Amneal Pharmaceuticals Inc Stock Price, News & Analysis

Amneal Pharmaceuticals (Nasdaq: AMRX) has submitted a Biologics License Application (BLA) to the FDA for a proposed biosimilar to XOLAIR® (omalizumab), developed by Kashiv BioSciences. The submission came earlier than expected for this therapeutic targeting the $4.1 billion U.S. market.

The biosimilar aims to treat moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, food allergies, and chronic spontaneous urticaria. This represents Amneal's potential first-wave entry into the omalizumab market, adding to their portfolio of three marketed biosimilars, with five more launches planned for 2026-2027.

Due to the early submission, Amneal will incur a $22.5 million R&D milestone charge in Q3 2025 instead of Q4, which was already included in their financial guidance.

Amneal Pharmaceuticals (NYSE:AMRX) has received FDA approval for its generic version of bimatoprost ophthalmic solution 0.01%, equivalent to LUMIGAN®. The treatment, indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, represents a significant addition to Amneal's Affordable Medicines portfolio.

The approval covers multiple sizes (2.5 mL, 5 mL and 7.5 mL) of the solution. According to IQVIA® data, the reference product generated approximately $685 million in U.S. annual sales for the 12 months ended July 2025, highlighting substantial market opportunity for Amneal.

Amneal Pharmaceuticals (NYSE:AMRX) has received FDA approval for its sodium oxybate oral solution 500 mg/mL ANDA, referencing Jazz Pharmaceuticals' Xyrem®. The drug is approved for treating cataplexy or excessive daytime sleepiness in narcolepsy patients aged 7 and older.

This approval expands Amneal's Affordable Medicines portfolio, offering a more cost-effective alternative in a market previously dominated by a single manufacturer. The drug addresses a rare neurological condition affecting approximately 150,000 individuals in the United States. Amneal had previously distributed an authorized generic version in limited quantities.

Amneal Pharmaceuticals (NYSE:AMRX) has received FDA approval for risperidone extended-release injectable suspension in multiple dosage strengths (12.5 mg, 25 mg, 37.5 mg, and 50 mg/vial), a generic version of Janssen's Risperdal Consta®. The product, which received Competitive Generic Therapy (CGT) designation with 180-day exclusivity, will be launched in Q4 2025.

The injectable suspension, designed for treating schizophrenia and Bipolar I disorder, demonstrates Amneal's expertise in complex pharmaceuticals, particularly in microsphere formulation and cold-chain manufacturing. The reference product generated approximately $194 million in U.S. annual sales for the 12 months ended July 2025, according to IQVIA®.

Amneal Pharmaceuticals (NASDAQ: AMRX) reported strong Q2 2025 financial results with net revenue of $725 million, up 3% year-over-year, and net income of $22 million. The company achieved notable growth with Adjusted EBITDA of $184 million, a 13% increase, and adjusted diluted EPS of $0.25, up 56% from Q2 2024.

Key highlights include a 23% increase in Specialty net revenue driven by products like CREXONT®, RYTARY®, and UNITHROID®. The company successfully completed a $2.7 billion debt refinancing, extending maturities to 2032 and reducing interest costs. Based on strong performance, Amneal raised its full year 2025 guidance, increasing adjusted EBITDA targets to $665-685 million and adjusted EPS to $0.70-0.75.

[ "Net revenue increased 3% to $725 million year-over-year", "Specialty segment revenue grew 23% driven by key branded products", "Adjusted EBITDA increased 13% to $184 million", "Adjusted diluted EPS grew 56% to $0.25", "Successfully completed $2.7B debt refinancing with extended maturities to 2032", "Raised full year 2025 guidance for adjusted EBITDA and EPS", "Operating cash flow guidance increased to $275-305 million" ]

Amneal Pharmaceuticals (NASDAQ: AMRX) has announced a major refinancing initiative through its subsidiary, Amneal Pharmaceuticals LLC. The company plans to secure $1.8 billion in new seven-year term B loans and is offering $750 million in senior secured notes due 2032.

The proceeds will be used to refinance existing term B loans, repay a portion of outstanding ABL facility borrowings, and cover related expenses. The notes will be guaranteed on a senior secured basis and will have first-priority liens on collateral (except ABL priority collateral) and second-priority liens on ABL priority collateral. The completion of these transactions remains subject to market conditions.

The notes will be offered exclusively to qualified institutional buyers under Rule 144A and non-U.S. persons under Regulation S of the Securities Act.

Amneal Pharmaceuticals (NASDAQ: AMRX) has released preliminary Q2 2025 financial results showing strong performance. The company reported net revenue of $720-730 million, up 3% year-over-year, and Adjusted EBITDA of $180-185 million, increasing approximately 13% from Q2 2024.

Key highlights include improved leverage metrics, with gross leverage decreasing to 3.8x from 4.1x and net leverage reducing to 3.7x from 3.9x. The quarter also marked the FDA approval of Brekiya® autoinjector for migraine treatment and strong uptake of CREXONT®. The company expects to meet or exceed its full-year 2025 guidance and plans to submit a BLA for a proposed XOLAIR® biosimilar in Q4 2025.

Amneal Pharmaceuticals (NASDAQ: AMRX), a global biopharmaceutical company, has scheduled its second quarter 2025 financial results announcement for Tuesday, August 5, 2025, before the market opens. The company will host an audio webcast at 8:30 a.m. ET to discuss the results.

Investors can access the webcast through Amneal's Investor Relations website at investors.amneal.com. For those joining via phone, the U.S. dial-in number is 1 (833) 470-1428 with access code 627786. A replay will be available after the call.

Amneal Pharmaceuticals (Nasdaq: AMRX) announced positive topline results from a Phase 3 clinical trial for ADL-018, a proposed biosimilar to XOLAIR® (omalizumab), developed by Kashiv BioSciences. The study met its primary and secondary endpoints, demonstrating therapeutic equivalence and comparable safety to XOLAIR® in 400 patients with Chronic Idiopathic/Spontaneous Urticaria.

The trial evaluated doses of 150mg or 300mg administered subcutaneously every four weeks over 24 weeks. Amneal holds exclusive U.S. commercialization rights, with a Biologics License Application (BLA) planned for Q4 2025. The biosimilar targets the $3.9 billion U.S. omalizumab market and is part of Amneal's strategy to launch six biosimilars across eight product presentations by 2027.