|Over a week ago|
Fly Intel: Pre-market Movers » 09:2406/0906/09/20
M, TIF, SIG, LOVE, AMPH, IMUX, SLNO
Check out this morning's…
Amphastar receives FDA approval for Succinylcholine Chloride Injection » 06:0606/0906/09/20
Amphastar Pharmaceuticals (AMPH) announces that the U.S. FDA has approved its Abbreviated New Drug Application for Succinylcholine Chloride Injection USP, 200 mg/10 mL Multiple-Dose Vial. Amphastar's newly approved drug product was determined by the FDA to be therapeutically equivalent to Quelicin Multiple-Dose Vial) distributed in the United States by Pfizer (PFE). Succinylcholine Chloride Injection is for intramuscular and intravenous use. It is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
|Over a month ago|
Amphastar reports Q1 adj. EPS 17c, consensus 8c » 16:3005/0705/07/20
Reports Q1 revenue…
Reports Q1 revenue $84.69M, consensus $82.83M. Jack Zhang, Amphastar's president and CEO, commented: "The first quarter of 2020 was very strong for Amphastar, as we had strong sales from Primatene(R) Mist and from our hospital products, including sales of Sodium Bicarbonate, which we filled in our newly approved finished product facility in South El Monte, California."
Fly Intel: Top five analyst initiations » 10:0905/0105/01/20
YMAB, LYFT, FGEN, LUMO, AMPH
Catch up on today's…
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Y-mAbs Therapeutics (YMAB) initiated with a Buy at Janney Montgomery Scott. 2. Lyft (LYFT) coverage resumed with a Buy at Citi. 3. FibroGen (FGEN) initiated with a Market Perform at Cowen. 4. Lumos Pharma (LUMO) initiated with a Buy at Roth Capital. 5. Amphastar (AMPH) initiated with an Outperform at Northland. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
Amphastar initiated with an Outperform at Northland » 08:3305/0105/01/20
Northland analyst Tim…
Northland analyst Tim Chiang initiated coverage of Amphastar Pharmaceuticals with an Outperform rating and $23 price target. The analyst believes the "steady ramp" of Primatene Mist sales in the U.S., along with additional potential approvals and launches within its Amphastar's generic drug pipeline, are potential catalysts for the shares. He points out that Primatene Mist is the only FDA approved over-the-counter inhaler for relief of intermittent asthma symptoms. Further, the company's pipeline includes more than 20 product candidates in the area of generics, biosimilars, and proprietary products, Chiang tells investors in a research note.
Amphastar granted ANDA for Epinephrine Injection by FDA » 06:0304/2704/27/20
Amphastar Pharmaceuticals announces that the FDA has granted approval of its Abbreviated New Drug Application, or ANDA, for Epinephrine Injection, USP 30mg/30mL Multiple Dose Vial. Amphastar's newly approved drug product was determined by the FDA to be therapeutically equivalent to Adrenalin distributed in the U.S. by Par Pharmaceutical, Epinephrine Injection Multiple Dose Vial is for intramuscular, subcutaneous, and intravenous use, and is indicated for emergency treatment of allergic reactions, including anaphylaxis, and to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. Additionally, the FDA granted 180 day exclusivity to Amphastar as the first generic filer. Amphastar plans to launch this Epinephrine Injection Multiple Dose Vial within two to three months.
|Over a quarter ago|
Amphastar currently has seven ANDAs filed with the FDA » 16:3103/1203/12/20
The Company currently has…
The Company currently has seven ANDAs filed with the FDA targeting products with a market size of approximately $1.9 billion, three biosimilar products in development targeting products with a market size of approximately $13 billion, and nine generic products in development targeting products with a market size of approximately $12 billion. This market information is based on IQVIA data for the 12 months ended December 31, 2019. The Company's proprietary pipeline includes a new drug application for intranasal naloxone. The Company is currently developing four other proprietary products, which include injectable and intranasal dosage forms.
Amphastar reports Q4 EPS 7c, consensus 7c » 16:3003/1203/12/20
Reports Q4 revenue…
Reports Q4 revenue $83.4M, consensus $81.79M. Dr. Jack Zhang, Amphastar's Chief Executive Officer, commented: "We finished 2019 with very strong sales of Primatene(R) Mist, with fourth quarter sales essentially equaling sales in the previous three quarters combined. Additionally, we have made great progress with our pipeline of product candidates, as we continue to move forward with clinical trials for both our insulin and inhalation products. In addition, the FDA accepted two more of our ANDAs."
Amphastar receives FDA approval of sNDA for Sodium Bicarbonate Injection » 06:0902/2702/27/20
Amphastar announced that…
Amphastar announced that the U.S. FDA granted approval of its supplemental Abbreviated New Drug Application for Sodium Bicarbonate Injection, USP, 8.4%, 50mEq/50mL Single-Dose Prefilled Syringe. This supplement is for manufacturing the product in the company's new manufacturing line at its International Medication Systems facility.
Gilead, Astellas Pharma sue Amphastar over Lexiscan copies, Bloomberg reports » 08:0602/2602/26/20
GILD, ALPMY, AMPH
Gilead (GILD) and…
Gilead (GILD) and Astellas Pharma (ALPMY) are seeking a court order to block copies of the Lexiscan drug by Amphastar's (AMPH) Internatinal Medication Systems unit, saying the Amphastar unit is infringing three patents, Bloomberg's Christopher Yasiejko reports. Gilead owns the patents and licenses for Lexiscan, which helps doctors detect coronary artery disease, and licenses them exclusively to Astellas, according to the report. Reference Link