InvestBio News

💊 Pipeline updates 〰〰〰〰〰〰〰〰〰〰〰 Company: $NMRA - Neumora Therapeutics Inc. Drug: NMRA-511 (Neuropsychiatric, Alzheimer's disease agitation) Stage: Phase 1b Catalyst: Phase 1b is ongoing, with clinical data expected in 4Q 2026. Phase 1b initiated, noted June 20, 2024. Phase 1b data reported a clinically meaningful effect size in people with AD agitation, noted January 5, 2025. Higher dose trial initiation due in 2026. 〰〰〰〰〰〰〰〰〰〰〰 Company: $LNTH - Lantheus Holdings Inc. Drug: TAUKLARIFY (Florquinitau F 18 injection (MK-6240)) (Alzheimer's disease) Stage: Approved Catalyst: FDA approved on August 14, 2026. 〰〰〰〰〰〰〰〰〰〰〰 Company: $ACOG - Alpha Cognition Inc. Drug: ZUNVEYL (benzgalantamine) (Mild-to-moderate Alzheimer's disease) Stage: Approved Catalyst: FDA approved on July 29, 2024. 〰〰〰〰〰〰〰〰〰〰〰 Company: $ETON - Eton Pharmaceuticals Inc. Drug: ET-700 (Wilson disease) Stage: Phase 1 Catalyst: Pilot trial topline results due early 2027. 〰〰〰〰〰〰〰〰〰〰〰 Company: $FATE - Fate Therapeutics Inc. Drug: FT819 - (RECLAIM-LN) (Systemic lupus erythematosus) Stage: Phase 2 Catalyst: Phase 2 study dosing commenced, noted August 14, 2026. Enrollment to be completed in 1H 2028. Phase 1 data presented at EULAR reported that a majority of evaluable patients on background glucocorticoids achieved either complete glucocorticoid discontinuation or guideline-based tapering targets, noted June 4, 2026. 〰〰〰〰〰〰〰〰〰〰〰 Company: $QNCX - Quince Therapeutics Inc. Drug: LAM-001 (Pulmonary hypertension associated with interstitial lung disease) Stage: Phase 2b Catalyst: Phase 2b is ongoing, with data expected in 1Q 2028. 〰〰〰〰〰〰〰〰〰〰〰 Company: $SKYE - Skye Bioscience Inc. Drug: RXC008 (Fibrostenotic Crohn's disease) Stage: Phase 2 Catalyst: Phase 2 study ongoing with topline data expected in 2H 2028. 〰〰〰〰〰〰〰〰〰〰〰 #ACOG #ETON #FATE #LNTH #NMRA #QNCX #SKYE

📰 Daily Biotech Stock Updates 〰〰〰〰〰〰〰〰〰〰〰〰 Daré Bioscience (NASDAQ: $DARE) announced the pricing of a $6.0 million registered direct offering at $1.37 per share, including concurrent Series A and B warrants, with the capital infusion intended to bolster its women’s health development pipeline while introducing notable equity dilution for shareholders. Shares closed down 32% at $0.93. NeOnc Technologies (NASDAQ: $NTHI) hosted an investor call highlighting favorable Phase 2a NEO100-01 results for recurrent IDH1-mutant high-grade glioma, reporting a PFS6 of 48.9% and median OS of 26.1 months that notably outperformed historical benchmarks; the company now intends to engage with the FDA regarding a randomized Phase 3 trial aimed at accelerated approval, with OS serving as the primary endpoint against lomustine. Shares closed up 31% at $4.22. Capricor Therapeutics (NASDAQ: $CAPR) shares closed up 58% at $6.65 following news that the FDA will evaluate supplemental deramiocel efficacy results for Duchenne muscular dystrophy, a move that may push back the August 22 PDUFA deadline while significantly reducing immediate regulatory hurdles and clarifying the path forward for its lead candidate. BeyondSpring (NASDAQ: $BYSI) subsidiary SEED Therapeutics secured FDA Orphan Drug Designation for ST-01156 to treat neuroblastoma, providing regulatory incentives and marketing exclusivity for the targeted protein degrader while highlighting the oncology program's progress through early-stage development. Shares closed down 16% at $0.84. Valneva (NASDAQ: $VALN) shares closed up 26% at $7.13 after the European Medicines Agency validated the marketing application for PF-07307405, a Lyme disease vaccine candidate partnered with Pfizer, which showed efficacy exceeding 70% in the Phase 3 VALOR study and a favorable safety profile as it enters European regulatory review. Eton Pharmaceuticals (NASDAQ: $ETON) saw its price target adjusted upward to $70.00 from $65.00 by analysts at H.C. Wainwright, reflecting continued confidence in the company's growth trajectory and commercial portfolio development. Shares closed up 44% at $58.86. Innate Pharma (NASDAQ: $IPHA) shares closed down 14% at $2.17 following the pricing of a €30 million private placement consisting of 17.65 million shares at €1.70 per share, with the €27.6 million in expected net proceeds earmarked for the clinical advancement of IPH4502 and other preclinical ADC assets, resulting in an estimated 18.8% dilution for existing shareholders. #BYSI #CAPR #DARE #ETON #IPHA #NTHI #VALN

📰 Pre-Market Biotech Stock 〰〰〰〰〰〰〰〰〰〰〰〰 Capricor Therapeutics (NASDAQ: $CAPR) surged over 100% in early trading after news that the FDA will evaluate supplemental deramiocel efficacy results for Duchenne muscular dystrophy, a move that may push back the August 22 PDUFA deadline while significantly reducing immediate regulatory hurdles and clarifying the path forward for its lead candidate. BeyondSpring (NASDAQ: $BYSI) subsidiary SEED Therapeutics secured FDA Orphan Drug Designation for ST-01156 to treat neuroblastoma, providing regulatory incentives and marketing exclusivity for the targeted protein degrader while highlighting the oncology program's progress through early-stage development. Valneva (NASDAQ: $VALN) jumped about in early trading after the European Medicines Agency validated the marketing application for PF-07307405, a Lyme disease vaccine candidate partnered with Pfizer, which showed efficacy exceeding 70% in the Phase 3 VALOR study and a favorable safety profile as it enters European regulatory review. Lantheus (NASDAQ: $LNTH) announced that the FDA approved TAUKLARIFY, its F 18 tau positron emission tomography imaging agent for adults with cognitive impairment suspected of having Alzheimer’s disease; the diagnostic tool specifically targets tau pathology to complement amyloid positron emission tomography imaging while excluding other non-Alzheimer’s tauopathy assessments, further strengthening the company's commercial radiopharmaceutical portfolio. Eton Pharmaceuticals (NASDAQ: $ETON) saw its price target adjusted upward to $70.00 from $65.00 by analysts at H.C. Wainwright, reflecting continued confidence in the company's growth trajectory and commercial portfolio development. Innate Pharma (NASDAQ: $IPHA) announced the pricing of a €30 million private placement consisting of 17.65 million shares at €1.70 per share, with the €27.6 million in expected net proceeds earmarked for the clinical advancement of IPH4502 and other preclinical ADC assets, resulting in an estimated 18.8% dilution for existing shareholders. #BYSI #CAPR #ETON #IPHA #LNTH #VALN

💊 Pipeline updates 〰〰〰〰〰〰〰〰〰〰〰 Company: $MGTX - MeiraGTx Holdings plc Drug: AAV2-hAQP1 - (AQUAx2) (Xerostomia) Stage: Phase 1 Catalyst: Phase 1 data readout expected in 2Q 2027 which, if positive, would support a BLA filing and potential approval targeted for the end of 2027. Phase 1 3-year data showed durable, clinically meaningful improvements in xerostomia symptoms (XQ scores) and sustained increases in whole saliva flow, with the therapy remaining safe across all dose cohorts, noted April 16, 2026. BLA filing due in 1H 2027. 〰〰〰〰〰〰〰〰〰〰〰 Company: $NRSN - NeuroSense Therapeutics Ltd. Drug: PrimeC - (PARAGON) (Amyotrophic Lateral Sclerosis) Stage: Phase 3 Catalyst: Phase 3 trial planned. 〰〰〰〰〰〰〰〰〰〰〰 Company: $CMND - Clearmind Medicine Inc. Drug: CMND-100 (Alcohol use disorder) Stage: Phase 1/2 Catalyst: Phase 1/2 independent Data Safety Monitoring Board has unanimously approved advancing the Company’s ongoing FDA-regulated clinical trial to Parts B and C, noted August 6, 2026. Phase 1/2 Part A safety results reported that all 24 participants enrolled across four ascending-dose cohorts successfully completed treatment as planned per protocol, noted July 30, 2026. 〰〰〰〰〰〰〰〰〰〰〰 Company: $BYSI - BeyondSpring Inc. Drug: ST-01156 (Solid tumors) Stage: IND-Enabling Catalyst: Investigational New Drug filing expected 2025. Orphan drug designation granted by the FDA, noted on August 13, 2026. 〰〰〰〰〰〰〰〰〰〰〰 Company: $FATE - Fate Therapeutics Inc. Drug: FT819 - (RECLAIM-LN) (Systemic lupus erythematosus) Stage: Phase 1 Catalyst: Phase 2 study dosing is ongoing, with enrollment to be completed in 1H 2028. Phase 1 data presented at EULAR reported that a majority of evaluable patients on background glucocorticoids achieved either complete glucocorticoid discontinuation or guideline-based tapering targets, noted June 4, 2026. 〰〰〰〰〰〰〰〰〰〰〰 #BYSI #CMND #FATE #MGTX #NRSN

📰 Daily Biotech Stock Updates 〰〰〰〰〰〰〰〰〰〰〰〰 BeyondSpring (NASDAQ: $BYSI) subsidiary SEED Therapeutics secured FDA Orphan Drug Designation for ST-01156 to treat neuroblastoma, providing regulatory incentives and marketing exclusivity for the targeted protein degrader while highlighting the oncology program's progress through early-stage development. Shares closed up 34% at $1. Lexaria Bioscience (NASDAQ: $LEXX) entered into a material transfer agreement with PegBio to evaluate DehydraTECH-enabled oral delivery of a proprietary GLP-1 molecule in animal pharmacokinetic trials, establishing a strategic pathway toward licensing or full commercialization should the platform enhance GLP-1 efficacy for diabetes, obesity, or Metabolic dysfunction-associated steatohepatitis. Shares closed up 32% at $8.1. Outlook Therapeutics (NASDAQ: $OTLK) priced a $55 million public offering of 55.6 million shares plus matching warrants at $0.99 per share-and-warrant unit, with $1.10 five-year warrants and an 8.3 million-share underwriter option, adding capital for LYTENAVA commercialization while creating significant dilution. Shares closed down 19% at $0.89. Omeros (NASDAQ: $OMER) maintained a Buy rating from H.C. Wainwright with a $33 price target, following a robust $28.5 million Q2 U.S. launch of YARTEMLEA that exceeded projections, alongside increasing clinical uptake, favorable reimbursement tailwinds, and diminished competition following a peer's setback in an adult C5 study. Shares closed up 27% at $17.35. INOVIO (NASDAQ: $INO) shares closed up 17% at $0.9 following a Q2 GAAP loss of $0.07 per share that outperformed analyst estimates by $0.15, as the company advances its lead candidate INO-3107 through the regulatory review process with $36.7 million in liquidity, excluding an additional $18.3 million in recent funding. Abeona Therapeutics (NASDAQ: $ABEO) posted a $20.2 million Q2 net loss, reflecting persistent cash burn as the firm progresses its pipeline of cell and gene therapies for rare diseases. Shares closed down 15% at $6.35. #ABEO #BYSI #INO #LEXX #OMER #OTLK

📰 Pre-Market Biotech Stock 〰〰〰〰〰〰〰〰〰〰〰〰 Outlook Therapeutics (NASDAQ: $OTLK) priced a $55 million public offering of 55.6 million shares plus matching warrants at $0.99 per share-and-warrant unit, with $1.10 five-year warrants and an 8.3 million-share underwriter option, adding capital for LYTENAVA commercialization while creating significant dilution. Omeros (NASDAQ: $OMER) maintained a Buy rating from H.C. Wainwright with a $33 price target, following a robust $28.5 million Q2 U.S. launch for YARTEMLEA that exceeded projections, alongside increasing clinical uptake, favorable reimbursement tailwinds, and diminished competition following a peer's adult C5 study setback. AbCellera (NASDAQ: $ABCL) priced an oversubscribed $200 million public offering of 17.4 million shares at $9.75 and 3.1 million pre-funded warrants at $9.74999, adding capital for ABCL635 and internal pipeline development while introducing dilution after recent positive Phase 2 vasomotor symptom data. Cullinan Therapeutics (NASDAQ: $CGEM) maintained a Buy rating from William Blair, following encouraging Phase 3 interim results for zipalertinib in treatment-naive Epidermal growth factor receptor exon 20-mutant non-small-cell lung cancer that demonstrated compelling progression-free survival benefit, with analysts highlighting significant label expansion potential for the Taiho-partnered program and upcoming pipeline catalysts. Lumexa Imaging (NASDAQ: $LMRI) posted a Q2 non-GAAP earnings per share of $0.20 that surpassed estimates by $0.06 and revenue of $264.2 million that also exceeded projections, driven by 6.8% advanced outpatient volume growth and a rise in net income to $2.7 million, while adjusted EBITDA held steady at $56.4 million with margin narrowing to 21.4%. Abeona Therapeutics (NASDAQ: $ABEO) posted a $20.2 million Q2 net loss, reflecting persistent cash burn as the firm progresses its pipeline of cell and gene therapies for rare diseases. #ABCL #ABEO #CGEM #LMRI #OMER #OTLK

💊 Pipeline updates 〰〰〰〰〰〰〰〰〰〰〰 Company: $DFTX - Definium Therapeutics Inc. Drug: DT120 ODT (MM120) (lysergide D-tartrate, LSD) - (Voyage) (Generalized Anxiety Disorder) Stage: Phase 3 Catalyst: Phase 3 dosing initiated, noted December 16, 2024. Phase 3 topline anticipated study met its primary endpoint, noted August 12, 2026. 〰〰〰〰〰〰〰〰〰〰〰 Company: $ABOS - Acumen Pharmaceuticals Inc. Drug: ACU193 - (ALTITUDE-AD) (Early Alzheimer's disease) Stage: Phase 2 Catalyst: Phase 2 early findings shared at Alzheimer's Association International Conference illustrate the diverse ways individuals respond to and cope with cognitive and functional changes, noted July 15, 2026. Phase 2 topline results to be shared in late 2026. 〰〰〰〰〰〰〰〰〰〰〰 Company: $APRE - Aprea Therapeutics Inc. Drug: APR-1051 - (ACESOT-1051) (Solid tumors) Stage: Phase 1 Catalyst: Phase 1 data expected at a medical meeting by 4Q 2026. Phase 1 additional update demonstrated early signs of single-agent activity along with a favorable tolerability profile in patients with difficult-to-treat cancers, noted July 30, 2026. Dose escalation and expansion cohorts in uterine serous carcinoma and platinum-resistant ovarian cancer are ongoing, with completion expected in 2Q 2027, noted June 1, 2026. 〰〰〰〰〰〰〰〰〰〰〰 Company: $NTHI - NeOnc Technologies Holdings Inc. Drug: NEO100-01 (Malignant recurrent World Health Organization Grade 3 /4 IDH1 Astrocytoma) Stage: Phase 2a Catalyst: Phase 2a topline study met its primary endpoint, noted August 12, 2026. Type B meeting will be requested from the FDA. 〰〰〰〰〰〰〰〰〰〰〰 #ABOS #APRE #DFTX #NTHI

📰 Daily Biotech Stock Updates 〰〰〰〰〰〰〰〰〰〰〰〰 Bone Biologics (NASDAQ: $BBLG) announced the extension of the validated shelf life for its rhNELL-1 protein to 32 months. This enhancement optimizes manufacturing and logistics as NB1 continues an Australian pilot trial for lumbar fusion in patients with degenerative disc disease. Shares closed down 28% at $0.66. Dermata Therapeutics (NASDAQ: $DRMA) plans to launch Tome Foundational Treatment on August 25, marking its transition to commercial-stage consumer skincare. Q2 net loss widened to $3.0 million, while $4.4 million in cash provides runway only into Q4 2026. Shares closed up 28% at $1.38. Sionna Therapeutics (NASDAQ: $SION) shares closed up 23% at $6.25 following a sharp decline after SION-719 failed its Phase 2a cystic fibrosis study by missing sweat chloride targets. The disappointing data sparked several analyst downgrades and solidified Vertex’s dominance in the sector, while Sionna placed its SION-451 development program under strategic evaluation. NeOnc Technologies (NASDAQ: $NTHI) reported that its Phase 2a NEO100-01 trial for recurrent/progressive IDH1-mutant Grade III/IV glioma achieved its primary goal, reaching a 48.9% six-month progression-free survival against a 20% benchmark. With median OS at 26.1 months and favorable safety data, the company intends to meet with the FDA to discuss a registrational pathway. Shares closed down 21% at $3.44. Curis (NASDAQ: $CRIS) submitted a filing to offer 3.73 million shares of common stock alongside warrants via placement agents A.G.P. and Laidlaw; the proposed dilutive financing is intended to support the ongoing clinical development of emavusertib. Shares closed down 28% at $1.67. Silo Pharma, Inc. (NASDAQ: $SILO) announced that the European Patent Office granted a patent for SPC-15, its intranasal lead candidate for Post-traumatic Stress Disorder and stress-induced disorders. The patent covers the use of serotonin 4 (5-HT4) receptor agonists to prevent stress-induced fear and depressive behaviors. Silo maintains an exclusive global license from Columbia University for the development and commercialization of the therapy. Shares closed down 13% at $3.1. FocalTherics (NASDAQ: $FOCL) expects Q2 revenue of $12.7–$13.2 million, up 34%–39%, with gross margin improving to 54%–56%. The company priced an $40 million public offering at $4.75 per American Depositary Share. Shares closed down 21% at $4.75. Check-Cap Ltd. (NASDAQ: $MBAI) announced a 1-for-7 reverse stock split effective August 13, consolidating its share count to approximately 1.35 million. The move is intended to satisfy the $4.00 minimum bid price for its Nasdaq listing and facilitate the pending MBody artificial intelligence merger. The transaction remains on track for a third-quarter close in 2026, contingent upon regulatory and shareholder clearance. #BBLG #CRIS #DRMA #FOCL #MBAI #NTHI #SILO #SION