Celcuity (CELC) | News Based Sentiment Analysis

• On October 1st, Celcuity Inc. experienced significant options trading activity, with 4,290 contracts traded – representing about 50.2% of its average daily volume (854,325 shares). Notably, 3,537 contracts of the $45 strike put option expiring on November 21, 2025, changed hands, coinciding with a 9.21% decline in the stock price that day. This suggests some investors were betting against the stock in the short term.
• Despite the options activity, Celcuity's stock price rebounded strongly on October 3rd, increasing by 9.29% to close at $49.42. This positive movement occurred the same day the FDA accepted Celcuity’s New Drug Application (NDA) for gedatolisib under the Real-Time Oncology Review program, a key regulatory milestone.
• The FDA’s acceptance of the NDA for gedatolisib on October 3rd is a major step towards potential market access for Celcuity’s breast cancer therapy. This acceptance, under the Real-Time Oncology Review program, could accelerate the review process.
• Celcuity currently trades at a price-to-book (P/B) ratio of 47.3x, significantly higher than the U.S. Biotechs industry average of 2.4x and its peer group’s average of 19.4x. While this indicates strong market optimism, a Simply Wall St Discounted Cash Flow (DCF) model estimates Celcuity’s fair value at $308.13 per share, 84% above its last close price of $49.42.
• Needham analyst Gil Blum reiterated a 'Buy' rating for Celcuity on October 3, 2025, maintaining a $70.00 price target. This positive outlook is driven by the anticipated results from the PIK3CA mutant cohort of the VIKTORIA-1 study, with Blum estimating a 55% probability of success, potentially leading to a 10% stock increase and a possible acquisition.
• On October 2nd, Celcuity engaged oncology expert Kathy Miller as a consultant or advisor, with compensation under $10,000 USD for the year. This indicates the company is actively seeking expert input in the oncology field as it progresses towards potential FDA approval.
• Celcuity has demonstrated a one-year total shareholder return of 2.3% as of October 3, 2025, indicating modest growth over the past year.

The Investment Story: October proved to be a pivotal month for Celcuity, marked by a volatile stock price, significant options trading, and a crucial FDA acceptance of its NDA for gedatolisib. The market appears optimistic, as reflected in the high P/B ratio, but a DCF model suggests potential undervaluation.

What It Means for Investors: The FDA’s acceptance of the NDA is a major catalyst, potentially accelerating the path to market for gedatolisib. While the high P/B ratio suggests the stock is already priced for success, the DCF analysis indicates room for further appreciation if the VIKTORIA-1 study delivers positive results. Investors should closely monitor the VIKTORIA-1 study results and any further regulatory updates.

Looking Ahead: Investors should watch for the results of the PIK3CA mutant cohort of the VIKTORIA-1 study, as this is a key driver of the analyst’s $70 price target. The November 21, 2025, expiration date of the significant $45 put option contracts will also be a date to watch for potential volatility.

The Bottom Line: Celcuity is navigating a critical period with the FDA acceptance of its NDA and anticipation of the VIKTORIA-1 study results. The stock presents a high-risk, high-reward opportunity, with significant potential upside if gedatolisib receives approval and the study meets its endpoint, but also downside risk if results are unfavorable.