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Goldman Sachs analyst… Goldman Sachs analyst Salveen Richter downgraded Reata Pharmaceuticals to Neutral from Buy with a price target of $39, down from $244, following the unanimous negative vote from an FDA panel with respect to the risk-benefit profile of the company's lead drug bardoxolone in patients with Alport syndrome. The analyst sees negative implications for the Phase 3 program of bardoxolone in autosomal dominant polycystic kidney disease, Reata's "key value driver," but notes its second drug omaveloxolone in Friedreich's ataxia "provides a valuation floor." | ||||
Cantor Fitzgerald analyst… Cantor Fitzgerald analyst Charles Duncan lowered the firm's price target on Reata Pharmaceuticals to $68 from $112 and keeps an Overweight rating on the shares. On December 8, the FDA hosted an advisory committee meeting to discuss Reata's NDA submission for bardoxolone for the treatment of Alport syndrome. With the committee's 13 members unanimously voting "no" on the question of whether "the provided evidence demonstrate that bardoxolone methyl is effective in slowing the progression of chronic kidney disease in Alport syndrome and that its benefits outweigh its risks," Duncan believes the likelihood of a positive review by/on the February 25, 2022 PDUFA target action date has been reduced to near-zero, the analyst tells investors in a research note. | ||||
Baird analyst Brian… Baird analyst Brian Skorney downgraded Reata Pharmaceuticals to Neutral from Outperform with a price target of $37, down from $110. The FDA panel discounted all of Reata's arguments, "leaving almost zero chance" of bardoxolone approval based on the CARDINAL study, Skorney tells investors in a research note. There may be ways to salvage this indication without another multi-year study, but "these are long shots" given the FDA's posture towards bardoxolone, says the analyst. Skorney sees a "multitude of questions" following the FDA review and Reata's relationship with the agency. | ||||
Barclays analyst Carter… Barclays analyst Carter Gould lowered the firm's price target on Reata Pharmaceuticals to $43 from $180 and keeps an Overweight rating on the shares. The negative FDA panel votes "leaves little hope" for bardoxolone methyl, Gould tells investors in a research note. | ||||
SVB Leerink analyst… SVB Leerink analyst Joseph Schwartz downgraded Reata Pharmaceuticals to Market Perform from Outperform with a $35 price target. | |
Baird analyst Brian… Baird analyst Brian Skorney downgraded Reata Pharmaceuticals to Neutral from Outperform with a price target of $37, down from $110. | |
Shares of Reata… Shares of Reata Pharmaceuticals are down 35% afterhours at $35.50 after the stock resumed trading following its announced outcome of FDA AdCom meeting on bardoxolone. The company had stated that the Advisory Committee voted NO on the question of whether the provided evidence demonstrated that bardoxolone is effective in slowing the progression of CKD in patients with Alport syndrome and that its benefits outweigh its risks. | |
Reata Pharmaceuticals… Reata Pharmaceuticals announced the outcome of the U.S. FDA Cardiovascular and Renal Drugs Advisory Committee meeting on bardoxolone methyl for the treatment of patients with chronic kidney disease caused by Alport syndrome. The Committee voted no on the question of whether the provided evidence demonstrated that bardoxolone is effective in slowing the progression of CKD in patients with Alport syndrome and that its benefits outweigh its risks. "We are disappointed with today's outcome of the Committee's vote regarding bardoxolone, an investigational drug with a novel mechanism of action," said Warren Huff, Reata's President and CEO. "We believe the scientific evidence supports bardoxolone approval in the U.S. for CKD in patients with Alport syndrome, which is one of the most rapidly progressive forms of CKD. We will continue to work with the FDA to answer any questions they may have." While the FDA is not required to follow the committee's vote, the agency considers the committee's recommendations when making its decision. Reata will continue to work closely with the agency to provide additional information and data until the upcoming Prescription Drug User-Fee Act date of February 25, 2022. | |
The Committee discusses… The Committee discusses Reata Pharmaceuticals New Drug Application (NDA) 215484, for the Nrf2 activator, bardoxolone methyl capsules which is used to slow the progression of chronic kidney disease caused by Alport syndrome in patients 12 years of age and older in a virtual meeting being held on December 8 at 9:30 am. Webcast Link |
