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STOCK RECAP #PipelineProspector

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Pipeline Prospector September 2025: Genmab buys Merus for ~US$ 8 billion, Pfizer buys Metsera to enter obesity race
September saw a major clampdown on imports of “branded or patented drugs” into the US, the world’s largest market for pharmaceuticals. Under the Trump administration’s policy, a 100 percent tariff on branded drugs imported by companies, which are not building plants in the US, took effect on October 1. This policy has led to confusion and raised many questions. While Singapore has sought clarifications, European drugmakers are wondering whether the trade deal signed by US President Donald Trump and European Commission President Ursula von der Leyen in July (with a flat tariff of 15 percent on EU pharmaceutical products) still applies or not.On their part, drugmakers continue to pledge investments into the US, with Eli Lilly and GSK announcing fresh investments in September.The UK, on the other hand, is facing withdrawals of planned investments. Drugmakers such as Sanofi, AstraZeneca, and Merck have either paused or suspended planned investments, due to the government's decision in June to nearly double the “clawback rate”, requiring companies to return 31.3 percent of sales on newer branded medicines to the National Health Service, up from 15.5 percent previously.The debate over vaccines continued in the US. However, the turbulence in the country’s regulatory and policy environment didn’t impact the pharma indices. The Nasdaq Biotechnology Index (NBI) rose 3.45 percent from 4,717.10 to 4,879.90 over the month. The SPDR S&P Biotech ETF (XBI) gained 9.76 percent from 91.29 to 100.20. And the S&P Biotechnology Select Industry Index (SPSIBI) climbed 11.53 percent from 6,998.36 to 7,805.59. Access the Pipeline Prospector Dashboard for September 2025 Newsmakers (Free Excel)Genmab buys Merus for US$ 8 billion; Pfizer enters obesity race with acquisition of MetseraAs September drew to a close, Genmab announced the acquisition of Netherlands-based Merus in deal worth approximately US$ 8 billion. The deal gives Genmab full rights to petosemtamab, an experimental two-in-one antibody drug for head and neck cancer. Overall, the buyout will strengthen Genmab’s pipeline of wholly owned late-stage cancer assets.After discontinuing the development of two experimental weight loss drugs, Pfizer finally joined the obesity race with the acquisition of Metsera and its next-generation obesity portfolio in a deal valued at up to US$ 7.3 billion.Roche agreed to buy San Francisco-based 89bio for up to US$ 3.5 billion. At the centre of the deal is the company’s lead drug pegozafermin, a late-stage candidate for metabolic dysfunction-associated steatohepatitis (MASH), a progressive liver disease tied to obesity.Novartis was the busiest dealmaker in September. The Swiss group struck several high-value deals across cardio, neurology and immunology. It has signed a licensing and options deal worth up to US$ 5.2 billion with China-based Argo Biopharmaceuticals for its experimental RNAi drug candidates targeting cardiovascular disease. The pact also gives Novartis options on two earlier-stage drugs, including one for mixed dyslipidemia (a condition characterized by high triglycerides and low levels of HDL-C, or good cholesterol), and another RNA-based therapy expected to enter trials next year.Novartis also struck an exclusive worldwide collaboration with Arrowhead Pharmaceuticals valued at up to US$ 2 billion. The deal focuses on Arrowhead’s experimental therapy ARO-SNCA, which targets Parkinson’s and related neurological conditions.Further, Novartis signed a deal worth up to US$ 5.7 billion with Monte Rosa Therapeutics to develop new drugs for immune diseases. Separately, Novartis is buying Tourmaline Bio for US$ 1.4 billion. Access the Pipeline Prospector Dashboard for September 2025 Newsmakers (Free Excel) FDA approves Lilly’s advanced breast cancer drug, J&J’s Inlexzo for bladder cancer, injectable version of KeytrudaThe month saw several key drug approvals by the US Food and Drug Administration (FDA). The agency approved Johnson & Johnson’s new bladder cancer treatment Inlexzo (gemcitabine) for patients who don’t respond to standard Bacillus Calmette-Guerin therapy (an immunotherapy for early stage bladder cancer) and cannot or choose not to undergo bladder removal surgery.The agency also approved Eli Lilly’s Inluriyo (imlunestrant) for advanced or metastatic breast cancer in adult patients who have received prior therapy.Patients with edema that is caused by heart, liver or kidney disease now have a new option — Enbumyst (bumetanide), the first FDA approved nasal spray for edema.FDA also approved Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), a new under-the-skin version of Merck’s cancer drug Keytruda (pembrolizumab). This option can now be used in most adults and teens with solid tumors, covering the same indications as the intravenous version.Crinetics’ Palsonify (paltusotine), the first once-daily oral treatment for adults with acromegaly, also received FDA approval. This rare hormonal disorder is caused by benign pituitary tumors that trigger excess growth hormone.Meanwhile, Novartis received FDA approval for Rhapsido (remibrutinib), the first oral therapy for adults with chronic spontaneous urticaria (a skin condition) whose symptoms persist despite standard treatments. Access the Pipeline Prospector Dashboard for September 2025 Newsmakers (Free Excel) Vertex strikes over US$ 2 bn deal with Enlaza; Merck’s cholesterol drug, United’s pulmonary fibrosis med score trial winsVertex Pharmaceuticals has struck a deal worth over US$ 2 billion with California-based biotech startup Enlaza to develop new autoimmune disease drugs and improve patient “conditioning” methods for gene therapies, like those used in sickle cell disease. The partnership aims for innovative, first-in-class medicines.Samsung Biologics signed a 1.8 trillion won (US$ 1.3 billion) manufacturing agreement with an undisclosed US-based pharmaceutical company. The contract, running through 2029, marks the company’s second-largest deal since it was founded in 2011. In clinical trials, Merck’s investigational oral drug enlicitide decanoate showed strong results in a phase 3 trial for adults with high cholesterol. The pill significantly lowered “bad” LDL cholesterol and other harmful lipid markers, even in patients already on statins or those who can’t tolerate them.Eli Lilly’s Jaypirca (pirtobrutinib) scored a win in a phase 3 trial for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who didn’t respond well to previous treatments. The drug significantly lowered the risk of disease progression or death compared to standard therapy. Lilly plans regulatory filings with the FDA later this year.United Therapeutics’ inhaled drug Tyvaso (treprostinil) showed positive results in a trial for people with idiopathic pulmonary fibrosis (IPF), a serious lung disease. The drug improved lung function and helped slow progression of the disease. Access the Pipeline Prospector Dashboard for September 2025 Newsmakers (Free Excel) Our viewSeptember was yet another turbulent month. Uncertainties over tariffs, the efficacy of vaccines and policies around regulation of the sector in the US have made the business environment for drugmakers difficult, to say the least. Post the pandemic, the industry has learnt to live with volatility and uncertainties. But this resilience can come with some casualties. Let’s hope it’s not innovation and risk-taking. Access the Pipeline Prospector Dashboard for September 2025 Newsmakers (Free Excel)  

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https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-september-2025-pfizer-buys-metsera-to-enter-obesity-race-fda-clears-lilly-s-advanced-breast-cancer-drug

#PharmaFlow by PHARMACOMPASS
02 Oct 2025

WEEKLY NEWS RECAP #Phispers

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Trump, Pfizer seal deal to offer drug discounts; FDA approves Eli Lilly’s oral breast cancer pill
This week, US President Donald Trump announced a deal with Pfizer to sell medicines through a new federal website, TrumpRx.gov, offering substantial discounts for patients not using insurance. Separately, Trump signed an executive order to boost AI research for childhood cancers with US$ 50 million in grants. In another major deal, Genmab announced an US$ 8 billion acquisition of Dutch biotech Merus, strengthening its late-stage cancer pipeline.Meanwhile, Asian pharmaceutical markets faced pressure as 100 percent US tariffs on branded and patented drugs took effect on October 1. In approvals, the FDA cleared multiple drugs, including Eli Lilly’s oral breast cancer drug, Crinetics’ pill for a rare hormonal disorder, and Regeneron’s shot for young children with a rare genetic disorder. Novartis also secured FDA approval for an oral pill to treat adults with a chronic skin condition.In clinical trials, MoonLake’s sonelokimab faced a setback in phase 3 studies for an inflammatory skin condition, while Merck’s Winrevair showed strong efficacy in pulmonary arterial hypertension.Trump announces deal with Pfizer to sell drugs directly to patients at lower pricesPresident Trump announced a deal with Pfizer to sell medicines through a federal website, TrumpRx.gov, offering discounts averaging about 50 percent and reaching as high as 85 percent for patients not using insurance. Pfizer also agreed to launch new drugs at the same price in the US as in other developed countries and to offer most-favored-nation pricing for Medicaid, the government program providing health coverage for low-income Americans. The deal includes a US$ 70 billion investment by Pfizer to reshore US drug manufacturing and a three-year tariff grace period. Pfizer’s shares increased by more than six percent on the day of the announcement.Separately, Trump signed an executive order to boost AI research for childhood cancers, providing US$ 50 million in grants to improve clinical trials, treatments, and prevention strategies. Meanwhile, PhRMA, a US pharmaceutical lobby group, has announced it will launch AmericasMedicines.com in January, letting drugmakers sell medicines directly to patients and connect them with programs offering lower prices.Healthcare stocks in US & Europe surge on Pfizer deal: US and European healthcare stocks rallied after the Trump-Pfizer deal. Europe’s healthcare sector index rose 5.3 percent a day after the announcement of the deal, its biggest one-day gain since 2008. The agreement, seen as less harsh than expected, offers drugmakers clarity after months of pressure over high US medicine costs.Genmab buys Merus for US$ 8 bn to boost cancer drug pipelineGenmab has announced an US$ 8 billion acquisition of Dutch biotech Merus, strengthening its pipeline of late-stage cancer therapies. The all-cash deal is expected to close in early Q1 2026. The acquisition gives Genmab full control of petosemtamab, a potential first- and best-in-class bispecific antibody for recurrent/metastatic head and neck cancer. Genmab hopes to bring the drug to market in 2027 if ongoing phase 3 trials succeed and projects US$1 billion in annual sales by 2029.FDA approves Eli Lilly’s oral drug for advanced breast cancerThe FDA has approved Eli Lilly’s Inluriyo (imlunestrant), an oral drug for adults with advanced breast cancer who have received prior therapy. In a phase 3 trial, Inluriyo cut the risk of the disease getting worse or causing death by 38 percent compared with current hormone therapies. Inluriyo, taken as a once-daily pill, blocks estrogen receptors that drive tumor growth.Okays Crinetics’ pill for rare pituitary disorder: The FDA has approved Crinetics’ Palsonify (paltusotine), the first once-daily oral treatment for adults with acromegaly. This rare hormonal disorder is caused by pituitary tumors that trigger excess growth hormone. Notably, this is the first FDA approval for the California-based company.Clears Regeneron’s Evkeeza shot for children: The FDA has approved Regeneron’s Evkeeza (evinacumab-dgnb) for children aged 1 to under 5 with homozygous familial hypercholesterolemia (HoFH), a rare genetic disorder causing dangerously high cholesterol from birth. Evkeeza was initially approved in 2021 for adults and adolescents aged 12 years and older. It was then approved for children aged 5 to 11 in 2023.Grants approval to Novartis’ Rhapsido for chronic hives: The FDA has approved Novartis’ oral pill Rhapsido (remibrutinib) for adults with symptoms of chronic spontaneous urticaria (a skin condition) despite standard therapies. The twice-daily pill, Rhapsido offers a convenient oral alternative to injectable therapies. Novartis is also testing the drug for other immune conditions.Asian pharma markets take a hit as 100% US tariffs on branded drugs kick inAsian pharmaceutical markets, including India, witnessed pressure as 100 percent US tariffs on imported branded drugs, announced earlier by Trump, took effect on October 1. Regardless, analysts say the impact may be limited, as India’s exports mainly consist of generic medicines, which are unlikely to face the tariffs. On the other hand, European and US pharma shares have remained largely steady. The tariffs target branded and patented medicines and aim to encourage drug production within the US.Roche, Novartis say Trump’s 100% US tariffs unlikely to hit them: Swiss pharmaceutical giants Roche and Novartis said Trump’s 100 percent tariffs on imported branded and patented drugs, which took effect on October 1, are unlikely to impact them. Both companies are investing heavily in US manufacturing, which may be deemed sufficient for exemptions. Roche has begun building a Genentech facility in North Carolina and pledged US$ 50 billion for US manufacturing and R&D, while Novartis announced US$ 23 billion in US investments and plans to start five new sites by year-end.MoonLake’s drug for skin condition hits speed bump in phase 3 trials; Merck’s therapy shows promiseMoonLake’s drug sonelokimab showed mixed results in phase 3 trials for hidradenitis suppurativa, an inflammatory skin condition. One trial met its main goals, while the other missed them due to a stronger-than-expected placebo response. MoonLake plans to discuss the results with regulators. Significantly, Merck & Co. made a nonbinding offer earlier this year valuing MoonLake at over US$ 3 billion. The bid, however, was rejected.Merck’s Winrevair cuts risk of pulmonary hypertension worsening: Merck’s Winrevair (sotatercept-csrk), a first-in-class therapy for pulmonary arterial hypertension (PAH), was approved by the FDA in 2024 for adults with this rare, progressive lung disease to improve exercise ability and slow disease worsening. Now, new results from the phase 3 study show that Winrevair, when added to standard PAH treatments, reduced the risk of disease worsening by 76 percent in patients who were recently diagnosed. 

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https://www.pharmacompass.com/radio-compass-phisper/trump-pfizer-seal-deal-to-offer-drug-discounts-fda-approves-eli-lilly-s-oral-breast-cancer-pill

#Phispers by PHARMACOMPASS
02 Oct 2025

NEWS #PharmaBuzz

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https://www.globenewswire.com/news-release/2026/06/02/3304905/0/en/crinetics-paradigm-shifting-portfolio-and-pipeline-on-display-at-endo-2026-with-six-presentations.html

GLOBENEWSWIRE
02 Jun 2026

https://www.globenewswire.com/news-release/2026/05/07/3290582/0/en/crinetics-pharmaceuticals-reports-first-quarter-2026-financial-results-and-provides-business-update.html

GLOBENEWSWIRE
07 May 2026

https://www.globenewswire.com/news-release/2026/04/27/3282095/0/en/crinetics-pharmaceuticals-announces-the-european-commission-approval-of-palsonify-paltusotine-for-the-treatment-of-acromegaly-in-adults.html

GLOBENEWSWIRE
26 Apr 2026

https://www.ema.europa.eu/en/medicines/human/EPAR/palsonify

EMA
23 Apr 2026

https://www.globenewswire.com/news-release/2026/03/26/3263394/0/en/Crinetics-Pharmaceuticals-Announces-Submission-of-Marketing-Authorization-Application-in-Brazil-for-Palsonify-Paltusotine-in-Acromegaly.html

GLOBENEWSWIRE
26 Mar 2026

https://www.globenewswire.com/news-release/2026/01/04/3212404/0/en/Crinetics-Pharmaceuticals-to-Provide-PALSONIFY-Business-Update-and-Announce-Topline-Results-from-Fourth-Cohort-of-Phase-2-Trial-of-Atumelnant-in-Congenital-Adrenal-Hyperplasia.html

GLOBENEWSWIRE
04 Jan 2026