Pfizer Begins Four Phase III Studies on Vaccine Candidates

Pfizer, Inc. PFE announced the start of four phase III studies on its various vaccine candidates.

The first subjects were recently administered immunization in two studies of 20-valent pneumococcal conjugate vaccine candidate, 20vPnC, in infants; one study of the respiratory syncytial virus (RSV) vaccine candidate, RSVpreF, in pregnant women; and one study of the pentavalent meningococcal vaccine candidate, MenABCWY in adolescents and young adults.

Pfizer expects to file a new drug application for 20vPnC in the fourth quarter of 2020. Please note that Merck MRK is also developing a 15-valent pneumococcal conjugate vaccine candidate in late-stage studies.

Pfizer’s20vPnC vaccine candidate includes all the 13 serotypes contained in its popular 13-valent pneumococcal conjugate vaccine, Prevnar 13 along with seven additional serotypes. Global Prevnar 13/Prevenar 13 revenues declined 1% to $1.45 billion in the first quarter of 2020.

Pfizer’s shares have lost 15.5% this year so far compared with the industry’s 1.8% decline.

 

 

In a separate press release, Pfizer announced that the European Medicines Agency has validated its application seeking expanded approval of its PD-L1 inhibitor Bavencio for the first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC). The label expansion filing is based on interim data from the phase III JAVELIN Bladder 100 study. The EMA will now review the application.

Pfizer has also filed a supplemental biologics license application (sBLA) to the FDA seeking expanded approval of Bavencio for the same indication. The sBLA is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program on a priority review basis.

Bavencio is presently approved for second-line treatment of locally advanced or metastatic urothelial carcinoma. Bavencio is also approved for Merkel cell carcinoma and in combination with Pfizer’s another cancer drug Inlyta for first-line treatment of advanced kidney cancer

Pfizer currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Some better-ranked large-cap pharma stocks are Eli Lilly & Company LLY, with a Zacks Rank #1, and AstraZeneca AZN, carrying a Zacks Rank #2 (Buy).

Lilly’s shares have risen 22.1% this year so far. Its earnings estimates for 2020 and 2021 have risen 0.6% and 0.5%, respectively over the past 60 days.

AstraZeneca’s shares have rallied 7.1% this year so far. Its earnings estimates for 2020 and 2021 have risen by 1% and 1.6%, respectively over the past 60 days.

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