InCarda Therapeutics — which is developing an inhaled paroxysmal atrial fibrillation drug — filed an SEC Form D confirming the sale of more than $35 million in equity. The Newark, Calif.–based drug-device combo company sold nearly $35.3 million since the first sale of the offering occurred on Oct. 20, 2017, according to yesterday’s filing. Get the full […]
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Insulet Q3 earnings beat The Street despite bottom-line slide
Insulet (NSDQ:PODD) shares are rising today on third-quarter results that topped the consensus forecast, despite a dip in profits. The Acton, Mass.–based company posted profits of $852,000, or 1¢ per share, on sales of $192.1 million for the three months ended Sept. 30, for a 48.6% bottom-line slide on sales growth of 27.1%. Adjusted to exclude […]
Log Pharma Packaging launches smart packaging
Log Pharma Packaging said today that it is launching its ActiveGuard Connect smart packaging solutions. ActiveGuard Connect is designed to address the lack of patient adherence to prescription medicine or supplementation of nutraceuticals. It is comprised of an integrated desiccant chamber designed to link and synchronize with a patient’s smartphone. The smart packaging product enables […]
Surmodics shares drop on Q3 earnings, Sundance DCB wins breakthrough FDA nod
Surmodics (NSDQ:SRDX) shares plummeted today despite third-quarter results that topped Wall Street projections. Eden Prairie, Minn.-based Surmodics posted profits of $3.55 million, or 26¢ per share, on sales of $30.8 million for the three months ended Sept. 30, moving from red to black on revenue growth of 33.8% compared with Q3 2018. Adjusted to exclude one-time […]
Intersect ENT’s Q3 beats on sales, misses on earnings
Intersect ENT (NSDQ:XENT) this morning posted wider-than-expected losses but topped the consensus sales estimate with its third-quarter results. Menlo Park, Calif.-based Intersect reported losses of -$12.8 million, or -41¢ per share, on sales of $24.1 million for the three months ended Sept. 30, widening its losses by 69.1% on a -2.5% sales decline compared with […]
Regenxbio pulls trigger on option to license Clearside Biomedical’s SCS Microinjector
Clearside Biomedical (NSDQ:CLSD) said yesterday that Regenxbio (NSDQ:RGNX) exercised its option to license Clearside’s in-office SCS Microinjector for delivering adeno-associated virus (AAV)-based therapeutics in treating wet age-related macular degeneration, diabetic retinopathy and other conditions. The two companies inked the option and licensing deal that they said at the time could be worth more than $130 million on […]
China approves Biotronik’s Orsiro drug-eluting stent
Biotronik said today that China’s National Medical Products Administration approved its Orsiro drug-eluting stent. Orsiro is a cobalt-chromium stent that elutes the drug sirolimus via the Berlin-based company’s Biolute bioabsorbable polymer coating. Biotronik said it plans to have Orsiro on the Chinese market “in the coming months.” “Orsiro will be a valuable addition to our […]
Pixarbio CEO Reynolds convicted in $13m investor fraud case
Pixarbio founder & CEO Frank Reynolds reportedly faces two decades behind bars after a jury yesterday convicted him of defrauding investors of nearly $13 million. Federal authorities arrested Reynolds, longtime friend and Pixarbio employee Jay Herod and PixarBio CIO Kenneth Stromsland in April 2018 on securities fraud charges, claiming they misled investors about the opioid substitute […]
FDA approves expanded indication for Liletta 6-year IUD
Medicines360 and its partner Allergan (NYSE:AGN) said today that the FDA approved Medicines360’s supplemental new drug application to extend the duration use of the Liletta intrauterine device for up to six years. The Liletta levonorgestrel-releasing intrauterine system now has the longest approved duration of use for a hormonal intrauterine device in the U.S., according to a […]
Insulet wins FDA nod for Omnipod with Novo Nordisk’s Fiasp insulin
Insulet (NSDQ:PODD) said last week that it won FDA clearance for the use of Novo Nordisk‘s (NYSE:NVO) Fiasp insulin with the Omnipod insulin management platform. Acton, Mass.-based Insulet said it completed extensive testing to ensure that Fiasp is safe and usable with the Omnipod and Omnipod Dash systems. It’s the first insulin pump in the U.S. […]