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Specifically, the New Drug Application seeks the U.S. approval of olanzapine extended-release injectable suspension (TEV-‘749) to treat adults with schizophrenia with a once-monthly subcutaneous injection.

The NDA is supported by data from the companies’ Phase 3 SOLARIS trial, which demonstrated that patients on TEV-‘749 were not required to undergo post-administration monitoring.

The global trial for schizophrenia patients aged 18 – 64 years also indicated that the safety profile of TEV-‘749 as a once-monthly was in line with currently approved olanzapine versions.

The current long-acting olanzapine formulations are available with an FDA-mandated Risk Evaluation and Mitigation Strategy, which involves a three-hour post-treatment monitoring period, among other requirements.

“For too long, the lack of a viable long-acting olanzapine formulation has limited the options available to these individuals,” said Eric Hughes, chief medical officer of Teva (TEVA). “And we look forward to working with the FDA on the review of this NDA for TEV-‘749 to help address this gap in care.”

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In August 2020, Teva (TEVA) received FDA approval to market a generic version of Korlym, a once-daily oral medication, also known as mifepristone, used to treat a rare condition called Cushing’s syndrome.

The U.S. Court of Appeals for the Federal District issued the ruling on Thursday after Corcept (CORT) appealed a ruling from a New Jersey District Court judge, who determined in 2023 that Teva (TEVA) has not infringed upon the company’s U.S. patents 10,195,214 and 10,842,800.

“Because we see no clear error in the district court’s fact findings regarding direct infringement, we need not and do not reach the additional finding of specific intent to induce infringement,” the appeals court judges wrote.

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The generic drugmaker gained about 6% in the preceding six sessions. Overall, the stock rose 47% last year, compared to the over 16% rise in the broader S&P 500 Index.

TEVA is up 5% over the past one month. The stock closed 2% higher on Wednesday at $33.21.

Looking at Seeking Alpha’s Quant Rating, TEVA has a Hold rating with a score of 3.35 out of 5. The company received an A in the prospect of momentum, while it got an F in the growth factor.

Turning to the Wall Street community, 12 analysts gave TEVA a Buy and above; no one gave the stock a Hold recommendation, and one recommended Sell. Seeking Alpha analysts are also cautious and see the stock as a Hold.

Earlier in the week, Israel-based Teva projected lower-than-expected financials for 2026 and a contraction in its business even as its Q4 2025 results exceeded expectations.

Still, Seeking Alpha analyst Motti Sapir is bullish on the stock.

“Unless the pipeline disappoints, regulators come down hard, or debt stops dropping, I see more upside ahead,” Sapir noted.

Another Seeking Alpha analyst, Robert J. Lake also said TEVA’s “Pivot to Growth” plan under new CEO Richard Francis emphasizes cost savings, divestitures, and a focus on innovative drug development for long-term growth.

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*Other Operating Data Consensus Source: Bloomberg

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Israel-based Teva (TEVA) recorded $17.3B in revenue for 2025 with ~4% YoY growth on a reported basis, marking its third consecutive year of expansion as its key revenue generators, Austedo, Ajovy, and Uzedy, added $3.1B in sales.

Migraine product Ajovy and schizophrenia therapy Uzedy brought in $673M and $191M in sales with 30% and 63% YoY growth in local currency terms, respectively, while Austedo global revenues hit $2.26B with ~34% YoY growth.

Having posted $2.93 of adjusted EPS last year, Teva (TEVA) projects $2.57 – $2.77 of non-GAAP EPS in 2026 on $16.4B – $16.8B of revenue, both of which at the midpoint fell short of $2.77 and $16.99B in the consensus, respectively.

However, the company recorded $4.7B in revenue for the quarter, beating the Street forecasts by $380M with ~11% YoY growth, as Austedo, Ajovy, and Uzedy collectively generated nearly $1B of quarterly sales for the first time.

“In 2025, our Pivot to Growth strategy drove Teva’s third year of consecutive growth, solidifying our transformation into a leading biopharmaceutical company,” CEO Richard Francis remarked.

During the quarter, the company’s non-GAAP gross profit margin and non-GAAP operating margin reached 60.3% and 32.5%, compared to 54.8% and 27.6% in the prior year period, respectively, while its adjusted EPS improved ~35% YoY to $0.96, exceeding the consensus by $0.32.

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South Carolina-based drug wholesaler Smith Drug filed the suit in the U.S. District Court for the Eastern District of New York, alleging that if not for the Novo (NVO)–Teva (TEVA) deal, generics against Victoza would have been available in the market since 2023.

In 2024, Teva (TEVA) launched the first generic version of Victoza, Novo’s (NVO) first-generation GLP-1, which had amassed $1.7B in annual sales as of April of that year.

While the lawsuit didn’t name the Israel-based drugmaker as a defendant, it alleged that Novo illegally paid to delay Teva’s (TEVA) generic under a 2019 settlement that resolved a patent dispute between the two companies.

According to Reuters, the suit seeks an unspecified amount of monetary damages for a proposed class of Victoza buyers.

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