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Pharma Stock Roundup: LLY to Buy Morphic, PFE Advances Obesity Drug Development
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This week, Pfizer (PFE - Free Report) announced that it will move forward with further development of a once-daily formulation of danuglipron, its GLP-1 candidate for obesity. Novo Nordisk (NVO - Free Report) faced FDA’s rejection in the United States for once-weekly basal insulin icodec for type I diabetes indication. Eli Lilly (LLY - Free Report) announced a definitive agreement to acquire Morphic Therapeutics to expand its immunology pipeline.
Recap of the Week’s Most Important Stories
Pfizer Advances Development of Once-Daily Weight-Loss Pill: Pfizer has selected its preferred once-daily modified-release formulation of danuglipron, its oral GLP-1R agonist, for further development as a weight loss pill, based on encouraging results from an ongoing study. Pfizer did not announce any detailed data from the study.
It evaluated several formulations of danuglipron and said that one showed “the most favorable profile.” In the second half of the year, Pfizer will conduct dose optimization studies on multiple doses of the preferred modified-release formulation to select the optimal dose to move forward to pivotal studies.
In December last year, Pfizer announced that it would not move forward with phase III studies on the twice-daily formulation of danuglipron. Though the candidate was effective in reducing weight in a phase IIb study, it caused several gastrointestinal side effects like nausea, vomiting and diarrhea. Back then, the company had said that it would continue the pharmacokinetic study of the once-daily formulation of danuglipron. Along with the latest release, Pfizer said that data from studies on the once-daily formulations have shown a similar safety profile to the twice-daily formulation. However, no increase in liver enzymes was observed in more than 1,400 study participants.
Lilly to Acquire Morphic for $3.2B: Lilly announced that it has offered to buy U.S. biotech Morphic Therapeutics for approximately $3.2 billion. The acquisition will add Morphic’s oral integrin therapies for treating serious chronic diseases to Lilly’s immunology pipeline. Morphic's lead pipeline candidate is MORF-057, an oral α4β7 inhibitor with the potential to improve outcomes in treating inflammatory bowel disease (IBD), which includes two conditions — Crohn's disease (“CD") and ulcerative colitis (“UC”).
MORF-057 is being evaluated in two phase II studies in UC and one phase II study in CD. Morphic also has preclinical candidates in its pipeline for treating autoimmune diseases, pulmonary hypertensive diseases, fibrotic diseases and cancer. The transaction has been approved by the boards of directors of both companies and is expected to close in the third quarter of 2024.
FDA’s CRL to Novo Nordisk’s Basal Insulin for Type I Diabetes: The FDA issued a complete response letter (CRL) to Novo Nordisk’s biologics license application (BLA) seeking approval for once-weekly basal insulin icodec for both type I and type II diabetes. In the CRL, the FDA has asked for more information related to the manufacturing process and the type I diabetes indication to complete the review. Novo Nordisk said it will not be able to provide the information this year. Nordisk had filed the BLA to the FDA in April 2023. In May 2024, an FDA committee said that the data available in the BLA were not sufficient to conclude a positive benefit-risk in type I diabetes indication. The FDA panel did not hold any discussion for the type II diabetes indication. Insulin icodec is already approved by the name of Awiqli in the EU, Canada, Australia, Japan and Switzerland for both type I and type II diabetes and in China for just type II diabetes.
The NYSE ARCA Pharmaceutical Index rose 2.8% in the last five trading sessions.
Image: Shutterstock
Pharma Stock Roundup: LLY to Buy Morphic, PFE Advances Obesity Drug Development
This week, Pfizer (PFE - Free Report) announced that it will move forward with further development of a once-daily formulation of danuglipron, its GLP-1 candidate for obesity. Novo Nordisk (NVO - Free Report) faced FDA’s rejection in the United States for once-weekly basal insulin icodec for type I diabetes indication. Eli Lilly (LLY - Free Report) announced a definitive agreement to acquire Morphic Therapeutics to expand its immunology pipeline.
Recap of the Week’s Most Important Stories
Pfizer Advances Development of Once-Daily Weight-Loss Pill: Pfizer has selected its preferred once-daily modified-release formulation of danuglipron, its oral GLP-1R agonist, for further development as a weight loss pill, based on encouraging results from an ongoing study. Pfizer did not announce any detailed data from the study.
It evaluated several formulations of danuglipron and said that one showed “the most favorable profile.” In the second half of the year, Pfizer will conduct dose optimization studies on multiple doses of the preferred modified-release formulation to select the optimal dose to move forward to pivotal studies.
In December last year, Pfizer announced that it would not move forward with phase III studies on the twice-daily formulation of danuglipron. Though the candidate was effective in reducing weight in a phase IIb study, it caused several gastrointestinal side effects like nausea, vomiting and diarrhea. Back then, the company had said that it would continue the pharmacokinetic study of the once-daily formulation of danuglipron. Along with the latest release, Pfizer said that data from studies on the once-daily formulations have shown a similar safety profile to the twice-daily formulation. However, no increase in liver enzymes was observed in more than 1,400 study participants.
Lilly to Acquire Morphic for $3.2B: Lilly announced that it has offered to buy U.S. biotech Morphic Therapeutics for approximately $3.2 billion. The acquisition will add Morphic’s oral integrin therapies for treating serious chronic diseases to Lilly’s immunology pipeline. Morphic's lead pipeline candidate is MORF-057, an oral α4β7 inhibitor with the potential to improve outcomes in treating inflammatory bowel disease (IBD), which includes two conditions — Crohn's disease (“CD") and ulcerative colitis (“UC”).
MORF-057 is being evaluated in two phase II studies in UC and one phase II study in CD. Morphic also has preclinical candidates in its pipeline for treating autoimmune diseases, pulmonary hypertensive diseases, fibrotic diseases and cancer. The transaction has been approved by the boards of directors of both companies and is expected to close in the third quarter of 2024.
FDA’s CRL to Novo Nordisk’s Basal Insulin for Type I Diabetes: The FDA issued a complete response letter (CRL) to Novo Nordisk’s biologics license application (BLA) seeking approval for once-weekly basal insulin icodec for both type I and type II diabetes. In the CRL, the FDA has asked for more information related to the manufacturing process and the type I diabetes indication to complete the review. Novo Nordisk said it will not be able to provide the information this year. Nordisk had filed the BLA to the FDA in April 2023. In May 2024, an FDA committee said that the data available in the BLA were not sufficient to conclude a positive benefit-risk in type I diabetes indication. The FDA panel did not hold any discussion for the type II diabetes indication. Insulin icodec is already approved by the name of Awiqli in the EU, Canada, Australia, Japan and Switzerland for both type I and type II diabetes and in China for just type II diabetes.
The NYSE ARCA Pharmaceutical Index rose 2.8% in the last five trading sessions.
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.
Image Source: Zacks Investment Research
In the last five trading sessions, all the stocks were in the green. Lilly rose the most (4.0%).
In the past six months, Lilly has risen the most (45.3%), while J&J has declined the most (7.8%).
(See the last pharma stock roundup here: Pharma Stock Roundup: FDA Nod to LLY’s Kisunla, SNY’s Dupixent Gets EU Nod for COPD)
What's Next in the Pharma World?
Watch this space for regular pipeline and regulatory updates next week.
Pfizer has a Zacks Rank #2 (Buy) currently while Lilly and Novo Nordisk have a Zacks Rank #3 (Hold) each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.