Scholar Rock (SRRK) Surges 10.9% on FDA Decision Looming: Is This the Catalyst to Unlock $2B Market Potential?

Summary
• SRRK surges 10.9% to $38.25, hitting a 52-week high of $46.98
• FDA’s Sept. 22 PDUFA date for apitegromab sparks regulatory optimism
• Phase 3 trial data in The Lancet Neurology shows 30.4% of patients achieved ≥3-point HFMSE improvement

Scholar Rock’s stock is trading at its highest level since early 2025 amid mounting anticipation for the FDA’s decision on apitegromab. The biotech’s shares have surged 300% year-to-date, driven by robust clinical data and a $295M cash runway. With a PDUFA date just 19 days away, investors are weighing the risks of a potential manufacturing delay against the drug’s unmet need in SMA. The stock’s intraday range of $34.61 to $38.62 reflects volatile positioning ahead of the regulatory verdict.

FDA Decision and Manufacturing Risk Fuel Volatility
Scholar Rock’s 10.9% intraday gain is directly tied to the FDA’s Sept. 22 PDUFA date for apitegromab, its SMA therapy. Despite a July manufacturing issue at Novo Nordisk’s Bloomington plant—linked to apitegromab’s fill-finish process—the company confirmed the FDA remains on track for the decision. Positive Phase 3 SAPPHIRE trial data, including a 1.8-point mean HFMSE improvement over placebo, has reinforced approval odds. However, investors are hedging against a potential delay, which could trigger a short-term dip but not derail the long-term approval narrative. The stock’s surge reflects optimism that the FDA will prioritize therapeutic need over manufacturing concerns.

Options Playbook: Leveraging Gamma and Theta for High-Volatility Setup
• 200-day MA: 35.59 (above) • RSI: 64.15 (neutral) • MACD: -0.0935 (bullish crossover) • Bollinger Bands: 30.42–34.68 (price at upper band)

SRRK’s technicals suggest a short-term bullish bias, with key support at $36.94 (200D MA) and resistance at $40.00. The stock’s 10.9% intraday gain has pushed it into overbought territory, but the RSI at 64.15 and MACD crossover indicate momentum remains intact. With the FDA decision approaching, options with high gamma and theta are ideal for capitalizing on volatility. Two top picks from the chain are:

• SRRK20251017C35 (Call, $35 strike, Oct 17 expiry):
- IV: 84.14% (high volatility)
- Delta: 0.690 (moderate sensitivity)
- Theta: -0.1034 (rapid time decay)
- Gamma: 0.0451 (strong price sensitivity)
- Turnover: $155,777 (liquid)
- Leverage: 8.06% (moderate)
- Payoff (5% up): $3.13/share
- This call benefits from a 5% price move, with high gamma amplifying gains as the stock approaches $35.

• SRRK20251017C40 (Call, $40 strike, Oct 17 expiry):
- IV: 77.72% (moderate)
- Delta: 0.429 (balanced exposure)
- Theta: -0.0915 (aggressive decay)
- Gamma: 0.0543 (high responsiveness)
- Turnover: $41,725 (active)
- Leverage: 18.47% (high)
- Payoff (5% up): $1.91/share
- This contract offers higher leverage and gamma, ideal for a breakout above $40. If SRRK closes above $40 by Oct 17, the option’s delta could surge to 0.75+, amplifying returns.

Trading View: Aggressive bulls should target SRRK20251017C40 into a $40.00 breakout. Conservative players may use SRRK20251017C35 as a hedge against a post-FDA rally. Watch for a pullback to $36.94 (200D MA) as a potential entry point.

Backtest Scholar Rock Holding Stock Performance
It looks like the event–level back-test engine threw an internal error before it could produce results. The most common reason for this particular stack-trace is that the engine received an empty event list (i.e., the system couldn’t find any days on which SRRK’s intraday high exceeded the previous close by ≥ 11 % between 2022-01-01 and today).Before we decide on the next step, please let me know which of the following you’d like to do:1. Double-check the data and confirm whether any ≥ 11 % intraday-surge days actually exist. 2. Relax the threshold a bit (e.g., ≥ 10 % or ≥ 8 %) to capture more events and then rerun the back-test. 3. Keep the 11 % threshold but switch to a simplified, custom calculation outside the built-in engine (I’d compute the post-event returns over 1/5/10/20 trading days and summarise them for you manually).Just tell me your preference and I’ll proceed accordingly.

FDA Decision in 19 Days: Position for $2B Market Catalyst
Scholar Rock’s 10.9% surge reflects a market pricing in a high-probability FDA approval for apitegromab, despite lingering manufacturing risks. The stock’s technicals and options activity suggest continued volatility ahead, with key levels at $36.94 (support) and $40.00 (resistance). Investors should monitor the Sept. 22 PDUFA date and Novo Nordisk’s manufacturing status. For context, Biogen (BIIB) rose 0.93% today, highlighting biotech sector resilience. Action: Buy SRRK20251017C40 if $40.00 breaks; short-term traders should watch for a $36.94 retest as a potential entry. The FDA decision is the ultimate catalyst—approval could unlock $2B in market potential, while a delay may offer a dip-buy opportunity.