Shares in SteadyMed (NSDQ:STDY) rose yesterday after the pharmaceutical company reported its 4th quarter results. The San Ramon, Calif.-based company posted losses of -$2.4 million, or -12¢ per share, on sales of $400,000 for the 3 months ended Dec. 31, for bottom-line growth of 63.1% on sales loss of -25.6% compared with the same period last year. […]
SteadyMed Therapeutics
SteadyMed details commercialization plans for Trevyent
SteadyMed Therapeutics (NSDQ:STDY) today detailed the development of its lead drug product candidate, Trevyent (treprostinil sodium), for the treatment of pulmonary arterial hypertension using its PatchPump tech at the Parenteral Drug Assn. Conference in Huntington Beach, Calif. PatchPump is the 1st single-use, wearable, pre-filled pump and treprostinil will be the 1st drug integrated with the delivery system, according to […]
SteadyMed raises $32m
SteadyMed Therapeutics (NASDAQ:STDY) today announced a new $32 million round of funding through a 2-tranche private placement. The round was led by new investor OrbiMed and joined by existing investors including Federated Investors and Deerfield Management, according to the San Ramon, Calif.-based company. “This financing is exciting news for our Company, strengthens our balance sheet and enables […]
Patent office to review United Therapeutics, SteadyMed patent conflict
SteadyMed Therapeutics (NASDAQ:STDY) said today it that the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office initiated an inter partes review against a United Therapeutics patent. The patent in question, No. 8,497,393, is related to a process to purify prostacyclin derivatives, such as treprostinil, which is used in United Therapeutics’ Remodulin and […]
SteadyMed still steady on Q2
SteadyMed Therapeutics (NASDAQ:STDY) yesterday released quarterly earnings that missed expectations and reported growing losses, but shares stayed steady. SteadyMed is a developer of hypertension and pain treatments given with a discrete, patented drug-delivery device called the PatchPump. The company is focusing on development and approval of Treyvant, a drug to treat pulmonary arterial hypertension. SteadyMed reported losses of […]
SteadyMed inks deal for EU, Canada, Middle East
SteadyMed Therapeutics (NSDQ:STDY) said last week that it inked an exclusive deal with Cardiome for commercialization of its Treyvant product in regions outside the U.S., hinging on its regulatory approval in those regions. Cardiome will have exclusive rights to the territories of the European Union, Canada and the Middle East, SteadyMed said. SteadyMed is a developer […]
Ex-FDA chief Hamburg moves to Institute of Medicine | Personnel Moves
Dr. Margaret Hamburg, who resigned as FDA commissioner in February, was named foreign secretary of the U.S. Institute of Medicine this week.
Hamburg spent 6 years leading the federal safety watchdog, overseeing a massive revamp of its medical device, drug, food and tobacco regulation.
CRM: BSX’s gain is STJ’s loss | Medtech Wall Street news for the week of March 23, 2015
SteadyMed sets terms for $55m IPO
SteadyMed Therapeutics yesterday set the terms for its pending debut on the public market, saying it plans to float 4.25 million shares at $12 to $14 apiece.
Histogenics appoints a new CEO | Personnel Moves
Histogenics has a new face in the corner office with the appointment of Peter Greenleaf, an AstraZeneca veteran favored by the board for his experience moving products toward commercialization.
The company has its eyes on an end-stage pivotal trial for NeoCart, a device that uses patients’ own cells to regenerate knee cartilage.
Misonix gains 19% on swing to black | Wall Street Beat
Misonix (NSDQ:MSON) shares are up 19% today after the medical device company swung to black ink for its fiscal 4th quarter and full year.
Farmingdale, N.Y.-based Misonix posted profits of $366,000, or 5¢ per share, on sales of $1.7 million for the 12 months ended June 30 – for a 26.7% top-line gain that helped Misonix swing from a $3.5 million loss during its last fiscal year.