Heartflow Plaque Analysis to be Covered by UnitedHealthcare Plans Nationwide
'UnitedHealthcare's decision to cover Heartflow Plaque Analysis nationwide is a tremendous step in advancing patient access to our proven AI-driven plaque technology,' said John Farquhar, President and CEO of Heartflow. 'We are pleased that this major commercial payer recognizes the innovation and value that Heartflow's technology can provide to its members and healthcare providers in diagnosing and managing coronary artery disease. This decision will increase access for early detection and quantification of plaque using our precision Plaque Analysis tool, setting a new standard for cardiovascular care coverage.'
The updated coverage will become effective October 1, 2025 for patients with acute or stable chest pain and mild-to-moderate narrowing of coronary arteries (1-70% stenosis) found on coronary computed tomography angiography (CCTA). Expanded access will allow for greater adoption of Heartflow Plaque Analysis for clinicians to incorporate into their diagnostic and patient management protocols, delivering more personalized treatment.
Heartflow Plaque Analysis is the only FDA-cleared, AI-enabled, noninvasive plaque quantification tool with a reported 95% agreement with the gold standard, IVUS, in a prospective, global trial using blinded core lab adjudication.1 It is proven to change medical management in over half of patients beyond CCTA alone, helping physicians to improve outcomes.2
This coverage milestone follows the recent presentation of clinical outcomes from the DECIDE registry, which found management changes informed by Heartflow Plaque Analysis led to an average LDL cholesterol decrease of 18.7mg/dL.3 This clinically significant reduction is associated with an estimated 15% decrease in the risk of a cardiac event, highlighting the potential of Heartflow Plaque Analysis to improve patient outcomes by guiding more effective medical therapy and interventions.4
Heartflow is dedicated to transforming CAD from the leading cause of death to a disease that can be proactively managed for life. In the United States, CAD is estimated to be responsible for one heart attack every 40 seconds and one out of every five deaths.5 Heartflow has been adopted by more than 1,400 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population worldwide.
About Heartflow, Inc.
Heartflow is advancing coronary care by transforming coronary artery disease into a screenable, diagnosable, and manageable condition. Heartflow One is the only complete, non-invasive, precision coronary care platform providing patient insights throughout the guideline-directed CCTA pathway. The AI-driven platform — including Roadmap™ Analysis , FFR CT Analysis and Plaque Analysis — is supported by the ACC/AHA Chest Pain Guideline and backed by more than 600 peer-reviewed publications. Heartflow has helped clinicians manage over 400,000 patients worldwide. Discover how we're shaping the future of cardiovascular care at www.heartflow.com .
Media Contact Elliot Levy
[email protected]
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Affinity Bancshares, Inc. Announces Second Quarter 2025 Financial Results
COVINGTON, Ga.--(BUSINESS WIRE)-- Affinity Bancshares, Inc. (NASDAQ:'AFBI') (the 'Company'), the holding company for Affinity Bank (the 'Bank'), today announced net income of $2.2 million for the three months ended June 30, 2025, as compared to $1.0 million for the three months ended June 30, 2024. Expand At or for the three months ended, Performance Ratios: June 30, 2025 March 31, 2025 December 31, 2024 September 30, 2024 June 30, 2024 Net income (in thousands) $ 2,152 $ 1,831 $ 1,345 $ 1,730 $ 1,031 Diluted earnings per share 0.33 0.28 0.20 0.26 0.16 Operating income (1) 2,316 1,996 1,738 1,883 1,763 Adjusted diluted earnings per share (1) 0.36 0.30 0.26 0.29 0.27 Common book value per share 19.66 19.25 20.14 20.02 19.49 Tangible book value per share (1) 16.80 16.40 17.30 17.18 16.64 Total assets (in thousands) 933,799 912,496 866,817 878,561 873,582 Return on average assets 0.94 % 0.83 % 0.61 % 0.78 % 0.48 % Return on average equity 7.01 % 5.68 % 4.14 % 5.43 % 3.33 % Equity to assets 13.29 % 13.40 % 14.90 % 14.61 % 14.32 % Tangible equity to tangible assets (1) 11.58 % 11.65 % 13.08 % 12.80 % 12.49 % Net interest margin 3.57 % 3.52 % 3.56 % 3.52 % 3.71 % Efficiency ratio 65.72 % 68.55 % 75.95 % 71.48 % 78.74 % (1) Non-GAAP measure - see 'Explanation of Certain Unaudited Non-GAAP Financial Measures' for more information and reconciliation to GAAP. Expand Net Income Net income was $4.0 million for six months ended June 30, 2025 as compared to $2.4 million for the six months ended June 30, 2024, as a result of an increase in net interest income along with a decrease in noninterest expenses offset by a decrease in noninterest income. Operating income for the six months ended June 30, 2025 was $4.3 million as compared to $3.1 million for the six months ended June 30, 2024. Net income was $2.2 million for three months ended June 30, 2025 as compared to $1.0 million for the three months ended June 30, 2024, as a result of an increase in net interest income along with a decrease in noninterest expenses offset by a decrease in noninterest income. Operating income for the three months ended June 30, 2025 was $2.3 million as compared to $1.8 million for the three months ended June 30, 2024. Results of Operations Net interest income was $15.1 million for the six months ended June 30, 2025 compared to $14.3 million for the six months ended June 30, 2024. The increase was due to an increase in interest income on loans and interest-earning deposits offset by increases in deposit and borrowing costs and a decrease in interest income on investment securities. Net interest margin for the six months ended June 30, 2025 and 2024 remained stable at 3.55%. Noninterest income decreased $269,000 to $1.0 million for the six months ended June 30, 2025, primarily due to lower service charges on deposit accounts and the absence of a gain on the sale of other real estate recorded in 2024. Non-interest expense decreased $1.5 million to $10.8 million for the six months ended June 30, 2025 compared to the 2024 period, due mainly to a decrease in other fees. Net interest income was $7.8 million for the three months ended June 30, 2025 compared to $7.6 million for the three months ended June 30, 2024. The increase was due to an increase in interest income on loans and interest-earning deposits, partially offset by increases in deposit and a decrease in interest income on investment securities. Net interest margin for the three months ended June 30, 2025 decreased to 3.57% from 3.71% for the three months ended June 30, 2024. The decrease in the margin relates to a decrease in our yield on earning assets decreasing 11 basis points while our deposits and borrowing cost of funds only decreased three basis points. Noninterest income decreased $166,000 to $540,000 for the three months ended June 30, 2025, primarily due to lower service charges on deposit accounts and the absence of a gain on the sale of other real estate recorded in 2024. Non-interest expense decreased $1.3 million to $5.5 million for the three months ended June 30, 2025 compared to the 2024 period, due mainly to a decrease in other fees. Financial Condition Total assets increased $67.0 million to $933.8 million at June 30, 2025 from $866.8 million at December 31, 2024, as we experienced loan growth and an increase in interest earning deposits which was funded from growth in our deposits. Total gross loans increased $17.0 million to $731.1 million at June 30, 2025 from $714.1 million at December 31, 2024. The increase was due to steady loan demand in construction and consumer loans, and commercial loans secured by real estate - owner occupied. Non-owner occupied office loans totaled $39.9 million at June 30, 2025; the average LTV on these loans is 48.8%, including $15.8 million medical/dental tenants and $24.1 million to other various tenants. Investment securities held-to-maturity unrealized gains were $240,000, net of tax. Investment securities available-for-sale unrealized losses were $5.0 million, net of tax. Cash and cash equivalents increased $48.2 million to $89.7 million at June 30, 2025 from $41.4 million at December 31, 2024. Deposits increased by $75.9 million to $749.3 million at June 30, 2025 compared to $673.5 million at December 31, 2024, with a $42.5 million net increase in demand deposits and a $33.4 million increase in certificates of deposits. Borrowings decreased by $4.8 million to $54.0 million at June 30, 2025 compared to $58.8 million at December 31, 2024 as an advance from the Bank Term Funding program was paid in full in first quarter of 2025. Equity decreased $5.0 million to $124.1 million at June 30, 2025 from $129.1 million at December 31, 2024 from payment of $1.50 per share dividend that was declared and paid in first quarter, along with $2.1 million common stock repurchases. Asset Quality Non-performing loans decreased to $4.6 million at June 30, 2025 from $4.8 million at December 31, 2024. The allowance for credit losses as a percentage of non-performing loans was 187.1% at June 30, 2025, as compared to 177.9% at December 31, 2024. Allowance for credit losses to total loans decreased to 1.17% at June 30, 2025 from 1.19% at December 31, 2024. Net loan charge-offs were $79,000 for the six months ended June 30, 2025, as compared to net loan charge-offs of $460,000 for the six months ended June 30, 2024. About Affinity Bancshares, Inc. The Company is a Maryland corporation based in Covington, Georgia. The Company's banking subsidiary, Affinity Bank, opened in 1928 and currently operates a full-service office in Atlanta, Georgia, two full-service offices in Covington, Georgia, and a loan production office serving the Alpharetta and Cumming, Georgia markets. Forward-Looking Statements In addition to historical information, this release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which describe the future plans, strategies and expectations of the Company. Forward-looking statements can be identified by the use of words such as 'estimate,' 'project,' 'believe,' 'intend,' 'anticipate,' 'assume,' 'plan,' 'seek,' 'expect,' 'will,' 'may,' 'should,' 'indicate,' 'would,' 'contemplate,' 'continue,' 'target' and words of similar meaning. Forward-looking statements are based on our current beliefs and expectations and are inherently subject to significant business, economic and competitive uncertainties and contingencies, many of which are beyond our control. In addition, these forward-looking statements are subject to assumptions with respect to future business strategies and decisions that are subject to change. Accordingly, you should not place undue reliance on such statements. We are under no duty to and do not take any obligation to update any forward-looking statements after the date of this report. Factors which could have a material adverse effect on the operations of the Company and its subsidiaries include, but are not limited to, changes in general economic conditions, interest rates and inflation; changes in asset quality; our ability to access cost-effective funding; fluctuations in real estate values; changes in laws or regulations; changes in liquidity, including the size and composition of our deposit portfolio and the percentage of uninsured deposits in the portfolio; changes in technology; failures or breaches of our IT security systems; our ability to introduce new products and services and capitalize on growth opportunities; changes in the value of our goodwill and other intangible assets; our ability to successfully integrate acquired operations or assets; changes in accounting policies and practices; our ability to retain key employees; and the effects of natural disasters and geopolitical events, including terrorism, conflict and acts of war. These risks and other uncertainties are further discussed in the reports that the Company files with the Securities and Exchange Commission. Average Balance Sheets The following tables set forth average balance sheets, average annualized yields and costs, and certain other information for the periods indicated. No tax-equivalent yield adjustments have been made, as the effects would be immaterial. All average balances are monthly average balances. Non-accrual loans were included in the computation of average balances. The yields set forth below include the effect of deferred fees, discounts, and premiums that are amortized or accreted to interest income or interest expense. For the Six Months Ended June 30, 2025 2024 (Dollars in thousands) Interest-earning assets: Loans $ 720,966 $ 21,843 6.11 % $ 673,282 $ 19,978 5.97 % Investment securities held-to-maturity 27,082 832 6.20 % 34,225 1,056 6.20 % Investment securities available-for-sale 39,465 679 3.47 % 47,875 942 3.96 % Interest-earning deposits and federal funds 65,896 1,385 4.24 % 50,527 1,296 5.16 % Other investments 6,206 189 6.14 % 5,467 171 6.29 % Total interest-earning assets 859,615 24,928 5.85 % 811,376 23,443 5.81 % Non-interest-earning assets 47,862 51,633 Total assets $ 907,477 $ 863,009 Interest-bearing liabilities: Interest-bearing checking accounts $ 82,740 $ 182 0.44 % $ 88,584 $ 217 0.49 % Money market accounts 161,502 2,421 3.02 % 143,243 2,258 3.17 % Savings accounts 81,370 1,147 2.84 % 74,093 1,054 2.86 % Certificates of deposit 247,512 5,021 4.09 % 219,315 4,571 4.19 % Total interest-bearing deposits 573,124 8,771 3.09 % 525,235 8,100 3.10 % FHLB advances and other borrowings 54,426 1,042 3.86 % 58,145 1,025 3.55 % Total interest-bearing liabilities 627,550 9,813 3.15 % 583,380 9,125 3.15 % Non-interest-bearing liabilities 152,991 156,177 Total liabilities 780,541 739,557 Total stockholders' equity 126,936 123,452 Total liabilities and stockholders' equity $ 907,477 $ 863,009 Net interest rate spread 2.70 % 2.66 % Net interest income $ 15,115 $ 14,318 Net interest margin 3.55 % 3.55 % Expand AFFINITY BANCSHARES, INC. Consolidated Balance Sheets (unaudited) June 30, 2025 (Dollars in thousands except per share amounts) Assets Cash and due from banks $ 5,876 $ 7,092 Interest-earning deposits in other depository institutions 83,790 34,333 Cash and cash equivalents 89,666 41,425 Investment securities available-for-sale 40,739 36,502 Investment securities held-to-maturity (estimated fair value of $24,724 net of allowance for credit losses of $37 at June 30, 2025 and estimated fair value of $27,286 net of allowance for credit losses of $45 at December 31, 2024) 24,366 27,299 Other investments 6,243 6,175 Loans 731,135 714,115 Allowance for credit loss on loans (8,542 ) (8,496 ) Net loans 722,593 705,619 Premises and equipment, net 3,075 3,261 Bank owned life insurance 16,690 16,487 Intangible assets 18,080 18,175 Other assets 12,347 11,874 Total assets $ 933,799 $ 866,817 Liabilities and Stockholders' Equity Liabilities: Non-interest-bearing checking $ 151,882 $ 151,395 Interest-bearing checking 83,713 73,841 Money market accounts 167,859 148,752 Savings accounts 89,084 76,053 Certificates of deposit 256,800 223,440 Total deposits 749,338 673,481 Federal Home Loan Bank advances and other borrowings 54,000 58,815 Accrued interest payable and other liabilities 6,361 5,406 Total liabilities 809,699 737,702 Stockholders' equity: Common stock (par value $0.01 per share, 40,000,000 shares authorized; 6,295,339 issued and outstanding at June 30, 2025 and 6,409,598 issued and outstanding at December 31, 2024) 63 64 Preferred stock (10,000,000 shares authorized, no shares outstanding) — — Additional paid in capital 61,197 62,355 Unearned ESOP shares (3,915 ) (4,378 ) Retained earnings 71,756 76,786 Accumulated other comprehensive loss (5,001 ) (5,712 ) Total stockholders' equity 124,100 129,115 Total liabilities and stockholders' equity $ 933,799 $ 866,817 Expand AFFINITY BANCSHARES, INC. Consolidated Statements of Income (unaudited) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 (Dollars in thousands except per share amounts) Interest income: Loans, including fees $ 11,195 $ 10,479 $ 21,843 $ 19,978 Investment securities 858 1,095 1,700 2,169 Interest-earning deposits 770 648 1,385 1,296 Total interest income 12,823 12,222 24,928 23,443 Interest expense: Deposits 4,525 4,099 8,771 8,100 FHLB advances and other borrowings 520 555 1,042 1,025 Total interest expense 5,045 4,654 9,813 9,125 Net interest income before provision for credit losses 7,778 7,568 15,115 14,318 Provision for credit losses 17 213 67 213 Net interest income after provision for credit losses 7,761 7,355 15,048 14,105 Noninterest income: Service charges on deposit accounts 337 391 653 786 Net gain on sale of other real estate owned — 135 — 135 Other 203 180 368 369 Total noninterest income 540 706 1,021 1,290 Noninterest expenses: Salaries and employee benefits 3,260 3,417 6,619 6,596 Occupancy 595 615 1,200 1,233 Data processing 550 508 1,093 1,019 Other 1,062 2,179 1,914 3,442 Total noninterest expenses 5,467 6,719 10,826 12,290 Income before income taxes 2,834 1,342 5,243 3,105 Income tax expense 682 311 1,260 739 Net income $ 2,152 $ 1,031 $ 3,983 $ 2,366 Weighted average common shares outstanding Basic 6,312,589 6,416,628 6,358,888 6,416,628 Diluted 6,457,397 6,544,450 6,504,838 6,534,751 Basic earnings per share $ 0.34 $ 0.16 $ 0.63 $ 0.37 Diluted earnings per share $ 0.33 $ 0.16 $ 0.61 $ 0.36 Expand Explanation of Certain Unaudited Non-GAAP Financial Measures Reported amounts are presented in accordance with GAAP. Additionally, the Company believes the following information is utilized by regulators and market analysts to evaluate a company's financial condition and, therefore, such information is useful to investors. These disclosures should not be viewed as a substitute for financial results in accordance with GAAP, nor are they necessarily comparable to non-GAAP performance measures which may be presented by other companies. Refer to the Non-GAAP Reconciliation tables below for details on the earnings impact of these items. For the Three Months Ended For the Year Ended Non-GAAP Reconciliation June 30, 2025 March 31, 2025 December 31, 2024 September 30, 2024 June 30, 2024 June 30, 2025 June 30, 2024 Operating net income reconciliation Net income (GAAP) $ 2,152 $ 1,831 $ 1,345 $ 1,730 $ 1,031 $ 3,983 $ 2,366 Net loss on securities available for sale — — 385 — — — — ESOP Compensation expense related to dividend 210 211 — — — 421 Merger-related expenses — — 119 196 939 — 989 Income tax expense (46 ) (46 ) (111 ) (43 ) (207 ) (93 ) (218 ) Operating net income $ 2,316 $ 1,996 $ 1,738 $ 1,883 $ 1,763 $ 4,311 $ 3,137 Weighted average diluted shares 6,457,397 6,547,817 6,620,602 6,611,468 6,544,450 6,504,838 6,534,751 Adjusted diluted earnings per share $ 0.36 $ 0.30 $ 0.26 $ 0.29 $ 0.27 $ 0.66 $ 0.48 Tangible book value per common share reconciliation Book Value per common share (GAAP) $ 19.66 $ 19.25 $ 20.14 $ 20.02 $ 19.49 $ 19.52 $ 19.49 Effect of goodwill and other intangibles (2.86 ) (2.85 ) (2.84 ) (2.84 ) (2.85 ) (2.84 ) (2.85 ) Tangible book value per common share $ 16.80 $ 16.40 $ 17.30 $ 17.18 $ 16.64 $ 16.68 $ 16.64 Tangible equity to tangible assets reconciliation Equity to assets (GAAP) 13.29 % 13.40 % 14.90 % 14.61 % 14.32 % 13.29 % 14.32 % Effect of goodwill and other intangibles (1.71 )% (1.75 )% (1.81 )% (1.81 )% (1.83 )% (1.71 )% (1.83 )% Tangible equity to tangible assets (1) 11.58 % 11.65 % 13.08 % 12.80 % 12.49 % 11.58 % 12.49 % (1) Tangible assets is total assets less intangible assets. Tangible equity is total equity less intangible assets. Expand
Business Wire
an hour ago
- Business Wire
Certain DWS Closed-End Funds Announce Extension of Share Repurchases and The Central and Eastern Europe Fund, Inc. Announces Extension of Minimum Period for Partial Advisory Fee Waiver
NEW YORK--(BUSINESS WIRE)--The Central and Eastern Europe Fund, Inc. (NYSE: CEE), The European Equity Fund, Inc. (NYSE: EEA), and The New Germany Fund, Inc. (NYSE: GF) (each, a 'Fund,' and collectively, the 'Funds') each announced today that its Board of Directors has approved an extension of the current repurchase authorization permitting open market share repurchases for an additional twelve-month period. Each Fund may continue to purchase outstanding shares of its common stock in open-market transactions over the twelve-month period from August 1, 2025 through July 31, 2026 when the Fund's shares trade at a discount to net asset value ('NAV') and such purchases are deemed to be in the best interests of the Fund. The amount and timing of the repurchases will be at the discretion of DWS Investment Management Americas, Inc., the Funds' administrator, and subject to market conditions and investment considerations. Any purchases will be made at prices that will be accretive to each Fund's NAV. The authorization of the extension of the Funds' repurchase programs follows the current repurchase programs, which commenced on August 1, 2024 and continue through July 31, 2025. Results of repurchases under each Fund's program appear in the Fund's shareholder reports. In addition, each Fund announced that its Board continues to reserve its discretion to determine if it would be appropriate to initiate a tender offer during the twelve-month period from August 1, 2025 through July 31, 2026. Each Board intends to continue to consider this matter on a regular basis. In addition, CEE announced today that the Fund's investment advisor, DWS International GmbH, has voluntarily agreed to continue to waive 50% of its advisory fee until further notice but at least until December 31, 2025. Previously, such partial fee waiver was to continue until further notice but at least through September 30, 2025. Important Information Closed-end funds, unlike open-end funds, are not continuously offered. There is a one-time public offering and once issued, shares of closed-end funds are sold in the open market through a stock exchange. Shares of closed-end funds frequently trade at a discount to net asset value. The price of the fund's shares is determined by a number of factors, several of which are beyond the control of the fund. Therefore, the fund cannot predict whether its shares will trade at, below or above net asset value. The Central and Eastern Europe Fund, Inc. is non-diversified and can take larger positions in fewer issues, increasing its potential risk. Investing in foreign securities presents certain risks, such as currency fluctuations, political and economic changes, and market risks. Emerging markets tend to be more volatile and less liquid than the markets of more mature economies, and generally have less diverse and less mature economic structures and less stable political systems than those of developed countries. Any fund that focuses in a particular segment of the market or region of the world will generally be more volatile than a fund that invests more broadly. This fund is non-diversified and can take larger positions in fewer issues, increasing its potential risk. The European Equity Fund, Inc. is diversified and primarily focuses its investments in equity securities of issuers domiciled in Europe, thereby increasing its vulnerability to developments in that region. The New Germany Fund, Inc. is diversified and primarily focuses its investments in Germany, thereby increasing its vulnerability to developments in that country. Investing in foreign securities, particularly of emerging markets, presents certain risks, such as currency fluctuations, and risks of currency and capital controls, political and economic changes, and market risks. Any fund that concentrates in a particular segment of the market or a particular geographical region will generally be more volatile than a fund that invests more broadly. War, terrorism, sanctions, economic uncertainty, trade disputes, public health crises and related geopolitical events have led, and, in the future, may lead to significant disruptions in US and world economies and markets, which may lead to increased market volatility and may have significant adverse effects on the Funds and their investments. The European Union, the United States and other countries have imposed sanctions on Russia in response to Russian military and other actions in recent years. These sanctions have adversely affected Russian individuals, issuers and the Russian economy. Russia, in turn, has imposed sanctions targeting Western individuals, businesses and products. The various sanctions have adversely affected, and may continue to adversely affect, not only the Russian economy, but also the economies of many countries in Europe, including countries in Central and Eastern Europe. In the case of the Central and Eastern Europe Fund, Inc., Russia's invasion of Ukraine has materially adversely affected, and may continue to materially adversely affect, the value and liquidity of the Fund's portfolio. This press release shall not constitute an offer to sell or a solicitation to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer or solicitation or sale would be unlawful prior to registration or qualification under the laws of such state or jurisdiction. Certain statements contained in this release may be forward-looking in nature. These include all statements relating to plans, expectations, and other statements that are not historical facts and typically use words like 'expect,' 'anticipate,' 'believe,' 'intend,' and similar expressions. Such statements represent management's current beliefs, based upon information available at the time the statements are made, with regard to the matters addressed. All forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed in, or implied by, such statements. Management does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. The following factors, among others, could cause actual results to differ materially from forward-looking statements: (i) the effects of adverse changes in market and economic conditions; (ii) legal and regulatory developments; and (iii) other additional risks and uncertainties, including public health crises (including the recent pandemic spread of the novel coronavirus), war, terrorism, trade disputes and related geopolitical events. Past performance is no guarantee of future results. NOT FDIC/ NCUA INSURED • MAY LOSE VALUE • NO BANK GUARANTEE NOT A DEPOSIT • NOT INSURED BY ANY FEDERAL GOVERNMENT AGENCY DWS Distributors, Inc. 222 South Riverside Plaza Chicago, IL 60606-5808 Tel (800) 621-1148 © 2025 DWS Group GmbH & Co. KGaA. All rights reserved The brand DWS represents DWS Group GmbH & Co. KGaA and any of its subsidiaries such as DWS Distributors, Inc. which offers investment products or DWS Investment Management Americas, Inc. and RREEF America L.L.C. which offer advisory services. (R-106684-1) (07/25)
Yahoo
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Rocket lays off staff; Abivax capitalizes on immune drug data
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Today, a brief rundown of news involving Rocket Pharmaceuticals and Atara Biotherapeutics, as well as updates from Abivax, Gate Bioscience and Matchpoint Therapeutics that you may have missed. Rocket Pharmaceuticals is laying off approximately 30% of its workforce and focusing resources on gene therapies for three inherited heart conditions, the company said Thursday. Rocket expects the cuts will reduce its operating expenses by one-quarter, which, together with existing cash reserves and the potential sale of a regulatory fast pass it might receive in the future, should help keep the company afloat into the second quarter of 2027. The Food and Drug Administration last year rejected an approval application for Rocket's gene therapy Kresladi, which the company hopes to resubmit. Rocket said it anticipates delays in advancing two other programs for Fanconi anemia and and pyruvate kinase deficiency. — Ned Pagliarulo Atara Biotherapeutics and partner Pierre Fabre Pharmaceuticals are taking a second shot at FDA approval of their T cell immunotherapy tab-cel, announcing Thursday that the agency has accepted their resubmission after rejecting an initial attempt over manufacturing in January. The FDA will decide on approval by Jan. 10, Atara said. Tab-cel was developed for previously treated adults and children who have post-transplant lymphoproliferative disease that's positive for the Epstein-Barr virus. — Ned Pagliarulo Abivax expects to raise at least $650 million via a sale of its American Depositary shares that it priced Thursday. The secondary stock offering follows the company's announcement this week of Phase 3 study results for an ulcerative colitis drug that impressed analysts and investors. Should the investment banks underwriting the offering exercise their options to purchase additional stock, Abivax could bring in nearly $750 million, which would be some ten times its current cash holdings. It expects the new funds will give it operating runway through 2027 and support further testing of the drug, obefazimod, in inflammatory bowel disease. — Ned Pagliarulo Gate Bioscience, a California-based biotechnology company, announced Thursday that it has entered into collaboration and licensing agreement with Eli Lilly. The deal includes an upfront payment, equity investment, and could also hold potential milestone and royalty payouts. A Gate spokesperson said the fresh funding provides more than a year of runway for the company and, all told, the deal value could reach up to $856 million. The company is backed by well-known life sciences investors like Versant Ventures, a16z, Arch Venture Partners and Alphabet's venture capital arm. It aims to create "molecular gates," a new class of medicines designed to stop cells from secreting disease-causing proteins. Through their collaboration, Lilly and Gate hope to identify therapies that can eliminate "specific difficult-to-drug proteins" and thereby provide novel ways to treat diseases with "high unmet medical need." — Jacob Bell Privately held Matchpoint Therapeutics is getting validation of its drug research from Novartis, which has agreed to pay the Watertown, Massachusetts-based biotech as much as $60 million in upfront and research funding fees. Under the deal, Matchpoint is responsible for advancing an undisclosed program through preclinical testing, at which point Novartis holds an option to exclusively license it. Matchpoint specializes in drugs that work by binding covalently to their target, and is taking aim at an unnamed transcription factor involved in inflammatory disease. — Ned Pagliarulo GSK will have to wait a little longer to learn whether its multiple myeloma drug Blenrep can make a return to the U.S. market. The FDA was set to decide on approval by July 23, but extended its review by three months to "review additional information" the company provided to support its application. Blenrep's new decision date is Oct. 23. An advisory committee voted last week that GSK's trial data did not prove a favorable benefit-risk balance for the patients the company hopes to treat. — Ned Pagliarulo Recommended Reading GSK prepares to relaunch Blenrep; Activists challenge another 'zombie' biotech
