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Pharma Stock Roundup: MRK to Buy IMGO, ABBV's Skyrizi Gets EU Nod for New Indication

This week, Merck MRK offered to buy Imago Biosciences IMGO, which is developing drugs to treat bone marrow diseases. The European Commission approved AbbVie’s ABBV immunology medicine, Skyrizi for its third indication, Crohn’s disease, in Europe. GSK GSK has begun the process to withdraw its approved multiple myeloma drug, Blenrep from the U.S. market.

Recap of the Week’s Most Important Stories

Merck to Buy Imago BioSciences: Merck announced a definitive agreement to acquire Imago BioSciences for $36.00 per share in cash for an approximate total equity value of $1.35 billion. The acquisition of Imago Biosciences is expected to strengthen Merck’s hematology portfolio by adding Imago’s lead candidate, bomedemstat. Bomedemstat, an oral LSD1 inhibitor, is being evaluated in multiple mid-stage clinical studies for treating bone marrow diseases like essential thrombocythemia, myelofibrosis  and polycythemia vera. The transaction is expected to be completed by first-quarter 2023.

Merck’s Keytruda combined with chemotherapy showed statistically significant improvement in overall survival as a first-line treatment of HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma when compared to those who were treated with chemotherapy alone. Patients who were administered Keytruda plus chemotherapy also showed meaningful improvements in progression-free survival and overall response rate. Keytruda is already approved in combination with Roche’s Herceptin (trastuzumab) and chemotherapy under the accelerated pathway for first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma based on data from the phase III KEYNOTE-811 study.

AbbVie’s Skyrizi Gets EU Nod for Crohn’s Disease: The European Commission approved AbbVie’s Skyrizi (risankizumab) to treat moderate-to-severe Crohn’s disease (“CD”). CD is the third approved indication for Skyrizi in Europe. In the United States, Skyrizi was approved for CD in June. Skyrizi is already approved in the European Union, the United States and some other countries for two other indications — plaque psoriasis and active psoriatic arthritis.

The FDA accepted and granted priority review to AbbVie and partner Genmab’s biologics license application (BLA) seeking approval for epcoritamab for the treatment of relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. In the EU too, a marketing authorization application seeking approval for epcoritamab for relapsed/refractory diffuse large B-cell lymphoma — a major subtype of LBCL — after two or more lines of systemic therapy, was validated by the European Medicines Agency in October. The BLA is supported by data from the LBCL cohort of phase I/II study, EPCORE NHL-1 evaluating subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell NHL, including LBCL.

GSK to End Sales of Blenrep in the United States: GSK said it has begun the process to withdraw the U.S. marketing authorization for Blenrep after the FDA’s request, which came following the failure of the phase III confirmatory study, DREAMM-3 on Blenrep. As a result of the withdrawal, GSK will stop selling Blenrep in the U.S. market.

Blenrep (belantamab mafatotin) was granted accelerated approval as a monotherapy for relapsed or refractory multiple myeloma (RRMM) patients who have received at leastfour prior therapies in 2020 based on the overall response rate results of the DREAMM-2 study. The final approval was contingent upon a confirmed clinical benefit from a randomized phase III study. However, in November, GSK announced that the DREAMM-3 study on Blenrep in patients with RRMM failed to meet its primary endpoint of PFS. GSK said additional trials within the DREAMM clinical trial program would continue. Data from DREAMM-7 and DREAMM-8 phase III studies are expected in the first half of 2023.

The NYSE ARCA Pharmaceutical Index rose 3.29% in the last five trading sessions.

Large Cap Pharmaceuticals Industry 5YR % Return

Large Cap Pharmaceuticals Industry 5YR % Return
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.

Zacks Investment Research
Zacks Investment Research

Image Source: Zacks Investment Research

In the last five trading sessions, Merck gained the most (2.4%), while Roche declined the most (2.0%).

In the past six months, Merck has gained the highest (15.7%), while Pfizer declined the most (9.5%).

(See the last pharma stock roundup here: RHHBY’s Alzheimer Study Failure, EU Nod for SNY’s Enjaymo)

What's Next in the Pharma World?

Watch out for regular pipeline and regulatory updates next week.

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