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Pharma Stock Roundup: FDA Nod to MRK's New Jab & Expanded Use of ABBV & AZN Drugs

This week, the FDA approved Merck’s MRK 21-valent pneumococcal conjugate vaccine, Capvaxive, AbbVie’s ABBV blockbuster drug, Skyrizi for ulcerative colitis, and AstraZeneca’s AZN PD-L1 inhibitor, Imfinzi as a combination therapy for an endometrial cancer indication. J&J JNJ filed an application with the FDA seeking approval of Tremfya for an inflammatory bowel disease (“IBD”), Crohn’s disease (“CD”).

Recap of the Week’s Most Important Stories

FDA Approves Merck’s 21-valent Pneumococcal Conjugate Vaccine: The FDA approved Capvaxive (V116), Merck’s 21-valent pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. Capvaxive became the first PCV specifically designed for adults to be approved by the FDA. It targets serotypes that account for approximately 84% of all invasive pneumococcal disease in older adults (50 years and older) in the United States, including eight serotypes not covered by currently licensed vaccines. Capvaxive’s approval was based on data from four phase III studies conducted across a range of adult populations. In the studies, Capvaxive demonstrated robust immune responses in both vaccine-naïve and vaccine-experienced adult populations.

The FDA also approved Merck’s blockbuster PD-L1 inhibitor Keytruda in combination with chemotherapy (carboplatin and paclitaxel), followed by Keytruda monotherapy for treating adult patients with primary advanced or recurrent endometrial carcinoma regardless of mismatch repair status. The approval is based on data from the phase KEYNOTE-868/NRG-GY018 study. This marks Keytruda’s third indication in endometrial carcinoma. Keytruda is already approved for certain types of advanced endometrial carcinoma as monotherapy and in combination with Eisai’s Lenvima.

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FDA Approves AbbVie’s Skyrizi for Fourth Indication: The FDA approved AbbVie’s Skyrizi for its fourth immune-mediated inflammatory disease indication — moderately to severely active ulcerative colitis (UC) — in the United States. Skyrizi is already approved in the United States and the EU for treating three other immune-mediated inflammatory diseases — plaque psoriasis, psoriatic arthritis, and CD. AbbVie has also applied for Skyrizi’s approval for the UC indication in the EU. Skyrizi’s FDA approval for the UC indication was based on data from two phase III studies, a 12-week induction study, INSPIRE1, and a 52-week maintenance study, COMMAND2. Both studies achieved the primary endpoint of clinical remission. Skyrizi’s approval for the UC indication has strengthened AbbVie’s portfolio across IBD.

FDA Approves Expanded Use of AstraZeneca’s Imfinzi in Endometrial Cancer: The FDA approved the expanded use of AstraZeneca’s Imfinzi (durvalumab) plus chemotherapy in endometrial cancer. With the latest FDA approval, Imfinzi can now be prescribed in combination with carboplatin and paclitaxel (chemotherapy), followed by Imfinzi monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR) advanced or recurrent endometrial cancer. The approval for the expanded use of Imfinzi was based on data from a prespecified exploratory subgroup analysis by MMR status in the phase III DUO-E study.

The three-arm DUO-E study also evaluates Imfinzi plus chemotherapy followed by Imfinzi plus Lynparza as maintenance therapy in advanced or recurrent endometrial cancer. Regulatory applications seeking approval for both Imfinzi as well as Imfinzi and Lynparza regimens are currently under review in Europe, Japan and other countries based on data from the DUO-E study. Imfinzi is presently approved for stage III non-small cell lung cancer, extensive-stage small-cell lung cancer, locally advanced or metastatic biliary tract cancer and in combination with Imjudo in unresectable hepatocellular carcinoma in some countries.

The European Commission approved AstraZeneca’s Truqap (capivasertib), in combination with Faslodex (fulvestrant), for treating advanced ER-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN-alterations following recurrence or progression on or after an endocrine-based regimen. The approval was based on data from the CAPItello-291 study.

Truqap, in combination with Faslodex, was approved in the United States in November 2023 and in Japan in March 2024.

J&J Files Tremfya sBLA for Crohn’s Disease Indication: J&J submitted a supplemental biologics license application (sBLA) seeking approval of Tremfya for a new indication — moderately to severely active Crohn’s disease.

Tremfya, an IL-23 inhibitor, is presently approved to treat certain patients with plaque psoriasis and active psoriatic arthritis in several countries, including the United States and the EU. The sBLA for the CD indication was based on 48-week data from the phase III GALAXI and GRAVITI study. Tremfya is already under review in the United States for the other IBD condition, ulcerative colitis.

J&J’s pivotal phase III GRAVITI study evaluating Tremfya subcutaneous (SC) induction therapy in adult patients with moderately to severely active Crohn’s disease met both co-primary endpoints. The study achieved statistically significant and clinically meaningful outcomes for clinical remission at Week 12 as well as endoscopic response at Week 12. The GRAVITI study with the SC induction therapy of Tremfya showed a similar clinical benefit to that previously seen with the IV induction in the GALAXI studies. The GALAXY head-to-head studies showed the superiority of Tremfya over J&J’s blockbuster drug Stelara in key endoscopic endpoints in Crohn’s disease.

The NYSE ARCA Pharmaceutical Index rose 0.3% in the last five trading sessions.

Here’s how the eight major stocks performed in the last five trading sessions.

In the last five trading sessions, Lilly rose the most (3.7%), while AstraZeneca declined the most (1.9%).

In the past six months, Lilly has risen the most (54.8%), while J&J has declined the most (4.6%).

(See the last pharma stock roundup here: Pharma Stock Roundup: FDA Panel Endorses LLY’s Donanemab, PFE’s DMD Therapy Study Fails)

What's Next in the Pharma World?

Watch this space for regular pipeline and regulatory updates next week.

Merck, J&J, AbbVie and AstraZeneca have a Zacks Rank #3 (Hold) each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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