Latest news with #OLC
Business Upturn
28-05-2025
- Business
- Business Upturn
Antique cuts target on Shilpa Medicare to Rs 1,090, retains ‘Buy' on long-term monetization potential
By News Desk Published on May 28, 2025, 08:31 IST Antique Broking has maintained a Buy rating on Shilpa Medicare (SLPA) while cutting the target price to ₹1,090 from ₹1,525, citing strong revenue growth in Q4FY25 but tempered expectations for the near term due to regulatory delays and cost pressures. Shilpa Medicare reported a 13% year-on-year increase in Q4FY25 revenue to ₹3,308 million, driven by an impressive 73% growth in the Finished Dosage Form (FDF) segment. The brokerage highlighted SLPA's exclusive licensing deal with Orion for recombinant human albumin in Europe, which holds significant commercial potential. Milestone-linked payments under this agreement are expected to begin in FY26. However, the firm flagged approval delays for Unicycive's NDA for Oxylanthanum Carbonate (OLC), a partnered product. The delay, caused by manufacturing issues, is expected to push associated revenues to FY27. Antique has cut its FY26/27 revenue estimates by 16%/20%, moderating its assumptions for growth in the API business and adjusting expectations for 505(b)(2) opportunities. It also lowered EBITDA margin assumptions to reflect persistent higher operating expenses. Despite these adjustments, the brokerage continues to see strong monetization potential in SLPA's product pipeline, positioning it well for medium to long-term growth. Disclaimer: The views and recommendations expressed above are those of the brokerage firm. Business Upturn does not endorse or offer any investment advice. News desk at
Business Standard
27-05-2025
- Business
- Business Standard
Shilpa Medicare slides after Q4 PAT drop 41% YoY to Rs 15-cr
Shilpa Medicare declined 1.25% to Rs 878.35 after the company's consolidated net profit fell 40.77% to Rs 14.51 crore while revenue from operations rose 13.40% to Rs 330.80 crore in Q4 FY25 over Q4 FY24. Profit before exceptional items and tax stood at Rs 43.35 crore in Q4 FY25, up 100.88% from Rs 21.58 crore posted in the corresponding quarter previous year. The firm reported exceptional items of Rs 28.08 crore during the quarter. EBITDA jumped 15% to Rs 84 crore in Q4 FY25 from Rs 73 crore in Q4 FY24. EBITDA margin remained constant at 25% in Q4 FY25 compared to Q4 FY24. Total expenses were up by 9.12% year on year to Rs 297.32 crore in the quarter ended 31 March 2025. The cost of materials consumed stood at Rs 85.14 crore (down 15.83% YoY), while employee benefits expense was at Rs 70.93 crore (up 6.72% YoY). On a full-year basis, the company's consolidated net profit surged 145.65% to Rs 78.29 crore on an 11.70% jump in revenue from operations to Rs 1,286.41 crore in FY25 over FY24. Vishnukant Bhutada, managing director of Shilpa Medicare, said, FY25 performance reflects our pursuit of a differentiated business model enabling us to grow with improved profitability. In FY25, Shilpa Medicare has emerged stronger, turning years of strategic investments and relentless perseverance into remarkable achievements in differentiated initiatives like the launch of two NDAs in US market, filing of transdermal patch product in EU, SEC clearance of Nor-UDCA in India and OLC filing by our partner with US FDA. Our unwavering commitment to innovation and R&D has borne fruit, with a significant breakthrough in out-licensing our flagship productrecombinant human albuminfor commercialization across EU region in strategic partnership with Orion Corporation. Besides this, we also saw a very successful year on the regulatory front, as we received EIR for our API Unit 1, along with EU GMP certifications for our FDF Unit 6 (having ODF & TDP manufacturing capabilities) and for our Biologics unit. I believe this will help in enabling us to further scale up our biologics CDMO platform and give us the opportunity to monetize our biosimilar pipeline for large regulated markets. With asset utilization improvement across key verticals, we remain confident of delivering improved profitability in FY26. As we advance, we remain committed to leveraging our R&D strengths, regulatory compliance, and operational agility to create long-term value. Meanwhile, the companys board has decided to pay a dividend of Rs 1 per equity share for FY 2024-2025. The final dividend, if approved by the members at the ensuing Annual General Meeting, shall be paid within the statutory timelines prescribed under applicable laws. Shilpa Medicare is a manufacturer of API, formulation, and development services. Shilpa Medicare (SML) started its operations as an API manufacturer way back in 1987 at Raichur, Karnataka, India.
Yahoo
14-05-2025
- Business
- Yahoo
Unicycive Therapeutics Announces First Quarter 2025 Financial Results and Provides Business Update
- Oxylanthanum carbonate (OLC) New Drug Application (NDA) for hyperphosphatemia in chronic kidney disease patients on dialysis under review by FDA with PDUFA target action date of June 28, 2025; ongoing commercial planning in preparation for anticipated commercial launch in late 2025 - New data from patient surveys and patient-reported outcomes studies highlight adherence challenges for patients with hyperphosphatemia on dialysis and emphasize the market potential of OLC LOS ALTOS, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the three months ended March 31, 2025, and provided a business update. 'We are making incredible strides as we prepare for the potential FDA approval of oxylanthanum carbonate (OLC) so we can bring this treatment to people with chronic kidney disease (CKD) on dialysis as efficiently as possible,' said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. 'The need for our differentiated treatment, which offers high potency and a significantly reduced pill burden for people struggling to control hyperphosphatemia, has been further validated by new patient survey findings and patient-reported outcomes data. We remain dedicated to bolstering our commercial infrastructure as we strive to deliver a much-needed solution to patients and healthcare providers.' Key Highlights & Upcoming Milestones The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025, for OLC. Unicycive continues to prepare for the potential launch of OLC by building key functions, engaging directly with prescribers and other stakeholders, and supporting market access. Expanded awareness of OLC and its potential to address significant needs for CKD patients by publishing data and presentations at medical meetings. Recently, findings were presented at the National Kidney Foundation (NKF) Spring Clinical Meetings and the 2025 American Nephrology Nurses Association (ANNA) National Symposium from a patient survey conducted in partnership with the NKF. The survey included a total of 200 dialysis patients who identified excessive pill numbers, large pill sizes, and forgetfulness as the primary barriers to phosphate binder adherence. Patients also expressed a strong preference for medication regimens with fewer and smaller pills. New patient-reported outcomes data from the pivotal Phase 2 study of OLC were presented at the 2025 American Dialysis Conference (ADC) and the NKF Spring Clinical Meeting, which demonstrated that patients preferred OLC in comparison to their pre-trial phosphate binder medications and significantly enhanced patient satisfaction. Financial Results for the Quarter Ended March 31, 2025 Research and Development (R&D) expenses were $2.2 million for the three months ended March 31, 2025, compared to $6.8 million for the three months ended March 31, 2024. The decrease in research and development expenses was primarily due to decreased drug development costs. General and Administrative (G&A) expenses were $5.8 million for the three months ended March 31, 2025, compared to $2.4 million for the three months ended March 31, 2024. The increase was primarily due to increased consulting and professional services related to our commercial launch preparation. In addition to the above launch expenses, we continue to focus on the manufacturing of commercial supplies, as reflected in prepaid expenses and other current assets on our balance sheet which increased from $4.8 million as of December 31, 2024 to $7.6 million as of March 31, 2025. Other income was $8.6 million for the three months ended March 31, 2025, compared to an expense of $11.8 million for the three months ended March 31, 2024, primarily due to a decrease in the fair value of our warrant liability. Net income attributable to common stockholders for the three months ended March 31, 2025, was $0.5 million, compared to a net loss attributable to common stockholders of $21.2 million for the three months ended March 31, 2024. The net income for the three-month period ended March 31, 2025, was primarily due to a decrease in the fair value of our warrant liability. As of March 31, 2025, cash and cash equivalents totaled $19.8 million. About Unicycive Therapeutics Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive's lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive's second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information about Unicycive, visit and follow us on LinkedIn and X. Forward-looking statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Unicycive's expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; our need to raise substantial additional capital in the future to fund our continuing operations and the development and commercialization of our current product candidates and future product candidates; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; risks related to delays in obtaining or failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; and our failure, or the failure of our third-party manufacturers, or their subcontractors, to comply with cGMPs or other applicable regulations, which could result in sanctions being imposed on us or the manufacturers, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could adversely affect supplies of our product candidates and harm our business and results of operations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled 'Risk Factors' in Unicycive's Annual Report on Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Investor Contacts: Kevin GardnerLifeSci Advisorskgardner@ Media Contact: Rachel Visi Real Chemistryredery@ SOURCE: Unicycive Therapeutics, Therapeutics, Inc. Balance Sheets (in thousands, except for share and per share amounts) As of As of December 31, March 31, 2024 2025 (Unaudited) Assets Current assets: Cash $ 26,142 $ 19,769 Prepaid expenses and other current assets 4,806 7,577 Total current assets 30,948 27,346 Right of use asset, net 645 518 Property, plant and equipment, net 75 83 Total assets $ 31,668 $ 27,947 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 1,058 $ 1,397 Accrued liabilities 3,562 4,143 Warrant liability 18,936 10,588 Operating lease liability - current 564 548 Total current liabilities 24,120 16,676 Operating lease liability - long term 117 - Total liabilities 24,237 16,676 Commitments and contingencies Stockholders' equity: Series A-2 Prime preferred stock, $0.001 par value per share - 21,338.01 Series A-2 Prime shares authorized at December 31, 2024 and March 31, 2025; 6,150.21 and 5,464.21 Series A-2 Prime shares issued and outstanding at December 31, 2024 and March 31, 2025, respectively - - Series B-2 preferred stock, $0.001 par value per share - 7,882 Series B-2 shares authorized at December 31, 2024 and March 31, 2025; 3,000 Series B-2 shares issued and outstanding at December 31, 2024 and March 31, 2025 - - Preferred stock: $0.001 par value per share - 9,846,891 shares authorized at December 31, 2024 and March 31, 2025; zero shares issued and outstanding at December 31, 2024 and March 31, 2025 - - Common stock, $0.001 par value per share - 400,000,000 shares authorized at December 31, 2024 and March 31, 2025; 113,842,364 and 119,749,743 shares issued and outstanding at December 31, 2024 and March 31, 2025, respectively 114 120 Additional paid-in capital 108,587 111,851 Accumulated deficit (101,270 ) (100,700 ) Total stockholders' equity 7,431 11,271 Total liabilities and stockholders' equity $ 31,668 $ 27,947 Unicycive Therapeutics, Inc. Statements of Operations (in thousands, except for share and per share amounts) (Unaudited) Three Months Ended March 31, 2024 2025 Operating expenses: Research and development $ 6,813 $ 2,171 General and administrative 2,391 5,818 Total operating expenses 9,204 7,989 Loss from operations (9,204 ) (7,989 ) Other income (expenses): Interest income 69 226 Interest expense (20 ) (15 ) Change in fair value of warrant liability (11,808 ) 8,348 Total other income (expenses) (11,759 ) 8,559 Net (loss) income (20,963 ) 570 Net (loss) income attributable to common stockholders, basic (21,171 ) 510 Net loss attributable to common stockholders, diluted (21,171 ) (6,214 ) Net (loss) income per share: Basic $ (0.61 ) $ - Diluted $ (0.61 ) $ (0.05 ) Weighted-average shares outstanding: Basic 34,912,692 116,818,811 Diluted 34,912,692 123,834,773
Yahoo
13-05-2025
- Business
- Yahoo
New Research Shows Students Want More AI Guidance from Faculty
Study from D2L and Online Learning Consortium shows higher education students use AI as an always-on study partner to support creativity and save time TORONTO, May 13, 2025 /CNW/ - D2L, a global learning technology company, alongside the Online Learning Consortium (OLC), has found that higher education students are supporting the charge in artificial intelligence (AI) adoption, using it to help generate ideas, save time and deepen engagement with materials – and they want faculty to keep up. Student Engagement and AI offers new research on AI usage in higher education, showing that students are learning how to apply AI to their studies independently, but they want more guidance from faculty on how they should do so. The survey also found that students can see AI as an always-on study partner and are turning to it for feedback, editing, and tutoring support when educators are unavailable, or if students are afraid to ask for help. The research also found that: Students use AI to spark creativity in brainstorming, save time on repetitive tasks and as a tutor to produce practice questions, step-by-step explanations or feedback – but note it's not always a reliable resource for conducting research. In its role as a study buddy or tutor, the research found that AI helps deepen emotional engagement with course materials, increasing interest, meaningfulness, and belonging. Some students find AI encourages the development of new skills, while others see a risk of becoming over-reliant and losing creativity and critical thinking skills. Students expressed a desire for faculty to be more willing to integrate AI into learning and to have more reasonable policies around AI use as opposed to forbidding it. "This new research helps show that students are unlocking the power of AI, and they want faculty and institutions to meet them where they are in their learning journey," said Dr. Cristi Ford, Chief Learning Officer at D2L. "The research also indicates that while students believe AI can help facilitate engagement in course materials, it can't replace the critical relationships between educators and students. This highlights the need for AI tools aligned with course material that can help boost engagement and facilitate important personal learning interactions." Read more about the D2L and OLC research here. "AI isn't going anywhere, and it's crucial to gain a better understanding of how students in higher education are using and perceiving these new technologies to support their studies," said Dr. Dylan Barth, Vice President of Innovation and Programs, Online Learning Consortium. "D2L is committed to transforming the way the world learns, and we're proud to work together to uncover how AI is shaping the future of higher education." The D2L Academic Affairs team worked with researchers from OLC to survey 87 students, ranging from first-year undergraduate to doctoral students, and conducted 18 in-depth interviews. The OLC is a collaborative community of higher education leaders and innovators, dedicated to advancing quality digital teaching and learning experiences designed to reach and engage learners. Watch the D2L webinar on the research findings here: What Students Are Saying About AI: New Insights on Engagement in Higher Ed. About D2L D2L is transforming the way the world learns, helping learners achieve more than they dreamed possible. Working closely with customers all over the world, D2L is on a mission to make learning more inspiring, engaging and human. Find out how D2L helps transform lives and delivers outstanding learning outcomes in K-12, higher education and business at X: @D2L© 2025 D2L Corporation. The D2L family of companies includes D2L Inc., D2L Corporation, D2L Ltd, D2L Australia Pty Ltd, D2L Europe Ltd, D2L Asia Pte Ltd, D2L India Pvt Ltd, D2L Brasil Soluções de Tecnologia para Educação Ltda and D2L Sistemas de Aprendizaje Innovadores, S. D2 R.L de C.V. All D2L marks are trademarks of D2L Corporation. Please visit for a list of D2L marks. All other trademarks are the property of their respective owners. View original content to download multimedia: SOURCE D2L View original content to download multimedia: Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Cision Canada
13-05-2025
- Business
- Cision Canada
New Research Shows Students Want More AI Guidance from Faculty
Study from D2L and Online Learning Consortium shows higher education students use AI as an always-on study partner to support creativity and save time TORONTO, May 13, 2025 /CNW/ - D2L, a global learning technology company, alongside the Online Learning Consortium (OLC), has found that higher education students are supporting the charge in artificial intelligence (AI) adoption, using it to help generate ideas, save time and deepen engagement with materials – and they want faculty to keep up. Student Engagement and AI offers new research on AI usage in higher education, showing that students are learning how to apply AI to their studies independently, but they want more guidance from faculty on how they should do so. The survey also found that students can see AI as an always-on study partner and are turning to it for feedback, editing, and tutoring support when educators are unavailable, or if students are afraid to ask for help. The research also found that: Students use AI to spark creativity in brainstorming, save time on repetitive tasks and as a tutor to produce practice questions, step-by-step explanations or feedback – but note it's not always a reliable resource for conducting research. In its role as a study buddy or tutor, the research found that AI helps deepen emotional engagement with course materials, increasing interest, meaningfulness, and belonging. Some students find AI encourages the development of new skills, while others see a risk of becoming over-reliant and losing creativity and critical thinking skills. Students expressed a desire for faculty to be more willing to integrate AI into learning and to have more reasonable policies around AI use as opposed to forbidding it. "This new research helps show that students are unlocking the power of AI, and they want faculty and institutions to meet them where they are in their learning journey," said Dr. Cristi Ford, Chief Learning Officer at D2L. "The research also indicates that while students believe AI can help facilitate engagement in course materials, it can't replace the critical relationships between educators and students. This highlights the need for AI tools aligned with course material that can help boost engagement and facilitate important personal learning interactions." "AI isn't going anywhere, and it's crucial to gain a better understanding of how students in higher education are using and perceiving these new technologies to support their studies," said Dr. Dylan Barth, Vice President of Innovation and Programs, Online Learning Consortium. "D2L is committed to transforming the way the world learns, and we're proud to work together to uncover how AI is shaping the future of higher education." The D2L Academic Affairs team worked with researchers from OLC to survey 87 students, ranging from first-year undergraduate to doctoral students, and conducted 18 in-depth interviews. The OLC is a collaborative community of higher education leaders and innovators, dedicated to advancing quality digital teaching and learning experiences designed to reach and engage learners. Watch the D2L webinar on the research findings here: What Students Are Saying About AI: New Insights on Engagement in Higher Ed. About D2L D2L is transforming the way the world learns, helping learners achieve more than they dreamed possible. Working closely with customers all over the world, D2L is on a mission to make learning more inspiring, engaging and human. Find out how D2L helps transform lives and delivers outstanding learning outcomes in K-12, higher education and business at X: @D2L © 2025 D2L Corporation. The D2L family of companies includes D2L Inc., D2L Corporation, D2L Ltd, D2L Australia Pty Ltd, D2L Europe Ltd, D2L Asia Pte Ltd, D2L India Pvt Ltd, D2L Brasil Soluções de Tecnologia para Educação Ltda and D2L Sistemas de Aprendizaje Innovadores, S. D2 R.L de C.V. All D2L marks are trademarks of D2L Corporation. Please visit for a list of D2L marks. All other trademarks are the property of their respective owners.
