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Pharma Stock Roundup: JNJ Beats on Q1 Earnings, MRK to Buy RXDX & Other Updates
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This week, J&J (JNJ - Free Report) began the first-quarter earnings season for the drug and biotech sector with strong results. Merck (MRK - Free Report) offered to buy Prometheus Biosciences for around $10.8 billion. The FDA approved AbbVie’s (ABBV - Free Report) Qulipta for chronic migraine indication.
Recap of the Week’s Most Important Stories
J&J Begins Q1 Earnings Season: J&J kickstarted the earnings season for the drug and biotech sector by reporting strong first-quarter results. It beat estimates for earnings as well as sales. All three segments delivered a strong performance in the quarter, with sales rising sequentially over the fourth quarter. The company raised its previously issued financial guidance for 2023. J&J raised its revenue guidance to a range of $97.9 billion to $98.9 billion from $96.9 billion to $97.9 billion. The adjusted earnings per share guidance was raised from a range of $10.45-$10.65 to $10.60-$10.70 per share. J&J also announced a 5.3% increase in the quarterly dividend to $1.19 per share from $1.13 per share.
Merck to Acquire Prometheus Biosciences: Merck announced a definitive agreement to acquire Prometheus Biosciences for $200 per share in cash for a total equity value of approximately $10.8 billion. The deal will add Prometheus’ lead product candidate, PRA023, a humanized monoclonal antibody (mAb). PRA023 is currently being developed in mid-stage studies for the treatment of immune-mediated diseases, including ulcerative colitis (UC), Crohn’s disease (CD) and other autoimmune conditions.
Merck and Moderna announced detailed data from a phase IIb study, which evaluated their personalized cancer vaccine (“PCV”) candidate, mRNA-4157/V940, in patients with stage III/IV melanoma. Earlier data from the study showed that mRNA-4157, when combined with Keytruda led to a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death by 44% compared with Keytruda alone. In the latest data presentation, Moderna and Merck revealed that subsequent to a follow-up period of around two years, 22.4% of patients treated with mRNA-4157/Keytruda combination reported disease recurrence/death compared to 40% in the control arm. Based on a detailed analysis of the above data, management now believes that the mRNA-4157/Keytruda combination has the potential to extend the lives of patients with high-risk melanoma. The companies plan to initiate a phase III study in patients with adjuvant melanoma in 2023.
FDA Approves AbbVie’s Qulipta for Chronic Migraine: The FDA approved AbbVie’s new drug Qulipta (60 mg) for the prevention of chronic migraine in adults. Qulipta is already approved for the preventive treatment of episodic migraine in adults at three different dose levels — 10 mg, 30 mg and 60 mg. With the latest label expansion, Qulipta is now the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent migraine across frequencies, including episodic and chronic migraines. The label-expansion approval is based on data from the phase III PROGRESS study.
The European Commission granted approval to AbbVie’s Rinvoq (upadacitinib – 15 mg and 30 mg) for the treatment of adults with moderately to severely active Crohn's disease. The approval was based on results from two induction studies and one maintenance study. Data from the studies showed that a significantly higher proportion of patients treated with Rinvoq achieved the co-primary endpoints of endoscopic response and clinical remission and the key secondary endpoint of corticosteroid-free clinical remission at weeks 12 and 52 compared to placebo. With the latest approval, Rinvoq is approved for seven indications in the European Union (EU).
The NYSE ARCA Pharmaceutical Index declined 0.93% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: JNJ Beats on Q1 Earnings, MRK to Buy RXDX & Other Updates
This week, J&J (JNJ - Free Report) began the first-quarter earnings season for the drug and biotech sector with strong results. Merck (MRK - Free Report) offered to buy Prometheus Biosciences for around $10.8 billion. The FDA approved AbbVie’s (ABBV - Free Report) Qulipta for chronic migraine indication.
Recap of the Week’s Most Important Stories
J&J Begins Q1 Earnings Season: J&J kickstarted the earnings season for the drug and biotech sector by reporting strong first-quarter results. It beat estimates for earnings as well as sales. All three segments delivered a strong performance in the quarter, with sales rising sequentially over the fourth quarter. The company raised its previously issued financial guidance for 2023. J&J raised its revenue guidance to a range of $97.9 billion to $98.9 billion from $96.9 billion to $97.9 billion. The adjusted earnings per share guidance was raised from a range of $10.45-$10.65 to $10.60-$10.70 per share. J&J also announced a 5.3% increase in the quarterly dividend to $1.19 per share from $1.13 per share.
Merck to Acquire Prometheus Biosciences: Merck announced a definitive agreement to acquire Prometheus Biosciences for $200 per share in cash for a total equity value of approximately $10.8 billion. The deal will add Prometheus’ lead product candidate, PRA023, a humanized monoclonal antibody (mAb). PRA023 is currently being developed in mid-stage studies for the treatment of immune-mediated diseases, including ulcerative colitis (UC), Crohn’s disease (CD) and other autoimmune conditions.
Merck and Moderna announced detailed data from a phase IIb study, which evaluated their personalized cancer vaccine (“PCV”) candidate, mRNA-4157/V940, in patients with stage III/IV melanoma. Earlier data from the study showed that mRNA-4157, when combined with Keytruda led to a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death by 44% compared with Keytruda alone. In the latest data presentation, Moderna and Merck revealed that subsequent to a follow-up period of around two years, 22.4% of patients treated with mRNA-4157/Keytruda combination reported disease recurrence/death compared to 40% in the control arm. Based on a detailed analysis of the above data, management now believes that the mRNA-4157/Keytruda combination has the potential to extend the lives of patients with high-risk melanoma. The companies plan to initiate a phase III study in patients with adjuvant melanoma in 2023.
FDA Approves AbbVie’s Qulipta for Chronic Migraine: The FDA approved AbbVie’s new drug Qulipta (60 mg) for the prevention of chronic migraine in adults. Qulipta is already approved for the preventive treatment of episodic migraine in adults at three different dose levels — 10 mg, 30 mg and 60 mg. With the latest label expansion, Qulipta is now the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent migraine across frequencies, including episodic and chronic migraines. The label-expansion approval is based on data from the phase III PROGRESS study.
The European Commission granted approval to AbbVie’s Rinvoq (upadacitinib – 15 mg and 30 mg) for the treatment of adults with moderately to severely active Crohn's disease. The approval was based on results from two induction studies and one maintenance study. Data from the studies showed that a significantly higher proportion of patients treated with Rinvoq achieved the co-primary endpoints of endoscopic response and clinical remission and the key secondary endpoint of corticosteroid-free clinical remission at weeks 12 and 52 compared to placebo. With the latest approval, Rinvoq is approved for seven indications in the European Union (EU).
The NYSE ARCA Pharmaceutical Index declined 0.93% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here’s how the eight major stocks performed in the last five trading sessions.
Image Source: Zacks Investment Research
In the last five trading sessions, all the stocks were in the red except Novartis (up 0.4%). Pfizer declined the most (3.9%).
In the past six months, AstraZeneca has risen the most (35.1%), while Pfizer has declined the most (12.5%).
(See the last pharma stock roundup here: FDA Rejects LLY’s Mirikizumab, NVO Ups 2023 Sales & Profit View)
What's Next in the Pharma World?
Watch out for the Q1 results of several large drugmakers and regular pipeline and regulatory updates next week.