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DATA COMPILATION #PharmaFlow

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Prostaglandin market to cross US$ 1.27 bn by 2035; Liquidia’s Yutrepia okayed for pulmonary hypertension
Prostaglandins are natural fatty acid compounds produced by the human body. They are made from a type of fat known as arachidonic acid and act like messengers, controlling many functions such as inflammation, blood flow, muscle contraction, and fluid drainage in the eye. Prostaglandin APIs are synthetic (lab-made) versions of natural prostaglandins that are used to create medicines. Prostaglandin-based medicines are used in obstetrics and gynecology, gastroenterology, urology, and cosmetics, and their use is also being explored in certain cardiovascular and respiratory conditions. One of the largest and most important uses of prostaglandin APIs is in ophthalmology (eye care), where they are used as first-line therapy for open-angle glaucoma (a chronic, progressive eye disease) and ocular hypertension (a condition where pressure inside the eye is consistently higher than normal). In ophthalmic applications, these drugs usually serve as prodrugs – inactive in the formulation but converted into their active form after entering the eye.According to estimates, the global prostaglandin market is valued at US$ 0.63 billion in 2025 and is poised to grow from US$ 0.68 billion in 2026 to US$ 1.27 billion by 2035, growing at a CAGR of 7.1 percent between 2026 and 2035.Prostaglandin API manufacturing is a highly specialised field, with only a few experienced manufacturers. Companies such as EUROAPI, Cayman Pharma, Chirogate International, Kyowa Pharma Chemical, Everlight Chemical, and Yonsung Fine Chemicals are key players with strong capabilities in complex chemistry.FDA allows Glaukos’ iDose TR to be re-administered for treating eye diseases; approves Liquidia’s Yutrepia The prostaglandin market continues to see steady regulatory activity and innovations. In ophthalmology, Glaukos Corporation’s iDose TR received a labelling supplement from the US Food and Drug Administration (FDA) that allows for re-administration of the medication indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). The intracameral implant was originally approved in December 2023 for single use. This update was supported by long-term safety data demonstrating good tolerability in patients with OAG and OHT. Similarly, Santen Pharmaceutical secured manufacturing and marketing approval in Japan for Setaneo (sepetaprost) ophthalmic solution 0.002% in August 2025 for the treatment of glaucoma and OHT. In April 2025, Santen also received approval in China for Tapcom (tafluprost + timolol maleate), a preservative-free fixed-dose combination therapy that lowers intraocular pressure (IOP) in patients with OAG and OHT.Beyond ophthalmology, prostaglandin APIs are also driving advancements in respiratory care. Liquidia Corporation received FDA approval in May 2025 for Yutrepia (treprostinil) inhalation powder for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). While PAH is a serious and progressive disease where blood pressure in the lung arteries rises, causing them to narrow and harden, PH-ILD is a serious complication in which high blood pressure develops in the lung arteries due to lung scarring. Yutrepia is the first and only prostacyclin dry-powder formulation enabled by Liquidia’s proprietary technology.  Access the Interactive Dashboard on Prostaglandin Developments (Free Excel Available)Nicox’s drug scores phase 3 win in glaucoma, OHT; United seeks expanded approval for Tyvaso to treat pulmonary fibrosisInnovation in prostaglandins is increasingly focused on enhanced efficacy and sustained drug delivery. French ophthalmology company Nicox has reported positive phase 3 results for its ophthalmic solution NCX 470, demonstrating consistent lowering of intraocular pressure in OAG and OHT. Nicox is likely to submit a new drug application for NCX 470 sometime soon, with a potential approval and launch expected in 2027.Meanwhile, US-based SpyGlass Pharma is advancing sustained-release innovation through intraocular lens (IOL)-based and ring-based drug delivery systems. Its Bimatoprost Drug Pad–Intraocular Lens (BIM-IOL) system (currently in phase 3 trials) integrates drug delivery with cataract surgery to enable sustained therapy for up to three years. The company is also developing a preclinical Bimatoprost Drug Ring System (BIM-DRS) designed for similarly extended drug release. In respiratory indications, Insmedis progressing treprostinil palmitil inhalation powder through phase 3 trials for PH-ILD, as well as for idiopathic pulmonary fibrosis and PAH.Additionally, United Therapeutics is expanding the clinical scope of Tyvaso DPI (treprostinil). Following its global approval in 2022 for PAH, the therapy is now under regulatory review in the US and Canada for progressive pulmonary fibrosis and idiopathic pulmonary fibrosis.  Access the Interactive Dashboard on Prostaglandin Developments (Free Excel Available)Glaukos sets up new R&D facility in Alabama, Inke acquires Pharmanoid to strengthen presence in prostaglandins Several players are expanding capacities due to rising demand across ophthalmology. Glaukos Corporation is setting up a new research, development, and manufacturing facility in Huntsville, Alabama. The planned 200,000 square-foot site, to be built on a 25-acre campus in Cummings Research Park, envisages an investment of over US$ 80 million. Expected to be completed by 2030, the facility is designed to augment the company’s existing infrastructure and support long-term growth, particularly in ophthalmic therapies including sustained-release drug delivery systems.EUROAPIis undertaking a significant capacity expansion at its Budapest site. The company has committed €50 million (US$ 54.8 million) to install a new state-of-the-art production plant focused on prostaglandins. The project aims to debottleneck existing operations and introduce new multi-purpose manufacturing equipment, ultimately more than doubling the site’s prostaglandin production capacity by 2027. The expansion will also strengthen EUROAPI’s highly potent API (HPAPI) capabilities.Alongside capacity additions by established players, the market is also witnessing consolidation and capability expansion through acquisitions. For instance, Essential Pharma acquired Ventavis (iloprost trometamol) from Bayer AG, including rights to the accompanying Breelib nebuliser delivery technology. Ventavis, a prostacyclin analogue, is a well-established treatment for adult patients with primary pulmonary hypertension.Inke strengthened its presence in ophthalmology-focused high-potency APIs (HPAPIs), including prostaglandins, through the acquisition of Pharmanoid in December 2025. Backed by regulatory approvals across 25+ countries, Pharmanoid enhances Inke’s capabilities in complex API production and supports its ambition to build a leading European platform for advanced API development and manufacturing. The Barcelona facility is capable of producing and handling APIs across all potency levels while adhering to SafeBridge Scale OEB4 (Occupational Exposure Band 4) containment protocols, a classification for high-potency substances requiring strict controls to limit occupational exposure.With more than two decades of experience, Inke is recognized for innovating and manufacturing high-quality APIs, delivering expertise, safety, and excellence across inhalation, CNS, and ophthalmic therapies, while supporting pharmaceutical companies worldwide. The ophthalmic API commercial portfolio includes bimatoprost, latanoprost, tafluprost, and travoprost, while the next-generation prostaglandin analog pipeline includes bimatoprost grenod and latanoprostene bunod.  Access the Interactive Dashboard on Prostaglandin Developments (Free Excel Available)Our viewInnovation is guiding the prostaglandins market towards long-acting, sustained-release formulations and novel delivery systems. These innovations are driving steady growth in prostaglandins, while capacity expansions are strengthening capabilities in complex and highly potent APIs. Overall, this remains a niche but important market to watch. 

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https://www.pharmacompass.com/radio-compass-blog/prostaglandin-market-to-cross-us-1-27-bn-by-2035-liquidia-s-yutrepia-okayed-for-pulmonary-hypertension

#PharmaFlow by PHARMACOMPASS
14 May 2026

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

NEWS #PharmaBuzz

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https://www.businesswire.com/news/home/20260518051865/en/United-Therapeutics-Corporation-Announces-TETON-1-Study-of-Tyvaso-Published-in-The-New-England-Journal-of-Medicine-and-Presented-at-ATS-2026

BUSINESSWIRE
18 May 2026

https://www.businesswire.com/news/home/20260330163294/en/United-Therapeutics-Corporation-Announces-TETON-1-Pivotal-Study-of-Tyvaso-Meets-Primary-Endpoint-for-Treatment-of-Idiopathic-Pulmonary-Fibrosis-Exceeding-Impressive-Treatment-Effect-Seen-in-TETON-2

BUSINESSWIRE
30 Mar 2026

https://www.fiercepharma.com/pharma/united-plots-tyvaso-fda-filing-after-repeat-success-lung-disease-portends-new-ipf-standard

FIERCE PHARMA
30 Mar 2026

https://www.pharmiweb.com/press-release/2025-09-19/united-therapeutics-corporation-to-review-data-from-the-successful-teton-2-pivotal-study-of-nebulize

PHARMAWEB
19 Sep 2025

https://www.reuters.com/sustainability/boards-policy-regulation/united-therapeutics-shares-hit-record-high-after-late-stage-win-lung-disease-2025-09-02/

REUTERS
03 Sep 2025

https://liquidia.com/news-releases/news-release-details/liquidia-receives-50-million-healthcare-royalty-hcrx-following

PRESS RELEASE
23 Jun 2025