NO PROMISES BUT THIS COULD BE A HUGE SCORE FOR US.-- A--->Reata sinks after STAT reports Billy Dunn leaving FDA 11:21 RETA B---->FDA PDUFA Date for Reata Pharmaceutical's Omaveloxolone is February 28, 2023 17:56 C-Goldman maintains Buy rating on Reata after report of Dunn leaving FDA 13:42 RETA
FRIDAY GOLDMAN-- Reata Pharmaceuticals price target raised to $117 from $115 at Goldman Sachs 11:08 RETA Goldman Sachs analyst Madhu Kumar raised the firm's price target on Reata Pharmaceuticals to $117 from $115 and keeps a Buy rating on the shares after updating its model to reflect the 10-K for FY22 results. The primary focus remains the PDUFA date for Reata's omaveloxolone for Friedreich's ataxia, or FA, coming up on February 28, said the firm, which models peak risk-adjusted sales of $2.8B with an 80% view on the odds of success.
SO GOLDMAN RECENTLY UPGRADED A BIT BUT HELD THE LINE TODAY IN VIEW OF THE NEWS AND SELL OFF. OPPORTUNITY> Reata Pharmaceuticals, Inc. (RETA) NasdaqGM - NasdaqGM Real Time Price. 31.26-13.24(-29.76%) As of 01:55PM EST.
Reata Stock Plummets As Official's Exit Shakes Up FDA's Neuroscience Unit Licensing 01:34 PM ET 02/27/2023 The Food and Drug Administration will decide whether to approve a neurological disease drug fromReata Pharmaceuticals(RETA) this week, but RETA stock plummeted Monday. 0 of 30 secondsVolume 0% The RETA stock dive comes in lockstep with news that Bill Dunn, who directs the FDA's Office of Neuroscience, will retire from the agency immediately. Dunn's office is in charge of reviewing neurological drugs like Reata's Friedreich's ataxia treatment, omaveloxolone. According to an internal email the FDA shared with Investor's Business Daily, Dunn will "explore other opportunities while continuing his focus on improving the lives of patients with neurological diseases." He will be succeeded by Teresa Buracchio. Buracchio has been the acting deputy director of the Office of Neuroscience since November. It's unclear what impact Dunn's departure will have on upcoming drug reviews, including Reata's, which is set for Tuesday. But in afternoon trading on today's stock market, RETA stock tumbled 34.2% near 29.30. Shares opened at 45.19 before Dunn's retirement announcement. RETA Stock: Approval In Question Ahead of a recent FDA meeting to discuss Amylyx Pharmaceuticals' (AMLX) now approved amyotrophic lateral sclerosis drug, Relyvrio, Buracchio noted "it is of vital importance and it is legally required for FDA to ensure that drugs are both effective and safe," SVB Securities analyst Joseph Schwartz said in a note to clients. This "may indicate that she could hold omaveloxolone to a fairly high standard, if she is indeed responsible for Reata's (review) decision tomorrow," Schwartz said. "We view the timing of Dunn's departure as curious; however, we also note given the proximity to the (review), the decision for omaveloxolone has likely already been made." He sees the decision as a coin flip and assigns a 50% chance omaveloxolone will gain approval and kept his market perform rating on RETA stock.
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