Piper Jaffray analyst Tyler Van Buren said the topline results presented by Bluebird Bio (BLUE) at ASH from the KarMMa trial are "impressive in these very sick patients" and he believes that the drug is "clearly approvable." However, he also said that the JNJ-4528 Legend data presented by Johnson & Johnson's (JNJ) Janssen "appears very competitive," adding that "we would be remiss if we didn't mention the continued deluge of anti-BCMA antibody data" from competitors including Amgen (AMGN), Bristol-Myers (BMY) and Regeneron (REGN). Van Buren keeps a Neutral rating on Bluebird Bio shares, citing valuation as well as his view on long-term competitive pressures.

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.

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.

Oppenheimer analyst Hartaj Singh raised the firm's price target on Regeneron to $1,175 from $1,125 and keeps an Outperform rating on the shares ahead of the Q1 earnings report on May 2. Oppenheimer believes the areas of focus will be the status and dynamics of the Eylea High Dose launch, questions around the impending Dupixent COPD PDUFA, the status of the two oncology approvals expected in 2024, updates on various pipeline projects in immunology and oncology, and comments on capital allocation and financial planning by the new CFO at the company.

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.

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

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.