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 […]
SteadyMed Therapeutics
United Therapeutics puts $216m on the table to buy rival SteadyMed
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 […]
Appeals court affirms ruling in United Therapeutics, SteadyMed patent spat
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 […]
SteadyMed requests meeting with FDA over rejected application for drug-device combo
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, […]
SteadyMed shares tumble after FDA refuses to review Trevyent NDA
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 […]
SteadyMed tops Q2 sales, EPS estimates
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 […]
SteadyMed seeks FDA nod for Trevyent drug-device combo
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.
SteadyMed raises another $5m from key shareholder
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 […]
SteadyMed raises $30m for Trevyent commercial launch
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 […]
SteadyMed studies accuracy and precision of PatchPump infusion system for Trevyent
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 […]
More trouble for United’s Remodulin
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 […]
