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Yahoo
a day ago
- Business
- Yahoo
Vera drug scores in closely watched study in rare kidney disease
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. An experimental medicine from Vera Therapeutics succeeded in a late-stage trial in a rare kidney disease, positioning the company to discuss an approval application with U.S. regulators in the near future. According to Vera, the drug, called atacicept, met its main goal in a Phase 3 trial in IgA nephropathy, a chronic condition that can lead to kidney failure. After 36 weeks of treatment, atacicept was associated with a 42% reduction versus a placebo — and a 46% decline from the study's start — in the amount of protein in participants' urine, an important marker of kidney health. Without providing specifics, Vera said atacicept's other efficacy results were 'consistent with or better than' what was observed in mid-stage testing and had a safety profile 'comparable to placebo.' The company will share the data with the Food and Drug Administration in the coming weeks and intends to file an accelerated approval request in the fourth quarter. Vera is one of the leaders in a push to develop new treatments for IgA nephropathy, or IgAN, a progressive disease that damages the kidneys. Some estimates hold 130,000 to 150,000 people in the U.S. have IgAN. While several medicines are approved, they don't totally stop patients' kidney function from deteriorating. That need, and a better understanding of the disease's biology, has led to an uptick in dealmaking involving IgAN. Drugs recently launched by Travere Therapeutics and Calliditas Therapeutics have performed well, too. Vera's atacicept is part of a newer wave of therapies aimed at immune-mediated drivers of the disease. Like several others in development, it targets a pair of cytokines called BAFF and April that stimulate production of the 'autoantibodies' that mistakenly target the body's own tissue. In Phase 2 testing, the drug stabilized a key marker of disease progression so well that some analysts viewed the findings as the bar for other competitors to meet. The findings also heightened anticipation for Vera's Phase 3 study. According to Marshall Fordyce, Vera's founder and CEO, the drug's effects on urine protein in the trial significantly 'exceed the bar' for what U.S. regulators have accepted in granting an accelerated approval to several other medications. The figure Vera reported also represents the 'deepest reduction' in a late-stage stage study in IgAN patients to date, he wrote in an email. Investors appear to agree, as Vera's shares climbed by nearly 60%, to over $30 apiece, in early trading on Monday. Vera has competition ahead, as Otsuka Pharmaceutical could win approval of a similar type of medicine by late November. The company will present detailed Phase 3 study results at a medical meeting on Friday and, though cross-trial comparisons come with caveats, analysts and investors will be paying close attention to how the two treatments stack up. Vera, for its part, believes the market for IgAN treatments is 'ripe for disruption,' according to Fordyce. There are currently 'low levels of approved product saturation,' Fordyce wrote, and newer drugs like atacicept 'may represent a differentiated approach.' The company is also studying the drug in people whose are at 'moderate' or 'low' risk of disease progression, which, if successful, could boost its sales potential. The Phase 3 trial, meanwhile, will continue on while Vera accumulates data on atacicept's impact on kidney function. Those findings are expected in 2027. Vera's results have implications for drugmakers like Biogen and Vertex Pharmaceuticals, which have both cut deals for companies developing IgAN drugs. Vertex has said it could file for approval of a drug that also targets BAFF and April early next year, if data are supportive.
Business Wire
12-05-2025
- Business
- Business Wire
Aurinia Pharmaceuticals Reports Financial Results for the Three Months Ended March 31, 2025
ROCKVILLE, Md. & EDMONTON, Alberta--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today announced financial results for the three months ended March 31, 2025. First Quarter 2025 Financial Results Total Revenue: For the three months ended March 31, 2025, total revenue was $62.5 million, up 24% from $50.3 million in the same period of 2024. Net Product Sales: For the three months ended March 31, 2025, net product sales of LUPKYNIS, the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis, were $60.0 million, up 25% from $48.1 million in the same period of 2024. License, Collaboration and Royalty Revenue: For the three months ended March 31, 2025, license, collaboration and royalty revenue, which includes manufacturing services revenue from Aurinia's collaboration partner, Otsuka, was $2.5 million, up 14% from $2.2 million in the same period of 2024. Net Income (Loss): For the three months ended March 31, 2025, net income (loss) was $23.3 million, compared to $(10.7) million in the same period of 2024. Cash Flow Provided by (Used in) Operating Activities: For the three months ended March 31, 2025, cash flow provided by (used in) operating activities was $1.3 million, compared to $(18.6) million in the same period of 2024. Excluding $11.1 million of cash payments made in connection with the November 2024 restructuring, cash flow generated from operations was $12.4 million for the three months ended March 31, 2025. Cash Position As of March 31, 2025, Aurinia had cash, cash equivalents, restricted cash and investments of $312.9 million, compared to $358.5 million at December 31, 2024. For the three months ended March 31, 2025, the Company repurchased 5.8 million of its common shares for $47.4 million. Full Year 2025 Total Revenue and Net Product Sales Guidance For 2025, Aurinia is reiterating its established total revenue guidance in the range of $250 million to $260 million and net product sales guidance in the range of $240 million to $250 million. 'We are pleased to report continued positive growth and momentum for LUPKYNIS in the first quarter of 2025 and are looking forward to a strong performance this year,' stated Peter Greenleaf, President and Chief Executive Officer of Aurinia. 'Following the recent update to the American College of Rheumatology lupus nephritis treatment guideline, which recommends the incorporation of drugs like LUPKYNIS into first-line therapy, our commercial organization is focused on educating rheumatologists about the benefits of initiating LUPKYNIS earlier in the treatment paradigm. We also remain on track to report initial results from our Phase 1 study of AUR200, a dual inhibitor of B cell activating factor (BAFF) and a proliferation inducing ligand (APRIL), later this quarter.' Webcast & Conference Call Details A webcast and conference call will be hosted today, May 12, at 8:30 a.m. ET. The link to the audio webcast is available here. To join the conference call, please dial 877-407-9170/+1 201-493-6756. A replay of the webcast will be available on Aurinia's website. About Aurinia Aurinia is a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS ® (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis. Aurinia is also developing AUR200, a dual inhibitor of B cell activating factor (BAFF) and a proliferation inducing ligand (APRIL) for the potential treatment of autoimmune diseases. Forward-Looking Statements This press release contains forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable U.S. securities law. We caution investors that forward-looking statements are based on management's expectations and assumptions as of the date of this press release and involve substantial risks and uncertainties that could cause the actual outcomes to differ materially from what we currently expect. These risks and uncertainties include, but are not limited to, those associated with: LUPKYNIS net product sales, the timing of clinical study results and other risks and uncertainties identified in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements in this press release apply only as of the date made, and we undertake no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia's most recent Annual Report on Form 10-K and its other public available filings available by accessing the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (SEDAR) website at or the U.S. Securities and Exchange Commission's Electronic Document Gathering and Retrieval System (EDGAR) website at and on Aurinia's website at (in thousands) December 31, 2024 (Unaudited) ASSETS Current assets: Cash, cash equivalents and restricted cash $ 66,428 $ 83,433 Short-term investments 246,473 275,043 Accounts receivable, net 40,350 36,544 Inventory, net 46,195 39,228 Prepaid expenses and deposits 5,535 11,219 Other current assets 781 1,129 Total current assets 405,762 446,596 Finance right-of-use lease assets 87,577 92,072 Intangible assets, net 4,158 4,355 Operating right-of-use lease assets 3,954 4,068 Property and equipment, net 2,576 2,731 Other noncurrent assets 823 823 Total assets $ 504,850 $ 550,645 LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Accounts payable $ 4,220 $ 5,187 Accrued expenses 42,353 64,971 Finance lease liabilities, current portion 14,508 14,046 Deferred revenue 4,594 11,002 Operating lease liabilities, current portion 1,036 1,026 Other current liabilities 1,695 1,531 Total current liabilities 68,406 97,763 Finance lease liabilities, less current portion 56,828 58,554 Deferred revenue, less current portion 12,450 1,699 Deferred compensation and other noncurrent liabilities 11,438 9,408 Operating lease liabilities, less current portion 5,538 5,743 Total liabilities 154,660 173,167 Shareholders' equity Common shares - no par value, unlimited shares authorized, 137,747 and 140,883 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively 1,163,262 1,187,696 Additional paid-in capital 100,979 126,999 Accumulated other comprehensive loss (825 ) (647 ) Accumulated deficit (913,226 ) (936,570 ) Total shareholders' equity 350,190 377,478 Total liabilities and shareholders' equity $ 504,850 $ 550,645 Expand AURINIA PHARMACEUTICALS INC. AND SUBSIDIARY (Unaudited) (in thousands, except per share data) Three months ended March 31, 2025 2024 Revenue Net product sales $ 59,971 $ 48,073 License, collaboration and royalty revenue 2,494 2,230 Total revenue 62,465 50,303 Operating expenses Cost of revenue 8,574 7,752 Selling, general and administrative 20,339 47,695 Research and development 5,743 5,551 Restructuring 1,533 6,683 Other expense (income), net 4,429 (4,125 ) Total operating expenses 40,618 63,556 Income (loss) from operations 21,847 (13,253 ) Interest income 3,569 4,526 Interest expense (1,067 ) (1,283 ) Net income (loss) before income taxes 24,349 (10,010 ) Income tax expense 1,005 739 Net income (loss) $ 23,344 $ (10,749 ) Earnings (loss) per share Basic $ 0.17 $ (0.07 ) Diluted $ 0.16 $ (0.07 ) Shares used in computing earnings (loss) per share Basic 138,917 144,013 Diluted 143,199 144,013 Expand AURINIA PHARMACEUTICALS INC. AND SUBSIDIARY (Unaudited) (in thousands) Three Months Ended March 31, 2025 2024 Cash flows from operating activities: Net income (loss) $ 23,344 $ (10,749 ) Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: Share-based compensation (3,409 ) 5,737 Amortization and depreciation 4,856 4,847 Foreign exchange loss (gain) on revaluation of finance lease liability (Monoplant) 1,812 (6,025 ) Net amortization of premiums and discounts on investments (2,656 ) (3,206 ) Other, net 2,325 1,559 Net changes in operating assets and liabilities: Accounts receivable, net (3,806 ) (4,820 ) Inventory, net (6,967 ) (56 ) Prepaid expenses and other current assets 6,033 873 Other noncurrent operating assets — 17 Accounts payable (974 ) 1,345 Accrued expenses and other liabilities (23,405 ) (7,936 ) Deferred revenue 4,342 (3 ) Operating lease liabilities (195 ) (181 ) Net cash provided by (used in) operating activities 1,300 (18,598 ) Cash flows from investing activities: Proceeds from the sale and maturities of investments 123,035 170,505 Purchases of investments (91,986 ) (121,260 ) Purchase of property, equipment and intangible assets (17 ) (12 ) Net cash provided by investing activities 31,032 49,233 Cash flows from financing activities: Repurchase of common shares (46,921 ) (12,301 ) Principal portion of finance lease payments (2,771 ) (2,778 ) Proceeds from issuance of common shares from exercise of stock options and vesting of RSUs and performance awards 9,288 5,524 Taxes paid related to net settlement of exercises of stock options and vesting of RSUs and performance awards (8,933 ) (5,496 ) Net cash used in financing activities (49,337 ) (15,051 ) Net (decrease) increase in cash, cash equivalents and restricted cash (17,005 ) 15,584 Cash, cash equivalents and restricted cash, beginning of the period 83,433 48,875 Cash, cash equivalents and restricted cash, end of the period $ 66,428 $ 64,459 Expand
Yahoo
27-02-2025
- Business
- Yahoo
Vera Therapeutics to Participate in the TD Cowen 45th Annual Health Care Conference
BRISBANE, Calif., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced that the Company's management team will participate in a fireside chat at the TD Cowen 45th Annual Health Care Conference, which is taking place in Boston, MA from March 3 – 5, 2025. The management team will also participate in one-on-one investor meetings. Fireside Chat Details:Date: Tuesday, March 4, 2025Time: 9:10 AM ESTWebcast: A replay of the event will be available for 90 days and can be accessed by visiting the 'Investor Calendar' section of the Vera Therapeutics website. About VeraVera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera's lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN, also known as Berger's disease, and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus (BKV), a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept and MAU868. Vera also holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B cell mediated diseases. For more information, please visit For more information, please contact: Investor Contact:Joyce AllaireLifeSci Advisors212-915-2569jallaire@ Media Contact:Madelin HawtinLifeSci CommunicationsMHawtin@ in to access your portfolio
