This week, the FDA granted priority review status to
Roche
’s
RHHBY
regulatory application for lymphoma candidate, Lunsumio.
AstraZeneca
AZN
announced a small acquisition that will strengthen its hematological cancer pipeline.
Pfizer
PFE
filed a new drug application (NDA) to the FDA for its oral COVID-19 pill, Paxlovid, which was until now authorized for emergency use in the United States.
Recap of the Week’s Most Important Stories
AstraZeneca’s New Acquisition to Strengthen Hematological Cancer Pipeline:
AstraZeneca announced that it has agreed to acquire TeneoTwo and its early-stage CD19/CD3 T-cell engager, TNB-486, which will
strengthen its hematological cancer pipeline
. TNB-486 is currently being evaluated in a phase I study in relapsed and refractory B-cell non-Hodgkin lymphoma1. Per the terms of the agreement, AstraZeneca will make an upfront payment of $100 million upon the closure of the deal. In addition to the upfront payment, the existing shareholders of TeneoTwo will also be eligible to receive contingent R&D-related milestone payments of up to $805 million and additional contingent commercial-related milestone payments of up to $360 million.
FDA’s Priority Tag to Roche’s Lymphoma Candidate BLA:
The FDA accepted and granted priority review to Roche’s biologics license application (BLA) for Lunsumio, to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies. Lunsumio is a
potential first-in-class
CD20xCD3 T-cell engaging bispecific antibody. The FDA is expected to give its decision on the BLA by Dec 29, 2022. The BLA is based on positive results from the pivotal phase I/II GO29781 study.
Pfizer Files NDA for Paxlovid:
Pfizer announced that it has filed a new drug application (NDA) to
seek formal approval from the FDA
for its oral COVID-19 antiviral pill, Paxlovid. Paxlovid was granted Emergency Use Authorization (EUA) in the United States in December 2021 for the treatment of mild-to-moderate COVID-19 in patients who are at high risk of progression to severe COVID-19. The NDA seeks approval of Paxlovid for patients who are at high risk for progression to severe illness from COVID-19. The NDA was based on data from the phase II/III EPIC-HR study. Paxlovid has already received emergency or conditional authorization for use in certain populations in more than 65 countries.
The NYSE ARCA Pharmaceutical Index rose 0.63% in the last five trading sessions.
Here’s how the eight major stocks performed in the last five trading sessions.
Image Source: Zacks Investment Research
In the last five trading sessions, Merck rose the most (2%) while AbbVie declined the most (0.8%).
In the past six months, Lilly rose the most (26.1%) while Roche declined the most (17.5%).
(See the last pharma stock roundup here:
FDA Panel Backs Updated COVID Jabs, EU Nod for SNY, MRK Drugs
)
What’s Next in the Pharma World?
Watch for regular pipeline and regulatory updates next week.
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