Amneal Pharmaceuticals Inc. (AMRX) shares surged 14.41% in after-hours on Wednesday, August 25, 2021, and closed the daily trading at $6.35. In the regular trading session of Wednesday, AMRX’s stock gained 0.18%. AMRX shares have risen 38.40% over the last 12 months, and they have moved up 11.22% in the past week. Over the past three months, the stock has lost 1.77%, while over the past six months, it has declined 13.50%.

Let’s see what’s going on with the company?

AMRX Topline results of IPX-203

On August 25, 2021, Amneal Pharmaceuticals, Inc (AMRX) reported positive topline results from the pivotal Phase 3 RISE-PD clinical trial that evaluated the novel formulation, IPX-203, in patients with Parkinson’s disease (PD) who have motor fluctuations. The trial met its primary endpoint, demonstrating superior “Good On” time from baseline in hours per day at the end of the 13-week double-blind treatment period with IPX-203 CD/LD extended-release capsules compared with immediate-release CD/LD.

Amneal plans to submit a New Drug Application (NDA) for IPX-203 with the U.S. Food and Drug Administration (FDA) in mid-2022, based on these topline results plus other supportive data.

AMRX latest financial results announcement

On August 09, 2021, Amneal Pharmaceuticals, Inc (AMRX) announced its results for the second quarter ended June 30, 2021.

Q2 2021 financial highlights

• AMRX reported net revenue of $535 million in Q2 2021 compared to $465 million in the second quarter of 2020.
• Selling, general and administrative expenses were $86.15 million in Q2 2021 compared to $81 million in Q2 2020.
• It earned a net income of $15 million in the second quarter of 2021 compared to a net loss of $12 million in the second quarter of 2020.
• Adjusted EBITDA was $151 million in Q2 2021 compared to $101.0 million in the second quarter of 2020.

FY 2021 financial outlook

For FY 2021, the company is expecting

• Net revenue to be in the range of $2.1 billion to $2.2 billion.
• Adjusted EBITDA in the range of $500 million to $540 million.
• Adjusted diluted EPS in the range of $0.70 to $0.85. 

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.

Conclusion

The AMRX stock performed well on Wednesday after the company published the topline results of IPX-203 for Alzheimer disease. It can continue to perform well in the coming trading sessions as well.