Credit Suisse analyst Vamil Divan notes that Bristol-Myers (BMY) reported topline data for the Phase 3 CheckMate-214 study of Opdivo + Yervoy in 1st line renal cell carcinoma. For the first two co-primary endpoints in the trial, the results were mixed, with the combination showing an improved objective response rate as compared to Pfizer's (PFE) Sutent but narrowly missing statistical significance on improved progression-free survival, he adds. With the revenue opportunity being pushed out and potentially down due to added competition, the analyst feels modest weakness in Bristol-Myers shares is reasonable, although the actual decline seen seems "a little excessive." Divan reiterates a Neutral rating and $58 price target on Bristol-Myers shares.

BofA lowered the firm's price target on Bristol Myers to $55 from $60 and keeps a Neutral rating on the shares, citing lower revenue and earnings expectations. Shares traded down yesterday despite a "largely in-line 1Q print and reiteration of 2024 guidance," which the firm suspects was due to "a lower quality quarter," the analyst tells investors. While 2024 guidance remains "beatable," the firm believes 2026 could be the trough year given the timing of Inflation Reduction Act impact on Eliquis and the end of Revlimid's authorized generics barrier.

Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has recommended approval of Opdivo, or nivolumab, in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. The European Commission, or EC, which has the authority to approve medicines for the European Union, will now review the CHMP recommendation. The final EC decision is expected in June 2024. The positive CHMP opinion is based on results from a sub-study of the CheckMate -901 trial which were presented at the European Society of Medical Oncology, or ESMO, Congress 2023. In the sub-study, Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy demonstrated statistically significant and clinically meaningful improvements in the primary efficacy endpoints of overall survival and progression-free survival as assessed by Blinded Independent Central Review. With a median follow up of approximately 33 months, treatment with Opdivo in combination with cisplatin and gemcitabine reduced the risk of death by 22%, demonstrating a median OS of 21.7 months versus 18.9 months with cisplatin-gemcitabine alone. Patients receiving Opdivo in combination with cisplatin and gemcitabine had their risk of disease progression or death reduced by 28%, with a median PFS of 7.9 months compared to 7.6 months with cisplatin-gemcitabine alone.

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.

Barclays lowered the firm's price target on Bristol Myers to $43 from $51 and keeps an Equal Weight rating on the shares post the Q1 report. Bristol Myers' growth portfolio continues to fall short of expectations and its messaging suggests trough guidance is less likely post-Inflation Reduction Action pricing disclosures in September, the analyst tells investors in a research note.

Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.  1... To see the rest of the story go to thefly.com. See Story Here

Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.  1... To see the rest of the story go to thefly.com. See Story Here

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.

Check out this morning's top movers from around Wall Street, compiled by The Fly.  UP AFTER EARNINGS... To see the rest of the story go to thefly.com. See Story Here

Reports Q1 revenue $11.9B, consensus $11.46B. "We had a good start to 2024, with revenue growth, important advances in our pipeline and the closure of several strategically important transactions. Our focus remains on strengthening the company's long-term growth profile. As a part of our continued evolution, we're executing a strategic productivity initiative that will allow us to be more agile, drive efficiency across the company, and prioritize investing in opportunities where we see the greatest potential to get the most promising medicines to patients as quickly as possible," said Christopher Boerner, Ph.D., board chair and chief executive officer, Bristol Myers Squibb. "

Notable companies reporting before tomorrow's open, with earnings consensus, include Merck (MRK), consensus $1.87... Caterpillar (CAT), consensus $5.14... Comcast (CMSCA), consensus 99c... Honeywell (HON), consensus $2.17... Bristol-Myers (BMY), consensus ($4.44)... Altria (MO), consensus $1.15... Keurig Dr. Pepper (KDP), consensus 35c... GE Vernova (GEV), consensus (37c)... Royal Caribbean (RCL), consensus $1.33... Tractor Supply (TSCO), consensus $1.72... Mobileye (MBLY), consensus (6c)... Textron (TXT), consensus $1.23... LabCorp (LH), consensus $3.48... Southwest Airlines (LUV), consensus (34c)... American Airlines (AAL), consensus (29c)... Harley-Davidson (HOG), consensus $1.51.