Catalyst Calendar
Wed, Aug 19, 2026
17 updatesUltragenyx Announces U.S. FDA Approval of GENGLYCOS™ Gene Therapy, the First-Ever FDA-Approved Treatment Designed to Treat the Underlying Cause of Glycogen Storage Disease Type Ia (GSDIa)
GENGLYCOS is the first gene therapy approval, and fifth FDA approval overall, for the company Approval provides a long-awaited first-ever option to reduce the burden of care associated with GSDIa Ultragenyx received a Priority Review Voucher upon approval Ultragenyx to host conference call on
vTv Therapeutics Announces Inducement Grants under Nasdaq Listing Rule 5635(c)(4)
HIGH POINT, N.C., Aug. 19, 2026 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company focused on the development of cadisegliatin, a novel, potential first-in-class oral adjunctive therapy to insulin being investigated for the treatment of type 1 diabetes
Regeneron Announces Investor Conference Presentations
TARRYTOWN, N.Y., Aug. 19, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) will webcast management participation as follows: 2026 Wells Fargo Healthcare Conference at 8:45 a.m. ET on Wednesday, September 9, 2026 Morgan Stanley 24 th Annual Global Healthcare Conference at
Replimune Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
WOBURN, Mass., Aug. 19, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a commercial stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced the grant of inducement equity awards to Michelle DiNapoli, the Company’s Chief Commercial
Jaguar Health Reports Second Quarter 2026 Financials
Company remains sharply focused on its ongoing global development program for crofelemer for rare intestinal failure (IF) diseases; as announced, presentation at ESPGHAN 2026 described additional groundbreaking results of evaluation of crofelemer as adjunctive oral therapy for the treatment of
Pasatru™ (garetosmab-grts) First and Only FDA-approved Treatment Demonstrating Reduction in New Heterotopic Ossification (HO) Lesions and Clinician-Assessed Flare-ups in a Placebo-controlled Trial in Adults with Fibrodysplasia Ossificans Progressiva (FOP)
FOP is an ultra-rare genetic disorder characterized by rogue bone formation that infiltrates muscles, tendons, ligaments and other connective tissues, resulting in significant disability Approval based on results from the OPTIMA trial demonstrating a 90% or greater reduction in new HO lesions at
Zipalertinib Plus Chemotherapy First-Line Phase 3 REZILIENT3 Trial Data Selected for Presidential Symposium Presentation at the IASLC 2026 World Conference on Lung Cancer
Presentation will feature results from the planned interim analysis of the Phase 3 REZILIENT3 trial, which met its primary endpoint of progression-free survival in first line EGFR exon 20 insertion mutation NSCLC PRINCETON, N.J., CAMBRIDGE, Mass., August 19, 2026 — Taiho Oncology, Inc.
AEON Reports Expanded Structural Data Supporting Molecular Similarity of ABP-450 to BOTOX®
- Complementary peptide-mapping methods increased coverage of the active botulinum neurotoxin primary sequence from approximately 93% to 98%, with 100% amino acid identity across all regions analyzed - Preliminary analysis demonstrates preservation of the critical disulfide bond architecture
Monopar Appoints Jeffrey D. Kent, M.D., as Executive Vice President, Head of Medical Affairs; Announces Two ALXN1840 Presentations at AASLD – The Liver Meeting® 2026
WILMETTE, Ill., Aug. 19, 2026 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced the appointment of Jeffrey D....
Humacyte Announces Lancet Digital Health Publication of V007 Phase 3 Hemodialysis Access Trial Results
– Phase 3 results highlight benefits of ATEV for patients at higher risk of fistula failure, including all women and men with obesity and diabetes – – Publication provides peer-reviewed validation for V007 Phase 3 data, and complements recent release of Phase 3 V012 data showing ATEV outperformed
Merck and Moderna Announce Phase 3 INTerpath-001 Trial of Intismeran Autogene Plus KEYTRUDA® Met Endpoints of Recurrence-Free Survival (RFS) and Distant Metastasis-Free Survival (DMFS) in Patients With Completely Resected Stage IIB-IV Melanoma
First and only combination regimen to demonstrate statistically significant and clinically meaningful improvements in RFS and DMFS compared to KEYTRUDA alone for these patients in the adjuvant melanoma setting The Companies plan to present data at an upcoming international medical meeting and will engage with regulators on filing submissions for intismeran...
Director/PDMR Shareholding
19 August 2026 Transaction by Person Discharging Managerial Responsibilities AstraZeneca PLC (the Company) announced that, on 17 August 2026, an award of the Company's ordinary shares of $0.25 each (Ordinary Shares) vested to the Company's Chief Financial Officer, Dr Aradhana Sarin, under the AstraZeneca Performance Share Plan (the AZPSP)....
Novartis data at ESC Congress 2026 reinforce cardiovascular leadership and showcase progress in next-generation therapies
Basel, August 19, 2026 – Novartis will present data from 10 abstracts across its cardiovascular portfolio at the 2026 European Society of Cardiology (ESC) Congress, reinforcing its leadership in addressing cardiovascular risk....
Tue, Aug 18, 2026
14 updatesZenas BioPharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
WALTHAM, Mass., Aug. 18, 2026 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative therapies for patients living with autoimmune
Silo Pharma Receives Notice of Allowance for Canadian Patent Application for Novel PTSD Treatment
Follows recent European patent grant and coverage in multiple international markets as Silo continues to strengthen licensed IP portfolio for lead therapeutic program SARASOTA, FLA., Aug. 18, 2026 (GLOBE NEWSWIRE) -- Silo Pharma (Nasdaq: SILO) (“Silo” or “the Company&#x...
Geron Corporation Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
FOSTER CITY, Calif., Aug. 18, 2026 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq: GERN), a commercial stage biopharmaceutical company, today reported that, effective August 17, 2026, it granted stock options to purchase an aggregate of 311,250 shares of common stock to six newly hired employees as
Amylyx Pharmaceuticals Announces $350.0 Million Proposed Public Offering of Common Stock
CAMBRIDGE, Mass. --(BUSINESS WIRE)--Aug. 18, 2026-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that it has commenced an underwritten public offering of $350.0 million of shares of its common stock. In addition, Amylyx intends to grant the underwriters a
Jaguar Health to Hold Investor Webcast August 19 Regarding Q2 2026 Financials & Corporate Updates
Company plans to file its Earnings Report on August 19, 2026 on Form 10-Q for the quarter ended June 30, 2026 SAN FRANCISCO, CA / ACCESS Newswire / August 18, 2026 / Jaguar Health, Inc. ( NASDAQ:JAGX) today announced that the company will conduct an investor webcast on Wednesday, August 19, 2026 at
Akari Therapeutics Builds Momentum for AKTX-101 with Compelling Urothelial Cancer Data Supporting Differentiated ADC Strategy
AKTX-101 demonstrated robust anti-tumor activity across multiple clinically relevant urothelial cancer preclinical models Data supports the potential of Akari’s novel PH1 RNA spliceosome-modulating payload to overcome payload-specific resistance Results strengthen the rationale for a differentiated
Entera Appoints Global Pharmaceutical Leader Riccardo Paolo Camisasca, M.D., as Chief Medical Officer Ahead of Planned EB613 Phase 3 Initiation
Dr. Camisasca joins Entera with 30 years of global pharmaceutical research and clinical development experience including roles at Sumitomo Pharma, Takeda, and Novartis Appointment further strengthens Entera’s clinical execution team and late-stage development capabilities ahead of planned EB613
Board-Certified Vascular and Endovascular Surgeon Performs First Commercial Symvess® Implantation; Cites Bioengineered Blood Vessel as “Revolutionary Advancement”
– Jeromy Brink, MD, Mayo Clinic–trained vascular surgeon in Phoenix, is the first surgeon in Arizona to implant Symvess, the first and only FDA-approved bioengineered human blood vessel – – Symvess is available off-the-shelf in the operating room, sparing surgeons the time required to harvest a
Alzamend Neuro's Phase 1/2A Lithium Imaging Data Accepted for Oral Presentation at ISMRM Workshop on X-Nuclei MR in Barcelona, Spain
Helus Pharma Appoints Regina Donohue as Chief People Officer and Suresh Durgam, M.D., to its Scientific Advisory Board
Former Intra-Cellular Therapies, Inc. (“Intra-Cellular”) executives bring complementary experience in organizational scale-up, central nervous system (“CNS”) drug development, regulatory approvals and commercialization Ms. Donohue is the former Chief Human Resources Officer of Intra-Cellular, where
Helus Pharma Appoints Regina Donohue as Chief People Officer and Suresh Durgam, M.D., to its Scientific Advisory Board
Former Intra-Cellular Therapies, Inc. (“Intra-Cellular”) executives bring complementary experience in organizational scale-up, central nervous system (“CNS”) drug development, regulatory approvals and commercialization Ms. Donohue is the former Chief Human Resources Officer of Intra-Cellular, where
Genprex Selects Leading Clinical and Commercial Contract Development and Manufacturing Organization for Manufacturing Scale Up of Diabetes Gene Therapy
Collaboration Allows Genprex to Accelerate Manufacturing Processes for IND-Enabling Preclinical Studies and Future Clinical Trials AUSTIN, Texas — (Aug.18, 2026) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ:...
Immatics Announces Second Quarter 2026 Financial Results and Business Update
Enrollment in the SUPRAME Phase 3 trial of anzu-cel (anzutresgene autoleucel, IMA203) remains on track to complete the required randomizations by year-end to support final analysis for the primary PFS endpoint; aggregate PFS events (progression or death) occurring more slowly than originally
Amylyx Pharmaceuticals Announces Positive Topline Results from Phase 3 LUCIDITY Clinical Trial of Avexitide in Post-Bariatric Hypoglycemia
LUCIDITY met FDA -agreed-upon primary endpoint; avexitide demonstrated a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events compared to placebo (p=0.000003) LUCIDITY met all secondary endpoints showing consistent, highly statistically significant, and clinically
Mon, Aug 17, 2026
19 updatesCoherus Oncology Announces Special Dividend of Biosimilar Contingent Value Rights
– Entitles holders to receive net proceeds from sale of remaining Legacy Biosimilar Assets – – Completes transformation of Coherus Oncology into a fully integrated, innovative immuno-oncology company – REDWOOD CITY, Calif., Aug. 17, 2026 (GLOBE NEWSWIRE) -- Coherus Oncology, Inc. (NASDAQ: CHRS)
Sagimet Biosciences Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)
FOSTER CITY, Calif., Aug. 17, 2026 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that, in connection with the hiring of 3 employees, the
Annexon Reports Inducement Grants to New Employees Under Nasdaq Listing Rule 5635(c)(4)
BRISBANE, Calif., Aug. 17, 2026 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing the next generation platform of targeted immunotherapies aimed at neuroinflammatory diseases that impact nearly 10 million people worldwide, today announced that it has granted
Amylyx Pharmaceuticals to Announce Topline Results from its Phase 3 LUCIDITY Clinical Trial of Avexitide in Post-Bariatric Hypoglycemia on August 18, 2026
CAMBRIDGE, Mass. --(BUSINESS WIRE)--Aug. 17, 2026-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) will announce topline results from its Phase 3 LUCIDITY Clinical Trial of Avexitide in Post-Bariatric Hypoglycemia on August 18, 2026.
Cocrystal Pharma Appoints Carol Brosgart, MD to its Board of Directors
BOTHELL, Wash., Aug. 17, 2026 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) ("Cocrystal" or the "Company"), a clinical-stage biotechnology company developing novel therapeutics to meet the growing global need for effective, safe antiviral treatments, today announced the appointment of Carol Brosgart, MD to its Board of Directors, effective...
People Living with Familial Chylomicronaemia Syndrome (FCS) in Germany Have Access to REDEMPLO® (plozasiran) as a New Treatment Option to Reduce Triglycerides
REDEMPLO® (plozasiran) is listed in the Lauer-Taxe® database as an adjunct to diet to reduce triglyceride levels in adult patients with familial chylomicronaemia syndrome (FCS), diagnosed either based on clinical symptoms alone or confirmed with a genetic test People living with this rare disease
Clene to Present at the Emerging Growth Conference
SALT LAKE CITY, Aug. 17, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) today announced that management will present at the Emerging Growth Conference. Virtual Presentation Details Date: August 19, 2026 Time of Presentation: 3:10 p.m. ET Format: Corporate update A webcast of the presentation
Evaxion expands and refocuses R&D pipeline with EVX-05, an AI-designed off-the-shelf brain cancer vaccine program
EVX-05 is an off-the-shelf therapeutic glioblastoma (brain cancer) vaccine designed based on patient tumor samples. It targets novel conserved antigens identified using Evaxion’s AI-Immunology™ platform Glioblastoma is characterized by high mortality rates and significant unmet medical needs.
UroGen Submits NDA for UGN-103, an Investigational Treatment of Recurrent LG-IR-NMIBC
PRINCETON, N.J., Aug. 17, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the submission of a New Drug Application (NDA) to the U.S.
United Therapeutics Corporation Announces Full Enrollment of the TETON-PPF Study of Inhaled Treprostinil for the Treatment of Progressive Pulmonary Fibrosis
NRx Pharmaceuticals (Nasdaq:NRXP) Reports Second Quarter 2026 Financial Results and Provides Corporate Update; Conference Call to be Held on Monday, August 17th at 4:30pm ET
Key recent and second quarter highlights include: Completed first-cycle FDA review of the Company’s ANDA for preservative-free ketamine with no drug-related major deficiencies. The sole remaining item, a manufacturer's attestation on the vial, has been submitted to FDA.
Fulcrum Therapeutics and Slate Medicines Announce Merger Agreement to Advance Next-Generation Migraine Therapies
Combined company to operate as Slate Medicines and focus on advancing Slate's portfolio of next-generation migraine therapeutics Slate’s lead product candidate, SLTE-1009, is a clinical stage, potentially best-in-class subcutaneous anti-PACAP/VIP monoclonal antibody for the preventative treatment
EyePoint Announces Topline Data from LUGANO, the First of Two Pivotal Phase 3 Clinical Trials for DURAVYU™ 2.7mg in Wet AMD
– DURAVYU was non-inferior to on-label aflibercept control (nominal p-value = 0.0096) in an ad hoc analysis excluding a 4% asymmetric cohort (9 of 211 patients) who experienced vision loss (≥ 15 letters) unrelated to wet AMD; primary endpoint not achieved in full dataset, confounded by this
Zai Lab and argenx Announce Positive Topline Results from Phase 3 ALKIVIA Trial of Efgartigimod in Autoimmune Myositis
Study met primary endpoint of mean Total Improvement Score (TIS) at Week 52 in the combined study population of IMNM and DM patients (p=0.0011) Patient improvements observed early and sustained throughout study; consistent treatment effect across IMNM and DM First Phase 3 study to show