Amneal Pharmaceuticals, Inc. reports developments across a diversified pharmaceutical business built around Affordable Medicines, Specialty and AvKARE. Its updates commonly cover U.S. launches of complex generics, injectables, biosimilars and other affordable medicines, including respiratory inhalation and ophthalmic products, as well as branded specialty treatments in neurology and endocrinology.
News about AMRX also includes clinical and regulatory disclosures for products such as CREXONT for Parkinson’s disease, financial results, capital-structure updates, material agreements and governance matters. AvKARE-related updates center on distribution of pharmaceuticals and medical products to U.S. federal, retail and institutional customers.
Amneal (Nasdaq: AMRX) reported Q4 2025 net revenue of $814 million and GAAP net income of $35 million (diluted EPS $0.11). Full‑year 2025 net revenue was $3.02 billion with GAAP net income of $72 million and adjusted diluted EPS of $0.83. The company provided 2026 guidance of $3.05–3.15 billion revenue, $720–760 million adjusted EBITDA and $0.93–1.03 adjusted diluted EPS.
The release highlights Specialty growth (CREXONT, UNITHROID), new branded launches, and AvKARE strength, while management reiterated assumptions behind non‑GAAP reconciliations and provided a Feb. 27, 2026 webcast for investors.
Amneal Pharmaceuticals (Nasdaq: AMRX) will be added to the S&P SmallCap 600 Index effective before market open on January 30, 2026. The inclusion reflects the company’s consistent operating and financial performance and places Amneal among select pharma and biotech small-cap peers.
The company said the listing may enhance visibility, broaden its investor base, and is typically associated with increased trading liquidity for affected stocks.
LegalZoom (NASD: LZ) will join the S&P SmallCap 600 effective prior to market open on Feb 2, 2026, as S&P Dow Jones Indices adjusts both the S&P MidCap 400 and S&P SmallCap 600.
Multiple additions and deletions occur on Jan 30, 2026 and Feb 2, 2026, including TTM Technologies, Dutch Bros, Advanced Energy Industries, American Healthcare REIT, and corresponding deletions tied to pending mergers and a liquidation.
Amneal (NASDAQ: AMRX) will report its fourth quarter and full year 2025 financial results on Friday, February 27, 2026, before market open. The company will host an audio webcast at 8:30 a.m. ET and post results and the live webcast via the Investor Relations website.
Investors can register for the webcast on the company IR site or join by conference line at 1 (833) 470-1428 (U.S.) using access code 937407; international toll-free numbers and a replay will be posted after the call.
KeifeRx announced a research collaboration and option agreement with Amneal Pharmaceuticals (AMRX) to support pre-IND development of KFRX06, a brain-penetrant LRRK2 inhibitor candidate for Parkinson’s disease. KeifeRx will run a research program to generate key pre-IND outputs to help Amneal evaluate KFRX06 and inform potential next-stage development and commercialization. Financial terms were not disclosed. The agreement frames a structured path for possible future development, leveraging Amneal’s Parkinson’s disease franchise and development, manufacturing, and commercialization capabilities.
Amneal (NASDAQ: AMRX) announced FDA approval of two denosumab biosimilars: Boncresa (denosumab-mobz) referencing Prolia and Oziltus (denosumab-mobz) referencing XGEVA, dated Dec 22, 2025.
Under the Amneal–mAbxience partnership, mAbxience handles development and manufacturing while Amneal holds exclusive U.S. commercialization rights. The company expects to commercialize six biosimilars across eight presentations by 2027. IQVIA reports combined U.S. annual sales for Prolia and XGEVA of approximately $5.3 billion for the 12 months ended Oct 2025.
Amneal (Nasdaq: AMRX) announced U.S. FDA approval of epinephrine injection USP 1 mg/mL in both single-dose (1 mL) and multi-dose (30 mL) vials for hospitals and acute care settings, dated Dec 9, 2025. The approval expands Amneal’s institutional injectables portfolio and targets emergency and perioperative use including treatment of anaphylaxis and septic-shock–related hypotension.
The release notes common adverse reactions and references prescribing information; IQVIA U.S. annual sales for single- and multi-dose epinephrine vials were ~$118 million for the 12 months ended October 2025.
Amneal (NASDAQ: AMRX) reported positive interim Phase 4 ELEVATE-PD results for CREXONT (carbidopa/levodopa extended-release) from the first 55 patients after six weeks.
Key metrics: Good On time increased +3.13 hours (from IR CD/LD), +2.31 hours (IR CD/LD+COMT), +1.80 hours (Rytary); Off time reduced −2.83, −2.36, and −2.57 hours respectively; MDS-UPDRS total score improved −14.2, −4.1, and −13.9 points respectively. Good On time per dose also rose across cohorts.
Safety: TEAEs were generally mild-to-moderate; common events ≥3%: nausea 5.5%, falls 3.6%, dizziness 3.6%, UTI 3.6%. Longer-term and patient-reported outcomes will be presented in 2026.
Amneal (Nasdaq: AMRX) announced executives will participate in two investor conferences and that presentations will be webcast. Chirag Patel, Co‑Chief Executive and President, and Tasos Konidaris, Chief Financial Officer, will join the Piper Sandler 2025 Healthcare Conference for a fireside chat on December 3, 2025 at 9:30 AM EST in New York. They will also present at the J.P. Morgan 2026 Healthcare Conference on January 13, 2026 at 4:30 PM PST in San Francisco. A webcast and limited-time replays will be available on Amneal's Investor Relations site.
Amneal (Nasdaq: AMRX) announced U.S. FDA approval of its albuterol sulfate inhalation aerosol (90 mcg/actuation), the generic equivalent of PROAIR HFA, on December 2, 2025. This approval follows Amneal's recent FDA approval of a beclomethasone dipropionate inhalation aerosol (generic QVAR) and represents the company's second complex respiratory therapeutic approval in Q4 2025.
The company highlighted its respiratory manufacturing platform and positioned these approvals as advancing a differentiated, high‑value respiratory portfolio. IQVIA U.S. annual sales for albuterol sulfate inhalation aerosol were reported at approximately $1.5 billion for the 12 months ended September 2025.