SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Kezar Life Sciences, Inc. (Nasdaq:KZR), a clinical- stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune- mediated diseases, today announced that the Food and Drug Administration (FDA) Division of Hepatology and Nutrition has granted Kezar a Type C meeting for the first quarter to discuss the development of zetomipzomib, a novel, selective inhibitor of the immunoproteasome, in patients with autoimmune hepatitis ...

Investors might want to bet on Kezar Life Sciences, Inc. (KZR) , as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years.The ...

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Financial Performance - The company reported a net loss of $41.5 million for the nine months ended September 30, 2025, compared to a net loss of $63.5 million for the same period in 2024, reflecting a decrease of $22.0 million [134]. - Total operating expenses for the nine months ended September 30, 2025, were $43.9 million, down from $69.0 million in 2024, representing a decrease of $25.1 million [134]. - The net loss for the nine months ended September 30, 2025, was $41.5 million, with an accumulated deficit of $476.0 million as of the same date [142]. - Cash used in operating activities was $39.8 million for the nine months ended September 30, 2025, compared to $57.4 million for the same period in 2024 [154]. - The company anticipates additional losses in the future as it evaluates strategic alternatives and manages discretionary spending [145]. Research and Development - Research and development expenses decreased by $21.0 million for the nine months ended September 30, 2025, primarily due to a reduction in clinical expenses from the termination of the PALIZADE trial and completion of the PORTOLA trial [135]. - Research and development expenses for the three months ended September 30, 2025, were $6.9 million, down from $16.2 million in 2024, a decrease of $9.3 million [129]. - The FDA removed the partial clinical hold on the PORTOLA Phase 2a clinical trial for zetomipzomib in July 2025, but a proposed registrational trial for relapsed and refractory autoimmune hepatitis was not aligned with the FDA [113][114]. Expenses and Charges - General and administrative expenses for the three months ended September 30, 2025, decreased by $0.9 million to $4.8 million compared to $5.7 million in 2024 [131]. - Restructuring and impairment charges decreased by $1.5 million for the nine months ended September 30, 2025, compared to the same period in 2024 [137]. - Interest income decreased by $1.0 million for the three months ended September 30, 2025, primarily due to a decrease in cash equivalents and lower interest rates [132]. - Interest income decreased by $3.1 million for the nine months ended September 30, 2025, primarily due to lower cash equivalents and interest rates [139]. Strategic Initiatives - The company is exploring strategic alternatives, including a restructuring plan and workforce reduction, to maximize stockholder value [115]. - The company reduced its workforce by approximately 70% as part of cost reduction efforts, estimating cash expenditures of about $6.0 million [144]. - The company has no committed external sources of funding and may need to pursue financing through equity offerings, debt financings, and collaborations [152]. Cash and Investments - As of September 30, 2025, the company had $90.2 million in cash, cash equivalents, and marketable securities, with an average maturity of approximately two months [141]. - Net cash provided by investing activities was $40.9 million for the nine months ended September 30, 2025, primarily from maturities of marketable securities [157]. - The company repaid $6.3 million under the Loan Agreement with Oxford Finance in October 2025, fully satisfying the outstanding amount [146].

Financial Position - As of September 30, 2025, Kezar Life Sciences, Inc. reported a preliminary cash, cash equivalents, and marketable securities position of $90.2 million[8]. Regulatory Updates - The company announced a regulatory update on its zetomipzomib program in autoimmune hepatitis[8]. - The press release regarding these updates was issued on October 16, 2025[8]. Strategic Alternatives - Kezar Life Sciences, Inc. is exploring strategic alternatives as part of its future growth strategy[8]. Rights Agreement - The Rights Agreement was amended to extend the Final Expiration Date to the day following the certification of the voting results of the Company's 2026 annual meeting of stockholders[11]. - If stockholders approve the Rights Agreement at the 2026 meeting, the expiration will extend to the day following the certification of the 2027 meeting results[11]. - The Rights Agreement remains unmodified and in full force and effect[11]. Company Classification and Listing - The company is classified as an emerging growth company under the Securities Act of 1933[6]. - The company is listed on The Nasdaq Stock Market LLC under the symbol KZR[5]. Report Signing - The report was signed by Marc L. Belsky, Chief Financial Officer and Secretary, on October 16, 2025[18].

Core Insights - Kezar Life Sciences, Inc. is a clinical-stage biotechnology company focused on developing small molecule therapeutics for immune-mediated diseases [1] - The company announced two presentations from the completed Phase 2a PORTOLA clinical trial for autoimmune hepatitis at The Liver Meeting 2025 [1] - The event is organized by the American Association for the Study of Liver Disease and will take place from November 7-11 in Washington, DC [1]

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Artiva Biotherapeutics, Inc. (ARTV) has increased by 124% to $6.22 [3] - Akanda Corp. (AKAN) is up 39% at $3.10 [3] - Kezar Life Sciences, Inc. (KZR) has risen 38% to $5.80 [3] - Carbon Revolution Public Limited Company (CREV) is also up 38% at $5.15 [3] - Safe & Green Holdings Corp. (SGBX) has increased by 28% to $3.96 [3] - Achieve Life Sciences, Inc. (ACHV) is up 23% at $3.80 [3] - Revolution Medicines, Inc. (RVMD) has risen 8% to $53.90 [3] - Erayak Power Solution Group Inc. (RAYA) is up 8% at $5.76 [3] - ProQR Therapeutics N.V. (PRQR) has increased by 7% to $3.00 [3] - Bio Green Med Solution, Inc. (BGMS) is up 6% at $4.04 [3] Premarket Losers - American Rebel Holdings, Inc. (AREB) has decreased by 41% to $2.09 [4] - Sadot Group Inc. (SDOT) is down 25% at $5.35 [4] - AVITA Medical, Inc. (RCEL) has fallen 24% to $4.04 [4] - Soluna Holdings, Inc. (SLNH) is down 23% at $3.22 [4] - American Battery Technology Company (ABAT) has decreased by 17% to $4.70 [4] - CID HoldCo, Inc. (DAIC) is down 17% at $2.16 [4] - Pinnacle Food Group Limited (PFAI) has fallen 12% to $3.12 [4] - OnKure Therapeutics, Inc. (OKUR) is down 12% at $2.52 [4] - Whitehawk Therapeutics, Inc. (WHWK) has decreased by 12% to $2.29 [4] - Aqua Metals, Inc. (AQMS) is down 7% at $14.50 [4]

Group 1: CSX Corp Performance - CSX Corp reported third-quarter revenue of $3.59 billion, exceeding analyst estimates of $3.58 billion [1] - The company achieved adjusted earnings of 44 cents per share, surpassing analyst expectations of 43 cents per share [1] - Following the earnings report, CSX shares increased by 4.2% to $37.51 in pre-market trading [1] Group 2: Other Stocks in Pre-Market Trading - Artiva Biotherapeutics Inc gained 98.6% to $5.50 after receiving FDA Fast Track Designation for AlloNK [4] - Safe & Green Holdings Corp surged 38.8% to $4.27 after completing Phase 1 of its intelligent wellsite monitoring system [4] - Kezar Life Sciences Inc rose 36% to $5.67 following a regulatory update on its Zetomipzomib program [4] - INVO Fertility Inc tumbled 34.6% to $0.92 after a significant rise of over 85% the previous day [4] - American Battery Technology Co shares dipped 19.8% to $4.55 after a 37% decline on Thursday due to the termination of a grant by the Department of Energy [4]

Company Overview - Verrica Pharmaceuticals Inc. (NASDAQ:VRCA) is focused on developing and commercializing treatments for skin diseases, with its lead product candidate, VP-102, targeting molluscum contagiosum [1] Financial Performance - VRCA has a Return on Invested Capital (ROIC) of -166.93%, significantly lower than its Weighted Average Cost of Capital (WACC) of 17.69%, indicating inefficiencies in capital utilization [2][6] - The ROIC to WACC ratio for VRCA is -9.44, further emphasizing the challenge in generating sufficient returns to cover its cost of capital [2] Comparative Analysis - Y-mAbs Therapeutics (YMAB) has a ROIC of -27.64% and a WACC of 6.11%, resulting in a ROIC to WACC ratio of -4.53, making it the least inefficient among its peers [3][5] - Scholar Rock Holding Corporation (SRRK) shows a ROIC of -109.48% against a WACC of 5.32%, leading to a ROIC to WACC ratio of -20.57, indicating similar inefficiencies as VRCA [4] - Crinetics Pharmaceuticals (CRNX) and Kezar Life Sciences (KZR) also exhibit negative ROIC to WACC ratios of -6.99 and -10.94, respectively, highlighting broader challenges within the sector [4][5] Sector Insights - All companies analyzed, including VRCA, are currently operating at a loss relative to their cost of capital, with Y-mAbs Therapeutics managing its capital more effectively than its peers [5][6]

Core Viewpoint - Kezar Life Sciences, Inc. (KZR) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Performance - The Zacks rating system tracks the Zacks Consensus Estimate, which reflects EPS estimates from sell-side analysts for the current and following years, highlighting the importance of earnings revisions in stock valuation [1][4]. - A strong correlation exists between changes in earnings estimates and near-term stock price movements, primarily due to institutional investors adjusting their valuations based on these estimates [4][6]. Recent Developments for Kezar Life Sciences - For the fiscal year ending December 2025, Kezar Life Sciences is expected to earn -$7.22 per share, which remains unchanged from the previous year, but analysts have raised their estimates by 3.4% over the past three months [8]. - The upgrade to Zacks Rank 2 places Kezar Life Sciences in the top 20% of Zacks-covered stocks, suggesting potential for higher stock prices in the near term [10]. Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a proven track record of Zacks Rank 1 stocks generating an average annual return of +25% since 1988 [7][9]. - The system maintains a balanced distribution of "buy" and "sell" ratings, ensuring that only the top 5% of stocks receive a "Strong Buy" rating, indicating superior earnings estimate revisions [9][10].