Eyes On MASH, IPF, and the MFN pricing program

We've had Eyes on MASH, IPF, and MFN Pricing. The latest M&A between Novo Nordisk and Akero Therapeutics focusing on MASH caught our eye, as well as Boehringer's newly approved Jascayde will provide a much needed new oral option for IPF patients -helping increase lung capacity and reducing the deterioration of lung function. We also saw that several more companies are working with the US on MFN pricing and domestic manufacturing.

Novo Nordisk has agreed to pay up to $5.2 billion to acquire Akero Therapeutics, setting the stage for a battle with Roche and other companies in the lucrative liver disease sector.When data was released in February that an analyst hailed as revolutionary, Akero’s share price doubled, solidifying its position as a major player in the metabolic dysfunction-associated steatohepatitis (MASH) field’

It was recently revealed that Roche increased negotiations with 89bio, one of Akero's main competitors, in response to the findings. In order to acquire the biotech’s FGF21 analogue, pegozafermin, Roche completed its 89bio acquisition last month.

Novo Nordisk has now agreed to pay roughly $4.7 billion up front to acquire Akero. The upfront deal value, at $54 per share, is 19% higher than the average price of Akero’s stock over the previous 30 days. In the immediate wake of the February data decline, the biotech’s stock price surged as high as $57. If efruxifermin (EFX) receives complete U.S. regulatory approval for the treatment of compensated cirrhosis caused by MASH by mid-2031, Akero stockholders could benefit by an additional $6 per share. The deal’s overall value could rise to $5.2 billion due to the contingent value right.

The investment will provide Novo with an additional strategy to target the MASH market. The FGF21 analogue EFX is in a phase 3 program and is expected to begin data delivery in the first half of 2026. According to Akero, the phase 3 program's assessment of EFX will proceed more quickly because of Novo’s expertise in cardio-metabolic disease.

Although the precise date Novo started pursuing Akero is unknown, the biotech apparently got buyout interest back in May. According to a statement from the new CEO, Mike Doustdar, EFX has the potential to be a key treatment for one of the metabolic diseases that is expanding the fastest in our time, either by itself or in combination with Wegovy.

In August, Novo’s Wegovy in MASH received FDA approval. Novo will have to compete for the chance. Rezdiffra from Madrigal Pharmaceuticals has already received MASH approval, and several other businesses are vying for it. With its agreement to pay up to $3.5 billion to acquire 89bio, Roche is expected to enter the contest. Since its April U.S. introduction, Madrigal’s Rezdiffra has had a great start to the year. The drug made $350 million in the first half of this year.

For more details:

PharmaTell Studio

PharmaTell Studio

PharmaTell Studio

PharmaTell Studio

Reuters

With a recently approved treatment option, Boehringer Ingelheim is reviving its leadership in the rare lung disease market, more than a decade after introducing one of the first therapies for idiopathic pulmonary fibrosis (IPF).

As the first novel treatment for IPF in almost ten years, Jascayd’s FDA clearance last week follows in the footsteps of Roche’s Esbriet and the company’s Ofev, both of which received FDA approval in 2014. The two of these drugs together comprise the current treatment market for IPF in the United States.

Boehringer’s novel option has the potential to influence the future of IPF treatment due to its established advantages in lung function and its superior tolerability compared to prior treatments. When compared to patients who got a placebo, those treated with the oral twice-daily medication, also known as nerandomilast, experienced a noticeably reduced decline in forced vial capacity (FVC) over the studies. The maximum volume of air that a person can forcibly expel after taking a deep breath is measured by FVC, a frequent lung disease endpoint.

For individuals with IPF, whose disease worsens over time and more than half of them pass away within five years of diagnosis, Jascayd may be a vital alternative due to its advantages in increasing lung capacity and reducing the deterioration of lung function. According to Boehringer, the illness might affect up to 3.6 million individuals worldwide and is more lethal than several prevalent tumours. However, only roughly 167,000 people are now receiving treatment due to the underdiagnosis and frequent misdiagnosis, creating a significant market gap.

According to the company, the medication demonstrated a nominally significant decrease in the risk of death in patients with IPF and those with the related condition progressive pulmonary fibrosis (PPF), even if it did not meet the requirements to establish a statistically meaningful survival advantage.

Nevertheless, the business claimed that Jascayd’s profile marks a significant advancement in the IPF field, which has seen more than 36 unsuccessful studies in the last ten years.The business is now prepared to ensure that patients have prompt access to the new therapy option. Since every day matters to IPS patients, Boehringer is prepared to deliver the medication in a matter of days.

Boehringer has almost ten years of IPF experience with Ofev, which provides a solid basis for Jascayd’s market debut. With $4 billion in sales last year, Ofev is still a top seller for Boehringer and is by no means outdated. Whether Jascayd can live up to its successful predecessor is still up in the air.

The team noted in a note to clients that they anticipate strong medication uptake given the limitations of the older medicines. However, they contended that the medicine represents a modest advancement because it has a relatively little effect on lung function, leaving potential for new competitors. 

According to the analysts, Jascayd’s approval marks a shift in the direction of IPF medication development and a sign that the future of standard of care will be very different. Boehringer has a lot of competition ahead of it since a number of other businesses are vying for market share in the IPF arena. Tyvaso, a nebulised inhalation solution from United Therapeutics, achieved a phase 3 victory last month, with United officials describing the results as extremely positive.

Both Boehringer and United are researching their respective medications in PPF, which is an additional indication that Boehringer is pursuing with the FDA.

For more details:

PharmaTell Studio

PharmaTell Studio

PharmaTell Studio

Fierce Pharma

President Trump’s most favoured nation (MFN) medication price program has identified another pharmaceutical heavyweight that is willing to comply. AstraZeneca said last week that it had secured a deal to reduce costs for eligible patients in the United States who have prescriptions for chronic illnesses and will take part in the TrumpRx direct-to-patient marketing website.

Pfizer became the first pharmaceutical business to specifically meet Trump’s MFN objectives late last month. The president is urging businesses to market their medications directly to patients as part of the MFN pricing strategy, which aims to bring U.S. prices into line with lower rates abroad.

Outlining those aims, the president wrote letters to the executives of 17 major pharmaceutical companies in July. He issued a deadline of September 29th for the industry leaders to present their pledges and threatened to use every weapon in his disposal to get companies to comply.In his letters, the president also urged the pharmaceutical companies to engage in more aggressive pricing negotiations with other nations and to bring back more of their overseas profits to the United States in order to help drive down local prices. AstraZeneca stated that its agreement fulfils every requirement the president has made.

Since Trump delivered the letters, businesses have been open to adopting some of the president’s proposals. Bristol Myers Squibb and AbbVie, two of the biggest pharmaceutical companies, have promised to provide new medications at premium, US-level costs in the UK.

The president’s DTC agenda has gained support from a wider range of businesses. Businesses like Amgen, AZ, BMS, Novartis, and Boehringer Ingelheim have implemented initiatives to provide their goods to patients who are willing to pay cash at significant savings over the list costs of their medications.

Last month, Pfizer became the first to formally sign a full agreement with the administration at a ceremony hosted by the Oval Office. The company agreed to provide TrumpRx with an average 50% discount on the vast majority of its primary care treatments as well as a few chosen speciality brands. Additionally, the business promised to invest $70 billion in the United States in the upcoming years. Pfizer was offered a three-year reprieve from possible pharmaceutical tariffs in exchange.

As part of the agreement, AstraZeneca obtained a three-year tariff exemption, much like Pfizer. Although the corporation stated that it will offer reductions of up to 80% off list pricing, other details of the agreement are still classified.

Crucially, the MFN scheme’s currently advertised discounts are only for patients who pay with cash and are unlikely to help the majority of Americans. As part of regular insurance coverage negotiations, the pharmaceutical sector already offers discounts on its medications; last year, a number of leading drugmakers averaged reductions of up to 50%.

The discounts in the instance of AstraZeneca are applicable to Medicaid costs. The system accounts for less than 5% of the company’s U.S. sales, according to analysts.

Trump administration representatives spoke about their intentions to announce a number of follow-up agreements with pharmaceutical behemoths at the Pfizer event late last month. AstraZeneca, meanwhile, has already completed a significant item on Trump’s agenda by deciding to begin construction on a $4.5 billion pharmaceutical facility in Virginia last week.

For more details:

PharmaTell Studio

PharmaTell Studio

PharmaTell Studio

AHA

By investing $248 million to construct a plant in Holly Springs, North Carolina, auto-injector expert Ypsomed is joining the American manufacturing trend. It will be the company’s first plant in the United States.

The declaration follows President Trump’s announcement two weeks ago that businesses who manufacture pharmaceutical items in the United States or establish domestic manufacturing facilities would not be subject to a proposed 100% tariff on medications imported into the country.

In a transaction valued at up to $513 million, Ypsomed sold its insulin pump development division to TecMed, a Swiss business, six months ago. The change enables Ypsomed to concentrate on the creation and manufacturing of self-injectors, which are used to administer GLP-1 drugs.

The decision also emphasises how crucial it is to establish alliances with biopharma businesses, something Ypsomed believes can be more successfully achieved with an operation in North Carolina.

According to the company, Ypsomed is purchasing a 160,000 square foot building in Holly Springs that offers space for expansion. Its initial building phase will be financed by the investment. In the beginning, Ypsomed anticipates creating 100 job opportunities, with ambitions to grow to 200 as demand rises.

By the end of 2027, the location will start supplying goods to the American market.Just 5% to 6% of Ypsomed’s medicines are transported to the United States, the company stated at an investor event last month. However, relocating to North Carolina is likely to alter that.

According to analysts, concerns regarding Ypsomed’s reliance on Novo Nordisk and uncertainties around the development of Cagrisema, the Danish company’s next-generation obesity treatment, are major factors contributing to the current spike in the Ypsomed’s share price pressure.

Earlier this year, Ypsomed launched a new manufacturing facility in Changzhou, China. Additionally, the company is investing several hundred million Swiss francs to upgrade the infrastructure at its production facility in Schwerin, Germany. Furthermore, it is investing 200 million Swiss francs to expand its location in Solothurn, Switzerland. According to the company, its global growth plan is intended to accommodate the growing demand for injection systems for self-medication on a global scale and to improve customer proximity.

For more details:

PharmaTell Studio

PharmaTell Studio

NCBiotech

Johnson & Johnson found itself in a challenging situation since, the pharmaceutical company has not yet reached a formal pricing agreement with the government.

However, J&J’s CEO’s remarks indicate that the business is generally in line with many of President Trump’s policy objectives regarding the cost and production of medications—and that a beneficial arrangement similar to those reached by Pfizer and AstraZeneca may be imminent.

The corporation has maintained an open line of communication with this government since day one and is constantly searching for areas of agreement to expand on the administration’s initiatives that align with our own. Priorities include ensuring that American patients can rapidly and affordably access innovation; preventing foreign entities from taking advantage of American innovation; ensuring that they can continue to maintain their position as the nation’s leader in the life sciences; and, lastly, ensuring that they keep investing in domestic manufacturing to create good middle-class jobs.

J&J is dedicated to achieving each of those goals, according to CEO Joaquin Duato. These goals are similar to many of the talking points the administration made this summer when it pressured 17 major pharmaceutical companies to adopt Trump’s most favoured nation (MFN) strategy for medicine pricing and sales.The framework essentially aims to match the cost of branded medications in the United States to that of more industrialised nations abroad. The President has also made harder negotiations on prescription prices in other countries and direct-to-consumer sales channels important parts of the MFN agenda.

Last week, Duato stated that talks between J&J and the administration are still going on, adding that he felt hopeful but was unable to provide specifics. With the exception of the announcement that it intends to spin off its orthopaedics company, J&J’s third-quarter results call was essentially business as usual.

In its most recent three-month financial period, J&J’s sales increased 6.8% to $24 billion. J&J’s new medicine engine was booming, delivering overall sales that were marginally higher than the almost $16 billion analyst consensus projection for the period.

Specifically, the business claimed that 11 of J&J’s new medications experienced double-digit growth in Q3. The business was particularly excited with Tremfya, J&J’s replacement for Stelara, which increased revenue by almost 40% to $1.4 billion between July and September. It is anticipated that the double-digit performers on that list—which also includes medications like Darzalex, Erleada, Spravato, and Caryvkti—will propel J&J’s growth for the remainder of the decade.

The business also highlighted Inlezxo, its most recent FDA-approved medication release device for bladder cancer, which was approved in early September. With confidence that the bladder cancer medicine is a $5 billion or more asset for the corporation, J&J’s Inlexzo field team is now fully launched. Physicians are already excited about the medicine.Following reports that J&J is seeking to acquire its immunology partner Protagonist Therapeutics, a deal that could value Protagonist at well over $4 billion, the executives stated that J&J intends to concentrate the majority of its financial resources internally, with much of the focus being on its current crop of branded drugs. In the meantime, J&J has raised its revenue forecast for the entire year in light of its performance during the quarter. From a previous range of $93.2 billion to $93.6 billion, the company now projects sales in 2025 to be between $93.5 billion and $93.9 billion.

For more details:

PharmaTell Studio

PharmaTell Studio

BioSpace

Introducing Eyes on Pharma AI Summary 

This new function, available for all 2025 Reports, gives you:     

✅ A quick guide to each report     

✅ Faster relevance checks     

✅ A clearer starting point for deeper analysis

With Eyes on Pharma: AI Summary, you’ll be able to determine in seconds whether a report is worth diving into, saving you valuable time while keeping you ahead.

View the Intro Video here: Intro to Eyes on Pharma | AI Summaries

If you are a PharmaTell Client, Login to PharmaTell Studio and check them out now.

If you are not a client drop us a note to get more info and a free demo, info@pharmatell.com.