Celcuity Submits SNDA To FDA For REVTORPYK In Advanced Breast Cancer

Celcuity (CELC) stock rose 2.9% pre-market after JPMorgan initiated coverage with an Overweight rating and $157 price target, citing Revtorpyk's commercial potential. JPMorgan's revenue estimates are conservative. Other analysts have higher targets. The FDA supplemental NDA submission could expand Revtorpyk's market. The broader market is up, boosting growth and healthcare names.

Celcuity Inc. (CELC) submitted an sNDA for REVTORPYK (gedatolisib) to treat HR+/HER2- advanced breast cancer with PIK3CA mutations, based on positive Phase 3 trial data. If approved, it would be the first therapy targeting all class I PI3K isoforms and both mTOR complexes. The company projects $817.9M revenue and $267.5M earnings by 2029, up from current losses. The sNDA builds on the July 2026 approval for non-mutant cases, potentially expanding market reach.

Celcuity (CELC) submitted a supplemental New Drug Application to the FDA for REVTORPYK to treat advanced breast cancer with PIK3CA mutations. The filing is supported by Phase 3 trial results showing improved progression-free survival. If approved, REVTORPYK could become the first therapy for this indication, potentially expanding Celcuity's market. Management estimates a US$5b to US$6b addressable market and potential peak revenue of US$2.5b to US$3b for gedatolisib in this setting.

Celcuity Inc. (CELC) reported a net loss of $78.86 million in Q2 2026, with first-half losses widening to $131.71 million. The company is advancing gedatolisib and preparing for commercialization, with FDA approval of REVTORPYK in July. Investors focus on whether REVTORPYK revenue can offset increased cash burn. Celcuity projects $817.9 million revenue and $267.5 million earnings by 2029, implying a 77% upside from current prices.

Celcuity Inc. (CELC) shares fell 26% after reporting trial results for gedatolisib in advanced breast cancer. The drug showed reduced disease progression but had treatment-related deaths. The company plans FDA filings based on these results and an upcoming decision in July.

Celcuity (CELC) reported Q2 2026 net loss of $78.9M ($1.44/ share), up from $45.3M last year. Cash reserves total $754M, with $557.2M raised from a convertible note offering. The company launched Revtopik, a drug for advanced breast cancer, and plans a supplemental New Drug Application. Clinical trials showed significant reduction in disease progression risk. Management expects cash to fund operations into 2029.