Welcome to our dedicated page for Kalvista Pharm news (Ticker: KALV), a resource for investors and traders seeking the latest updates and insights on Kalvista Pharm stock.
KalVista Pharmaceuticals Inc (KALV) is a clinical-stage biopharmaceutical company advancing novel protease inhibitors for rare diseases. This dedicated news hub provides investors and healthcare professionals with essential updates on clinical developments, regulatory milestones, and strategic initiatives.
Our curated collection offers immediate access to KALV's latest press releases, including progress on oral plasma kallikrein inhibitors for hereditary angioedema and diabetic macular edema therapies. Track updates across all development phases – from preclinical research to late-stage trials – while staying informed about partnership announcements and financial disclosures.
Key coverage areas include clinical trial results, FDA communications, intellectual property developments, and scientific presentations. The resource is particularly valuable for monitoring KALV's Factor XIIa inhibitor program and comparative effectiveness data against existing therapies.
Bookmark this page for real-time updates on KalVista's innovative pipeline and regulatory progress. For comprehensive tracking of this clinical-stage innovator's journey in protease inhibition therapeutics, we recommend checking back regularly.
KalVista Pharmaceuticals (NASDAQ: KALV) reported Q2 fiscal 2024 results and provided updates on sebetralstat, its investigational oral treatment for hereditary angioedema (HAE) attacks. The FDA accepted the New Drug Application with a PDUFA date of June 17, 2025. The company submitted Marketing Authorization Applications in multiple countries.
Financial highlights include pro forma cash and equivalents of $292.2 million, providing runway into second half 2027. The company raised $160 million through synthetic royalty financing and equity offerings. Q2 showed no revenue, R&D expenses of $16.6 million (down from $19.1 million), and G&A expenses of $29.2 million (up from $10.7 million) primarily due to pre-commercial activities.
KalVista Pharmaceuticals (NASDAQ: KALV) announced the granting of inducement stock options to five newly-hired employees. The compensation committee approved options to purchase 36,000 shares of common stock at an exercise price of $10.27 per share, matching the closing price on December 2, 2024. The options vest over four years, with 25% vesting after one year and the remainder vesting monthly over three years, contingent on continued employment. These 10-year term options were granted under KalVista's Inducement Equity Incentive Plan in accordance with Nasdaq Listing Rule 5635(c)(4).
KalVista Pharmaceuticals (NASDAQ: KALV) announced the appointment of Laurence Reid, Ph.D., to its Board of Directors, effective immediately. Dr. Reid brings over three decades of experience in biotech leadership and company-building. KalVista CEO Ben Palleiko highlighted Dr. Reid's biopharmaceutical and strategic expertise as a significant asset for advancing sebetralstat towards global market approval and commercialization. Dr. Reid expressed enthusiasm for joining at a pivotal time, noting sebetralstat's potential to improve lives of hereditary angioedema patients. Dr. Reid's previous roles include CEO of Decibel Therapeutics, entrepreneur in residence at Third Rock Ventures, and CEO of Warp Drive Bio. He currently chairs the board of Broken String Biosciences and holds board positions at Garuda Therapeutics and The Possible Zone.
KalVista Pharmaceuticals (NASDAQ: KALV) has announced its participation in two upcoming investor conferences. The company will engage in fireside chats at the Stifel 2024 Healthcare Conference on Tuesday, November 19, 2024, at 9:10 a.m. EST, and the Jefferies London Healthcare Conference on Thursday, November 21, 2024, at 11:00 a.m. GMT.
Both presentations will be available via live webcast on KalVista's website, with audio archives remaining accessible for 30 days following the events.
KalVista Pharmaceuticals (NASDAQ: KALV) announced that its compensation committee has granted stock options to twelve newly-hired employees. The inducement grants total 78,000 shares of common stock with an exercise price of $10.61 per share, matching the closing price on November 1, 2024. The options vest over four years, with 25% vesting after one year and the remainder vesting monthly over three years, contingent on continued employment. These 10-year term options were granted under KalVista's Inducement Equity Incentive Plan in accordance with Nasdaq Listing Rule 5635(c)(4).
KalVista Pharmaceuticals (KALV) has announced the pricing of an underwritten offering of 5.5 million shares at $10.00 per share, expecting to raise $55 million. Concurrently, the company entered a private placement agreement with DRI Healthcare Acquisitions LP for an additional 500,000 shares at the same price, raising an additional $5 million. The proceeds will fund the clinical development of sebetralstat and its planned commercialization. The offerings are expected to close on November 5, 2024, with Jefferies, BofA Securities, TD Cowen, and Stifel acting as joint book-running managers.
KalVista Pharmaceuticals (NASDAQ: KALV) has secured a synthetic royalty financing agreement with DRI Healthcare Trust worth up to $184 million to support the commercial launch of sebetralstat, potentially the first oral on-demand therapy for hereditary angioedema (HAE). The deal includes a $100 million upfront payment, an optional $22 million payment upon U.S. approval, and up to $57 million in sales-based milestones. The FDA has set a PDUFA target date of June 17, 2025. Under the agreement, KalVista will pay DRI tiered royalties ranging from 0.25% to 5.00% based on annual global net sales thresholds. DRI has also expressed interest in a potential $5 million equity investment in KalVista.
KalVista Pharmaceuticals (NASDAQ: KALV) presented new data for sebetralstat at the 2024 American College of Allergy Asthma and Immunology. Phase 3 trial results showed that early treatment leads to faster attack resolution in hereditary angioedema (HAE) patients. The data demonstrated that sebetralstat 300mg and 600mg achieved faster reduction in symptom burden compared to placebo, with median times of 5.0 and 5.2 hours versus >12 hours. A network meta-analysis found no significant differences between sebetralstat 300mg and IV recombinant C1-inhibitor in time to symptom relief. For laryngeal attacks, sebetralstat 600mg showed median time to symptom relief of 1.5 hours.
KalVista Pharmaceuticals (NASDAQ: KALV) announced the acceptance of five abstracts for e-Poster presentation at the 2024 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) in Boston, MA from October 24-28. The presentations focus on various aspects of hereditary angioedema (HAE) treatment, including:
- Patient-reported anxiety impacts on injectable on-demand treatment utilization
- Sebetralstat's effectiveness in treating laryngeal HAE attacks
- Reduction of HAE attack symptom burden in the KONFIDENT Phase 3 trial
- Indirect treatment comparison between oral sebetralstat and intravenous rhC1-INH
- Correlation of treatment timing with attack duration in the KONFIDENT Phase 3 trial
The e-Poster presentations are scheduled for October 25 at various times in Exhibit Hall A. Links to all posters and presentations will be available on the KalVista website under "Publications".
KalVista Pharmaceuticals presented data at the 2024 HAEi Global Angioedema Forum showing the effectiveness of sebetralstat in reducing anxiety during hereditary angioedema (HAE) attacks. The data, from the KONFIDENT phase 3 clinical trial, revealed that sebetralstat significantly reduced anxiety compared to placebo, especially in patients with moderate-to-extreme anxiety.
Key findings include:
- Anxiety reduction correlated with earlier symptom relief
- Sebetralstat 300mg and 600mg doses showed significant anxiety reduction versus placebo
- For moderate-to-extreme anxiety, sebetralstat showed greater improvement at 4 and 12 hours compared to placebo
Additional presentations highlighted the impact of HAE attacks on quality of life, work productivity, and the potential benefits of early treatment with oral on-demand therapies.
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