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The FDA has accepted a supplemental application to use REVTORPYK for patients with HR+/HER2- breast cancer that also carries a PIK3CA mutation. This mutation is a common driver of cancer growth that can make tumors harder to treat with standard therapies.
This is a key step in broadening the drug's reach. While REVTORPYK is already available for some patients, this expansion would allow Celcuity to target a specific group where its drug, which blocks multiple growth pathways at once, may offer a clear advantage over existing treatments.
Source: GlobeNewsWire
H.C. Wainwright reiterated its Buy rating on Celcuity this week. Other analysts also remain positive on the company's transition to a commercial business, with the average price target across all firms currently sitting at $159. While price targets are just estimates, the consensus suggests analysts believe the stock is worth significantly more than its current price of about $70 as the rollout of REVTORPYK gains traction.
Source: HC Wainwright & Co.
Celcuity reported a loss of $1.21 per share for the third quarter, which was better than the $1.51 loss analysts expected. The big news is that REVTORPYK became commercially available on the final day of the quarter, marking the company's official move from a research firm to one that actually sells medicine.
Early data on the launch is encouraging. Management noted that 78 percent of the top 36 strategic cancer accounts have already prescribed the drug, and 91 percent of patients are covered by health plans that pay for the treatment. For a long-term owner, the focus now shifts from clinical trial results to how quickly the company can turn this early interest into steady revenue.
See the full quarter, and how our tracked metrics did
Source: 8-K filing
In a study of patients with a specific genetic mutation and no liver metastases, those taking a REVTORPYK combination went a median of 21.5 months without their cancer worsening. This was more than double the 9.1 months seen in patients taking alpelisib, a common existing treatment.
These results are important because they provide the clinical evidence doctors need to switch patients to Celcuity's new therapy. By showing it can keep cancer at bay for much longer than the current standard, the company strengthens its case for REVTORPYK becoming a preferred choice for advanced breast cancer.
Source: GlobeNewsWire
Management has a consistent record of setting conservative targets and clearing them by a small margin. This pattern makes their financial forecasts reliable as the company moves into its first full year of sales.
| Expectation | |
|---|---|
| EPS | $-1.05 |
| Revenue | $14M |