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STOCK RECAP #PipelineProspector

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Pipeline Prospector 2025 highlights: FDA approves pill version of Novo’s Wegovy; BioMarin acquires Amicus for US$ 4.8 bn
Even though the biotech indices delivered strong gains through 2025, December closed on a muted note. The Nasdaq Biotechnology Index (NBI) declined 1.12 percent in December, slipping from 5,772.06 to 5,707.20. The SPDR S&P Biotech ETF (XBI) was largely flat, edging up 0.07 percent from 121.85 to 121.93. Meanwhile, the S&P Biotechnology Select Industry Index (SPSIBI) fell 0.62 percent, from 9,588.09 to 9,528.24.Overall, biotech indices showed sharp gains during 2025. From January to December, NBI rose 31.48 percent, climbing from 4,340.87 to 5,707.20. XBI gained 34.06 percent over the same period, increasing from 90.95 to 121.93, while SPSIBI jumped 36.52 percent, advancing from 7,023.04 to 9,528.24.The year saw the world’s largest pharmaceutical market put pressure on drugmakers to invest and reduce drug prices. In December, US President Donald Trump and nine major drugmakers — including Bristol Myers Squibb, Gilead Sciences, Merck, Genentech, Novartis, Amgen, Boehringer Ingelheim, Sanofi and GSK — announced agreements to lower prescription drug prices for the Medicaid program and for cash-paying patients under a most-favored-nation (MFN) pricing framework. These announcements built on earlier MFN pricing agreements the administration had signed with Pfizer and AstraZeneca.During 2025, several big drugmakers announced new US investments to avert the looming threat of import tariffs. In all, drugmakers pledged over US$ 370 billion in the US in 2025.In December, the US also finalized a trade agreement with the UK, eliminating US tariffs on British pharmaceutical products and medical technology for at least three years in return for Britain spending more on medicines and overhauling how it values drugs. Access the Pipeline Prospector Dashboard for December 2025 Newsmakers (Free Excel) FDA approves pill version of Novo’s Wegovy, GSK’s treatment for eosinophilic asthma okayedRegulatory approvals remained a major theme in December 2025. Novo Nordisk (stock up 4 percent in December) gained an edge in the obesity market after the FDA approved the oral pill version of its blockbuster Wegovy (semaglutide) for weight management and reduction of cardiovascular risk in overweight and obese patients. The drug is approved for maintenance doses of up to 25 mg. On December 16, GSK secured FDA approval for Exdensur (depemokimab) as an add-on maintenance treatment for patients aged 12 and older with eosinophilic asthma. During the same week, UK regulators approved Exdensur for both asthma and nasal polyps. GSK also received FDA approval for a label expansion of Blujepa (gepotidacin) — now approved as a treatment for gonorrhea for the same age bracket.California-based Innoviva received FDA approval for Nuzolvence (zoliflodacin), a first-in-class oral antibiotic for uncomplicated gonorrhea for patients aged 12 and older. Milestone Pharmaceuticals secured FDA approval for Cardamyst (etripamil), becoming the the first and only approved nasal spray to treat acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT), a type of abnormal heart rhythm.Cytokinetics secured FDA approval for Myqorzo (aficamten), an oral treatment for obstructive hypertrophic cardiomyopathy. The approval marks the company’s first FDA-cleared product.Vanda Pharmaceuticals received FDA approval for Nereus (tradipitant) to prevent motion-induced vomiting, becoming the first new FDA-approved treatment for the condition in more than 40 years.US-based Agios Pharmaceuticals won FDA approval to expand the use of mitapivat, sold as Aqvesme, to treat anemia in adults with alpha- or beta-thalassemia, making it the first oral therapy for anemia in both transfusion-dependent and non-transfusion-dependent patients. Access the Pipeline Prospector Dashboard for December 2025 Newsmakers (Free Excel) BioMarin acquires Amicus for US$ 4.8 bn, Sanofi buys Dynavax, Shionogi bags Tanabe’s ALS bizDecember 2025 witnessed some mid-sized deals. BioMarin Pharmaceutical (stock up 6 percent) agreed to acquire Amicus Therapeutics in an all-cash transaction valued at approximately US$ 4.8 billion, marking the largest deal in BioMarin’s 28-year history. The acquisition adds two approved and fast-growing rare disease therapies — Galafold (migalastat) for Fabry disease and the Pompe disease combination treatment Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) — to BioMarin’s portfolio.Sanofi announced the acquisition of Dynavax Technologies for around US$ 2.2 billion (€1.9 billion). The transaction, all cash, strengthens Sanofi’s vaccine portfolio with an approved adult hepatitis B vaccine and an experimental shingles shot. In all, Sanofi cracked over a dozen deals in 2025.Japan-based Shionogi agreed to acquire Tanabe Pharma’s ALS business for US$ 2.5 billion, gaining both the oral and intravenous formulations of Radicava (edaravone), a US Food and Drug Administration (FDA)-approved treatment for amyotrophic lateral sclerosis (a progressive neurodegenerative disorder). Under the deal, Tanabe Pharma will set up a new company in the US to hold the rights to Radicava, which Shionogi will then acquire outright. Access the Pipeline Prospector Dashboard for December 2025 Newsmakers (Free Excel) Lilly to build new API plant in Alabama for its GLP-1 drug; Ultragenyx faces phase 3 setbackThe year 2025 was a good year for Eli Lilly — it inked nearly 30 deals through the year and became the first healthcare company in the world to reach a market capitalization of US$ 1 trillion in November. Lilly closed the year by pledging over  US$ 6 billion towards building a new API manufacturing facility in Huntsville, Alabama. The plant will produce small-molecule and peptide medicines, including orforglipron, Lilly’s oral GLP-1 weight-loss drug. Earlier in the year, Lilly had committed US$ 27 billion towards expanding US manufacturing capacity. After failing to bag an FDA approval for its rare disease gene therapy in July, Ultragenyx Pharmaceutical faced yet another setback in December when a late-stage trial of its experimental drug setrusumab failed to meet its primary endpoint in children and young adults with osteogenesis imperfecta (brittle bone disease). The trials were conducted in partnership with Mereo BioPharma. Ultragenyx’s stock was down 33 percent in December.There was some good news for patients suffering from Duchenne muscular dystrophy (DMD). Capricor Therapeutics reported positive phase 3 results for its DMD cell therapy — deramiocel. This success comes after Sarepta’s gene therapy Elevidys (delandistrogene moxeparvovec-rokl) suffered a setback in June, following patient deaths. Access the Pipeline Prospector Dashboard for December 2025 Newsmakers (Free Excel) Our viewThe pharmaceutical industry is growing at a healthy rate, and is expected to attain a size of US$ 1.19 trillion in 2026 (up from US$ 1.16 trillion in 2025). The industry is also expected to witness innovations, especially in fields such as weight management, rare diseases and oncology.However, we do expect some tug-of-war on drug prices. According to a Reuters report, drugmakers plan to raise US prices on at least 350 branded medications including some vaccines, even as the US administration pressures them for price cuts.On the geopolitical front, 2026 began with the US military capturing Venezuelan president Nicolás Maduro. Such developments can add to the volatility and uncertainties in the market, impacting supply chains, energy prices and investor sentiments. 

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https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-2025-highlights-fda-approves-pill-version-of-novo-s-wegovy-biomarin-acquires-amicus-for-us-4-8-bn

#PharmaFlow by PHARMACOMPASS
08 Jan 2026

NEWS #PharmaBuzz

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https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-fda-approval-of-nereus-tradipitant-for-the-prevention-of-vomiting-induced-by-motion-a-historic-scientific-milestone-in-the-prevention-of-motion-sickness-302650965.html

PR NEWSWIRE
30 Dec 2025

https://www.prnewswire.com/news-releases/fda-lifts-partial-clinical-hold-on-tradipitant-for-motion-sickness-302633583.html

PR NEWSWIRE
04 Dec 2025

https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-provides-regulatory-update-on-tradipitant-for-motion-sickness-302627878.html

PR NEWSWIRE
28 Nov 2025

https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-positive-results-for-tradipitant-in-preventing-glp-1-induced-nausea-and-vomiting-302617739.html

PR NEWSWIRE
18 Nov 2025

https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-third-quarter-2025-financial-results-302598878.html

PR NEWSWIRE
29 Oct 2025

https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-collaborative-framework-for-resolution-of-disputes-with-the-us-food-and-drug-administration-302573077.html

PR NEWSWIRE
01 Oct 2025