FDA Accepts Teva's New Long-Acting Schizophrenia Treatment Application

Teva Pharmaceuticals Industries Ltd (NYSE:TEVA) on Friday announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for olanzapine extended-release injectable suspension.

Potential FDA Approval For Schizophrenia Drug

The marketing application for TEV-‘749 is based on results from the Phase 3 SOLARIS trial, which demonstrated an efficacy and safety profile consistent with currently available olanzapine formulations.

This investigational drug aims to improve treatment adherence for individuals living with schizophrenia, addressing a critical gap in care.

In the SOLARIS trial, TEV-‘749 was administered as a once-monthly subcutaneous injection, showing no evidence for the need for post-injection monitoring, which is typically required for other formulations.

The acceptance of this NDA marks a significant milestone for Teva as it seeks to provide a long-acting option for patients who rely on olanzapine.

TEV-‘749 utilizes SteadyTeq, a copolymer technology proprietary to Medincell that provides a controlled, steady, sustained release of olanzapine.

The company’s other schizophrenia drug, Uzedy (risperidone), generated revenues of $191 million in fiscal 2025, up 63%, above the management expectation of $190 million – $200 million.

Technical Analysis

Currently, the stock is trading 10.5% below its 20-day simple moving average (SMA) and 8.2% below its 100-day SMA, indicating some short-term weakness. Over the past 12 months, shares have increased by 12.4%, and they are currently positioned closer to their 52-week highs than lows.

The RSI is at 50.00, indicating neutral territory, while the MACD is at 0.10, below its signal line at 0.15, suggesting bearish pressure on the stock. The combination of neutral RSI and bearish MACD indicates mixed momentum.

• Key Resistance: $37.00
• Key Support: $32.00

Analyst Consensus & Recent Actions: The stock carries a Buy Rating with an average price target of $34.09. Recent analyst moves include:

• Truist Securities: Buy (Raises Target to $42.00) (Feb. 18)
• Goldman Sachs: Buy (Raises Target to $45.00) (Feb. 9)
• Barclays: Overweight (Raises Target to $38.00) (Jan. 30)

TEVA Price Action: Teva Pharmaceutical Indus shares were down 1.37% at $33.75 during premarket trading on Monday, according to Benzinga Pro data.

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