Voclosporin

surreal book concept pages flying out of book iStock, francescoch Nearly 90% of senior leaders who were at the FDA a year ago are no longer with the agency, a BioSpace analysis shows. None remain from the Office of the Commissioner. In late March, I was shocked to come back from a family vacation to learn that Peter Marks was stepping down as director of the FDA’s Center for Biologics Evaluation and Research. Little did we know, that was just the beginning. Marks’ departure, together with this week’s shocker—Richard Pazdur’s retirement just three weeks into his new role as director of CBER’s sister department, the Center for Drug Evaluation and Research—bookend a year of rapid fire and often drama-filled turnover in the most senior ranks of the FDA. When Pazdur leaves, just three names from the agency’s senior organizational chart from a year ago will remain standing. The U.S. biopharma industry has been shrouded in uncertainty this year, from drug pricing reform to tariffs to the long-term shortage of capital. Amid this backdrop, the continued instability of the leadership at the country’s drug regulator is an unforced error we can’t afford. After news of Marks’ resignation broke, BIO President John Crowley issued a statement imploring the retention of scientific expertise and strong leadership. On Tuesday afternoon, in response to Pazdur’s move toward retirement, he didn’t hold back. “Dr. Pazdur’s departure raises serious concerns about the repeated turnover in key leadership occurring at the FDA,” Crowley wrote in a prepared statement . “This constant turmoil is undermining America’s leadership in biotechnology, creating unprecedented regulatory instability and unpredictability, and risks ceding this critical sector to China.” A Mountain of Institutional Knowledge Lost A well-respected regulator in a world of novel modalities, Marks had pledged to work with the incoming administration despite ideological differences and a massive workforce reduction. But it seems a lack of trust ultimately forced him out . Marks apparently refused to grant editing access for the Vaccines Adverse Event Reporting System (VAERS) to the team of Health Secretary Robert F. Kennedy Jr. for fear that “they’d write over it or erase the whole database,” according to the Associated Press . He was then given the choice to resign or be fired. In his resignation letter, Marks wrote that he had been hoping to work with Kennedy and address his “concerns regarding vaccine safety.” But that collaboration was not in the cards. “It has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies,” Marks wrote. Marks’ ousting was what first prompted us here at BioSpace to take a closer look at the turnover of FDA’s leadership. At that time, in early April, more than half the roles in FDA’s senior organizational chart, which includes the Office of the Commissioner and FDA HQ offices, had turned over since the election the previous November. Editorial FDA Gutted Under Trump, RFK Jr., With More Than Half of Senior Leadership Now Gone While it’s not unusual for certain positions to turn over with a new administration, the number of senior-level FDA staffers who have recently left the agency is unprecedented. The lack of communication, transparency and human decency is as well. April 4, 2025 · 7 min read · Jef Akst Since then, there have been several more surprise exits —not to mention the astonishing return of Marks’ replacement, Vinay Prasad, after a short hiatus following the Sarepta drama this summer. Some of these leaders have gone out quietly. Yashika Rahaman, who reported to the FDA commissioner as director of the Office of Planning, Evaluation, and Risk Management for the last five years of her 17-year tenure at the agency and was director of the FDA Enterprise Risk Management Program before that, noted her July departure from the agency on LinkedIn but it did not make the news. Others, of course, have made countless headlines, in BioSpace and other industry brands as well as national newspapers. George Tidmarsh, who resigned as CDER director at the beginning of November but said he would fight to clear his name, is a prime example. He stepped down as an investigation into his personal conduct was getting underway. In a now-deleted LinkedIn post, Tidmarsh questioned the market approval of Aurinia Pharmaceuticals’ lupus nephritis drug Lupkynis. Kevin Tang, chair of Aurinia’s board of directors and well-known in the industry for buying up struggling biotechs through Concentra Biosciences, filed a complaint. And if we thought that was fit for TV, Pazdur’s sudden retirement is the twist we maybe should have predicted. He reportedly declined the CDER role when it was first offered to him but FDA Commissioner Marty Makary fought for him and he ultimately agreed—and the industry breathed a sigh of relief. But ultimately Pazdur, an FDA veteran of nearly three decades, plans to walk away from it all—director of CDER and his former role as director of the Oncology Center of Excellence, a department he founded in 2017. And he’s apparently doing so over concerns about how the FDA is conducting itself. RBC Capital Markets described Pazdur’s departure succinctly. “[It] rekindles regulatory uncertainty as record FDA leadership turnover continues,” the analysts wrote in a Tuesday afternoon note to investors. “[It’s] a significant, sudden and surprising turn.” Clearly, the FDA soap opera has not yet concluded. Could Makary be the next episode? The Wall Street Journal reported last month that Kennedy was considering limiting Makary’s role or bringing on someone else to run the agency, even if Makary stayed on as a figurehead . Just before Thanksgiving, the White House denied a promotion for Makary’s aide. RBC analysts certainly didn’t dismiss the idea. “Given Dr. Pazdur’s departure, and the multiple high-ranking officials that have left, even if temporarily, in our view it would not be unreasonable should Dr. Makary’s tenure be on shaky ground,” they wrote. And what would that mean for biopharma companies navigating this unstable and uncertain regulatory environment? Unfortunately, they may just have to stay tuned to find out—a wait-and-see game that puts the industry under immense strain. Crowley expressed the desperation of the situation. “We are at a tipping point,” he wrote. “It is time to right this ship.” FDA FDA’s Lost Leaders: Where Are They Now? After a chaotic year that has seen the attrition of over half the FDA’s senior leadership, many of these individuals have landed new roles—at Eli Lilly, Pfizer, Iovance and more. The FDA’s loss, it seems, is largely the pharmaceutical industry’s gain. October 20, 2025 · 8 min read · Heather McKenzie

ROCKVILLE, Md. & EDMONTON, Alberta--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today announced financial results for the three and nine months ended September 30, 2025, and provided an update on recent business progress. Financial Results Total Revenue: For the three and nine months ended September 30, 2025, total revenue was $73.5 million and $205.9 million, up 8% and 17%, respectively, from $67.8 million and $175.3 million, respectively, for the same periods of 2024. Net Product Sales: For the three and nine months ended September 30, 2025, net product sales of LUPKYNIS, the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis, were $70.6 million and $197.2 million, up 27% and 24%, respectively, from $55.5 million and $158.6 million, respectively, for the same periods of 2024. License, Collaboration and Royalty Revenue: For the three and nine months ended September 30, 2025, license, collaboration and royalty revenue, which includes manufacturing services revenue from Aurinia’s collaboration partner, Otsuka, was $2.8 million and $8.8 million, respectively, compared to $12.3 million and $16.7 million, respectively, in the same periods of 2024. The 2024 periods included a milestone payment of $10.0 million associated with LUPKYNIS regulatory approval in Japan. Net Product Sales: For the three and nine months ended September 30, 2025, net product sales of LUPKYNIS, the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis, were $70.6 million and $197.2 million, up 27% and 24%, respectively, from $55.5 million and $158.6 million, respectively, for the same periods of 2024. License, Collaboration and Royalty Revenue: For the three and nine months ended September 30, 2025, license, collaboration and royalty revenue, which includes manufacturing services revenue from Aurinia’s collaboration partner, Otsuka, was $2.8 million and $8.8 million, respectively, compared to $12.3 million and $16.7 million, respectively, in the same periods of 2024. The 2024 periods included a milestone payment of $10.0 million associated with LUPKYNIS regulatory approval in Japan. Net Income: For the three and nine months ended September 30, 2025, net income was $31.6 million and $76.4 million, up 119% and 1677%, respectively, compared to $14.4 million and $4.3 million, respectively, for the same periods of 2024. Diluted Earnings per Share: For the three and nine months ended September 30, 2025, diluted earnings per share was $0.23 and $0.55, up 130% and 1733%, respectively, compared to $0.10 and $0.03, respectively, for the same periods of 2024. Cash Flows from Operating Activities: For the three and nine months ended September 30, 2025, cash flows from operating activities were $44.5 million and $90.0 million, up 162% and 529%, respectively, compared to $17.0 million and $14.3 million, respectively, for the same periods of 2024. Cash Position As of September 30, 2025, Aurinia had cash, cash equivalents, restricted cash and investments of $351.8 million, compared to $358.5 million at December 31, 2024. For the nine months ended September 30, 2025, the Company repurchased 12.2 million of its common shares for $98.2 million. Full Year 2025 Total Revenue and Net Product Sales Guidance For 2025, Aurinia is increasing total revenue guidance from a range of $260 million to $270 million to a range of $275 million to $280 million and net product sales guidance from a range of $250 million to $260 million to a range of $265 million to $270 million. “LUPKYNIS sales experienced continued momentum following last year’s update to the American College of Rheumatology lupus nephritis treatment guidelines, which recommend the incorporation of drugs like LUPKYNIS into first-line therapy in order to preserve kidney function,” stated Peter Greenleaf, President and Chief Executive Officer of Aurinia. “Additionally, we are excited about the positive results from our Phase 1 study of aritinercept, a dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL) and look forward to initiating clinical studies in two autoimmune diseases by the end of this year.” Webcast & Conference Call Details A webcast and conference call will be hosted today, November 4, 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 aritinercept, 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 www.sedarplus.ca or the U.S. Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar, and on Aurinia’s website at www.auriniapharma.com. AURINIA PHARMACEUTICALS INC. AND SUBSIDIARY CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) September 30, 2025 December 31, 2024 (Unaudited) ASSETS Current assets: Cash, cash equivalents and restricted cash $ 73,189 $ 83,433 Short-term investments 278,619 275,043 Accounts receivable, net 30,728 36,544 Inventory, net 44,793 39,228 Prepaid expenses and deposits 11,107 11,219 Other current assets 301 1,129 Total current assets 438,737 446,596 Finance right-of-use lease assets 78,813 92,072 Intangible assets, net 3,901 4,355 Operating right-of-use lease assets 3,718 4,068 Property and equipment, net 2,266 2,731 Other noncurrent assets 93 823 Total assets $ 527,528 $ 550,645 LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Accounts payable $ 2,214 $ 5,187 Accrued expenses 49,536 64,971 Finance lease liabilities, current portion 16,309 14,046 Deferred revenue 4,602 11,002 Operating lease liabilities, current portion 1,057 1,026 Other current liabilities 2,502 1,531 Total current liabilities 76,220 97,763 Finance lease liabilities, less current portion 55,727 58,554 Deferred revenue, less current portion 12,249 1,699 Deferred compensation and other noncurrent liabilities 12,442 9,408 Operating lease liabilities, less current portion 5,119 5,743 Total liabilities 161,757 173,167 Shareholders' equity Common shares - no par value, unlimited shares authorized, 131,841 and 140,883 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively 1,116,797 1,187,696 Additional paid-in capital 109,885 126,999 Accumulated other comprehensive loss (749 ) (647 ) Accumulated deficit (860,162 ) (936,570 ) Total shareholders' equity 365,771 377,478 Total liabilities and shareholders' equity $ 527,528 $ 550,645 AURINIA PHARMACEUTICALS INC. AND SUBSIDIARY CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (in thousands, except per share data) Three Months Ended Nine Months Ended September 30, September 30, 2025 2024 2025 2024 Revenue Net product sales $ 70,627 $ 55,503 $ 197,172 $ 158,604 License, collaboration and royalty revenue 2,841 12,268 8,769 16,662 Total revenue 73,468 67,771 205,941 175,266 Operating expenses Cost of revenue 8,177 6,035 23,866 22,696 Selling, general and administrative 26,182 42,367 72,539 134,996 Research and development 8,435 3,047 21,610 12,678 Restructuring — — 1,647 7,755 Other expense, net 929 4,574 14,604 159 Total operating expenses 43,723 56,023 134,266 178,284 Income (loss) from operations 29,745 11,748 71,675 (3,018 ) Interest income 3,316 4,267 10,075 12,982 Interest expense (1,099 ) (1,208 ) (3,283 ) (3,689 ) Net income before income taxes 31,962 14,807 78,467 6,275 Income tax expense 411 457 2,059 1,952 Net income $ 31,551 $ 14,350 $ 76,408 $ 4,323 Earnings per share Basic $ 0.24 $ 0.10 $ 0.57 $ 0.03 Diluted $ 0.23 $ 0.10 $ 0.55 $ 0.03 Shares used in computing earnings per share Basic 131,808 143,051 135,163 143,353 Diluted 136,008 145,651 138,959 145,010 AURINIA PHARMACEUTICALS INC. AND SUBSIDIARY CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) (in thousands) Nine Months Ended September 30, 2025 2024 Cash flows from operating activities: Net income $ 76,408 $ 4,323 Adjustments to reconcile net income to cash flows from operating activities: Share-based compensation 7,950 22,650 Amortization and depreciation 14,585 14,583 Foreign exchange loss (gain) on revaluation of Monoplant finance lease liability 9,318 (718 ) Net amortization of premiums and discounts on investments (7,844 ) (9,752 ) Other, net 4,852 220 Net changes in operating assets and liabilities: Accounts receivable, net 5,816 (12,394 ) Inventory, net (5,565 ) 991 Prepaid expenses and other current assets 940 (6,001 ) Other noncurrent operating assets 730 (12 ) Accounts payable (2,973 ) 4,551 Accrued expenses and other liabilities (17,777 ) (4,139 ) Deferred revenue 4,150 522 Lease liabilities (600 ) (550 ) Cash flows from operating activities 89,990 14,274 Cash flows from investing activities: Proceeds from the sale and maturities of investments 348,785 461,448 Purchases of investments (344,618 ) (461,140 ) Purchases of property, equipment and intangible assets (180 ) (225 ) Upfront lease payment — (44 ) Cash flows from investing activities 3,987 39 Cash flows from financing activities: Repurchase of common shares (98,156 ) (18,435 ) Principal portion of finance lease payments (9,649 ) (8,959 ) Proceeds from issuance of common shares from exercise of stock options and vesting of RSUs and performance awards 12,583 6,537 Proceeds from issuance of common shares under ESPP 401 703 Taxes paid related to net settlement of exercises of stock options and vesting of RSUs and performance awards (9,400 ) (5,892 ) Cash flows from financing activities (104,221 ) (26,046 ) Net decrease in cash, cash equivalents and restricted cash (10,244 ) (11,733 ) Cash, cash equivalents and restricted cash, beginning of the period 83,433 48,875 Cash, cash equivalents and restricted cash, end of the period $ 73,189 $ 37,142