KalVista Submits New Drug Application For FDA Review Of Sebetralstat

6/18/24 6:32:18 AM ET

Biotechnology: Pharmaceutical Preparations

Health Care

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Sebetralstat is a novel investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE) attacks in adults and pediatric patients aged 12 years and older.

The FDA has a 60-day filing review period to determine whether the NDA is complete and accepted for review. The Company currently anticipates receiving notification from the FDA on the status of the submission in September. KalVista intends to submit additional marketing authorization applications to other global health authorities throughout 2024.

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Recent Analyst Ratings for
$KALV

Date	Price Target	Rating	Analyst
3/11/2022	$48.00 → $42.00	Buy	Needham
12/10/2021	$50.00 → $48.00	Buy	Needham

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$KALV
Leadership Updates

Live Leadership Updates

KalVista Appoints Brian Piekos as Chief Financial Officer
KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), today announced that Brian Piekos has joined the Company as Chief Financial Officer (CFO). Mr. Piekos is an experienced public company CFO who brings a demonstrated track record of successfully leading companies across the biotechnology sector. "Brian's deep industry experience and expertise in managing financial and capital strategies makes him a strong addition to KalVista as we prepare for the commercialization of sebetralstat," said Ben Palleiko, Chief Executive Officer at KalVista. "I'm excited to welcome Brian to KalVista, as he shares our commitment to patients and a results-driven approach to business excellence." "I am excited to join
9/10/24 6:30:00 AM ET
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Biotechnology: Pharmaceutical Preparations
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KalVista Pharmaceuticals Appoints William C. Fairey to Board of Directors
KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today announced that William C. Fairey has been appointed to the Company's Board of Directors, effective immediately. Mr. Fairey was most recently the Chief Commercial Officer at MyoKardia, Inc., a clinical stage biopharmaceutical company, and is a business leader with significant experience building markets and launching novel therapeutics to treat specialty and rare/orphan diseases. "We welcome Bill to our Board of Directors," said Ben Palleiko, CEO of KalVista. "His experience in commercial and me
4/22/24 6:30:00 AM ET
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Biotechnology: Pharmaceutical Preparations
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KalVista Pharmaceuticals Reports Third Fiscal Quarter Results and Provides Operational Update
- Sebetralstat Phase 3 KONFIDENT clinical trial met all endpoints and demonstrated a favorable safety profile as first oral on-demand therapy for hereditary angioedema - - CEO transition supports ongoing evolution into commercial company - KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today provided an operational update and released financial results for the third fiscal quarter ended January 31, 2024. "This has been an exciting and busy period for KalVista, as we achieved key milestones with the release of our phase 3 KONFIDENT data and th
3/11/24 6:30:00 AM ET
$KALV
Biotechnology: Pharmaceutical Preparations
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KalVista Pharmaceuticals to Present at Upcoming Investor Conferences
KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), today announced that the Company will participate in a fireside chat at each of the following investor conferences: Stifel 2024 Healthcare Conference on Tuesday, November 19, 2024, at 9:10 a.m. EST Jefferies London Healthcare Conference on Thursday, November 21, 2024, at 11:00 a.m. GMT Each presentation will be live webcast on the Company's website at www.kalvista.com. After the presentations, an audio archive will be available on KalVista's website for 30 days. About KalVista Pharmaceuticals, Inc. KalVista Pharmaceuticals, Inc. is a global pharmaceutical company whose mission is to develop and deliver life-changing oral medicines f
11/12/24 6:30:00 AM ET
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Biotechnology: Pharmaceutical Preparations
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KalVista Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), today announced that the compensation committee of KalVista's board of directors granted twelve newly-hired employees inducement options to purchase an aggregate of 78,000 shares of KalVista common stock on November 1, 2024 as inducements material to each employee entering into employment with KalVista. The options were granted in accordance with Nasdaq Listing Rule 5635(c)(4). The options have an exercise price of $10.61 per share, which was equal to the closing price of KalVista common stock on the grant date. One-fourth of the options vest on the one-year anniversary of the vesting commencement date and the remainder vest in equal monthly in
11/5/24 6:30:00 AM ET
$KALV
Biotechnology: Pharmaceutical Preparations
Health Care
DRI Healthcare Trust Announces Acquisition of a Synthetic Royalty Interest in the Worldwide Sales of Sebetralstat for the Treatment of Hereditary Angioedema Plus an Equity Investment in KalVista Pharmaceuticals
– First pre-approval royalty acquisition and first equity investment highlight evolving investment strategy – – Up to US$184 million investment brings capital deployment to over US$1 billion since IPO – – Long-term asset in new therapeutic area further increases portfolio duration and diversification – TORONTO, Nov. 4, 2024 /CNW/ - DRI Healthcare Trust (TSX:DHT) (TSX:DHT) (the "Trust"), a global leader in providing financing to advance innovation in the life sciences industry, has acquired a royalty interest in the worldwide net sales of all formulations of sebetralstat from KalVista Pharmaceuticals ("KalVista") for an aggregate purchase price of up to US$179 million, comprised of a US$100 m
11/4/24 7:06:00 AM ET
$KALV
Biotechnology: Pharmaceutical Preparations
Health Care

KalVista Submits New Drug Application For FDA Review Of Sebetralstat

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Recent Analyst Ratings for $KALV

$KALV Financials

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KalVista Pharmaceuticals Reports Phase 3 KONFIDENT Trial Meets All Endpoints for Sebetralstat as First Oral On-demand Therapy for Hereditary Angioedema

$KALV Leadership Updates

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KalVista Appoints Brian Piekos as Chief Financial Officer

KalVista Pharmaceuticals Appoints William C. Fairey to Board of Directors

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$KALV Large Ownership Changes

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Amendment: SEC Form SC 13G/A filed by KalVista Pharmaceuticals Inc.

Amendment: SEC Form SC 13G/A filed by KalVista Pharmaceuticals Inc.

SEC Form SC 13G filed by KalVista Pharmaceuticals Inc.

$KALV Market Insights

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KalVista Pharmaceuticals Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Unregistered Sales of Equity Securities, Regulation FD Disclosure

SEC Form 424B5 filed by KalVista Pharmaceuticals Inc.

KalVista Pharmaceuticals Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Creation of a Direct Financial Obligation, Regulation FD Disclosure

KalVista Pharmaceuticals to Present at Upcoming Investor Conferences

KalVista Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

DRI Healthcare Trust Announces Acquisition of a Synthetic Royalty Interest in the Worldwide Sales of Sebetralstat for the Treatment of Hereditary Angioedema Plus an Equity Investment in KalVista Pharmaceuticals

Venrock Healthcare Capital Partners Iii, L.P. bought $1,257,829 worth of shares (86,048 units at $14.62) (SEC Form 4)

Venrock Healthcare Capital Partners Iii, L.P. bought $1,274,793 worth of shares (88,099 units at $14.47) (SEC Form 4)

Venrock Healthcare Capital Partners Iii, L.P. bought $1,289,802 worth of shares (91,804 units at $14.05) (SEC Form 4)

CHIEF EXECUTIVE OFFICER Palleiko Benjamin L converted options into 30,198 shares and sold $133,294 worth of shares (14,400 units at $9.26), increasing direct ownership by 6% to 266,598 units (SEC Form 4)

CHIEF DEVELOPMENT OFFICER Yea Christopher converted options into 11,496 shares and sold $66,573 worth of shares (7,192 units at $9.26), increasing direct ownership by 5% to 89,980 units (SEC Form 4)

CHIEF MEDICAL OFFICER Audhya Paul K. converted options into 18,531 shares and sold $74,766 worth of shares (8,077 units at $9.26), increasing direct ownership by 12% to 94,199 units (SEC Form 4)

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Needham reiterated coverage on KalVista Pharmaceuticals with a new price target

Needham reiterated coverage on KalVista Pharmaceuticals with a new price target

SVB Leerink resumed coverage on KalVista Pharmaceuticals

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