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.
Just Released: Zacks Top 10 Stocks for 2022
In addition to the investment ideas discussed above, would you like to know about our 10 top picks for the entirety of 2022?
From inception in 2012 through 2021, the
Zacks Top 10 Stocks
portfolios gained an impressive +1,001.2% versus the S&P 500’s +348.7%. Now our Director of Research has combed through 4,000 companies covered by the Zacks Rank and has handpicked the best 10 tickers to buy and hold. Don’t miss your chance to get in…because the sooner you do, the more upside you stand to grab.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days.
Click to get this free report