In the ongoing Phase 2/3 study of tovecimig (DLL4 x VEGF-A bispecific antibody) in patients with advanced biliary tract cancer, fewer deaths have been observed than originally projected. We believe this may suggest that tovecimig could be affecting overall survival in the patient population. As a result, the analysis of the secondary endpoints, including overall survival, is now expected in Q1 2026. In the ongoing Phase 1...Read more
BASEL, Switzerland and LONDON and NEW YORK, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today reported its financial results for the first quarter ended June 30, 2025, and provided a business update. Brepocitinib VALOR Phase 3 study in dermatomyositis (DM) remains on track for topline data readout in the second half of calendar year 2025, with last patient last visit completed in July; Roivant and Priovant hosted an...Read more
CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) net trade sales of approximately $439 million CARVYKTI® demonstrated positive long-term outcomes in CARTITUDE-1 study with one-third of patients remaining progression-free for ≥5 years Presented other important CARVYKTI® and new solid tumor data at ASCO Over 7,500 patients treated to date Cash and cash equivalents, and time deposits of $1.0 billion, as of June 30,...Read more
JUPITER, Fla., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) (“Ligand”) announced today its intention to offer $400.0 million aggregate principal amount of convertible senior notes due 2030 (the “notes”) in a private placement (the “offering”) to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities...Read more
Reported positive KT-621 (STAT6) Phase 1 healthy volunteer data surpassing Kymera’s target product profile, and further validating its oral, dupilumab-like profile KT-621 BroADen Phase 1b trial in moderate to severe atopic dermatitis (AD) patients on track to report data in 4Q25 Doses selected for KT-621 Phase 2b trials in AD and asthma, which are on track to initiate in 4Q25 and 1Q26, respectively KT-579 (IRF5) IND-enabling studies...Read more
Initiated a second potentially registrational study of IMVT-1402 in Graves’ disease (GD) and a potentially registrational study of IMVT-1402 in Sjögren’s disease (SjD), both in June 2025 All other clinical trials in previously announced six-indications remain on track with increased focus on clinical execution Remission data from the batoclimab proof-of-concept study in GD to be reported at the American Thyroid Association (ATA)...Read more
Tinlarebant granted Breakthrough Therapy Designation for Stargardt disease (STGD1) by the U.S. Food and Drug Administration (FDA) DRAGON trial completion expected by Q4 2025 (including a three-month follow-up period) Enrollment completed with 529 subjects in the pivotal phase 3 PHOENIX trial in geographic atrophy (GA) Raised approximately $15 million in gross proceeds in a registered direct offering on August 8, 2025 Conference...Read more
Positive 16-week data from APEX Phase 2 Part A met all primary and key secondary endpoints for APG777, a potentially best-in-class anti-IL-13 antibody, in moderate-to-severe atopic dermatitis APEX Part A testing every 3- or 6-month maintenance dosing, a significant improvement versus standard of care which is dosed every two weeks, is ongoing with 52-week readout anticipated in 1H 2026 Driven by strong enrollment, APEX Phase 2 Part B...Read more
Cash, cash equivalents, marketable securities and restricted cash as of June 30, 2025, totaled approximately $408.2 million VYGLXIA NDA for spinocerebellar ataxia (SCA) PDUFA date 4Q2025, completed clinical trial inspections by FDA without observations or findings, and filing review remains ongoing MoDE and TRAP degrader platforms advance in clinical development, IgG reductions of up to 87% observed with MoDE degrader BHV-1300 in...Read more
VANCOUVER, British Columbia, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease, today announced the appointments of Greg Ciongoli and Robert E. Landry to the Company’s Board of Directors,...Read more
Global, pivotal Phase 3 study will evaluate efficacy and safety of zorevunersen compared to sham over a 52-week treatment period Dravet syndrome is a rare genetic disease characterized by refractory seizures and neurodevelopmental impairments, with no currently approved medicines that address the underlying cause of the disease BEDFORD, Mass., & CAMBRIDGE, Mass. / Aug 11, 2025 / Business Wire / Stoke Therapeutics, Inc....Read more
Sebetralstat is one of only two hereditary angioedema therapies to maintain orphan designation, underscoring its major contribution to patient care If approved, sebetralstat will be granted 10 years of market exclusivity in EU CAMBRIDGE, Mass. & SALISBURY, England / Aug 11, 2025 / Business Wire / KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the Committee for Orphan Medicinal Products (COMP) of the European...Read more
Total revenues of $301,000 for quarter, and $818,000 for first six months of 2025, from sales and collaborative research agreement 82 civilian hospitals now have VAC approval to purchase Symvess™ ECAT approval makes Symvess available to 35 Military Treatment Facilities and 160 U.S. Department of Veterans Affairs hospitals Conference call today at 8:00 am ET DURHAM, N.C., Aug. 11, 2025 (GLOBE NEWSWIRE) --...Read more
Appointment recognizes Mr. Durso’s extensive commercial expertise as Altimmune prepares for Phase 3 development of pemvidutide in MASH Mitchel Sayare, Ph.D., to remain on the Board as Independent Director GAITHERSBURG, Md., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced...Read more
Enrollment in the planned second dose expansion cohort completed ahead of expectations Topline results expected in Q1 2026 Positive Phase 1b dose escalation data presented at ESMO GI on July 2nd ROCKVILLE, Md., Aug. 11, 2025 (GLOBE NEWSWIRE) -- I-Mab (NASDAQ: IMAB) (the Company), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, today announced that...Read more
Zydus Lifesciences collaboration to close in Q3 with $91M capital infusion to support clinical and regulatory milestones BOT/BAL delivers 42% two-year survival in refractory MSS CRC and consistent activity across multiple solid cancers, to be presented at an oral session at ESMO Regulatory alignment secured for Phase 3 trial initiation, expected to commence in Q4 2025 August 27th virtual stakeholder meeting set for a detailed...Read more
TORONTO, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (Upstream: QNTM) (“Quantum BioPharma” or the “Company”), a biopharmaceutical company dedicated to innovative therapies for neurodegenerative disorders, today announces through its subsidiary, Huge Biopharma Australia Pty Ltd., that it has signed an agreement with a leading contract development and manufacturing organization (CDMO) to...Read more
New Patient Screening for Phase 3 SENTRY Trial in Myelofibrosis Expected to Close This Week; Top-Line Results Anticipated in March 2026 Total Revenue was $37.9 Million; U.S. XPOVIO® (selinexor) Net Product Revenue was $29.7 Million, up 6% compared to Second Quarter of 2024 Reaffirms Full-Year 2025 Total Revenue Guidance of $140 Million to $155 Million; Updates U.S. XPOVIO Net Product Revenue Guidance to $110 Million to...Read more
The first patient in Cohort 3, the fifth patient in the trial, has completed the first week of cycle 1 following the successful safety review of Cohort 2 with no safety or tolerability issues observedThe company plans on releasing initial Phase 1 results later in 2025 following completion of additional dose cohorts SAN FRANCISCO, CALIFORNIA, Aug. 11, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a...Read more
VANCOUVER, BC, Aug. 11, 2025 /CNW/ - Filament Health Corp. (OTC: FLHLF) ("Filament" or the "Company"), a clinical‐stage natural psychedelic drug development company, released its second quarter financial results and operational highlights for the period ended June 30, 2025. "This quarter, we took deliberate steps to position Filament Health for long-term growth, including streamlining our public listings to reduce costs...Read more
Boca Raton, Florida--(Newsfile Corp. - August 11, 2025) - Entero Therapeutics, Inc. (NASDAQ: ENTO) (the "Company"), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that it has entered into definitive agreements with institutional investors for the purchase and sale of approximately $3 million of pre-funded and common...Read more
Published results from the 96-Week Phase 2b SYMMETRY trial in the New England Journal of Medicine Three presentations at the EASL Congress 2025 highlighted data demonstrating statistically significant reversal of compensated cirrhosis (F4) due to MASH and corroborating the anti-fibrotic activity of EFX seen in patients with pre-cirrhotic (F2-F3) MASH Cash, cash equivalents and short and long-term marketable securities of $1,086.2...Read more
Announced best-in-disease durability data in BOND-003 Cohort C and promising early signal in Cohort P for cretostimogene grenadenorepvec at the American Urological Association Annual Meeting Initiated CORE-008 Cohort CX evaluating the combination of cretostimogene and gemcitabine in patients with high-risk (HR) BCG-exposed NMIBC Announced unanimous verdict that CG Oncology owes no future royalties or other payments to ANI...Read more
Filing based on pivotal Phase 3 VERITAC-2 clinical trial demonstrating statistically significant and clinically meaningful improvement in median progression-free survival versus fulvestrant Vepdegestrant is the first PROteolysis TArgeting Chimera (PROTAC) to demonstrate clinical benefit in patients with breast cancer NEW HAVEN, Conn., Aug. 08, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), today with its partner...Read more
Second Quarter 2025 Financial Results and Corporate Update Rescheduled to Monday, August 11, 2025, at 4:30 p.m. ET – SAN DIEGO, Aug. 08, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced that a Type A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled to...Read more
Reported Total Revenues of $19.5 million for the second quarter of 2025, exceeding the high end of the Company’s guidance range of between $17 million and $19 million SERB Pharmaceuticals to acquire Y-mAbs in $412.0 million transaction; transaction expected to close by the fourth quarter of 2025, subject to completion of tender offer and other customary conditions As of June 30, 2025, cash and cash equivalents were $62.3 million In...Read more
BOSTON, Aug. 08, 2025 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics, will release its financial results for the quarter ended June 30, 2025 and host a webcast and conference call to provide an update on the ongoing tovecimig Phase 2/3 study, clinical data for CTX-8371 and preclinical data for CTX-10726,...Read more
Continued advancement across research and development pipeline, with key program updates expected in 2H 2025 Phase 1/2 Duravelo-4 trial for zelenectide pevedotin in NECTIN4-amplified non-small cell lung cancer open and actively recruiting patients Strengthened clinical leadership and bolstered roster of scientific advisors with additions to Board of Directors and creation of Research and Innovation Advisory Board Strategic cost...Read more
MALVERN, Pa., Aug. 08, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that it has entered into a securities purchase agreement with Janus Henderson Investors, a global asset management firm, to purchase 20,000,000 shares of common stock and warrants to purchase up to an aggregate of 20,000,000 shares of common stock...Read more
Generated Q2 2025 Net Revenue of $37.2 million and year-to-date revenue of $76.1 million; reaffirmed 2025 Net Revenue Guidance of $153 million - $163 million Delivered record year-to-date 2025 Adjusted EBITDA of $7.9 million, raised full-year 2025 Adjusted EBITDA Guidance from $4.0 million - $12.0 million to $9.0 million - $13.0 million ZYNRELEF® unit demand grew 6.3% in Q2 2025 as compared to Q1 2025, with revenue impacted by a...Read more
94% reduction in HSV-2 shedding rate and 98% reduction in high viral load shedding rate, both statistically significant, observed in cohort evaluating 350 mg weekly oral dose compared to placebo over 29-day evaluation period 94% reduction in genital lesion rate, also statistically significant, observed with 350 mg weekly oral dose compared to placebo over same period Favorable safety and tolerability profile observed...Read more
Presented preclinical data at the American Society of Clinical Oncology (ASCO) on CLD-401 demonstrating biological efficacy IL-15 superagonist delivery to metastatic tumor sites and reduced immune clearance through engineered CD55 membrane expression; IND filing expected by the end of 2026 Received FDA Fast Track Designation for CLD-201, a first-in-class stem-cell loaded intratumoral viral therapy for the treatment of patients with...Read more
FDA-approved protocol update significantly expands patient eligibility criteria for the BACKBEAT global pivotal study (“BACKBEAT study”), resulting in an estimated more than 24-fold increase in the potentially eligible patient pool as compared to original study protocol Expanded eligibility criteria now include screening of any hypertensive patients who have received or are scheduled to receive a Medtronic Azure™ or...Read more
Ongoing Joint Clinical Study Could Pave the Way for Testing Efficacy of Quantum’s Investigational MS drug, Lucid-21-302 TORONTO, Aug. 08, 2025 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (“Quantum BioPharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, announces that the Positron Emission Tomography (PET) tracer used...Read more
Key opinion leader event and pancreatic cancer clinical data validate decision to engage with regulators on plans for a registration-enabling study New members of the management team bring expertise in progressing clinical programs and executing successful biotech transactions Translational data further elucidate pelareorep's mechanism of action and ability to prime the tumor microenvironment for treatment Commitment to limiting...Read more
FDA provides pivotal agreement on EB613 Phase 3 design, confirming Bone Mineral Density (BMD) as primary endpoint and clearing streamlined pathway for first oral anabolic osteoporosis treatment Significant regulatory and pipeline advancements achieved including FDA waiver of additional safety studies and next-gen EB613 expected to enter Phase 1 in November 2025 Strong momentum across OPKO collaboration with obesity program showing...Read more
Daniel Chao, M.D., Ph.D., joins Surrozen as Vice President of Clinical Development Surrozen forms Clinical Advisory Board comprised of leading retinal specialists Data Presentations at Association for Research in Vision and Ophthalmology Annual Meeting and Clinical Trials at the Summit SOUTH SAN FRANCISCO, Calif., Aug. 08, 2025 (GLOBE NEWSWIRE) -- Surrozen, Inc. (“Surrozen” or the “Company”) (Nasdaq: SRZN), a biotechnology company...Read more
FDA grants meeting for AVERSA™ FENTANYL (abuse deterrent transdermal system) to provide feedback on the Chemistry, Manufacturing, and Controls plans for the product through commercialization. Nutriband is partnering with Kindeva to develop AVERSA™ FENTANYL which combines Nutriband’s AVERSA™ abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch. ORLANDO, Fla., Aug. 08, 2025 (GLOBE NEWSWIRE) -- Nutriband Inc....Read more
Entered into worldwide licensing agreement with Debiopharm for lunresertib Evaluating strategic alternatives to maximize shareholder value Initial data for LIONS and POLAR trials expected to be reported in Q4 2025 $109.5 million in cash and cash equivalents and marketable securities CAMBRIDGE, Mass. & MONTREAL / Aug 08, 2025 / Business Wire / Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a clinical-stage...Read more
Independent Study and Bioanalysis Suggests More Effective Nerve Repair and Faster Wound Healing TORONTO and HAIFA, Israel, Aug. 08, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”) today announced that an independent study showed that exosomes produced by NurExone outperformed a recognized commercial industry standard in areas that strongly support key healing tasks...Read more
Completed patient enrollment in Phase 2b CHASE trial of KPI-012 in Persistent Corneal Epithelial Defect (PCED); topline data expected at the end of September 2025 Cash resources of $31.9 million as of June 30, 2025, expected to fund operations into 1Q 2026 ARLINGTON, Mass., Aug. 08, 2025 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research,...Read more
REDWOOD CITY, Calif. / Aug 08, 2025 / Business Wire / Exicure, Inc. (Nasdaq: XCUR, the “Company”) releases the following financial results for the fiscal quarter ended June 30, 2025. Second Quarter 2025 Financial Results Cash Position: Cash and cash equivalents were $7.9 million as of June 30, 2025, as compared to $12.5 million as of December 31, 2024. Research and Development (R&D) Expense: Research and development expenses were...Read more
TORONTO, Aug. 08, 2025 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today reported financial results for the three and nine months ended June 30, 2025 and provided an update on its business. During the quarter, the company advanced manufacturing-related activities to support U.S. regulatory approval of a...Read more
$5.0 million upfront with up to an additional $12.5 million of potential aggregate gross proceeds upon the exercise in full of short-term warrants MIAMI, Aug. 08, 2025 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening, rare pediatric and chronic aging-related conditions, today announced the...Read more
Encinitas, California--(Newsfile Corp. - August 8, 2025) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company") today announced second quarter 2025 financial results and provided an update on its pipeline of therapeutics for the treatment of retinal diseases. Key second quarter and 2025 year-to-date corporate highlights include: KIO-104 Initiated KLARITY, a Phase 2 clinical trial evaluating KIO-104 for the treatment...Read more
CALGARY, Alberta, Aug. 08, 2025 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. (“XORTX” or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat gout and progressive kidney disease, announces the closing of its previously announced non-brokered private placement of units (“Units”), whereby it issued 156,849 Units at a price of US$0.73 per...Read more
SAN DIEGO / Aug 08, 2025 / Business Wire / Revelation Biosciences, Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), a clinical-stage life sciences company that is focused on rebalancing inflammation to optimize health, today reported its financial results for the three and six months ended June 30, 2025. Corporate Highlights Completed dosing of patients in PRIME Phase 1b Clinical Study of Gemini in CKD Patients Received gross...Read more
TARRYTOWN, N.Y., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) will webcast management participation as follows: Cantor Global Healthcare Conference 2025 at 1:35 p.m. ET on Wednesday, September 3, 2025 2025 Wells Fargo Healthcare Conference at 9:30 a.m. ET on Thursday, September 4, 2025 Morgan Stanley 23rd Annual Global Healthcare Conference at 11:30 a.m. ET on Monday, September 8, 2025 Bernstein...Read more
ARIKAYCE® (amikacin liposome inhalation suspension) Total Revenue of $107.4 Million for the Second Quarter of 2025, Reflecting 19% Growth Over the Second Quarter of 2024 NDA for Brensocatib in Patients with Bronchiectasis Remains on Track, with a PDUFA Target Action Date of August 12, 2025 TPIP Program Advancing with Phase 3 Studies Planned to Begin for PH-ILD in the Second Half of 2025 and for PAH in Early 2026 Topline Data...Read more
Epcoritamab in combination with rituximab and lenalidomide (R2) demonstrated statistically significant improvement in Overall Response Rate (ORR; 95.7%, p < 0.0001) and Progression-Free Survival (HR 0.21, p-value <0.0001) versus R2 alone in patients with relapsed/refractory (R/R) Follicular Lymphoma (FL) Results from EPCORE FL-1 form the basis of global regulatory submissions U.S. FDA has accepted for priority review new...Read more
Q2 2025 revenue of €103.0 million for YORVIPATH® and €50.7 million for SKYTROFA® TransCon® CNP (navepegritide) NDA under Priority Review for the treatment of children with achondroplasia with PDUFA date of November 30, 2025 SKYTROFA® (lonapegsomatropin-tcgd) approved in the U.S. for treatment of adults with growth hormone deficiency; first of many planned label expansions Week 26 Interim Results for COACH trial highlight...Read more
Aligned with FDA on del-brax accelerated and full approval pathways for FSHD, reported positive topline data from Phase 1/2 FORTITUDE™ trial, and initiated global confirmatory Phase 3 study Planned del-zota BLA submission at year end 2025 for DMD44 on track to be Avidity's first BLA submission On track for three potential BLA submissions over a 12-month period Strong balance sheet and cash runway to mid-2027 enabling global...Read more
Initiated rolling NDA submission for zidesamtinib for TKI pre-treated patients with advanced ROS1-positive NSCLC, with target completion in the third quarter of 2025 Initiated ALKAZAR Phase 3 randomized, controlled trial of neladalkib for front-line ALK-positive NSCLC Topline pivotal data for neladalkib for TKI pre-treated patients with advanced ALK-positive NSCLC expected by year-end 2025 Preliminary data for neladalkib in patients...Read more
Regulatory Reviews of Aficamten for Obstructive HCM Progressing in U.S., E.U. and China; Late-Cycle Meeting with U.S. FDA Scheduled for September Ahead of December 26, 2025 PDUFA Date Primary Results from MAPLE-HCM to be Presented in a Hot Line Session at the European Society of Cardiology Congress 2025 ~$1.0 Billion in Cash, Cash Equivalents and Investments as of June 30, 2025 SOUTH SAN FRANCISCO, Calif., Aug. 07, 2025...Read more
Presented preliminary data from a May 1, 2025 data cutoff date for all 117 patients with a median follow-up of 12.6 months in the Phase 2 pivotal iMMagine-1 study of anito-cel in patients with RRMM 97% ORR, 68% CR/sCR at a median follow-up of 12.6 months; 6-, 12-, and 18-month PFS rates were 92%, 79%, and 66%, respectively No delayed neurotoxicities including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barré...Read more
Total revenues grew 9% y-o-y to $110.0 million for the second quarter of 2025; reaffirming full-year 2025 revenue guidance of $560 million to $590 million VYVGART reached record patient utilization in the second quarter; updated national guidelines elevate VYVGART’s role as a treatment for both acute and maintenance gMG Operating loss improved by 28% year-over-year to $54.9 million for the second quarter of 2025, and by 37% to $34.2...Read more
Second quarter performance driven by strong portfolio royalty revenue growth of 57% 2025 full year revenue guidance increased to $200 million - $225 million (previously $180 million - $200 million) and adjusted earnings per diluted share1 increased to $6.70 - $7.00 (previously $6.00 - $6.25) Conference call begins at 8:30 a.m. Eastern Time today JUPITER, Fla., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Ligand Pharmaceuticals Incorporated...Read more
Regulatory Interactions and Commercial, Medical and Corporate Preparations On-Track for PALSONIFY™ (paltusotine) New Drug Application with September 25, 2025 PDUFA Date Continued Progress on the Global Development Program for Atumelnant Across Multiple Trials, Including the BALANCE-CAH Phase 2/3 Study for the Treatment of Children with Congenital Adrenal Hyperplasia Expected to Initiate this Year $1.2B in Cash, Cash...Read more
The offering was to a single large existing institutional shareholder SAN DIEGO, Aug. 07, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc ("BLTE" or the "Company") (Nasdaq: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that it has entered into a securities purchase agreement for the purchase and sale...Read more
Conference Call and Webcast Today, August 7, 2025, at 4:30 p.m. ET PASADENA, Calif. / Aug 07, 2025 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal 2025 third quarter ended June 30, 2025. The Company is hosting a conference call today, August 7, 2025, at 4:30 p.m. ET to discuss the results. “Arrowhead continues to achieve strong execution in discovery, clinical and...Read more
Company on track to submit NDA for bitopertin in erythropoietic protoporphyria (EPP) under accelerated approval pathway in October 2025, supported by successful pre-NDA meeting Expect initial data from Phase 2 study of DISC-0974 in patients with anemia of myelofibrosis (MF) and multiple dose data from Phase 1b study of DISC-0974 in patients with anemia of non-dialysis-dependent chronic kidney disease (NDD-CKD) in Q4 2025 Initiated...Read more
KIMMTRAK® (tebentafusp-tebn) net revenues of $98.0 million in Q2 2025, growing by 30% year-over-year Phase 3 TEBE-AM trial on track to complete enrollment in 1H 2026 Dose selection for PRISM-MEL-301 Phase 3 trial expected in 2H 2025 Phase 1 single ascending dose HBV data for IMC-I109V will be presented at the 2025 AASLD Liver Meeting Cash, cash equivalents and marketable securities of $883 million as of June 30, 2025 Conference...Read more
Strong execution and continued progress across pipeline Unprecedented data delivered from Phase 2 CSU study demonstrating profound, sustained complete response and improved quality of life 7 months after completion of barzolvolimab dosing Data anticipated from Phase 2 studies of barzolvolimab in EoE and CIndU and Phase 1 study of CDX-622 in healthy volunteers in 2H 2025 HAMPTON, N.J., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Celldex...Read more
Phase 2b NAVIGATE clinical trial evaluating CD388 for the prevention of seasonal influenza met primary and all secondary efficacy endpoints for all dose groups End of Phase 2 meeting request submitted to the U.S. Food and Drug Administration (FDA) Closed upsized public offering for gross proceeds of $402.5 million; significantly strengthened balance sheet to conduct planned Phase 3 program for CD388 Added to Russell 2000® and Russell...Read more
R&D Day highlighted TRACTr, TRACIr, and ARM pipeline progress and best-in-class potential of novel bispecific ARM platform for autoimmune diseases Enrollment ongoing for JANX007 and JANX008 Updates on JANX007 and JANX008 expected in the second half of 2025 First patient dosed in lead collaboration program triggers $10 million milestone payment from Merck $996.0 million in cash, cash equivalents, and short-term investments at end...Read more
ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis Phase 3 topline histology data expected in 1H 2027 and in 2028, respectively; each trial designed to support accelerated approval to treat patients with metabolic dysfunction-associated steatohepatitis (MASH) ENTRUST Phase 3 topline data in severe hypertriglyceridemia (SHTG) expected in 1Q 2026 Cash, cash equivalents, and marketable securities totaled $561.2 million as of June 30,...Read more
Announced positive top-line data from the open-label extension MESA trial of sevasemten in participants with Becker muscular dystrophy who previously completed ARCH and CANYON studies Announced encouraging top-line data from the Phase 2 LYNX and FOX trials of sevasemten in Duchenne muscular dystrophy Advanced the Phase 2 CIRRUS-HCM trial of EDG-7500 in Hypertrophic Cardiomyopathy (HCM) BOULDER, Colo., Aug. 7,...Read more
VANCOUVER, British Columbia / Aug 07, 2025 / Business Wire / AbCellera (Nasdaq: ABCL) today announced financial results for the second quarter of 2025 and that dosing has begun in a Phase 1 clinical trial of ABCL635 for the potential treatment of moderate-to-severe vasomotor symptoms (VMS) associated with menopause. All financial information in this press release is reported in U.S. dollars, unless otherwise indicated. “In the second...Read more
Record HEPLISAV-B® quarterly net product revenue of $92 million, representing 31% year-over-year growth Refines full year 2025 HEPLISAV-B net product revenue guidance range to $315 to $325 million, from $305 to $325 million Top-line results in Part 1 of Phase 1/2 shingles vaccine trial expected in August 2025 Completed dosing in Part 1 of Phase 1/2 trial of pandemic influenza adjuvant program Conference call today at 4:30...Read more
Enrollment in the global Phase 3 MAGNITUDE trial of nexiguran ziclumeran (nex-z) in ATTR with cardiomyopathy (ATTR-CM) continues to track ahead of projections; Tracking to enroll at least 650 patients cumulatively by year-end Expanding total enrollment of the MAGNITUDE study to approximately 1,200 patients, subject to health authority review, with no expected impact on previous projected enrollment or financial runway Expect to...Read more
Total revenue increased 49% YoY to $71.5 million; Recorlev® revenue grew 136% YoY Raises full-year 2025 total revenue guidance to $280-$290 million from previous range of $260-$275 million Provided long-term outlook at Analyst and Investor Day in June Hosts conference call and webcast today at 8:30 a.m. ET CHICAGO / Aug 07, 2025 / Business Wire / Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing biopharmaceutical company...Read more
Announced positive topline results from its Phase 2b CORAL trial of Haduvio for the treatment of chronic cough in patients with IPF Closed $115 million underwritten offering with expected cash runway into 2029 Management to host a conference call and webcast today at 4:30 p.m. ET NEW HAVEN, Conn., Aug. 7, 2025 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company...Read more
Investigational new drug (IND) application cleared by the United States Food and Drug Administration (FDA) for ZW251 with first-in-human studies planned to initiate in 2025 China and European approval for zanidatamab in 2L HER2-positive biliary tract cancer (BTC) expands international patient access $48.7 million in revenue for 2Q-2025 from continued progress on existing partnerships Ziihera® net product sales by Jazz were $5.5...Read more
Continued Vafseo® (vadadustat) growth with Q2 2025 net product revenues increasing to $13.3 million; Total Q2 2025 net product revenues increased to $60.5 million DaVita physicians are expected to begin treating patients with Vafseo in August 2025 as part of an operational pilot at 100+ DaVita dialysis clinics Patient enrollment completed in VOICE, a collaborative clinical trial of Vafseo conducted by USRC Akebia to host Conference...Read more
ZUSDURI™ (mitomycin) for intravesical solution now available as the first and only FDA-approved medication for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) JELMYTO® achieved net product sales of $24.2 million in Q2 2025, compared with $21.8 million in Q2 2024, representing 11% year-over-year growth $161.6 million in cash, cash equivalents and marketable securities as of June...Read more
Received U.S. Food and Drug Administration (FDA) approval for IBTROZI™ (taletrectinib), a next-generation oral treatment for advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) on June 11, 2025 Successfully started 70 patients on IBTROZI as of July 31, 2025, approximately seven weeks after U.S. FDA approval National Comprehensive Cancer Network® added taletrectinib (IBTROZI) as a Preferred Option to Clinical Practice...Read more
Global pivotal program initiation on track for 2026 Engagement with FDA on GH001 IND complete response ongoing The fully completed Open-Label Extension analysis confirms a 73% remission rate at 6 months with infrequent treatment visits and no psychotherapy Treatment was well tolerated and no treatment related serious adverse events were reported. There was no evidence of treatment-emergent suicidal ideation or behavior Cash, cash...Read more
Q2 2025 Net Revenue of $39.7mm; Net Income of $19.8mm; Adjusted EBITDA of $22.4mm Company Announces Acquisition of Melinta Therapeutics Conference Call Scheduled for Today at 8:30 a.m. Eastern Time BERKELEY HEIGHTS, N.J., Aug. 07, 2025 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD) today announced financial results for the second quarter and six months ended June 30, 2025 and provided an update on its business...Read more
Transformational deal for CorMedix that expands and diversifies company’s commercial product portfolio, with seven innovative drug products and a pipeline expansion indication with near-term revenue growth potential Transaction expected to be near-term accretive to EPS with double-digit accretion expected in 2026; annual run-rate synergies expected to be ~$35 to $45 million Pro forma 2025 combined revenues estimated to be $305 to $335...Read more
$60.0M in 2Q25 Total Product Revenue More than 100 Patients Treated with Amtagvi® in 2Q25 Strategic Restructuring Extends Cash Runway into 4Q26 FY25 Total Product Revenue Guidance of $250M-$300M Reiterated SAN CARLOS, Calif., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating...Read more
Completion of recruitment for pivotal Phase 3 LUCIDITY trial of avexitide in PBH expected in 2025, with topline data anticipated in first half of 2026 Cash, cash equivalents, and marketable securities of $180.8 million as of June 30, 2025; cash runway expected through the end of 2026 Management to host conference call and webcast today at 8:00 a.m. Eastern Time CAMBRIDGE, Mass. / Aug 07, 2025 / Business Wire / Amylyx Pharmaceuticals,...Read more
Over 580,000 VOQUEZNA® prescriptions filled to date, reflecting 49% growth since last earnings report Net revenues of $39.5 million reported for Q2 Full-year 2025 revenue guidance of $165 million to $175 million Company remains focused on path to profitability in 2026 Management to host conference call today, August 7, 2025, at 8:00 a.m. ET FLORHAM PARK, N.J., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc....Read more
Announced positive data from two patients in Phase 1/2 clinical trial in Chronic Granulomatous Disease (CGD), providing clinical proof-of-concept for Prime Editing; plan to have regulatory interactions based on current dataset Completed follow-on offering, raising $144.2 million in gross proceeds and extending cash runway into 2027 Secured up to $24 million in additional funding from the Cystic Fibrosis Foundation to...Read more
Phase 2 MaGic trial of claseprubart (DNTH103) in generalized Myasthenia Gravis (gMG) top-line results anticipated in September 2025; the first of three catalysts for the claseprubart neuromuscular franchise by YE’26 Phase 3 CAPTIVATE trial of claseprubart in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) ongoing; interim responder analysis anticipated in 2H’26 Phase 2 MoMeNtum trial of claseprubart in Multifocal Motor...Read more
Ginkgo provides an update on its restructuring, including achievement of its expanded $250 million cost savings targets BOSTON, Aug. 7, 2025 /PRNewswire/ -- Ginkgo Bioworks Holdings, Inc. (NYSE: DNA, "Ginkgo"), which is building the leading platform for cell programming and biosecurity, today announced its results for the second quarter ended June 30, 2025. The update, including a webcast slide presentation with additional...Read more
Presented updated data at ASCO showing consistency with prior data, including 10.3-month median PFS and 39% ORR in patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer Initiated Phase 3 ReDiscover-2 trial in Q2 Approximately $657 million in cash, cash equivalents and investments at end of Q2 2025 CAMBRIDGE, Mass., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage, small molecule...Read more
RAP-219 Phase 2a trial in patients with drug-resistant focal onset seizures is fully enrolled and on track for topline results in September 2025 Phase 2 trial of RAP-219 in bipolar mania has been initiated and is enrolling patients; trial remains on track, with topline results anticipated in the first half of 2027 Ended the quarter with $260.4 million in cash, cash equivalents, and short-term investments, excluding restricted cash,...Read more
FDA Priority Review of New Drug Application (NDA) for ziftomenib in adults with R/R NPM1-m AML with Prescription Drug User Fee Act (PDUFA) target action date set for November 30, 2025 Fully engaged in commercial readiness activities in alignment with regulatory review timeline – KOMET-017-IC (intensive chemotherapy) and NIC (non-intensive chemotherapy) phase 3 studies in newly diagnosed AML on track to start in 2H...Read more
Last patient visit completed in Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis; topline results expected in mid-September 2025. SAN DIEGO, Aug. 07, 2025 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: ATYR) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced second quarter...Read more
Q2 2025 product sales of $18.9 million, representing 108% growth over Q2 2024 and the 18th straight quarter of sequential product sales growth Q2 2025 basic and fully diluted GAAP EPS of $(0.10), non-GAAP fully diluted EPS of $0.03, and Adjusted EBITDA of $3.1 million Launched KHINDIVI™ (hydrocortisone) Oral Solution Reached 100 active INCRELEX® patients, ahead of previous guidance of year end Company projects reaching an annual...Read more
| Company | Change | Last Trade |
|---|---|---|
| Bolt Biotherapeutics | 4.99 891.07 | $5.55 |
| Bright Minds Biosciences | 4.02 11.55 | $38.82 |
| Alnylam Pharmaceuticals | 3.83 0.88 | $438.93 |
| Ligand Pharmaceuticals | 3.74 2.56 | $150.06 |
| Soleno Therapeutics | 3.64 4.62 | $82.35 |
| Madrigal Pharmaceuticals | 3.39 0.99 | $345.73 |
| Regeneron Pharmaceuticals | 3.20 0.57 | $563.00 |
| Quantum BioPharma | 3.20 12.30 | $29.21 |
| Assembly Biosciences | 2.78 13.10 | $24.00 |
| SIGA Technologies | 2.78 44.98 | $8.96 |
| LENZ Therapeutics | 2.56 7.97 | $34.68 |
| Krystal Biotech | 2.56 1.88 | $138.66 |
| NewAmsterdam Pharma | 2.35 10.24 | $25.31 |
| Viking Therapeutics | 2.33 6.55 | $37.89 |
| United Therapeutics | 2.08 0.69 | $301.50 |
Assertio is a leading commercial pharmaceutical company bringing differentiated products to patients. The Company has a robust portfolio of branded prescription products in three areas: neurology, hospital, and pain and inflammation. Assertio has grown through...
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Terns Pharmaceuticals is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including GLP-1 receptor...
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