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Fly News Breaks for December 18, 2019
PFE, SLDB, SRPT
Dec 18, 2019 | 11:54 EDT
JMP Securities analyst Liisa Bayko's key takeaway from Solid Biosciences' (SLDB) SGT-001 biomarker data is that there are sufficient expression of micro-dystrophin based on the theoretical hurdle of 10%, although lower than the bar set by Pfizer (PFE) and Sarepta Therapeutics (SRPT). Despite the trial still being on clinical hold, the data keeps Solid Biosciences "in the race," Bayko tells investors in a research note. The analyst continues to recommend Sarepta shares with SRP-9001 appearing to have the highest micro-dystrophin expression. She keeps an Outperform rating on the name with a $280 price target. She cautions, however, that Pfizer is also expected to start a Phase 3 trial next year and manufacturing capacity is an "overhand for all three players."
News For SRPT;SLDB;PFE From the Last 2 Days
PFE
Apr 26, 2024 | 06:48 EDT
Pfizer announced that the FDA has approved BEQVE, or fidanacogene elaparvovec-dzkt, for the treatment of adults with moderate to severe hemophilia B who currently use factor IX, or FIX, prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes, and do not have neutralizing antibodies to adeno-associated virus serotype Rh74var, or AAVRh74var, capsid as detected by an FDA-approved test. BEQVEZ is a one-time treatment that is designed to enable people living with hemophilia B to produce FIX themselves rather than the current standard of care, which requires regular intravenous infusions of FIX that are often administered multiple times a week or multiple times a month. Hemophilia B is a rare genetic bleeding disorder that prevents normal blood clotting because of a deficiency in FIX that causes those with the disease to bleed more frequently and longer than others. With BEQVEZ now approved for use, Pfizer is launching an innovative warranty program based on durability of patient response to treatment. The goal of the warranty is to provide greater certainty to payers, maximize access for eligible patients who receive BEQVEZ, and offer financial protection by insuring against the risk of efficacy failure. BEQVEZ is currently under review with the European Medicines Agency, and the treatment recently received regulatory approval in Canada.
PFE
Apr 25, 2024 | 10:25 EDT
Bullish option flow detected in Pfizer with 50,393 calls trading, 2x expected, and implied vol increasing over 2 points to 28.83%. Sep-24 27.5 calls and Mar-25 42.5 calls are the most active options, with total volume in those strikes near 27,600 contracts. The Put/Call Ratio is 0.21. Earnings are expected on May 1st.