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Krystal Biotech to Present at 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2026-01-05 13:00
PITTSBURGH, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today announced that the Company will participate in the 44th Annual J.P. Morgan Healthcare Conference on January 12, 2026, in San Francisco. Krish S. Krishnan, Chairman and Chief Executive Officer, is scheduled to give a presentation at 10:30 am ET / 7:30 am PT and host investor meetings throughout the day. A webcast of the presentation will be available here beginning at 10:30 am ET / 7:30 am PT on Monday, J ...
Oppenheimer & Co. Inc. Strengthens Equities and Biotech Research Teams with Addition of Kostas Biliouris, Ph.D.
Prnewswire· 2025-12-08 11:00
Core Insights - Oppenheimer & Co. Inc. has strengthened its Biotech Research Team by hiring Kostas Biliouris as Managing Director, enhancing its long-standing expertise in the biotech sector [1][3] - Biliouris brings extensive experience from BMO Capital Markets and Morgan Stanley, along with a Ph.D. in biochemical engineering, which will contribute to Oppenheimer's research capabilities in genetic medicines and biotech [2][3] - The firm aims to expand its research coverage in biotech, an area characterized by rapid innovation, to better serve its institutional and corporate clients [3][4] Company Overview - Oppenheimer & Co. Inc. is a subsidiary of Oppenheimer Holdings Inc., providing a comprehensive range of wealth management, securities brokerage, and investment banking services [4] - The healthcare franchise, including biotechnology, pharmaceuticals, and medical technology, has been a core area of expertise for Oppenheimer [3]
Financial Comparison: Passage Bio (NASDAQ:PASG) versus PepGen (NASDAQ:PEPG)
Defense World· 2025-12-07 08:02
Core Insights - Passage Bio and PepGen are small-cap medical companies being compared based on various financial and operational metrics to determine which stock is more favorable [1][3][4]. Institutional Ownership - Passage Bio has 53.5% of its shares owned by institutional investors, while PepGen has 58.0% [1]. - Insider ownership stands at 5.0% for Passage Bio and 5.2% for PepGen, indicating a similar level of insider investment [1]. Analyst Ratings - Passage Bio has a consensus target price of $42.67, suggesting a potential upside of 363.26% [3][4]. - PepGen's consensus target price is $10.00, indicating a potential upside of 83.82% [3][4]. - Passage Bio has a stronger consensus rating with a score of 2.50 compared to PepGen's score of 2.33 [3]. Earnings and Valuation - Passage Bio reported a net income of -$64.77 million with an earnings per share (EPS) of -$14.40 [5]. - PepGen's net income is -$89.98 million with an EPS of -$2.82 [5]. - Passage Bio has a higher price-to-earnings ratio compared to PepGen, which is currently trading at a lower valuation [5]. Profitability - Passage Bio has a net margin of -102.09% and a return on equity of -52.97% [6]. - PepGen's net margin is -84.15% with a return on equity of -65.59% [6]. Risk & Volatility - Passage Bio has a beta of 1.86, indicating it is 86% more volatile than the S&P 500 [7]. - PepGen has a beta of 1.91, meaning it is 91% more volatile than the S&P 500 [7]. Summary - PepGen outperforms Passage Bio in 6 out of 11 factors compared [8].
Krystal Biotech to Present at 8th Annual Evercore Healthcare Conference
Globenewswire· 2025-11-26 13:00
Core Insights - Krystal Biotech, Inc. will participate in the 8th Annual Evercore Healthcare Conference on December 3, 2025, in Miami, with CEO Krish S. Krishnan scheduled for a fireside chat at 10:00 am ET [1] - A webcast of the presentation will be available on the Company's website starting at the same time [2] Company Overview - Krystal Biotech, Inc. is a global biotechnology company focused on genetic medicines for diseases with high unmet medical needs, with its first product, VYJUVEK®, being the first-ever redosable gene therapy approved in the US, Europe, and Japan for dystrophic epidermolysis bullosa [3] - The Company is advancing a pipeline of investigational genetic medicines across various fields including respiratory, oncology, dermatology, ophthalmology, and aesthetics [3]
Korro Bio Early Trial Results Fall Short; Stock Hits New Low
Benzinga· 2025-11-13 19:26
Core Insights - Korro Bio, Inc. (NASDAQ:KRRO) is experiencing a significant decline in stock price, down 80% to $6.27, with a trading volume of 6.68 million shares compared to the average of 1.42 million shares [1][8] - The company provided an update on its Phase 1/2a REWRITE clinical trial for KRRO-110, which targets alpha-1 antitrypsin deficiency (AATD) [1][2] - KRRO-110 successfully generated functional M-AAT protein in AATD patients, but the protein levels achieved were below preclinical projections [2][3] Clinical Trial Results - In a study involving five AATD patients, the peak total AAT protein reached approximately 10 µM, with a maximum increase from baseline of about 3 µM [3] - The total AAT protein levels did not meet the protective threshold of 11 µM, although no serious adverse events were reported [3] Strategic Restructuring - The company is implementing a strategic restructuring that includes a workforce reduction of approximately 34% to focus on generating clinical data and advancing liver-targeted programs [4][6] - This restructuring is expected to extend the company's cash runway into the second half of 2027, with cash and marketable securities reported at $102.5 million [6] Future Development Plans - Korro has nominated KRRO-121 as the next development candidate for hyperammonemia, with regulatory filing anticipated in the second half of 2026 [5] - The company amended its collaboration agreement with Novo Nordisk, establishing a 12-month pause to reassess the current research program [5] Analyst Commentary - William Blair downgraded Korro shares from Outperform to Market Perform, citing concerns over the non-competitive clinical profile of KRRO-110 despite the validation of ADAR-mediated editing [7] - The analyst expressed continued interest in Korro's expansion into urea cycle disorders with KRRO-121 but noted the company's shift back to a preclinical stage [7]
Passage Bio Reports Third Quarter 2025 Financial Results and Provides Recent Business Highlights
Globenewswire· 2025-11-10 21:15
Core Insights - Passage Bio, Inc. is actively enrolling patients in Cohort 3 (FTD-GRN) and Cohort 4 (FTD-C9orf72) for the ongoing upliFT-D clinical trial of PBFT02, recognizing the urgent need for disease-modifying therapies for frontotemporal dementia (FTD) [1][2] - The company has aligned with the FDA on an analytical approach to establish comparability of a high-productivity, suspension-based manufacturing process for PBFT02, which is expected to yield over 1,000 doses per batch with over 90% purity [5][2] - Passage Bio is on track to obtain regulatory feedback on the registrational trial design for FTD-GRN in the first half of 2026, with plans to report updated interim safety and biomarker data from Dose 2 during the same period [5][4] Recent Highlights - The upliFT-D trial is a Phase 1/2 global, multi-center, open-label clinical trial aimed at evaluating the safety and tolerability of PBFT02, with secondary endpoints including disease biomarkers and clinical outcome measures [6] - The trial protocol has been amended to allow for the enrollment of patients who are prodromal or have mild cognitive impairment, while excluding those with more severe progression [5] Financial Overview - As of September 30, 2025, the company reported cash, cash equivalents, and marketable securities totaling $52.8 million, down from $84.8 million a year prior, with an expected cash runway into the first quarter of 2027 [11] - Research and Development (R&D) expenses for the third quarter of 2025 were $4.3 million, a decrease from $8.7 million in the same quarter of 2024 [11] - General and Administrative (G&A) expenses also decreased to $4.3 million from $7.3 million year-over-year [11] - The net loss for the third quarter of 2025 was $7.7 million, or $2.44 per share, compared to a net loss of $19.3 million, or $6.15 per share, for the same period in 2024 [11][16]
Passage Bio to Present at Guggenheim Securities 2nd Annual Healthcare Innovation Conference
Globenewswire· 2025-11-05 12:00
Core Viewpoint - Passage Bio, Inc. is actively engaged in the development of genetic medicines aimed at treating neurodegenerative diseases, with a focus on innovative one-time therapies [3]. Company Overview - Passage Bio is a clinical stage genetic medicines company dedicated to improving the lives of patients suffering from neurodegenerative diseases [3]. - The company's lead product candidate, PBFT02, targets conditions such as frontotemporal dementia by increasing progranulin levels to restore lysosomal function and slow disease progression [3]. Upcoming Events - Will Chou, M.D., the president and CEO of Passage Bio, will participate in a fireside chat at the Guggenheim Securities 2 Annual Healthcare Innovation Conference on November 12, 2025, at 9:30 a.m. ET in Boston, MA [1]. - A live webcast of the event will be accessible on the Investors & News section of Passage Bio's website, with a replay available for 90 days post-event [2].
Krystal(KRYS) - 2025 Q3 - Earnings Call Presentation
2025-11-03 13:30
VYJUVEK Launch and Revenue - Since launch, VYJUVEK has generated over $623 million in net revenue[10] - Q3 2025 VYJUVEK product revenue reached $97.8 million, compared to $83.8 million in Q3 2024[35] - The company has secured over 615 reimbursement approvals for VYJUVEK in the U S[14] European and Japanese Expansion - VYJUVEK launched in Germany in late August, with over 10 prescribing centers and prescriptions for an estimated 20 DEB patients[15] - VYJUVEK launched in Japan in October, targeting over 500 estimated DEB patients[17, 18] - The company is building a specialty distributor partner network to reach thousands of potential DEB patients in rest-of-world markets[20] Pipeline Development - The FDA granted Platform Technology Designation for KB801, potentially accelerating its path to market[21] - The company expects to report molecular data from the KB407 Phase 1 trial for Cystic Fibrosis by year-end[28] - KB111 is entering clinical trials for the treatment of Hailey-Hailey disease, targeting an estimated 10,000-15,000 patients in the U S and Europe[34] Financial Performance - The company's cash and investments totaled $864.2 million as of September 30, 2025[35] - Net income for Q3 2025 was $79.4 million, compared to $27.2 million in Q3 2024[35] - Non-GAAP R&D and SG&A expense guidance for full year 2025 is updated to $145 million to $155 million[36]
Krystal Biotech Announces Third Quarter 2025 Financial and Operating Results
Globenewswire· 2025-11-03 12:00
Financial Performance - The company reported $97.8 million in net product revenue for VYJUVEK in Q3 2025, an increase from $83.8 million in Q3 2024, reflecting a growth of approximately 16.7% year-over-year [3][23][37] - Gross margin for the quarter was 96%, indicating strong profitability from product sales [3] - Net income for Q3 2025 was $79.4 million, or $2.74 per common share (basic), compared to $27.2 million, or $0.95 per common share (basic) in Q3 2024, representing a significant increase [23][36] Product Development and Market Expansion - VYJUVEK was launched in Germany in Q3 2025, with approximately 20 patients prescribed the therapy across over 10 centers [3] - The product was also launched in France and Japan in Q4 2025, following successful pricing negotiations [3][4] - The FDA approved a label update for VYJUVEK, expanding the eligible patient population to include DEB patients from birth and allowing for home application by patients or caregivers [3][24] Pipeline and Future Prospects - The company is advancing its pipeline with multiple near-term readouts, including interim results for cystic fibrosis expected in Q4 2025 [2][6] - The company is preparing regulatory filings for the UK and Switzerland and is initiating pricing discussions in other key Western European markets [3][4] - The company continues to enroll in clinical trials for KB407 and KB408, with interim data readouts expected in late 2025 and early 2026 [6][11] Financial Guidance - The company provided guidance for FY 2025, estimating non-GAAP combined R&D and SG&A expenses to be between $145 million and $155 million [20]
4DMT to Participate in Chardan's 9th Annual Genetic Medicines Conference
Globenewswire· 2025-10-14 12:00
Company Overview - 4D Molecular Therapeutics (4DMT) is a late-stage biotechnology company focused on developing durable and disease-targeted therapeutics that aim to transform treatment paradigms and provide significant benefits to patients [3] - The lead product candidate, 4D-150, is designed for the treatment of blinding retinal vascular diseases, offering multi-year sustained delivery of anti-VEGF through a single intravitreal injection, thereby reducing treatment burden [3] - 4D-150 is currently in Phase 3 development for wet age-related macular degeneration and is also being studied for diabetic macular edema [3] - The second product candidate, 4D-710, is the first genetic medicine to successfully deliver and express the CFTR transgene in the lungs of cystic fibrosis patients via aerosol delivery [3] Upcoming Events - Management will participate in panel discussions at Chardan's 9th Annual Genetic Medicines Conference on October 21, 2025 [1] - Two panels will be featured: "In Vivo Gene Therapy: Breaking into Competitive Ophthalmic Indications" at 9:30 a.m. ET and "In Vivo Gene Therapies in the Lung: Treating CF and Beyond" at 2:00 p.m. ET [2] - Archived webcasts of the panels will be available for up to one year on the 4DMT website [2]