After the FDA approved Retacrit, Pfizer's (PFE) biosimilar version of Amgen's (AMGN) Epogen, Morgan Stanley analyst Matthew Harrison said he does not see significant impact to his forecasts due to the news, noting that Amgen has already discounted Epogen net selling price significantly to secure an extended supply agreement with DaVita (DVA). Amgen renegotiated the supply agreement in early 2017 and the vast majority of Epogen volume is from DaVita, added Harrison, who maintains an Overweight rating and $200 price target on Amgen shares.

Amgen announced the imminent submission of a Marketing Authorization Application, or MAA, to the European Medicines Agency, or EMA, for teprotumumab, a fully human monoclonal antibody and targeted inhibitor of the insulin-like growth factor-1 receptor, or IGF-1R, for the treatment of moderate to severe Thyroid Eye Disease, or TED, in adults. TED is a serious, progressive, debilitating and potentially vision-threatening autoimmune disease that can cause proptosis, diplopia, eye pain, redness and swelling.1 If approved, teprotumumab would be the first and only medicine approved for TED in the European Union. The MAA is supported by multiple well-controlled clinical studies - a Phase 2 clinical study NCT01868997, Phase 3 confirmatory clinical study OPTIC NCT03298867, a Phase 4 study NCT04583735, and a Phase 3 clinical trial in Japan OPTIC-J, jRCT2031210453 - providing statistically significant and clinically meaningful improvements across multiple facets of TED, including in proptosis and diplopia, among the 287 total patients studied. Additionally, the studies assessed TED signs and symptoms such as pain, inflammation, redness and functional vision. Clinical improvements were seen in proptosis as early as six weeks, with continued improvement across the 24-week treatment period.2 Teprotumumab has a well-established safety profile.

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.

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.