This week, the FDA approved Pfizer’s PFE respiratory syncytial virus (RSV) vaccine, Abrysvo to help protect infants through immunization of their pregnant mothers. Abrysvo was also approved in Europe for maternal immunization as well as for older adults. Merck MRK announced positive data from a kidney cancer study on its drug, Welireg.  Roche RHHBY accidentally disclosed data from a late-stage study evaluating a combination of its cancer drugs in PD-L1-high metastatic non-small cell lung cancer (NSCLC). J&J JNJ announced final results of the exchange offer for its spin-off Consumer Health company, Kenvue. Japan’s regulatory body approved the expanded use of AstraZeneca’s AZN drugs, Lynparza and Soliris.

Recap of the Week’s Most Important Stories

FDA and EU Approve Pfizer’s RSV Vaccine for Pregnant Mothers to Protect Infants: The FDA approved Pfizer’s RSV vaccine, Abrysvo for the prevention of lower respiratory tract disease in infants through administration to pregnant women. The approval was expected, as, in May, the Vaccines and Related Biological Products Advisory Committee voted in favor of approving Abrysvo for the prevention of RSV in infants through maternal immunization.

Abrysvo was approved for older adults in the United States in May. With the latest approval, Pfizer’s vaccine has become the first maternal immunization vaccine to be approved to help protect infants at first breath through their first six months of life from RSV disease in the United States.

The European Commission also approved Abrysvo to help protect infants through immunization of their pregnant mothers as well as for older adults 60 years of age and older

Pfizer is now the only company that has an RSV vaccine to help protect older adults, as well as infants through maternal immunization in the United States as well as EU.

J&J Finalizes Kenvue Separation: J&J said that the exchange offer made to shareholders for its Consumer Health spinoff company, Kenvue, was oversubscribed. The percentage of J&J shares swapped for Kenvue shares held by J&J was 23.2%. Per the terms of the exchange offer, 8.0324 shares of Kenvue’s common stock were exchanged for each J&J share. J&J traded over 1.5 billion shares of Kenvue’s common stock, which represented 80.1% of the latter’s common stock. After completion of the exchange offer, J&J retains a 9.5% stake in Kenvue’s common stock. Kenvue will now operate as a separate and fully independent company

With the complete separation of the Consumer Health segment, J&J has become a two-sector company focused on the Pharmaceutical and MedTech fields. J&J intends to provide its updated financial guidance for 2023 on Aug 30.

Merck’s Kidney Cancer Study on Welireg Meets PFS Goal: Merck’s phase III LITESPARK-005 study evaluating Welireg (belzutifan) in certain adult patients with advanced renal cell carcinoma, a type of kidney cancer, met the primary endpoint of progression-free survival (PFS). Based on an interim data analysis conducted by an independent Data Monitoring Committee, Welireg showed a statistically significant and clinically meaningful improvement in PFS compared to everolimus, in the study. Though a favorable trend was observed in the study’s other primary endpoint of overall survival (“OS”), it did not reach statistical significance. The study investigators will test the OS endpoint at a subsequent analysis.

The LITESPARK-005 study also achieved its secondary endpoint of statistically significant improvement in the objective response rate. Welireg/belzutifan, Merck’s novel HIF-2α inhibitor, is presently approved to treat some von Hippel-Lindau disease-associated tumors.

Roche’s Accidental Disclosure of Cancer Combo Study Data: Roche was made aware of the inadvertent disclosure of data from its second interim analysis of the late-stage SKYSCRAPER-01 study. The study is evaluating the combination of Roche’s investigational anti-TIGIT drug tiragolumab plus blockbuster PD-L1 drug Tecentriq (atezolizumab) compared to Tecentriq monotherapy, as a first-line treatment for patients with PD-L1-high locally advanced or metastatic NSCLC.

Per the data readout, the results for the primary endpoint of OS were not mature at the time of the second interim analysis. It was observed that the median OS for the tiragolumab/Tecentriq combo arm was estimated at 22.9 months, while that in the Tecentriq monotherapy arm was 16.7 months. The difference in the OS in the two arms yielded a hazard ratio of 0.81. A high hazard ratio likely suggests that the tiragolumab-Tecentriq combination was more effective than treatment with Tecentriq alone. Roche intends to continue this study until the final analysis of data.

AstraZeneca’s Lynparza and Soliris Get Approvals for Expanded Use in Japan: AstraZeneca and partner Merck announced that the Japanese Ministry of Health, Labour and Welfare has granted approval to Lynparza for expanded use in prostate cancer. The recent approval is for Lynparza in combination with J&J’s Zytiga (abiraterone) and corticosteroid prednisone or prednisolone for patients with BRCA-mutated (BRCAm) castration-resistant prostate cancer with distant metastasis (mCRPC), based on data from the PROpel study. Lynparza is already approved in EU and the United States for similar expanded use. At present Lynparza is approved in Japan as a monotherapy for patients with BRCAm mCRPC based on results of the Profound study,

The Japanese regulatory body also approved AstraZeneca’s rare disease drug Soliris to treat generalised myasthenia gravis (gMG) in pediatric patients who are anti-acetylcholine receptor (AChR) antibody-positive (AChR Ab+). Soliris is already approved to treat adults patients with gMG In Japan. Soliris is also approved in EU for expanded use in refractory gMG (who are AChR Ab+) in children and adolescents aged six to 17 years.

The NYSE ARCA Pharmaceutical Index declined 0.9% 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.

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Zacks Investment Research

Image Source: Zacks Investment Research

In the last five trading sessions, Lilly rose the most (up 2%), while J&J declined the most (5.1%).

In the past six months, Lilly has risen the most (73.1%), while Pfizer has declined the most (11.4%).

(See the last pharma stock roundup here: FDA Okays PFE & JNJ Drugs, EU Approves ABBV’s Migraine Drug)

What’s Next in the Pharma World?

Watch out for regular pipeline and regulatory updates next week.

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