Research analysts who have asked questions during NOVO NORDISK A S earnings calls.
Peter Verdult
Citigroup Inc.
7 questions for NVO
James Quigley
Goldman Sachs
6 questions for NVO
Sachin Jain
Bank of America
6 questions for NVO
Michael Nedelcovych
TD Cowen
5 questions for NVO
Richard Vosser
JPMorgan Chase & Co.
5 questions for NVO
Harry Sephton
UBS
4 questions for NVO
Martin Parkhoi
SEB
4 questions for NVO
Emmanuel Papadakis
Deutsche Bank
3 questions for NVO
Jo Walton
UBS
3 questions for NVO
Simon Baker
Redburn Atlantic
3 questions for NVO
Callum Morris
Berenberg
2 questions for NVO
Carsten Lomberg Madsen
Danske Bank
2 questions for NVO
Evan Seigerman
BMO Capital Markets
2 questions for NVO
Florent Cespedes
Bernstein
2 questions for NVO
Michael Leuchten
Jefferies
2 questions for NVO
Richard Foster
JPMorgan Chase & Co.
2 questions for NVO
Thibault Boutherin
Morgan Stanley
2 questions for NVO
Yihan Li
Barclays
2 questions for NVO
Emily Field
Barclays
1 question for NVO
James Creedy
Goldman Sachs Group Inc.
1 question for NVO
Laura Hindley
Berenberg Bank
1 question for NVO
Michael Novod
Nordea
1 question for NVO
Peter Welford
Jefferies
1 question for NVO
Rajesh Kumar
HSBC
1 question for NVO
Richard Parkes
BNP Paribas Exane
1 question for NVO
Recent press releases and 8-K filings for NVO.
- The US Food and Drug Administration (FDA) has approved Novo Nordisk's Wegovy® pill (once-daily oral semaglutide 25 mg) for reducing excess body weight, maintaining weight reduction long term, and reducing the risk of major adverse cardiovascular events.
- This approval establishes the Wegovy® pill as the first oral glucagon-like peptide-1 (GLP-1) receptor agonist therapy approved for weight management.
- In the OASIS 4 trial, the Wegovy® pill demonstrated a mean weight loss of 16.6%, which is similar to the injectable Wegovy® 2.4 mg.
- Novo Nordisk expects to launch the Wegovy® pill in the US in early January 2026.
- The US Food and Drug Administration (FDA) has approved Novo Nordisk's Wegovy® pill (once-daily oral semaglutide 25 mg) for reducing excess body weight, maintaining weight reduction long-term, and reducing the risk of major adverse cardiovascular events.
- This approval marks the first oral glucagon-like peptide-1 (GLP-1) receptor agonist therapy for weight management, demonstrating a mean weight loss of 16.6% in the OASIS 4 trial.
- Novo Nordisk expects to launch the Wegovy® pill in the US in early January 2026.
- The company has also submitted oral semaglutide 25 mg for obesity to the European Medicines Agency (EMA) and other regulatory authorities during the second half of 2025.
- Novo Nordisk received FDA approval for an oral formulation of Wegovy, marking it the first GLP-1 pill cleared in the U.S. for obesity and related cardiovascular risk, with a planned launch in January.
- The approval led to Novo Nordisk shares jumping approximately 8.3%.
- In late-stage testing, the highest sold dose (25 mg) of the oral Wegovy produced roughly 14% average weight loss, and regulators also cleared the pill to reduce cardiovascular events.
- This oral version is expected to broaden access due to its convenience and lack of cold storage requirements, with an initial cash price for the starting dose estimated at $149 per month.
- Internationally, Wegovy also secured conditional approval in Canada for MASH and approval in China to reduce heart attack and stroke risk.
- The U.S. FDA approved a 25 mg oral semaglutide pill (Wegovy) for chronic weight management, which led to Novo Nordisk's U.S. shares jumping about 8%.
- Emcure Pharmaceuticals commercially launched Poviztra, a once-weekly Novo Nordisk semaglutide injection, in India, with competitive pricing starting around ₹8,790 per month for four weekly doses.
- Semaglutide patent expiries are scheduled for March 2026, which is expected to invite lower-cost generics and increase pricing flexibility in the market.
- Veru Inc. reported a net loss of $22.7 million, or $1.55 per share, for fiscal year 2025, which ended September 30, 2025, representing a decrease from the prior fiscal year.
- The company announced positive efficacy and safety results from its Phase 2b QUALITY study for enobosarm, demonstrating preservation of total lean mass and 58% more fat loss compared to the placebo group by the end of the 28-week study.
- Veru received FDA regulatory clarity for enobosarm in combination with GLP-1 RA, confirming incremental weight loss as an acceptable primary endpoint and 3 mg as an acceptable dosage for future clinical development.
- The company plans to initiate the Phase 2b PLATEAU clinical study in Q1 calendar year 2026, with interim analysis results anticipated in Q1 calendar year 2027.
- Post fiscal year end, Veru completed a public offering, generating net proceeds of approximately $23.4 million.
- Novo Nordisk filed a supplemental New Drug Application with the FDA for approval of Wegovy® injection 7.2 mg, a higher dose intended to provide greater weight loss potential for adults with obesity.
- In the 72-week STEP UP Phase 3 trial, patients taking semaglutide 7.2 mg achieved an average weight loss of 20.7%, compared to 17.5% with the currently approved 2.4 mg dose.
- The submission will undergo an accelerated review process of 1-2 months under the FDA's Commissioner's National Priority Voucher pilot program.
- The European Medicines Agency's Committee for Medicinal Products for Human Use (EMA CHMP) has issued a positive opinion for Novo Nordisk's higher dose of Wegovy (semaglutide 7.2 mg), signaling a step closer to approval for use in the EU.
- Clinical trials showed the new dose resulted in an average weight loss of 20.7% over 72 weeks in people with obesity who do not have diabetes, with one-third of participants achieving 25% or more weight loss.
- This formulation primarily targets fat loss while maintaining muscle function and offers additional benefits, including reduced risks of cardiovascular events and relief from knee osteoarthritis pain.
- Novo Nordisk is also pursuing regulatory reviews in the U.S., U.K., and other countries, with potential for expedited FDA review in the U.S. due to a Commissioner's National Priority Voucher, possibly leading to availability early next year.
- Novo Nordisk's CEO has indicated the company is "all in" on the upcoming launch of oral semaglutide for weight loss, emphasizing robust supply readiness ahead of an anticipated year-end FDA decision.
- Despite low top-of-mind awareness for its obesity indication (14% of primary care physicians and 11% of endocrinologists), physicians are highly familiar with oral semaglutide from its use in type 2 diabetes.
- A significant majority of physicians, 88% of primary care physicians and 91% of endocrinologists, expect to prescribe oral semaglutide within the first six months of its launch for obesity.
- Primary care physicians overwhelmingly prefer oral semaglutide (71%) over competing pipeline compounds, driven by familiarity with semaglutide and the appeal of an oral option.
- Structure Therapeutics' experimental oral GLP-1 small molecule, aleniglipron, achieved 11.3–12.1% average body-weight loss at 36 weeks with lower doses and 14.2–15.3% with higher titrated doses in mid-stage trials.
- The trials reported high gastrointestinal side effects, including 65% nausea and 32% vomiting, leading to an 11% patient discontinuation rate due to adverse events.
- Analysts consider aleniglipron a potential oral challenger to injectable market leaders like Novo Nordisk and Eli Lilly in the GLP-1 market, which is projected to be worth $150 billion annually by the early 2030s.
- Structure Therapeutics plans to begin a late-stage (Phase 3) trial in mid-2026, with tolerability and real-world safety being critical for its commercial uptake.
- Novo Nordisk has entered into a licensing agreement with Omeros Corporation for the clinical-stage MASP-3 inhibitor, zaltenibart (formerly OMS906), gaining exclusive global rights for its development and commercialization.
- The agreement includes an upfront payment of $240 million to Omeros and eligibility for up to $2.1 billion in total milestone payments and royalties.
- Zaltenibart is a first-in-class humanized monoclonal antibody targeting MASP-3, which Novo Nordisk aims to position as a best-in-class treatment for rare blood and kidney disorders.
Quarterly earnings call transcripts for NOVO NORDISK A S.
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