After Celgene Europe (BMY) announced the decision to withdraw its marketing authorization application, or MAA, for Idhifa for the treatment of relapsed/refractory AML to the EMA, JPMorgan analyst Anupam Rama said there could be some incremental volatility today for Agios (AGIO) on the back of this update. He connected with Agios, which currently receives royalty payments from Idhifa sales from Celgene, and his understanding is that Celgene decided to withdraw the MAA primarily because the single-arm, phase 1 trial did not fully address the major objections raised by the CHMP to support a positive benefit-risk assessment in the proposed R/R indication. The company plans to assess resubmission once the phase 3 IDHENTIFY trial is complete, said Rama. While he does see potential risk to the ongoing Tibsovo review in the EU, given it was also filed based on a single-arm study, his sense from talking to Agios is that there was increased focus on historical control aspect of the Tibsovo filing. The focus for Agios in the near-to-intermediate term is on mitapivat, for which there are important clinical catalysts in 2020, said Rama, who reiterated his Overweight rating on Agios 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.

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

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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.