BioXcel Therapeutics Inc. (NASDAQ:BTAI) shares are up during Thursday’s premarket session following positive topline results from a Phase 2 study evaluating BXCL501 for treating opioid withdrawal symptoms.
Cuts Opioid Withdrawal Symptoms
The Phase 2 trial, led by Columbia University, suggested that BXCL501 may be as effective as or superior to BioCorRx Pharmaceuticals Inc.’s lofexidine (Lucemyra) for reducing the symptoms of opioid withdrawal during methadone taper, while having a more convenient dosing regimen.
BXCL501 240 µg BID reduced opioid withdrawal symptoms compared to placebo, as measured by the Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop).
After receiving BXCL501 240 µg, patients experienced a greater than 30% reduction in SOWS-Gossop scores, with peak symptom improvement observed on days 3 and 4.
The reduction in withdrawal symptoms with BXCL501 numerically exceeded that observed with lofexidine 0.54 mg administered four times daily.
The trial indicated that BXCL501 demonstrated a favorable tolerability profile compared to lofexidine, with similar or lower rates of cardiovascular effects.
Pipeline Within Product
The results reinforce BXCL501’s potential as a “pipeline within a product,” suggesting its applicability across multiple indications, including acute agitation associated with bipolar disorder and schizophrenia.
In September 2025, BioXcel Therapeutics released topline exploratory efficacy data from the SERENITY At-Home Pivotal Phase 3 safety trial, which demonstrated that BXCL501 had continued effects and consistent benefit with repeat dosing.
BioXcel Therapeutics Technical Analysis
The stock is currently trading 1.5% above its 20-day simple moving average (SMA) and 5.2% below its 100-day SMA, indicating some short-term strength but longer-term challenges.
Shares have decreased approximately 76% over the past 12 months and are currently positioned closer to their 52-week lows than highs.
The RSI is at 50.00, considered neutral territory, suggesting the stock is neither overbought nor oversold.
Meanwhile, MACD is at 0.10, below its signal line at 0.15, indicating bearish pressure on the stock.
The combination of neutral RSI and bearish MACD suggests mixed momentum.
- Key Resistance: $2.00
- Key Support: $1.50
BTAI Price Action: BioXcel Therapeutics shares were up 17.58% at $1.94 during premarket trading on Thursday, according to Benzinga Pro data.
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