Latest news with #BenPalleiko
Business Wire
5 days ago
- Health
- Business Wire
KalVista Pharmaceuticals Receives Positive CHMP Opinion for Sebetralstat for the Treatment of Hereditary Angioedema Attacks
CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for sebetralstat, a novel oral plasma kallikrein inhibitor, for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older. The European Commission (EC) final decision is expected by early October. 'This positive CHMP opinion is an important step forward for people living with HAE in Europe, where there remains a high need for effective, easy-to-administer on-demand treatments,' said Ben Palleiko, CEO of KalVista. 'Coming just weeks after regulatory approvals in the US and UK, this milestone highlights the potential of sebetralstat to transform how HAE is managed globally. Sebetralstat is expected to become the first and only oral on-demand treatment for HAE available in Europe, bringing forward a new treatment approach that enables adherence to guidelines and empowers people to treat attacks quickly, wherever they occur.' The CHMP based its opinion on results from the phase 3 KONFIDENT clinical trial, which was the largest clinical trial ever conducted in HAE. Data from KONFIDENT was published in the New England Journal of Medicine in May 2024, showing that sebetralstat achieved significantly faster symptom relief, reduction in attack severity and attack resolution than placebo, and was well-tolerated with a safety profile similar to placebo.1 The trial randomized 136 HAE patients from 66 clinical sites across 20 countries. 'Access to on-demand treatments that offer easy self-administration and rapid symptom relief is critical for patients living with HAE,' said Emel Aygören-Pürsün, M.D., Assistant Professor, Internal Medicine and Hemostaseology, Department for Children and Adolescents, University Hospital Frankfurt. 'Until now, on-demand therapies for HAE attacks required parenteral administration via injections. The positive CHMP opinion for sebetralstat is an essential move toward a novel, long-awaited oral on-demand option that could help patients treat attacks early and independently, as advocated by guidelines, with the goal of improving outcomes and normalizing lives.' Sebetralstat is approved in the United States and United Kingdom under the brand name EKTERLY® for the treatment of HAE attacks in people 12 years of age and older. It is currently under review with regulatory authorities in Japan as well as multiple other territories. About Hereditary Angioedema Hereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the area affected. Treatment guidelines recommend treating attacks as early as possible to prevent progression of swelling and shorten the time to attack resolution, and to consider treatment for all attacks, regardless of anatomic location or severity. About Sebetralstat Sebetralstat is a novel plasma kallikrein inhibitor approved in the United States and United Kingdom for the treatment of acute attacks of hereditary angioedema (HAE) in people 12 years of age and older. It is the first and only oral on-demand treatment for HAE. With ongoing studies exploring its use in children aged two to 11 and multiple regulatory applications under review in key global markets, sebetralstat has the potential to become the foundational therapy for HAE management worldwide. U.S. INDICATION AND IMPORTANT SAFETY INFORMATION What is EKTERLY® (sebetralstat)? EKTERLY is a prescription medicine used to treat sudden (acute) attacks of hereditary angioedema (HAE) in adults and children aged 12 years of age and older. It is not known if EKTERLY is safe and effective in children under 12 years of age. IMPORTANT SAFETY INFORMATION Before taking EKTERLY, tell your healthcare provider about all of your medical conditions, including if you: Are pregnant or planning to become pregnant. It is not known if EKTERLY can harm your unborn baby. Are breastfeeding or plan to breastfeed. It is not known if EKTERLY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking EKTERLY. Have liver problems. Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking EKTERLY with certain other medicines can cause side effects or affect how well EKTERLY or the other medicines work. Especially tell your healthcare provider if you take any of the following, as their use with EKTERLY is not recommended: itraconazole, phenytoin, efavirenz. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine. What are the possible side effects of EKTERLY? The most common side effects of EKTERLY include headache. For more information, ask your healthcare provider or pharmacist. Talk to your doctor for medical advice about side effects. You are encouraged to report side effects related to KalVista products by calling 1-855-258-4782. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit or call 1-800-FDA-1088. Please click here for full Prescribing Information, including Patient Information. About KalVista Pharmaceuticals, Inc. KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. In the U.S., KalVista markets EKTERLY®, the first and only oral on-demand treatment for hereditary angioedema (HAE). The Company has multiple regulatory applications under review in key global markets. For more information about KalVista, please visit and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statements This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, information relating to our business and business plans, the success of our efforts to commercialize EKTERLY® (sebetralstat), our ability to successfully obtain foreign regulatory approvals for sebetralstat, including approval by the EC, our expectations about the timing of the EC's final decision, our expectations about the safety and efficacy of sebetralstat and our other product candidates, the timing of clinical trials and their results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and the ability of EKTERLY to treat HAE. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2025, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. _______________________ Expand 1Riedl MA, et al. Oral sebetralstat for on-demand treatment of hereditary angioedema attacks. N Engl J Med. 2024;391(1):32–43. Expand
Business Wire
15-07-2025
- Business
- Business Wire
KalVista Pharmaceuticals Announces UK MHRA Approval of EKTERLY ® (sebetralstat), First and Only Oral On-demand Treatment for Hereditary Angioedema
CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)-- KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) has granted marketing authorization for EKTERLY ® (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older. EKTERLY is the first and only oral on-demand treatment for HAE approved in the UK. 'The approval of EKTERLY in the United Kingdom builds on our recent FDA approval and advances our global commitment to bring this innovative treatment option to people living with HAE,' said Ben Palleiko, CEO of KalVista. 'This approval holds particular significance for KalVista as EKTERLY was discovered in our Salisbury, UK labs—making it even more exciting that now we will be able to offer this therapy to people living with HAE in the UK. More broadly, this is another example of the incredible skills of our entire team in pursuing what we expect to be the fastest global launch of an HAE therapy ever.' The MHRA's marketing authorization for EKTERLY is based on results from the phase 3 KONFIDENT clinical trial, which was the largest clinical study ever conducted in HAE. Data from KONFIDENT was published in the New England Journal of Medicine in May 2024, showing that EKTERLY achieved significantly faster symptom relief, reduction in attack severity and attack resolution than placebo, and was well-tolerated with a safety profile similar to placebo. The trial randomized 136 HAE patients from 66 clinical sites across 20 countries. 'The MHRA approval of EKTERLY brings us one step closer to having an oral on-demand treatment available to patients in the UK for the first time,' said Dr. Sinisa Savic, Professor of Clinical Immunology, St James's University Hospital Leeds and sebetralstat investigator. 'I look forward to seeing the impact this new treatment option will have on the HAE community in the UK.' EKTERLY also met the requirements of the MHRA Orphan Designation criteria and will be added to the Orphan Register held by the MHRA, allowing it to benefit from up to 10 years of market exclusivity. In March of this year, sebetralstat was granted a positive scientific opinion for an Early Access to Medicines Scheme (EAMS) from the MHRA for the treatment of HAE attacks. This has enabled healthcare professionals to prescribe the treatment prior to marketing authorization, based on clinical factors for patients with a clear unmet need. It will continue to be available through the EAMS until KalVista receives a decision from the National Institute for Health and Care Excellence (NICE) for use of EKTERLY under the UK's National Health Service (NHS), which is anticipated in the first half of 2026. On July 3, 2025, EKTERLY was approved by the U.S. Food and Drug Administration for the treatment of HAE attacks in people 12 years of age and older. KalVista has submitted marketing authorization applications for sebetralstat in the EU, Japan and other key global markets. About Hereditary Angioedema Hereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the area affected. Treatment guidelines recommend treating attacks as early as possible to prevent progression of swelling and shorten the time to attack resolution, and to consider treatment for all attacks, regardless of anatomic location or severity. About EKTERLY ® (sebetralstat) EKTERLY (sebetralstat), a novel plasma kallikrein inhibitor, is the first and only oral on-demand treatment for hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older. With ongoing studies exploring its use in children aged two to 11 and multiple regulatory applications under review in key global markets, EKTERLY has the potential to become the foundational therapy for HAE management worldwide. For complete product information, please see the Summary of Product Characteristics that can be found on About KalVista Pharmaceuticals, Inc. KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. In the U.S., KalVista markets EKTERLY ®, the first and only oral on-demand treatment for hereditary angioedema (HAE). The Company has multiple regulatory applications under review in key global markets. For more information about KalVista, please visit and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statements This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, information relating to our business and business plans, the success of our efforts to commercialize EKTERLY ® (sebetralstat), our ability to successfully obtain foreign regulatory approvals for sebetralstat, including the outcome of the decision from the NICE regarding the use of EKTERLY under the UK's NHS, our expectations about the safety and efficacy of sebetralstat and our other product candidates, the timing of clinical trials and their results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and the ability of EKTERLY to treat HAE , and the future progress and potential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2025, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Yahoo
10-07-2025
- Business
- Yahoo
KalVista Pharmaceuticals Provides Operational Update and Fiscal Year 2025 Financial Results
– Received FDA approval of EKTERLY® (sebetralstat)—the first and only oral on-demand treatment for hereditary angioedema; U.S. launch underway – – Six additional global regulatory submissions under review – – Entered licensing agreements for sebetralstat commercialization in Japan and Canada – – $220.6M in cash, providing runway into 2027 – CAMBRIDGE, Mass. & SALISBURY, England, July 10, 2025--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (Nasdaq: KALV), today provided an operational update and released financial results for the fiscal year ended April 30, 2025. "The FDA approval of EKTERLY represents a major milestone—not only as the first commercial product for KalVista, but more importantly, as the first and only oral on-demand therapy for people living with HAE," said Ben Palleiko, CEO of KalVista Pharmaceuticals. "EKTERLY delivers a long-awaited treatment that is safe, effective, and easy to administer. Our commercial team is actively engaging in the field, leveraging their expertise to educate and activate patients and physicians to enable timely access, drive awareness, and support informed treatment decisions around this important new therapy. With commercial partners now in place in Canada and Japan, and six global regulatory submissions under review, we believe EKTERLY is poised to become the foundational therapy for HAE management worldwide." Recent Business Highlights EKTERLY® (sebetralstat) On July 7, 2025, KalVista announced FDA approval of EKTERLY (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. KalVista further strengthened the robust body of clinical evidence supporting the efficacy and safety of EKTERLY (sebetralstat) for the treatment of HAE. The Company presented new data at the European Academy of Allergy and Clinical Immunology Congress 2025 (EAACI), the 14th C1-inhibitor Deficiency & Angioedema (C1-INH) Workshop in Budapest, Hungary, and the Eastern Allergy Conference (EAC) in Palm Beach, Florida. Key highlights from these medical congresses are outlined below: EAACI: Data showed the efficacy of EKTERLY (sebetralstat) for the on-demand treatment of HAE attacks among patients receiving long-term prophylaxis (LTP). Real world data highlighted significant challenges with LTP adherence, and ongoing reliance on on-demand medications. In KONFIDENT-S, EKTERLY (sebetralstat) delivered rapid, consistent relief for attacks, regardless of LTP mechanism of action with a median time to beginning of symptom relief of 1.3 hours. C1-INH: Analysis from nearly 1,600 attacks in KONFIDENT-S showed a median time to end of attack progression of 19.8 minutes. These results aligned closely with KONFIDENT, reinforcing the rapid effect of EKTERLY (sebetralstat) after absorption. Interim data from KONFIDENT-S highlighted the role of EKTERLY (sebetralstat) in treating mucosal attacks with a median time to beginning of symptom relief of 1.3 hours for both abdominal and laryngeal attacks. EAC: In KONFIDENT-S, EKTERLY (sebetralstat) was used to treat 76 attacks that had progressed to severe or very severe after a median of 2.16 hours from attack onset, demonstrating its utility in more advanced stages of HAE attacks. The median time to beginning of symptom relief for these attacks was 1.36 hours, with reduction in attack severity and substantial reduction of symptom burden in a median of 1.77 hours and 9.15 hours, respectively. Organizational In April, KalVista entered into an exclusive agreement with Kaken Pharmaceutical, Co., Ltd. to commercialize sebetralstat in Japan. Under the terms of the deal, in June 2025 KalVista received an upfront payment of $11 million, and an additional $11 million will be paid upon achieving a regulatory milestone anticipated in early 2026. This agreement also includes potential commercial milestone payments of up to $2 million and royalties based on the Japan National Health Insurance (NHI) price, with royalties expected to be in the mid-twenties as a percentage of sales. In June, KalVista granted Pendopharm, a division of Pharmascience Inc., the exclusive rights to manage the regulatory approval process and commercialization of sebetralstat in Canada. Financial Results for Fiscal Year Ended April 30, 2025: Research and development expenses were $71.7 million and $86.2 million for the fiscal years ended April 30, 2025, and 2024, respectively. The decrease in R&D was primarily attributable to reduced clinical trial expenses, preclinical activities and recognizing expense associated with EKTERLY (sebetralstat) pre-commercial awareness within General & Administrative. General and administrative expenses were $116.3 million and $54.3 million for the fiscal years ended April 30, 2025, and 2024, respectively. The increase in G&A expenses was primarily due to pre-commercial planning expenses related to EKTERLY (sebetralstat). Cash, cash equivalents and marketable securities were $220.6 million on April 30, 2025, compared to $210.4 million on April 30, 2024. About KalVista Pharmaceuticals, Inc. KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. In the U.S., KalVista markets EKTERLY®, the first and only oral on-demand treatment for hereditary angioedema (HAE). The Company has multiple regulatory applications under review in key global markets. For more information about KalVista, please visit and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statements This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, information relating to our business and business plans, the success of our efforts to commercialize EKTERLY® (sebetralstat), our ability to successfully obtain foreign regulatory approvals for sebetralstat, our expectations about the safety and efficacy of sebetralstat and our other product candidates, the timing of clinical trials and their results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and the ability of EKTERLY to treat HAE , and the future progress and potential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2025, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. KALVISTA PHARMACEUTICALS, INC. Consolidated Balance Sheets April 30, 2025 and 2024 (in thousands except share and per share amounts) (Unaudited) 2025 2024 Cash, cash equivalents & Marketable securities $ 220,617 $ 210,401 Other current assets 21,073 15,289 Total current assets 241,690 225,690 Other assets 9,080 9,714 Total assets $ 250,770 $ 235,404 Current liabilities $ 45,167 $ 22,807 Long-term liabilities 110,212 6,015 Total Liabilities 155,379 28,822 Stockholders' equity 95,391 206,582 Total liabilities and stockholders' equity $ 250,770 $ 235,404 KALVISTA PHARMACEUTICALS, INC. Consolidated Statements of Operations and Comprehensive Loss Years Ended April 30, 2025 and 2024 (in thousands, except share and per share amounts) (Unaudited) 2025 2024 Research and development $ 71,709 $ 86,167 General and administrative 116,286 54,278 Total operating expenses 187,995 140,445 Operating loss (187,995 ) (140,445 ) Other income: Interest income 6,435 3,896 Interest (expense) (5,785 ) — Foreign currency exchange gain (loss) 2,481 138 Other income (expenses), net 4,812 9,767 Total other income 7,943 13,801 Loss before income taxes (180,052 ) (126,644 ) Income tax (benefit) expense 3,392 — Net loss $ (183,444 ) $ (126,644 ) Net loss per share, basic and diluted $ (3.69 ) $ (3.44 ) Weighted average common shares outstanding, basic and diluted 49,652,878 36,786,575 View source version on Contacts Investors: Ryan BakerHead, Investor Relations(617) Media: Molly CameronDirector, Corporate Communications(857) 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
Medscape
07-07-2025
- Health
- Medscape
US FDA Approves KalVista's Oral Swelling Disorder Drug, Shares Rise
(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 18%. The FDA's decision follows an extended review of the drug last month due to heavy workloads and limited resources at the regulator. Ekterly, which offers a convenient alternative to injectable treatments, is expected to be available by mid-July, KalVista's financial chief Nicole Sweeny said. The wholesale acquisition cost for the drug will be $16,720 per dose compared to other on-demand treatments that cost between $11,000 and $17,000 per dose. Other on-demand treatments for hereditary angioedema (HAE), 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. 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. KalVista CEO Ben Palleiko said the company anticipates U.S. sales of "the on-demand segment of the HAE market will grow by 70% (to) $1.2 billion by 2030 ... fueled by the introduction of Ekterly." TD Cowen analyst Stacy Ku estimates peak U.S. sales of the drug at over $750 million, adding the brokerage believes "there should be high demand for Ekterly's convenience." Approval of the drug was based on a trial in which it achieved the beginning of symptom relief in 1.6 hours, while a later study showed it could treat attacks in 10 minutes, the company said. (Reporting by Puyaan Singh, Padmanabhan Ananthan and Siddhi Mahatole in Bengaluru; Editing by Arun Koyyur and Tasim Zahid)
Yahoo
07-07-2025
- 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
