Latest news with #Ekterly
Yahoo
4 days ago
- Business
- Yahoo
KalVista price target raised to $37 from $22 at BofA
BofA raised the firm's price target on KalVista (KALV) to $37 from $22 and keeps a Buy rating on the shares after the company announced the approval of Ekterly for on-demand treatment of hereditary angioedema attacks with a broad label and no restrictions on type of HAE attack or background LTP usage for patients 12 and older. The firm, which says the approval was in-line with its expectations and it is 'encouraged by the broad label,' remains 'bullish' on Ekterly's differentiation as the only oral on-demand treatment on the market, the analyst tells investors. Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See the top stocks recommended by analysts >> Read More on KALV: Disclaimer & DisclosureReport an Issue KalVista price target raised to $27 from $19 at Citizens JMP KalVista price target raised to $20 from $18 at Leerink Buy Rating for KalVista Pharmaceuticals Driven by FDA Approval and Strategic Market Entry of Ekterly KalVista price target raised to $40 from $32 at Jefferies Musk to launch new political party, Trump threatens BRICS tariff: Morning Buzz Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
WebMD
5 days ago
- Health
- WebMD
FDA Approves First Oral Treatment for Rare Swelling Disorder
July 8, 2025 – The FDA has approved the first-ever pill for a rare genetic swelling disorder. The drug, known as sebetralstat but sold as Ekterly, is for adults and children age 12 years or older with hereditary angioedema (HAE), which affects about 1 in 50,000 people and causes sudden and painful swelling that can sometimes be life-threatening. These easy-to-take pills help stop an attack whenever it happens, offering an advantage over other treatments that need to be injected either into the veins or under the skin. HAE happens when a person has a faulty gene that causes their body to make too little of a protein called C1 inhibitor, or the protein doesn't work well. This protein usually helps control swelling and inflammation in the body. This genetic defect can cause swelling in the face, throat, abdomen, or limbs, which can sometimes be serious. Those with the condition who have swelling in the abdomen can have stomach pain, vomiting, or diarrhea. Swelling in the throat or face can make it hard to breathe. Even with regular treatment, many people with HAE still have sudden attacks and always need fast-acting medicine available to them. "As the first orally administered on-demand therapy for HAE attacks, Ekterly provides patients and physicians with an important and welcome advance in HAE treatment options," Anthony J. Castaldo, chief executive officer of the US Hereditary Angioedema Association, said in a statement. Ekterly was approved after a study involving 136 people with HAE across 20 countries showed that it could quickly relieve symptoms and help end attacks sooner, compared to a placebo, regardless of how severe the attack was. In a follow-up study, many people were able to take the pill within 10 minutes of an attack, and symptoms began to improve in about 1.3 hours, according to a news release from KalVista Pharmaceuticals, the drug's maker. Ekterly works by blocking an enzyme called plasma kallikrein, which causes swelling. In people with HAE, this enzyme is too active because the C1 inhibitor protein does not work properly. By blocking this enzyme, Ekterly helps stop sudden swelling and pain from happening. The pill lets people treat attacks early, giving them more control and helping doctors lower the impact of the disease. According to KalVista, the medicine will be available right away. Headaches are the only reported side effect of the new treatment. It's not known if the medicine is safe during pregnancy or breastfeeding, so patients should tell their doctor if they are pregnant, planning to become pregnant, or breastfeeding. Patients should also tell their doctor if they have liver problems or are taking other medicines, especially for fungal or viral infections, or epilepsy.
Cision Canada
6 days ago
- Business
- Cision Canada
DRI Healthcare Comments on FDA Approval and our Increased Investment in KalVista Pharmaceuticals' Ekterly® (sebetralstat)
– Ekterly is the first and only oral on-demand therapy for treating attacks associated with hereditary angioedema – – DRI Healthcare is entitled to a tiered royalty on worldwide net sales of Ekterly – – KalVista has elected to receive additional funding increasing our total investment to $127 million – TORONTO, July 8, 2025 /CNW/ - DRI Healthcare Trust (TSX: (TSX: DHT.U) ("DRI Healthcare") today announced KalVista Pharmaceuticals ("KalVista") has disclosed it has received approval from the U.S. Food and Drug Administration ("FDA") for Ekterly (sebetralstat). Ekterly is approved for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. HAE is a rare genetic disorder characterized by recurring episodes of severe swelling in various parts of the body, including the face, extremities, gastrointestinal tract, and airways. "We are very pleased that the FDA has approved Ekterly as the first and only oral on-demand therapy for treating HAE attacks," said Ali Hedayat, Chief Executive Officer of DRI Healthcare. "The addition of the long-dated Ekterly cash flows demonstrates the value that a pre-approval transaction can bring to our portfolio." "We congratulate our partners at KalVista, who worked diligently to develop Ekterly to help transform the lives of patients who suffer from HAE," added Navin Jacob, Executive Vice President & Chief Investment Officer. KalVista has notified DRI Healthcare that it has elected to receive the optional payment of $22 million as part of the November 2024 royalty transaction. As a result of receiving this one-time payment, the royalty rate on the first sales tranche steps up and the sales-based milestone amount increases. The transaction now entitles DRI Healthcare to a tiered royalty of 6.00% on net sales up to and including $500 million, 1.10% on net sales above $500 million and up to and including $750 million, and 0.25% on net sales above $750 million. KalVista is entitled to a potential one-time sales-based milestone payment of $57 million if annual worldwide net sales of sebetralstat meet or exceed $550 million in any calendar year before January 1, 2031. About DRI Healthcare DRI Healthcare is a pioneer in global pharmaceutical royalty monetization. Since our founding in 1989, we have deployed more than $3.0 billion, acquiring more than 75 royalties on 45-plus drugs, including Ekterly, Eylea, Keytruda, Orserdu, Remicade, Spinraza, Stelara, Vonjo and Zytiga. DRI Healthcare's units are listed and trade on the Toronto Stock Exchange in Canadian dollars under the symbol " and in U.S. dollars under the symbol "DHT.U". To learn more, visit or follow us on LinkedIn.
Yahoo
6 days ago
- Business
- Yahoo
US FDA approves KalVista Pharma's swelling disorder drug, shares rise
By Puyaan Singh (Reuters) -KalVista Pharmaceuticals said on Monday the U.S. Food and Drug Administration has approved its drug, the first on-demand oral treatment for a type of hereditary swelling disorder, sending its shares up more than 17% in premarket trading. The regulator's decision follows an extended review of the drug last month due to heavy workloads and limited resources. Ekterly, which offers a convenient alternative to injectable treatments, will be launched immediately, the company said. KalVista CEO Ben Palleiko said patients find it 'really burdensome' to carry injectable treatments, which are 'almost twice the size of an iPhone,' while Ekterly is packaged 'in a little cardboard wallet, about the size of a credit card.' Other on-demand treatments for hereditary angioedema, which affects about 8,000 people in the United States, include CSL's Berinert, Takeda's Cinryze, and Pharming's Ruconest, which are administered intravenously, as well as injectables such as Takeda's Kalbitor and Firazyr. Needham analyst Serge Belanger said KalVista previously indicated it would likely price Ekterly at a slight premium to Firazyr, the most commonly used on-demand treatment, which costs $11,000 per unit. The life-threatening condition causes sudden, dangerous swelling in the body, including the skin, digestive tract and upper respiratory system, due to deficiency in a protein known as C1 inhibitor. Citizens Bank analyst Jonathan Wolleben estimates peak U.S. sales of Ekterly at around $250 million, adding the early launch could exceed expectations due to potential premium pricing and rapid adoption. Approval of the drug was based on a trial in which Ekterly achieved the beginning of symptom relief in 1.6 hours, while a later trial showed the drug could treat attacks in 10 minutes, the company said. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Reuters
7 days ago
- Health
- Reuters
US FDA approves KalVista Pharma's swelling disorder drug
July 7 (Reuters) - KalVista Pharmaceuticals (KALV.O), opens new tab said on Monday the U.S. Food and Drug Administration has approved its drug for a type of hereditary swelling disorder, sending its shares up 33.3% in premarket trading. The regulator's greenlight comes after it extended the review of the drug, Ekterly, due to heavy workload and limited resources. With the approval, Ekterly becomes the first on-demand oral treatment for hereditary angioedema, offering a convenient alternative to injectable treatments. The life-threatening condition causes sudden, dangerous swelling in the body, including the skin, digestive tract and upper respiratory system, due to deficiency in a protein known as C1 inhibitor.
