Arvinas, Inc., a clinical-stage biotechnology company, engages in the discovery, development, and commercialization of therapies to degrade disease-causing proteins. The company engineers proteolysis targeting chimeras (PROTAC) targeted protein degraders that are designed to harness the body's own natural protein disposal system to degrade and remove disease-causing proteins. Its product pipeline includes Bavdegalutamide and ARV-766, investigational orally bioavailable PROTAC protein degraders for the treatment of men with metastatic castration-resistant prostate cancer, which are in Phase 1/2 clinical trials; and ARV-471, an orally bioavailable estrogen receptor degrading PROTAC targeted protein degrader for the treatment of patients with locally advanced or metastatic estrogen receptor+/human epidermal growth factor receptor 2-breast cancer, which is Phase 3 clinical trial. Arvinas, Inc. has collaborations with Pfizer Inc., Genentech, Inc., F. Hoffman-La Roche Ltd., Carrick Therapeutics Limited, and Bayer AG. The company was founded in 2013 and is based in New Haven, Connecticut.

Arvinas, Inc.

Johnson & Johnson JNJ announced that it has submitted a new drug application (NDA) to the FDA seeking approval for its investigational oral peptide, icotrokinra, for treating moderate-to-severe plaque psoriasis (PsO) in adults and pediatric patients aged 12 years and above.
The NDA was based on data from four phase III studies, ICONIC-LEADa, ICONIC-TOTALb and ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2 – all part of the ICONIC clinical development program evaluating icotrokinra, a IL-23 inhibitor across PsO and psoriatic arthritis indications.
Across the four pivotal studies, treatment with icotrokinra achieved all primary and co-primary endpoints by showing significant skin clearance and a favorable safety profile with once-daily oral dosing in adults and adolescents with moderate-to-severe plaque PsO.
Previously, data from the ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 studies, which evaluated icotrokinra against Bristol Myers’ BMY psoriasis drug, Sotyktu (deucravacitinib), also met the co-primary endpoints. The studies demonstrated the icotrokinra’s superiority over Bristol Myers’ Sotyktu.
JNJ's Price Performance
Shares of J&J have rallied 13.7% so far this year against the industry’s decline of 2.1%.
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Given its rapid development and strong clinical data reported to date, management believes icotrokinra has the potential to change the treatment landscape for plaque psoriasis and can position itself as the new standard in the treatment of the disease.
Icotrokinra is uniquely engineered to block the IL-23 receptor, a key driver of inflammation in plaque psoriasis, with potential applications in other IL-23-driven diseases. Upon potential approval, icotrokinra might become a convenient and effective new treatment option for patients with psoriasis.
JNJ's Ongoing Development Activities With Icotrokinra
Icotrokinra is being jointly developed by J&J and Protagonist Therapeutics PTGX under a license and collaboration agreement signed in 2017. Per the terms, J&J holds exclusive worldwide rights to develop the drug in phase II studies and beyond.
Besides dermatology, J&J and Protagonist are also exploring icotrokinra’s potential in the inflammatory bowel disease space.
Earlier this year, JNJ and PTGX reported positive results from the phase IIb ANTHEM-UC study, which evaluated icotrokinra in adults with moderately to severely active ulcerative colitis. The study met its primary endpoint of clinical response across all dose groups.
Given that icotrokinra has already demonstrated superiority over BMY’s Sotyktu, J&J is now conducting the phase III ICONIC-ASCEND study — a head-to-head study comparing icotrokinra with its own blockbuster immunology drug, Stelara (ustekinumab) — in patients with moderate-to-severe plaque psoriasis. With icotrokinra, J&J aims to offer a more convenient oral alternative to Stelara, which is injection-based and currently facing generic erosion in the United States.
JNJ's Zacks Rank & Another Stock to Consider
J&J currently carries a Zacks Rank #2 (Buy).
A top-ranked stock in the biotech sector is Arvinas ARVN, sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Arvinas’ 2025 loss per share have narrowed from $1.60 to $1.51. Loss per share estimates for 2026 have narrowed from $3.28 to $2.98 during the same period. ARVN stock has plunged 60.7% year to date.
Arvinas’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 82.09%.
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JNJ Seeks FDA Approval for Oral Psoriasis Drug Icotrokinra

Shares of OptiNose OPTN soared 52.5% on Thursday after the company announced that it is set to be acquired by Paratek Pharmaceuticals, a private biotech. This deal will add OPTN’s approved product, Xhance (fluticasone propionate), to the latter’s commercial portfolio.
Xhance is an innovative drug-device therapy for chronic rhinosinusitis (CRS), with or without nasal polyps. Utilizing its proprietary Exhalation Delivery System, it delivers a corticosteroid directly to the site of inflammation, improving patient outcomes while potentially reducing the need for invasive or costly treatments.
The acquisition enables OptiNose to expand Xhance’s market reach, addressing long-standing challenges in adoption. Paratek’s strong commercial infrastructure will help drive awareness, particularly among primary care providers who treat most CRS patients.
Paratek’s recently expanded primary care field force, combined with OptiNose’s specialist sales expertise, positions the company to accelerate Xhance’s adoption across both ear, nose, and throat (ENT) and allergy specialists and the broader primary care market, maximizing its commercial potential.
Year to date, shares of OptiNose have rallied 37% against the industry’s 0.1% decline.
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Xhance was initially approved in 2017 for CRS with nasal polyps and marketed primarily to ENT and allergy specialists. In 2024, the product’s label was expanded to include CRS without nasal polyps, increasing its market potential nearly tenfold by bringing primary care providers into its prescriber base. Subsequently, OPTN’s Xhance became the only approved therapy for CRS patients regardless of nasal polyp status, reinforcing its position in a market with substantial unmet clinical needs.
This impending acquisition will also broaden Paratek’s commercial portfolio beyond its flagship antibiotic, Nuzyra (omadacycline). It will reinforce Paratek’s status as a multi-product company dedicated to developing innovative specialty therapies for primary care providers and specialists, tackling critical medical health challenges.
Nuzyra is a once-daily oral and intravenous antibiotic approved for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Notably, a significant portion of the primary care physicians currently engaged by Paratek for Nuzyra also manage patients with CRS, presenting a meaningful overlap that enhances salesforce efficiency and market reach.
Financial Consideration for OPTN’s Impending Acquisition
Under the agreement, all outstanding shares of OptiNose will be acquired by Paratek for $9 per share in cash, with the potential for an additional $5 per share in contingent value rights, depending on Xhance achieving certain specified revenue milestones. This brings the total deal value to up to $330 million.
The upfront cash payment of $9 per share represents a 50% premium over OptiNose’s closing share price on March 19, 2025.
The transaction is expected to be completed in mid-2025, subject to the fulfillment of certain customary and regulatory closing conditions.
OptiNose, Inc. Price and Consensus
OptiNose, Inc. price-consensus-chart | OptiNose, Inc. Quote
OPTN’s Zacks Rank & Stocks to Consider
OptiNose currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the sector are Gilead Sciences GILD, Dynavax Technologies Corporation DVAX and Arvinas ARVN, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, Gilead Sciences’ earnings estimate for 2025 has improved from $7.80 to $7.87 per share. During the same timeframe, the estimate for earnings per share for 2026 has improved from $8.12 to $8.27. Year to date, shares of Gilead Sciences have gained 14.6%.
GILD’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.47%.
In the past 30 days, estimates for Dynavax’s earnings per share have increased from 32 cents to 33 cents for 2025. During the same time, earnings per share have increased from 49 cents to 57 cents for 2026. Year to date, shares of DVAX have gained 6.7%.
DVAX’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 9.58%.
In the past 30 days, estimates for Arvinas’ loss per share have narrowed from $3.73 to $3.49 for 2025. During the same time, loss per share has narrowed from $3.67 to $3.65 for 2026. Year to date, shares of ARVN have plunged 53.1%.
ARVN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 32.56%.
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OPTN Stock Soars 53% on Inking $330M Deal to be Acquired by Paratek

Mirum Pharmaceuticals’ MIRM lead product, Livmarli (maralixibat), an orally administered ileal bile acid transporter (“IBAT”) inhibitor, is approved for the treatment of cholestatic pruritus in patients with Alagille syndrome worldwide.
The drug is also approved for treating certain patients with progressive familial intrahepatic cholestasis in the United States and Europe.
Sales of Livmarli have been rising steadily since its approval and launch worldwide. In 2024, Livmarli generated sales worth $213.3 million, reflecting an increase of 50.4% on a year-over-year basis. Though Livmarli is witnessing continued demand and driving the top line, the company’s high dependence on the drug remains a concern.
In the past year, shares of Mirum have surged 83.2% against the industry’s decline of 8.5%.
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More on MIRM's Livmarli & Other Products
Mirum is evaluating Livmarli in the phase III EXPAND study for treating pruritus in rare cholestatic conditions. Enrollment in the study is expected to be completed in 2026.
Mirum acquired Travere Therapeutics’ bile acid products in August 2023, which added the latter’s Cholbam capsules and chenodiol tablets to its portfolio of commercialized drugs.
Cholbam is approved for treating bile acid synthesis disorders (“BASD”) and Zellweger spectrum disorders (“ZSD”).
In February 2025, the FDA approved Ctexli (chenodiol) tablets, a bile acid, for the treatment of adults with cerebrotendinous xanthomatosis (“CTX”). Following the nod, Ctexli became the first and only treatment to be approved for this rare, progressive and debilitating disease.
Though revenues from bile acid products are adding to Mirum’s top-line growth, it remains to be seen whether Cholbam and Ctexli can reduce the heavy dependence on Livmarli for revenues in future quarters.
MIRM's Other Pipeline Updates
Mirum’s lead pipeline candidate, volixibat, is currently being evaluated in two phase IIb studies for treating patients with primary biliary cholangitis (the VANTAGE study) and primary sclerosing cholangitis (the VISTAS study).
Enrollment in the VISTAS study is expected to be completed in the second half of 2025, with top-line data expected to be announced in 2026. The company anticipates completing enrollment in the VANTAGE study by 2026.
Mirum also plans to initiate a phase II study on its recently in-licensed PDE4D inhibitor, MRM-3379, for treating Fragile X syndrome later in 2025.
MIRM's Overdependence on Livmarli for Growth a Woe
Mirum’s heavy dependence on Livmarli for revenues remains a woe. Any regulatory setback for the drug could hurt the stock. Also, failure to generate sufficient revenues from the sale of Livmarli will hurt the stock in future quarters.
Pipeline setbacks are also an area of concern. In December 2023, Mirum announced disappointing top-line data from the phase IIb EMBARK study, which evaluated Livmarli in patients with biliary atresia (BA), who have undergone a Kasai surgery. The study did not meet its primary endpoint of mean change in bilirubin from baseline to week 26 or the key secondary endpoints. Subsequently, Mirum discontinued the BA clinical study. Similar setbacks in the future will impede the company’s growth prospects.
MIRM's Zacks Rank & Stocks to Consider
Mirum currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are Gilead Sciences, Inc. GILD, Dynavax Technologies Corporation DVAX and Arvinas Inc ARVN, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Gilead’s earnings per share have increased from $7.56 to $7.87 for 2025. During the same time, earnings per share estimates for 2026 have increased from $7.76 to $8.27. In the past year, shares of GILD have rallied 45.8%.
GILD’s earnings beat estimates in each of the trailing four quarters, the average surprise being 19.47%.
In the past 60 days, estimates for Dynavax’s 2025 earnings per share have increased from 32 cents to 33 cents. During the same time, estimates for 2026 have increased from 49 cents to 57 cents. In the past year, shares of DVAX have rallied 10.8%.
DVAX’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 9.58%.
In the past 60 days, estimates for Arvinas’ loss per share have narrowed from $4.42 to $3.49 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.19 to $3.65. In the past year, shares of ARVN have plunged 78.5%.
ARVN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 32.56%.
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Mirum's Heavy Dependence on Livmarli for Revenues Remains a Woe

Shares of Plus Therapeutics, Inc. PSTV were up a staggering 170.1% on March 20 after the company announced that the FDA has conditionally accepted — Reyobiq — as the new proprietary name for PSTV’s lead therapeutic candidate, rhenium Re186 obisbemeda.
Plus Therapeutics’ request for a proprietary name review for Reyobiq must be submitted after the new drug application (NDA) is filed for the candidate.
Per the company, going forward, all communications related to the USAN-adopted and INN-proposed rhenium Re186 obisbemeda generic name will now use the newly accepted proprietary name of Reyobiq.
A novel injectable radiotherapy, Reyobiq (rhenium Re186 obisbemeda), is being specifically developed to deliver highly targeted high-dose radiation in central nervous system tumors, with the potential to reduce risks and improve patient outcomes.
In the past year, shares of Plus Therapeutics have declined 26.2% compared with the industry’s decrease of 6.7%.
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Recent Updates on PSTV's Reyobiq
Plus Therapeutics is developing Reyobiq for treating leptomeningeal metastases (“LM”) and recurrent glioblastoma (GBM).
Earlier this month, the FDA granted an Orphan Drug Designation to Reyobiq for the treatment of LM in patients with lung cancer. LM is a rare cancer complication in which the primary cancer spreads to the cerebrospinal fluid and leptomeninges that cover the brain and spinal cord.
Enrollment has been completed in the ReSPECT-LM phase I single-dose escalation study, which will evaluate the safety, tolerability and potential efficacy of intrathecally administered Reyobiq in patients with LM.
PSTV is now gearing up for a phase II single-dose expansion study and a phase I multiple-dose study on Reyobiq for patients with LM.
The company is evaluating Reyobiq in the phase I/II ReSPECT-GBM study for the treatment of recurrent glioblastoma.
In the absence of a marketed product, successful development of Reyobiq remains in key focus for Plus Therapeutics.
PSTV's Zacks Rank & Stocks to Consider
Plus Therapeutics currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Gilead Sciences, Inc. GILD, Dynavax Technologies Corporation DVAX and Arvinas Inc. ARVN, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Gilead’s earnings per share have increased from $7.56 to $7.87 for 2025. During the same time, earnings per share estimates for 2026 have increased from $7.76 to $8.27. In the past year, shares of GILD have rallied 45.8%.
GILD’s earnings beat estimates in each of the trailing four quarters, the average surprise being 19.47%.
In the past 60 days, estimates for Dynavax’s earnings per share have increased from 32 cents to 33 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from 49 cents to 57 cents. In the past year, shares of DVAX have rallied 10.8%.
DVAX’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 9.58%.
In the past 60 days, estimates for Arvinas’ loss per share have narrowed from $4.42 to $3.49 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.19 to $3.65. In the past year, shares of ARVN have plunged 78.5%.
ARVN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 32.56%.
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PSTV Stock Surges as FDA Accepts Proprietary Name for Lead Drug

Johnson & Johnson JNJ announced that the FDA has granted a Fast Track designation (“FTD’) to its investigational drug, nipocalimab, for treating adult patients with moderate-to-severe Sjögren’s disease (“SjD”), a chronic autoimmune disease.
Currently, there are no advanced therapies approved by the FDA for the given indication.
The Fast Track designation from the FDA facilitates rapid development and expedites the review of drug candidates that are being developed to treat serious conditions and for which clinical data demonstrate the potential to address unmet medical needs. The goal is to make these treatments rapidly available to patients in need.
Besides SjD, the FDA has granted FTD to nipocalimab in three other indications, hemolytic disease of the fetus and newborn (“HDFN”) and warm autoimmune hemolytic anemia (wAIHA), generalized myasthenia gravis (gMG) and fetal neonatal alloimmune thrombocytopenia.
The FDA granted Breakthrough Therapy designation to nipocalimab for SjD in November 2024. In February this year, J&J announced positive top-line data from a phase II study in SjD. Nipocalimab met the primary endpoint of the phase II DAHLIAS dose-ranging study in SjD. J&J is now enrolling patients in the phase III DAFFODIL study.
JNJ Stock's Performance
In the past year, J&J’s shares have gained 5.4% against the industry’s decline of 4.3%.
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JNJ's Nipocalimab Nearing Potential Approval for gMG
A biologics license application (“BLA”) seeking approval for nipocalimab is currently under review for treating gMG.
The FDA accepted J&J’s regulatory filing seeking approval for nipocalimab in gMG indication in January 2025.
The BLA has been granted priority review by the FDA. We expect a final decision from the regulatory body in the third quarter of 2025.
The filing is supported by data from the phase III Vivacity-MG3 study, gMG is an autoantibody-driven neuromuscular disease marked by fluctuating muscle weakness.
JNJ's Nipocalimab Development Plans
Besides gMG and SjD, J&J is also developing nipocalimab in separate mid to late-stage clinical studies for treating autoantibody-driven rare diseases.
The company is evaluating nipocalimab in late-stage studies for chronic inflammatory demyelinating polyneuropathy, HDFN and wAIHA. The candidate is also being evaluated in separate mid-stage studies for idiopathic inflammatory myopathy and systemic lupus erythematosus.
Nipocalimab was added to J&J’s pipeline following the acquisition of Momenta Pharmaceuticals in 2020.
JNJ's Zacks Rank & Stocks to Consider
J&J currently carries a Zacks Rank #3 (Sell).
Some better-ranked stocks in the biotech sector are Gilead Sciences, Inc. GILD, Dynavax Technologies Corporation DVAX and Arvinas Inc ARVN, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Gilead’s earnings per share have increased from $7.56 to $7.87 for 2025. During the same time, earnings per share have increased from $7.76 to $8.27 for 2026. In the past year, shares of GILD have rallied 49%.
GILD’s earnings beat estimates in each of the trailing four quarters, the average surprise being 19.47%.
In the past 60 days, estimates for Dynavax’s earnings per share have increased from 32 cents to 33 cents for 2025. During the same time, earnings per share have increased from 49 cents to 57 cents for 2026. In the past year, shares of DVAX have rallied 14.9%.
DVAX’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 9.58%.
In the past 60 days, estimates for Arvinas’ loss per share have narrowed from $4.42 to $3.75 for 2025. During the same time, loss per share has narrowed from $4.19 to $3.65 for 2026. In the past year, shares of ARVN have plunged 80.9%.
ARVN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 32.56%.
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JNJ's Nipocalimab Gets FDA's Fast Track Tag for Sjogren's Disease

For Immediate Release
Chicago, IL – March 14, 2025 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Novo Nordisk NVO, Roche RHHBY, Pfizer PFE, Arvinas ARVN and J&J JNJ.
Here are highlights from Thursday’s Analyst Blog:
Pharma Stock Roundup: Roche, Novo & More
This week, Novo Nordisk announced disappointing data from a phase III study on a novel obesity candidate, CagriSema. Roche announced a license and collaboration deal with Denmark's Zealand Pharma to co-develop its lead obesity candidate petrelintide. Pfizer and partner Arvinas announced mixed phase III data for breast cancer therapy, vepdegestrant. J&J and partner Protagonist Therapeutics' investigational targeted oral peptide, icotrokinra met the primary endpoint of clinical response in ulcerative colitis study.
Here's a recap of the week's most important stories.
NVO's Novel Obesity Treatment Disappoints in Phase III Study
Novo Nordisk's phase III REDEFINE 2 study evaluating its next-gen subcutaneous obesity candidate, CagriSema, met its primary endpoint. CagriSema is a fixed-dose combination of a long-acting amylin analog, cagrilintide (2.4 mg) and semaglutide (2.4 mg). In the study, 61.9% of patients were given the highest dose of the drug.
Top-line data from the phase III REDEFINE 2 study showed that treatment with CagriSema led to a weight loss of 15.7% after 68 weeks compared to a reduction of 3.1% with placebo alone in people with obesity and type II diabetes. However, the weight loss of 15.7% fell short of expectations as investors were probably expecting a more pronounced weight loss outcome at 68 weeks. Shares of NVO shrank on the news. On applying the treatment policy estimand, the weight loss achieved with CagriSema was 13.7% compared with 3.4% with placebo.
Data showed that 89.7% of patients treated with CagriSema achieved a weight loss of 5% or more after 68 weeks, which was the study's co-primary endpoint.
In December, NVO's other phase III study, REDEFINE 1, showed a weight loss of 22.7% in patients treated with CagriSema, which also fell short of the expected loss of 25%.
NVO plans to file regulatory applications seeking approval for CagriSema in the first quarter of 2026.
Roche Buys Rights to Obesity Drug from Zealand Pharma
Roche announced that it has in-licensed co-development and co-commercialization rights from Denmark's Zealand Pharma for the latter's long-acting amylin analog, petrelintide. Roche plans to develop petrelintide as a monotherapy as well as a fixed-dose combination with its lead incretin candidate CT-388, a dual GLP-1/GIP receptor agonist, as a potential foundational therapy for obese and overweight people.
Petrelintide is currently being evaluated in phase IIb studies in people who are obese or overweight without type II diabetes. In clinical and pre-clinical studies, petrelintide has shown the potential to deliver weight loss comparable to GLP-1 drugs but with a better tolerability profile.
For the deal, Roche will make an upfront cash payment of $1.65 billion, with Zealand Pharma also being entitled to up to $1.2 billion in development milestones and another $2.4 billion in sales-based milestones. This brings the total deal value to around $5.3 billion. The transaction is expected to close in the second quarter of 2025.
As part of the deal, Zealand Pharma and Roche will co-commercialize petrelintide in the United States and Europe, whereas Roche will have exclusive rights to market the drug in the rest of the world.
Pfizer & ARVN's Mixed Data from Vepdegestrant Breast Cancer Study
Pfizer and Arvinas announced data from the phase III study called VERITAC-2 evaluating vepdegestrant, its investigational oral PROTAC ER degrader, in patients with ER+/HER2- advanced or metastatic breast cancer (MBC). The study achieved the primary endpoint by showing a statistically significant and clinically meaningful improvement in progression-free survival in patients whose tumors harbor ESR1 mutations. However, the study failed to show statistical significance in improvement in PFS in the intent-to-treat (ITT) population. Additional details will be shared at an upcoming medical meeting.
JNJ Icotrokinra Meets Goal in Ulcerative Colitis Study
J&J and Protagonist Therapeutics' phase IIb study evaluating key pipeline candidate icotrokinra (JNJ-2113) to treat moderately to severely active ulcerative colitis (UC) met its primary endpoint of clinical response. Data from the ANTHEM-UC study showed that all three doses of icotrokinra, a targeted oral peptide, achieved clinical remission at week 12.
For the highest dose, a clinical response rate of 63.5% and a clinical remission rate of 30.2% were achieved at week 12, which continued to improve through week 28. The study also demonstrated clinically meaningful differences versus placebo in key secondary endpoints of clinical remission, symptomatic remission and endoscopic improvement at week 12.
Pfizer, Novo Nordisk, Roche and J&J carry a Zacks Rank #3 (Hold) each, while Arvinas is a #2 Ranked (Buy) stock. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
The NYSE ARCA Pharmaceutical Index has declined 5.4% in the past five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
In the last five trading sessions, all the stocks were in the red except Merck and AbbVie, which rose 0.2% each.
In the past six months, AbbVie rose the most (8.3%), while Novo Nordisk declined the most (45.4%).
(See the last pharma stock roundup here: BAYRY's Q4 Results, ABBV's Obesity Deal & More)
What's Next in the Pharma World?
Watch this space for regular pipeline and regulatory updates next week.
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Roche Holding AG (RHHBY) : Free Stock Analysis Report
Johnson & Johnson (JNJ) : Free Stock Analysis Report
Pfizer Inc. (PFE) : Free Stock Analysis Report
Novo Nordisk A/S (NVO) : Free Stock Analysis Report
Arvinas, Inc. (ARVN) : Free Stock Analysis Report
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The Zacks Analyst Blog Highlights Novo Nordisk, Roche, Pfizer, Arvinas and J&J

This week, Novo Nordisk NVO announced disappointing data from a phase III study on a novel obesity candidate, CagriSema. Roche RHHBY announced a license and collaboration deal with Denmark’s Zealand Pharma to co-develop its lead obesity candidate petrelintide. Pfizer PFE and partner Arvinas ARVN announced mixed phase III data for breast cancer therapy, vepdegestrant. J&J JNJ and partner Protagonist Therapeutics’ investigational targeted oral peptide, icotrokinra met the primary endpoint of clinical response in ulcerative colitis study.
Here's a recap of the week’s most important stories.
NVO's Novel Obesity Treatment Disappoints in Phase III Study
Novo Nordisk’s phase III REDEFINE 2 study evaluating its next-gen subcutaneous obesity candidate, CagriSema, met its primary endpoint. CagriSema is a fixed-dose combination of a long-acting amylin analog, cagrilintide (2.4 mg) and semaglutide (2.4 mg). In the study, 61.9% of patients were given the highest dose of the drug.
Top-line data from the phase III REDEFINE 2 study showed that treatment with CagriSema led to a weight loss of 15.7% after 68 weeks compared to a reduction of 3.1% with placebo alone in people with obesity and type II diabetes. However, the weight loss of 15.7% fell short of expectations as investors were probably expecting a more pronounced weight loss outcome at 68 weeks. Shares of NVO shrank on the news. On applying the treatment policy estimand, the weight loss achieved with CagriSema was 13.7% compared with 3.4% with placebo.
Data showed that 89.7% of patients treated with CagriSema achieved a weight loss of 5% or more after 68 weeks, which was the study’s co-primary endpoint.
In December, NVO’s other phase III study, REDEFINE 1, showed a weight loss of 22.7% in patients treated with CagriSema, which also fell short of the expected loss of 25%.
NVO plans to file regulatory applications seeking approval for CagriSema in the first quarter of 2026.
Roche Buys Rights to Obesity Drug From Zealand Pharma
Roche announced that it has in-licensed co-development and co-commercialization rights from Denmark’s Zealand Pharma for the latter’s long-acting amylin analog, petrelintide. Roche plans to develop petrelintide as a monotherapy as well as a fixed-dose combination with its lead incretin candidate CT-388, a dual GLP-1/GIP receptor agonist, as a potential foundational therapy for obese and overweight people.
Petrelintide is currently being evaluated in phase IIb studies in people who are obese or overweight without type II diabetes. In clinical and pre-clinical studies, petrelintide, has shown the potential to deliver weight loss comparable to GLP-1 drugs but with a better tolerability profile.
For the deal, Roche will make an upfront cash payment of $1.65 billion, with Zealand Pharma also being entitled to up to $1.2 billion in development milestones and another $2.4 billion in sales-based milestones. This brings the total deal value to around $5.3 billion. The transaction is expected to close in the second quarter of 2025.
As part of the deal, Zealand Pharma and Roche will co-commercialize petrelintide in the United States and Europe, whereas Roche will have exclusive rights to market the drug in the rest of the world.
Pfizer & ARVN’s Mixed Data from Vepdegestrant Breast Cancer Study
Pfizer and Arvinas announced data from the phase III study called VERITAC-2 evaluating vepdegestrant, its investigational oral PROTAC ER degrader, in patients with ER+/HER2- advanced or metastatic breast cancer (MBC). The study achieved the primary endpoint by showing a statistically significant and clinically meaningful improvement in progression-free survival in patients whose tumors harbor ESR1 mutations. However, the study failed to show statistical significance in improvement in PFS in the intent-to-treat (ITT) population. Additional details will be shared at an upcoming medical meeting.
JNJ Icotrokinra Meets Goal in Ulcerative Colitis Study
J&J and Protagonist Therapeutics’ phase IIb study evaluating key pipeline candidate icotrokinra (JNJ-2113) to treat moderately to severely active ulcerative colitis (UC) met its primary endpoint of clinical response. Data from the ANTHEM-UC study showed that all three doses of icotrokinra, a targeted oral peptide, achieved clinical remission at week 12. For the highest dose, a clinical response rate of 63.5% and a clinical remission rate of 30.2% were achieved at week 12, which continued to improve through week 28. The study also demonstrated clinically meaningful differences versus placebo in key secondary endpoints of clinical remission, symptomatic remission and endoscopic improvement at week 12.
Pfizer, Novo Nordisk, Roche and J&J carry a Zacks Rank #3 (Hold) each, while Arvinas is a #2 Ranked (Buy) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The NYSE ARCA Pharmaceutical Index has declined 5.4% in the past 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 previous five trading sessions.
Image Source: Zacks Investment Research
In the last five trading sessions, all the stocks were in the red except Merck and AbbVie, which rose 0.2% each.
In the past six months, AbbVie rose the most (8.3%), while Novo Nordisk declined the most (45.4%).
(See the last pharma stock roundup here: BAYRY’s Q4 Results, ABBV’s Obesity Deal & More)
What's Next in the Pharma World?
Watch this space for regular pipeline and regulatory updates next week.
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Roche Holding AG (RHHBY) : Free Stock Analysis Report
Johnson & Johnson (JNJ) : Free Stock Analysis Report
Pfizer Inc. (PFE) : Free Stock Analysis Report
Novo Nordisk A/S (NVO) : Free Stock Analysis Report
Arvinas, Inc. (ARVN) : Free Stock Analysis Report
This article originally published on Zacks Investment Research (zacks.com).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Pharma Stock Roundup: RHHBY Obesity Drug Rights Buyout, NVO Pipeline Update

Shares of Arvinas ARVN plummeted 52.7% on Tuesday after the company and partner, Pfizer PFE, announced mixed results from a late-stage breast cancer study of its lead candidate, vepdegestrant. PFE shares were also down 2.4% on Tuesday following the news release.
Vepdegestrant is being developed in the phase III VERITAC-2 study as a monotherapy in adult patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer (MBC) compared to AstraZeneca’s AZN Faslodex (fulvestrant). The patient population includes those whose disease progressed following prior treatment with CDK 4/6 inhibitors and endocrine therapy.
ARVN/PFE’s Breast Cancer Study Results in Detail
Arvinas/Pfizer’s VERITAC-2 study achieved its primary endpoint in the estrogen receptor 1-mutant (ESR1m) patient population. It showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) upon treatment with vepdegestrant compared to AstraZeneca’s Faslodex. The results surpassed the pre-specified target hazard ratio of 0.60 for the ESR1m population.
However, the study did not demonstrate a statistically significant improvement in PFS for the intent-to-treat population, which included all patients who received the candidate, regardless of whether they adhered to or finished treatment. This outcome disappointed the investors, driving down the share prices of both companies.
Vepdegestrant is an orally bioavailable PROTAC protein degrader and enjoys the FDA’s Fast Track designation as a monotherapy to treat MBC in the United States.
In six months, Arvinas shares have plunged 66.9% compared with the industry’s 9.6% decline.
Image Source: Zacks Investment Research
At the time of analysis, overall survival — a key secondary endpoint of the study was not mature, as fewer than a quarter of the required events had occurred. The study will continue to monitor overall survival. Vepdegestrant was generally well-tolerated, with a safety profile consistent with previous studies. Detailed findings from VERITAC-2 will be presented at a medical meeting later this year and shared with global regulatory authorities to potentially support regulatory submissions.
ARVN projects that nearly 320,000 people in the United States will be diagnosed with breast cancer in 2025, with ER+/HER2- cases accounting for about 70%. Around 30% of women initially diagnosed with early-stage breast cancer eventually develop MBC, the most advanced stage where the disease spreads beyond the breast.
Arvinas signed a collaboration agreement with Pfizer in 2021 to co-develop and co-commercialize vepdegestrant for the treatment of MBC. Per the deal, ARVN and PFE share worldwide development costs, commercialization expenses and profits.
AstraZeneca’s Faslodex, administered as an intramuscular injection, is currently approved in the United States for the MBC indication. Having lost patent protection, the drug’s sales have been facing generic competition.
Arvinas, Inc. Price and Consensus
Arvinas, Inc. price-consensus-chart | Arvinas, Inc. Quote
ARVN’s Zacks Rank and Another Stock to Consider
Arvinas currently carries a Zacks Rank #2 (Buy).
Another top-ranked stock from the sector is Gilead Sciences GILD, carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, Gilead Sciences’ earnings estimate for 2025 has improved from $7.60 to $7.87 per share. During the same timeframe, the estimate for earnings per share for 2026 has improved from $7.93 to $8.27. In six months, shares of Gilead Sciences have gained 38.2%.
GILD’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.47%.
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AstraZeneca PLC (AZN) : Free Stock Analysis Report
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Arvinas, Inc. (ARVN) : Free Stock Analysis Report
This article originally published on Zacks Investment Research (zacks.com).
Zacks Investment Research
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

ARVN Stock Plunges 53% Following Mixed Data From Breast Cancer Study

(RTTNews) - Arvinas, Inc. (ARVN) and Pfizer Inc. (PFE) Tuesday announced positive topline results from the Phase 3 VERITAC-2 study.
The study is designed to evaluate the companies' vepdegestrant compared to AstraZeneca's fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer.
The trial met its primary goal in the estrogen receptor 1-mutant (ESR1m) population showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to fulvestrant. However, in the intent-to-treat (ITT) population, the study did not reach statistical significance in improvement in PFS.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Arvinas, Pfizer Report Positive Topline Data From Phase 3 VERITAC-2 Study

The following companies are expected to report earnings prior to market open on 02/11/2025. Visit our Earnings Calendar for a full list of expected earnings releases.
Marriott International (MAR)is reporting for the quarter ending December 31, 2024. The consensus earnings per share forecast from the 9 analysts that follow the stock is $2.38. MAR reported earnings of $3.57 per share for the same quarter a year ago; representing a a decrease of -33.33%.GlobalFoundries Inc. (GFS)is reporting for the quarter ending December 31, 2024. The consensus earnings per share forecast from the 7 analysts that follow the stock is $0.36. GFS reported earnings of $0.55 per share for the same quarter a year ago; representing a a decrease of -34.55%. The "days to cover" for this stock exceeds 10 days.The Carlyle Group Inc. (CG)is reporting for the quarter ending December 31, 2024. The consensus earnings per share forecast from the 7 analysts that follow the stock is $1.00. CG reported earnings of $0.86 per share for the same quarter a year ago; representing a a increase of 16.28%.Royalty Pharma plc (RPRX)is reporting for the quarter ending December 31, 2024. The consensus earnings per share forecast from the 3 analysts that follow the stock is $1.09. RPRX reported earnings of $1.15 per share for the same quarter a year ago; representing a a decrease of -5.22%.TPG Inc. (TPG)is reporting for the quarter ending December 31, 2024. The consensus earnings per share forecast from the 6 analysts that follow the stock is $0.52. TPG reported earnings of $0.51 per share for the same quarter a year ago; representing a a increase of 1.96%.IPG Photonics Corporation (IPGP)is reporting for the quarter ending December 31, 2024. The consensus earnings per share forecast from the 6 analysts that follow the stock is $0.20. IPGP reported earnings of $0.89 per share for the same quarter a year ago; representing a a decrease of -77.53%.Arvinas, Inc. (ARVN)is reporting for the quarter ending December 31, 2024. The consensus earnings per share forecast from the 11 analysts that follow the stock is $-1.07. ARVN reported earnings of $-2.53 per share for the same quarter a year ago; representing a a decrease of -57.71%. The "days to cover" for this stock exceeds 13 days.Ceragon Networks Ltd. (CRNT)is reporting for the quarter ending December 31, 2024. The consensus earnings per share forecast from the 2 analysts that follow the stock is $0.10. CRNT reported earnings of $0.03 per share for the same quarter a year ago; representing a a increase of 233.33%.Organigram Holdings Inc. (OGI)is reporting for the quarter ending December 31, 2024. The consensus earnings per share forecast from the 2 analysts that follow the stock is $-0.03. OGI reported earnings of $-0.14 per share for the same quarter a year ago; representing a a decrease of -78.57%.Yatra Online, Inc. (YTRA)is reporting for the quarter ending December 31, 2024. The consensus earnings per share forecast from the 1 analyst that follows the stock is $0.02. YTRA reported earnings of $-0.01 per share for the same quarter a year ago; representing a a decrease of -300.00%.Orion Energy Systems, Inc. (OESX)is reporting for the quarter ending December 31, 2024. The consensus earnings per share forecast from the 2 analysts that follow the stock is $-0.05. OESX reported earnings of $-0.07 per share for the same quarter a year ago; representing a a decrease of -28.57%.AutoNation, Inc. (AN)is reporting for the quarter ending December 31, 2024. The consensus earnings per share forecast from the 6 analysts that follow the stock is $4.26. AN reported earnings of $5.02 per share for the same quarter a year ago; representing a a decrease of -15.14%.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Arvinas, Inc.

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