Yahoo Finance Pharma Stock Roundup: SNY to Buy Kadmon, New Approvals for AZN & MRK's Drugs
This week Sanofi SNY offered $1.9 billion to buy Kadmon Holdings, which will add the latter’s newly approved drug Rezurock to its portfolio. AstraZeneca’s AZN rare disease drug, Ultomiris, was approved for use in children and adolescents in Europe while Merck’s MRK Keytruda was approved for first-line advanced esophageal cancer in China.
Recap of the Week’s Most Important Stories
Sanofi Offers to Buy Kadmon for $1.9B: Sanofi offered $1.9 billion ($9.50 per share) in an all-cash deal to buy Kadmon Holdings to strengthen its transplant business. The acquisition, if successfully closed, will add Rezurock (belumosudil), Kadmon’s FDA-approved treatment for chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy, to Sanofi’s portfolio. Rezurock was approved by the FDA in July and became available last month.
Sanofi’s investigational BTK inhibitor rilzabrutinib failed to meet its primary or key secondary endpoints in a phase III study evaluating it for treating pemphigus, a rare skin disorder. Rilzabrutinib was added to its portfolio with last year’s acquisition of Principia Biopharma.
AstraZeneca’s Ultomiris Gets Approval in Europe for Use in Kids: The European Commission granted approval to AstraZeneca for expanded use of Ultomiris for use in children and adolescents with paroxysmal nocturnal haemoglobinuria (PNH), an ultra-rare and severe blood disorder. Ultomiris was added to AstraZeneca’s portfolio with the recent acquisition of Alexion. Ultomiris is already approved in the EU for the treatment of adults with PNH. In the United States, it was approved to treat PNH in children (one month of age and older) and adolescents in June.
AstraZeneca’s, PT027, a fixed-dose combination of albuterol and budesonide, showed statistically significant benefits in patients with asthma, in MANDALA and DENALI phase III studies. In the MANDALA study, PT027 significantly reduced the risk of severe exacerbations compared to albuterol in moderate to severe asthma patients when used as a rescue medicine in response to symptoms. In the DENALI study, PT027 significantly improved lung function compared to individual components, albuterol, and budesonide in mild to moderate asthma.
Merck’s Keytruda Gets Approval for Esophageal Cancer in China: Merck’s Keytruda was approved in China as a first-line treatment in combination with chemotherapy for certain patients with locally advanced unresectable or metastatic esophageal or gastroesophageal junction (GEJ) carcinoma. The approval was based on results from the pivotal phase III KEYNOTE-590 study. Keytruda was approved for a similar indication by the FDA in March and in Europe in June.
Bayer’s Chronic Cough Candidate Meets Goal in Phase II: Bayer BAYRY announced data from a phase IIb dose-finding study that showed that its pipeline candidate, eliapixant, significantly decreased cough frequency in patients with refractory chronic cough. The study met its primary efficacy outcome by showing that after 12 weeks of treatment, eliapixant 75 mg twice daily led to a statistically significant reduction in the 24-hour cough count of up to 27% over placebo.
FDA’s Breakthrough Tag for Lilly’s Jardiance for Heart Failure Indication: The FDA granted Breakthrough Therapy designation to Lilly LLY and its partner Boehringer Ingelheim’s diabetes medicines, Jardiance, for treating heart failure with preserved ejection fraction (HFpEF). The designation was based on data from the late-stage study (EMPEROR-Preserved) for the HFpEF indication. Lilly expects to file regulatory submissions for the HFpEF indication later this year. Jardiance was approved for chronic heart failure in people with reduced injection fraction (HFrEF) in the United States and Europe earlier this year based on data from the EMPEROR-Reduced study.
FDA Accepts Pfizer/Myovant Myfembree sNDA for Review: Pfizer PFE and partner Myovant Sciences announced that the FDA has accepted their supplemental new drug application (sNDA) seeking approval of Myfembree (relugolix combination tablet) for a second indication — management of moderate to severe pain associated with endometriosis. The FDA is expected to give its decision on May 6, 2022. The sNDA was based on data from the phase III SPIRIT program and an open-label extension study.
Myfembree was approved for heavy menstrual bleeding associated with uterine fibroids in premenopausal women in May this year. Myovant and Pfizer have a deal to jointly commercialize Myfembree in the United States.
The regulatory authority in the United Kingdom approved Pfizer’s JAK inhibitor pipeline candidate, abrocitinib, for the treatment of adults and adolescents with moderate-to-severe atopic dermatitis (AD). The drug will be marketed by the trade name of Cibinqo. Regulatory applications seeking approval for abrocitinib are under review in the United States and Europe. However, in the United States, the FDA has twice delayed the decision on abrocitinib NDA due to the ongoing review (now completed) of a safety study on Pfizer’s marketed JAK inhibitor medicine, Xeljanz, for rheumatoid arthritis.
The NYSE ARCA Pharmaceutical Index declined 3.8% 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
All the stocks declined in the last five trading sessions. While Lilly declined the most (7.5%) Pfizer recorded the least fall (1.7%).
In the past six months, Pfizer recorded the maximum gain (32.6%) while Merck declined the most (1.1%).
(See the last pharma stock roundup here: New Warning Order by FDA for JAK Drugs, & Pipeline Updates)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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