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United Therapeutics $216m deal for SteadyMed clears HRS Act waiting period

July 20, 2018 By Fink Densford Leave a Comment

United Therapeutics (NSDQ:UTHR) said today that it stepped closer to completing its $216 million acquisition of SteadyMed (NSDQ:STDY) after terminating the the HSR Act waiting period. The merger combines two companies that were in court as recently as last November, fighting over patents covering treprostinil, the active ingredient in both companies’ lead products. Read the whole story on our sister […]

Filed Under: Business/Financial News, Drug-Device Combinations, Mergers & Acquisitions, Pharmaceutical, Vascular Tagged With: SteadyMed Therapeutics, United Therapeutics

United Therapeutics puts $216m on the table to buy rival SteadyMed

April 30, 2018 By Sarah Faulkner Leave a Comment

United Therapeutics (NSDQ:UTHR) today signed a deal to acquire competitor SteadyMed (NSDQ:STDY) for $4.46 per share in cash at closing and $2.63 per share in cash if the combined company can win approval for SteadyMed’s Trevyent drug-device combination therapy. The merger, valued at $216 million, combines two companies that were in court as recently as last November, fighting […]

Filed Under: Drug-Device Combinations, Mergers & Acquisitions, Pharmaceutical, Vascular, Wall Street Beat Tagged With: SteadyMed Therapeutics, United Therapeutics

Appeals court affirms ruling in United Therapeutics, SteadyMed patent spat

November 14, 2017 By Sarah Faulkner Leave a Comment

A federal appeals court has affirmed an earlier ruling by the Patient Trial and Appeal Board of the U.S. Patent and Trademark Office, invalidating 22 claims of a patent owned by United Therapeutics (NSDQ:UTHR). The patent covered treprostinil, the active ingredient in both SteadyMed‘s (NSDQ:STDY) Trevyent and United Therapeutics’ Remodulin. The court’s ruling sent STDY shares up 8% today, trading […]

Filed Under: Drug-Device Combinations, Legal News, Patent Infringement, Pharmaceutical, Vascular, Wall Street Beat Tagged With: SteadyMed Therapeutics, United Therapeutics

SteadyMed requests meeting with FDA over rejected application for drug-device combo

September 28, 2017 By Sarah Faulkner Leave a Comment

Shares in SteadyMed (NSDQ:STDY) fell last month after the FDA decided it would not review the new drug application for the company’s drug-device combination product, Trevyent. SteadyMed received a refused to file letter, indicating that its NDA is incomplete and that the regulatory agency will not look it over. The company submitted its application to the FDA in June, […]

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance, Wall Street Beat Tagged With: SteadyMed Therapeutics

SteadyMed shares tumble after FDA refuses to review Trevyent NDA

August 31, 2017 By Sarah Faulkner Leave a Comment

Shares in SteadyMed (NSDQ:STDY) fell more than -35% today after the company announced that the FDA will not review the new drug application for its drug-device combo product, Trevyent. The company received a refused to file letter, indicating that its NDA is incomplete and that the regulatory agency will not look it over. This is the […]

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA) Tagged With: SteadyMed Therapeutics

SteadyMed tops Q2 sales, EPS estimates

August 11, 2017 By Sarah Faulkner Leave a Comment

Shares in SteadyMed (NSDQ:STDY) fell today after the pharmaceutical company beat sales expectations on Wall Street with its second quarter results, but missed EPS estimates. The San Ramon, Calif.-based company posted a net loss of -$8.1 million on sales of $319,000 for the 3 months ended June 30, for bottom-line loss of -14% on sales growth of […]

Filed Under: Cardiovascular, Drug-Device Combinations, Food & Drug Administration (FDA), MassDevice Earnings Roundup, Pharmaceutical, Wall Street Beat Tagged With: SteadyMed Therapeutics

SteadyMed seeks FDA nod for Trevyent drug-device combo

July 3, 2017 By Sarah Faulkner Leave a Comment

SteadyMed (NSDQ:STDY) said today that it submitted a new drug application to the FDA for its drug-device pulmonary arterial hypertension therapy. The San Ramon, Calif.-based company’s lead product candidate is a combination of treprostinil and the PatchPump prefilled, disposable infusion system. Get the full story at our sister site, Drug Delivery Business News.

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance, Vascular, Wall Street Beat Tagged With: Cardiome Pharma Corp, SteadyMed Therapeutics

SteadyMed raises another $5m from key shareholder

May 26, 2017 By Sarah Faulkner Leave a Comment

SteadyMed (NSDQ:STDY) said today that 1 of its largest institutional shareholders exercised warrants to purchase additional shares of the company that the investor got in conjunction with the 1st tranche of a previous private placement. Thanks to the exercise, San Ramon, Calif.-based SteadyMed received an additional $5 million in proceeds. Get the full story at our […]

Filed Under: Cardiovascular, Funding Roundup, Pharmaceutical, Wall Street Beat Tagged With: SteadyMed Therapeutics

SteadyMed raises $30m for Trevyent commercial launch

April 21, 2017 By Sarah Faulkner Leave a Comment

Shares in SteadyMed (NSDQ:STDY) rose 6% today after the company said it inked a $30 million private placement with Adage Capital Management, OrbiMed, Deerfield Management and Kingon Capital Management. The San Ramon, Calif.-based company plans to use its newly-acquired funds to prepare for the commercial launch of its pulmonary arterial hypertension treatment, Trevyent. The therapy is […]

Filed Under: Cardiovascular, Drug-Device Combinations, Funding Roundup, Wall Street Beat Tagged With: SteadyMed Therapeutics

SteadyMed studies accuracy and precision of PatchPump infusion system for Trevyent

April 6, 2017 By Sarah Faulkner Leave a Comment

SteadyMed (NSDQ:STDY) said yesterday that it finished a clinical study for its lead drug candidate, Trevyent. The pulmonary arterial hypertension treatment is a combination of treprostinil and the PatchPump prefilled, disposable infusion system. The San Ramon, Calif.-based company said it is on track to submit a New Drug Application for Trevyent in the 2nd quarter […]

Filed Under: Cardiovascular, Clinical Trials, Drug Pumps, Drug-Device Combinations, Food & Drug Administration (FDA), Pharmaceutical Tagged With: Cardiome Pharma Corp, SteadyMed Therapeutics

More trouble for United’s Remodulin

April 4, 2017 By Sarah Faulkner Leave a Comment

The Patent Trial and Appeal Board of the U.S. Patent and Trademark Office ruled yesterday that the claims of United Therapeutics‘s (NSDQ:UTHR) patent, which covers Remodulin, are unpatenable due to obviousness. SteadyMed (NSDQ:STDY) challenged the patent in October last year. The patent, No. 8,497,393, relates to the process to purify prostacyclin derivatives, including treprostinil, which is […]

Filed Under: Cardiovascular, Drug-Device Combinations, Pharmaceutical, Vascular, Wall Street Beat Tagged With: SteadyMed Therapeutics, United Therapeutics

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