Laidlaw & co reiterates Buy rating on kazia therapeutics (KZIA). This afternoon, one of KZIA's competitors, CELC, reported that the FDA has approved Revtorpyk (gedatolisib) in combination with fulvestrant, with or without palbociclib, for treating HR+/HER2- locally advanced or metastatic breast cancer without PIK3CA mutation following progression on or after treatment with at least one line of endocrine therapy. Its takeaway is the major readthrough from Revtorpyk approval is since the MOA of paxalisib also targets PI3K and mTOR, this potentially could further de-risk paxalisib clinical development, especially in HR+/HER2- BC. Since TNBC is the initial indication target for paxalisib, Revtorpyk approval will likely have very limited impact on paxalisib's near-term commercial opportunity. Revtorpyk's approval as a second-plus line therapy is based on robust gedatolisib combination in HR+/HER2- breast cancer Phase III (VIKTORIA-1) trial results. Revtorpyk is dosed at 180mg delivered via IV once weekly on days 1, 8, and 15 of a 28-day cycle with fulvestrant + palbociclib. CELC plans to launch Revtorpyk in late 3Q26, and also seek approval for Revtorpyk in PIK3CA mutated patients. As a reminder, the ongoing paxalisib in TNBC Phase I study size has increased to 36 from the initial 12 with updates expected later in 2026, which could include potential reporting at the SABCS meeting (12/8-12/2026). Besides TNBC, HR+/HER2- and BRACm BC patients are also being explored in the current study. The approval of Revtorpyk is overall positive for KZIA since the major readthrough is it should bode well for the potential of paxalisib development since both share a general MOA by targeting PI3K and mTOR. This could be particularly true as paxalisib also is exploring the opportunity of HR+/HER2- BC besides TNBC. Revtorpyk is the third approved PI3K-based HR+/HER2 breast cancer treatment. Laidlaw & Co. is reiterating its Buy rating and $25 target price.

The FDA has approved Celcuity's REVTORPYK (gedatolisib) for treating hormone receptor positive, HER2-negative, locally advanced or metastatic breast cancer without PIK3CA mutations in patients who have progressed after at least one line of endocrine therapy. REVTORPYK is the first FDA-approved therapy that inhibits all class I PI3K isoforms and mTOR complexes mTORC1 and mTORC2. In the Phase 3 VIKTORIA-1 trial, REVTORPYK combined with palbociclib and fulvestrant reduced the risk of disease progression or death by 76% compared to fulvestrant alone. When combined only with fulvestrant, it reduced the risk by 67%. HR+/HER2- breast cancer represents approximately 70% of all breast cancers, with around 60% of these cases having PIK3CA wild-type disease. The approval addresses what CEO Brian Sullivan called a "20-year challenge" in comprehensively inhibiting the PI3K/AKT/mTOR pathway.

With FDA approval for its breast cancer blockbuster hopeful, Celcuity could 'belong in the hands' of a Big Pharma. The FDA has approved a new small molecule inhibitor from Celcuity with blockbuster potential that could become a new standard of care for patients with breast cancer. The regulator is allowing Celcuity to market gedatolisib, now called Revtorpyk, for previously treated patients with hormone receptor-positive, HER2-negative breast cancer without any mutations in the PIK3CA gene. Revtorpyk is used in combination with fulvestrant and with or without Pfizer's Ibrance (palbociclib). The company is also developing the drug for patients with PIK3CA mutations and plans to file a supplemental application with the FDA in the third quarter of this year. Speaking to Fierce ahead of the approval, Celcuity CEO Brian Sullivan said the company hopes Revtorpyk can grant these patients "more time to feel like the disease is under control" so they can maintain "some semblance of a normal life." Announcement of the approval sent Celcuity's share price on a quick spike to a closing value of $111.05, up from its previous close of $103.79. "There's a potential it could be a very big drug," Andrew Berens, M.D., an analyst with Leerink Partners, told Fierce ahead of the announcement. "The efficacy is there, [and] the community docs, where a lot of these patients are treated, seem very receptive." "For patients with HR+/HER2- locally advanced or metastatic breast cancer, there is an urgent need for new treatment options that can meaningfully increase the likelihood of survival without disease progression or death," Sara Hurvitz, M.D., a medical oncologist at Fred Hutchinson Cancer Center and co-lead investigator of Revtorpyk's pivotal trial, said in a statement Tuesday. "Oncologists now have an effective new treatment option for these patients." Celcuity already has a sales force and commercial organization ready to go, Sullivan said, with pricing details still to come. "We are committed to making gedatolisib available to as many patients as possible and plan to have a patient assistance program in place," the CEO said. For Revtorpyk to achieve its full potential, it will need to garner subsequent FDA nods not only in first-line breast cancer but also in prostate cancer, where it's currently being tested in a phase 1/2 trial. Becoming the standard in breast and prostate cancer is tricky, Berens told Fierce. FIERCE PHARMA WEEK 2026 Are you an early-career PHARMA or biotech professional? Sept 14-17, 2026 | Pennsylvania Convention Center Your chance to become a 2026 Fierce Pharma Week Rising Star ends July 31. Ready to shine? Apply Today "Breast and prostate both have options, so the bar is higher," he said. That bar is higher still for an intravenous drug like Revtorpyk, which requires patients to regularly travel to an infusion center for treatment. Eventually, first-line patients "could be on the drug for four years," Berens said. "Think about someone going into the doctor's office once a week, three times a month." Celcuity's Sullivan said the biotech is developing an injectable form of gedatolisib, which he noted would be "particularly important in the first-line patient populations." In terms of efficacy, though, Sullivan has few doubts that his company's first medicine - which he rescued from the back of a Pfizer shelf in 2021 - can perform across indications. Gedatolisib gave patients 48.6 months of progression-free survival in a first-line breast cancer phase 1b study, "an unheard of number in solid tumors, where the standard of care is about 24 months," Sullivan said. And in second-line patients with PIK3CA mutations, gedatolisib trumped Novartis' Piqray in a head-to-head comparison. At June's American Society of Clinical Oncology annual meeting, Sullivan told Fierce that he thinks gedatolisib can anchor Celcuity's efforts to become a $10 billion company. The drug targets all components of an important cancer pathway called PAM, which the CEO pointed out had long been thought undruggable, much like the RAS pathway now being revolutionized by Revolution Medicines. "This pathway is intrinsically involved in this disease process, because it regulates the glycolic uptake of these cells," Sullivan said. "It's essentially regulating the power plant of tumor cells. If you can disrupt that, shut that activity down, and then you can have an outsized effect." But unlike RevMed, Celcuity doesn't have any other known drug candidates in its pipeline. "We've essentially combined several drugs in one," Sullivan explained, because gedatolisib hits all the main components of its targeted pathway. "That's what makes it such a unique molecule." To diversify its pipeline would require looking at other pathways that could be inhibited in combination with PAM, Sullivan said, though the CEO "can't really commit to anything" at the moment. Without a clear pipeline established, but with a potential multibillion-dollar blockbuster now set to hit the market, Leerink's Berens sees Celcuity more as an acquisition target than a potential new standalone pharma dynamo. "Any company that's going to have multi-blockbuster revenues before the end of the decade is a strategic target for large pharma," Berens said. "If this launch goes well, the strategic values could be very, very high. My perception is that investors believe this is a company that belongs in the hands of a large pharma company." Let Google know we are your trusted source. Add our editorial as a preferred source in your search results. Resource Center Key considerations for labeling your cell or gene therapy. This white paper outlines key considerations for labeling cell and gene therapies, focusing on cryogenic durability, regulatory compliance, global scalability, and flexible primary/secondary labeling strategies to protect product integrity throughout clinical trials. Cold chain services for clinical trial success. 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