Citi analyst Andrew Baum raised his price target for Bristol-Myers Squibb (BMY) to $78 from $72 saying three developments over the last week have increased the probability of a Pfizer (PFE) takeover to near 65% from 50%. Bristol closed yesterday up $3.64, or 5.6%, to $68.98. First, Bristol's revenue potential in non-small cell lung cancer is partly de-risked through Checkmate-227 tumor mutation burden data, Baum tells investors in a research note. Second, the NKTR-214 development collaboration and equity stake in Nektar Therapeutics (NKTR) could materially increase Bristol's Opdivo market share, the analyst adds. And third, he believes Pfizer's immuno-oncology efforts "are looking increasingly suspect." Bristol-Myers is likely Pfizer's last chance to have a meaningful position in the $50B-plus per annum immuno-oncology market, Baum contends. He reiterates a Buy rating on Bristol shares.

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.

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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.

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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.

Biolojic Design announced that Nektar exercised its license option to develop a program resulting from the companies' research collaboration initiated in 2021. The research collaboration was established to design and test agonistic antibodies targeting tumor necrosis factor receptor type II, a novel, biologically-validated disease target implicated in a wide range of autoimmune diseases that has been difficult to drug with conventional medicines. The antibody program selected for development is designed to modulate the TNFR2 pathway in order to agonize - or activate - T regulatory cells and other anti-inflammatory cell populations, making this a promising approach to stimulating the immune system in ulcerative colitis, multiple sclerosis, vitiligo, and other autoimmune disease states. Under the 2021 research agreement, Nektar has tested antibodies computationally designed by Biolojic Design to precisely agonize the TNFR2 receptor. Following successful preclinical in vitro and in vivo studies, Nektar decided to exercise the license option and has been advancing the program through IND enabling studies since late December, 2023. If the NKTR-0165 candidate proceeds through clinical development, Biolojic Design is entitled to development milestones and sales royalties.