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Pfizer (PFE) Gets FDA Nod for New Indication of Immunoglobulin
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Pfizer (PFE - Free Report) announced that the FDA has granted approval to its intravenous immunoglobulin, Panzyga for a new indication. The approval is for treating chronic inflammatory demyelinating polyneuropathy (CIDP), a rare neurological disease of the peripheral nerves. With the approval, Panzyga becomes the first and only FDA-approved intravenous immunoglobulin that offers two maintenance dosing options for CIDP, thereby catering to different needs of this patient population.
Panzyga is presently indicated for the treatment of adult patients with chronic immune thrombocytopenia (cITP) to raise platelet counts to control or prevent bleeding. It is also approved to treat primary immunodeficiency (PI) in patients two years of age.
In the past year, Pfizer’s stock has risen 4.5% compared with an increase of 9.5% for the industry.
The approval for the CDIP indication was based on data from a randomized, multi-center phase IIII study. The study met the primary endpoint as 80% of CIDP patients in the study achieved an INCAT (Inflammatory Neuropathy Cause and Treatment) response with the 1.0 g/kg dose. The INCAT disability score is a measure of activity limitation. The study’s primary endpoint was the proportion of responders, which means a patient with a decrease of at least one point in the adjusted 10-point INCAT disability score.
Pfizer markets Panzyga in partnership with private human protein manufacturer Octapharma per which Pfizer markets the medicine in the United States while Octapharma markets it in outside U.S. markets.
Some better-ranked drugmakers/biotech companies are J&J (JNJ - Free Report) , Moderna (MRNA - Free Report) and Acorda Therapeutics , all carrying a Zacks Rank of 2 (Buy).
J&J’s stock is up 5.8% this year so far. Its earnings estimate for 2021 have risen 6.6% in the past 30 days.
Moderna’s stock has risen 75.9% this year so far. Its earnings estimate for 2021 have risen 21.7% in the past 30 days.
Acorda’s loss estimates for 2021 have narrowed from $8.32 per share to $7.33 per share over the past 30 days. Its shares have surged 81.9% this year so far.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by referendums and legislation, this industry is expected to blast from an already robust $17.7 billion in 2019 to a staggering $73.6 billion by 2027. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
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Pfizer (PFE) Gets FDA Nod for New Indication of Immunoglobulin
Pfizer (PFE - Free Report) announced that the FDA has granted approval to its intravenous immunoglobulin, Panzyga for a new indication. The approval is for treating chronic inflammatory demyelinating polyneuropathy (CIDP), a rare neurological disease of the peripheral nerves. With the approval, Panzyga becomes the first and only FDA-approved intravenous immunoglobulin that offers two maintenance dosing options for CIDP, thereby catering to different needs of this patient population.
Panzyga is presently indicated for the treatment of adult patients with chronic immune thrombocytopenia (cITP) to raise platelet counts to control or prevent bleeding. It is also approved to treat primary immunodeficiency (PI) in patients two years of age.
In the past year, Pfizer’s stock has risen 4.5% compared with an increase of 9.5% for the industry.
The approval for the CDIP indication was based on data from a randomized, multi-center phase IIII study. The study met the primary endpoint as 80% of CIDP patients in the study achieved an INCAT (Inflammatory Neuropathy Cause and Treatment) response with the 1.0 g/kg dose. The INCAT disability score is a measure of activity limitation. The study’s primary endpoint was the proportion of responders, which means a patient with a decrease of at least one point in the adjusted 10-point INCAT disability score.
Pfizer markets Panzyga in partnership with private human protein manufacturer Octapharma per which Pfizer markets the medicine in the United States while Octapharma markets it in outside U.S. markets.
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 drugmakers/biotech companies are J&J (JNJ - Free Report) , Moderna (MRNA - Free Report) and Acorda Therapeutics , all carrying a Zacks Rank of 2 (Buy).
J&J’s stock is up 5.8% this year so far. Its earnings estimate for 2021 have risen 6.6% in the past 30 days.
Moderna’s stock has risen 75.9% this year so far. Its earnings estimate for 2021 have risen 21.7% in the past 30 days.
Acorda’s loss estimates for 2021 have narrowed from $8.32 per share to $7.33 per share over the past 30 days. Its shares have surged 81.9% this year so far.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by referendums and legislation, this industry is expected to blast from an already robust $17.7 billion in 2019 to a staggering $73.6 billion by 2027. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
See the pot stocks we're targeting >>