect Acquisition (Non Open Market) at $8.50 per share. 10,948,952
Mar 25, 2015 FLYNN JAMES Beneficial Owner (10% or more) 737,555 Indirect Purchase at $8.50 per share. 6,269,217
Mar 25, 2015 GINOR RON Director 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

[BioSpecialist]

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
http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9NjA4MDY0fENoaWxkSUQ9MzIxMjA1fFR5cGU9MQ==&t=1


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
information
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


http://finance.yahoo.com/q/it?s=STDY+Insider+Transactions

Mar 25, 2015 STARK BRIAN JAY Director 1,288,112 Indirect Acquisition (Non Open Market) at $8.50 per share. 10,948,952
Mar 25, 2015 FLYNN JAMES E Beneficial Owner (10% or more) 737,555 Indirect Purchase at $8.50 per share. 6,269,217
Mar 25, 2015 GINOR RON Director 1,075,102 Indirect Acquisition (Non Open Market) at $8.50 per share. 9,138,367
Mar 25, 2015 BANK KEITH Director 2,294,283 Indirect Acquisition (Non Open Market) at $8.50 per share. 19,501,405


Top Shareholders

http://data.cnbc.com/quotes/STDY/tab/8

Total Number of Shares Held 10.8M


Some ‘cheap’ biotech stocks that could be buyout targets, RBC says
http://www.marketwatch.com/story/some-cheap-biotech-stocks-that-could-be-buyout-targets-rbc-says-2016-01-25?siteid=yhoof2

Shares of Arbutus Biopharma, SteadyMed and Endocyte are trading below cash value
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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.