Amneal Pharmaceuticals Inc. (AMRX) shares rose 7.18% in after-hours on Monday, July 19, 2021, and closed at $4.63 per share. Earlier in the morning, AMRX’s stock gained 0.23% to close Monday’s session at $4.32 per share. AMRX shares have fallen 11.11% over the last 12 months, and they have moved down 10.19% in the past week. Over the past three months, the stock has lost 23.94%, while over the past six months, it has shed 10.56%.
Let’s have a look at its recent news and developments.
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FDA approved ANDA for TobraDex
On July 19, 2021, Amneal Pharmaceuticals, Inc received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for the generic version of TobraDex®, which adds another complex ophthalmic product to the generics portfolio.
Dexamethasone and Tobramycin Ophthalmic Suspension 0.3%/0.1% is the generic version of TobraDex®, which is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
Upcoming financial results announcement
Amneal Pharmaceuticals, Inc will release its second-quarter 2021 financial results on Monday, August 9, 2021, before the market opens. The Company will host a conference call and live webcast with the investment community at 8:00 a.m. Eastern Time on August 9, 2021.
FDA accepted marketing application seeking approval for Bevacizumab
On June 17, 2021, the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for Bevacizumab, according to Section 351(k) pathway of the Public Health Service Act, and with a standard review goal date in the second quarter of 2022 according to the BsUFA (Biosimilar User Fee Act).
Amneal Pharmaceuticalsdeveloped biosimilar in collaboration with mAbxience, which is a Spain-based biotechnology company. Bevacizumab is the biosimilar version of Avastin® and when approved will be marketed under the proprietary name AlymsysTM.
FDA approved NDA for Dihydroergotamine (DHE) Autoinjector
On June 7, 2021, Amneal Pharmaceuticals, Inc announced that the Food and Drug Administration recently accepted Amneal’s 505(b)(2) New Drug Application for a newly licensed dihydroergotamine (DHE) prefilled syringe autoinjector and the company said it anticipates a decision by the middle of 2022. If approved, Amneal anticipates a commercial launch in the second half of 2022. Amneal plans to commercialize the product solely in the U.S. market.
Recent financial results announcement
On May 7, 2021, Amneal Pharmaceuticals announced its financial results for the first quarter ended March 31, 2021.
Q1 2021 financial highlights
- Amneal Pharmaceuticals reported net revenue of $493 million in Q1 2021 compared to $499 million in the first quarter of 2020.
- Net income was $7 million in Q1 2021 compared to net income of $115 million in Q1 2020.
- Adjusted EBITDA was $126 million in Q1 2021 compared to $134.4 million in Q1 2020.
The FDA approval of TobraDex was the reason behind AMRX good performance on Monday and it can continue its momentum in the coming days.