BAKER BROS. ADVISORS LP sold $317.8M of CELC (indirect holdings)

Celcuity (CELC) reported a net loss of $78.9M in Q2 2026, up from $45.3M in Q2 2025, due to commercial expansion. The company submitted an sNDA for REVTORPYK in HR+/HER2- breast cancer with PIK3CA mutation, following its initial approval. The drug showed superior efficacy in trials, with a median PFS of 11.1 months compared to 5.6 months for the standard treatment. Celcuity has $754M in cash but faces high short interest and debt concerns.

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) submitted a supplemental New Drug Application to the FDA for REVTORPYK, an investigational therapy for advanced breast cancer with a PIK3CA mutation. The application is supported by Phase 3 trial data showing significant improvements in progression-free survival and response rates. If approved, REVTORPYK would be the first therapy of its kind for this patient population. CELC stock closed at $92.27, up 1.63%.

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.