Catalyst Calendar

Grant of waivers of Listing Rule 7.3.4

Lilly breaks ground in Houston, one of ten U.S. manufacturing sites announced since 2020

New facility will manufacture active pharmaceutical ingredients for medicines like Foundayo (orforglipron), strengthening domestic supply chain Site will employ more than 600 people in high-wage jobs $12.5 million in support to build talent pipeline, workforce training center with San Jacinto

Helus Pharma to Participate at the TD Cowen 6th Annual Novel Mechanisms in Neuropsychiatry Summit

CEO Michael Halstead to participate in a fireside chat on September 23, 2026 at 9:00 a.m. EDT NEW YORK and TORONTO, Sept. 21, 2026 (GLOBE NEWSWIRE) -- Helus Pharma (Nasdaq: HELP) (Cboe CA: HELP) (the “Company” or “Helus Pharma”), a clinical-stage pharmaceutical company committed to helping minds

Helus Pharma to Participate at the TD Cowen 6th Annual Novel Mechanisms in Neuropsychiatry Summit

CEO Michael Halstead to participate in a fireside chat on September 23, 2026 at 9:00 a.m. EDT NEW YORK and TORONTO, Sept. 21, 2026 (GLOBE NEWSWIRE) -- Helus Pharma (Nasdaq: HELP) (Cboe CA: HELP) (the “Company” or “Helus Pharma”), a clinical-stage pharmaceutical company committed to helping minds

Anaptys Announces Second Quarter and Transitional Fiscal Year 2026 Financial Results and Provides Business Update

Jemperli global net sales of $644 million (£480 million) for the six months ended June 30, 2026, representing 34% year-over-year growth Positive interim results from the pivotal AZUR-1 trial of Jemperli in untreated stage II/III dMMR/MSI-H locally advanced rectal cancer announced in July; FDA PDUFA

Abivax Presents Business Updates and First Half 2026 Financial Results

Abivax Presents Business Updates and First Half 2026 Financial Results Chris Rabbat to succeed Fabio Cataldi as Chief Medical Officer; Tim Kelly appointed Chief Technical Officer to advance commercial supply readiness and lead Abivax’s Chemistry, Manufacturing and Controls (“CMC”), Quality and

Mineralys Therapeutics Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)

Xenon to Present at TD Cowen Novel Mechanisms in Neuropsychiatry & Epilepsy Summit

VANCOUVER, BC and BOSTON, MA, Sept. 21, 2026 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq: XENE), a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development and commercialization of life-changing therapeutics for patients in need, today announced

Scinai Regains Compliance with Nasdaq Minimum Bid Price Requirement

‍ ‍ ‍ Nasdaq confirms compliance with Listing Rule 5550(a)(2) after 19 consecutive business days with a closing bid price at or above $1.00; minimum bid price matter is closed ‍ ‍ JERUSALEM, Sept. 21, 2026 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq:...

Cullinan Therapeutics to Participate in the Stifel 2026 Virtual Immunology and Inflammation Forum

CAMBRIDGE, Mass., Sept. 21, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, today announced that Nadim

European Commission approves Roche’s Susvimo® for the treatment of neovascular age-related macular degeneration (nAMD)

By continuously delivering medicine into the eye through the Contivue refillable implant, Susvimo is the first and only continuous delivery treatment that offers an alternative to standard-of-care eye injections for nAMD 1-3 Susvimo helps people with nAMD maintain their vision with as few as two treatments per year 1-3 Data from the Phase III Archway study...

Q32 Bio Announces Upcoming Late-Breaking Presentation of Results from Part B of the SIGNAL-AA Clinical Trial of Bempikibart in Alopecia Areata at the European Academy of Dermatology and Venereology Congress 2026

-- Late-breaking oral and poster presentations to feature additional 36-week results and initial findings from the 16-week off-drug period from Part B of the SIGNAL-AA clinical trial of bempikibart in alopecia areata -- WALTHAM, Mass., Sept. 21, 2026 /PRNewswire/ -- Q32 Bio Inc.

NewAmsterdam Pharma and Menarini Group Receive European Commission Approval for Ubeslo® (Obicetrapib Monotherapy) and Evlarco® (Obicetrapib Plus Ezetimibe Fixed-Dose Combination)

- First-in-Class approval supported by Phase 3 BROADWAY, BROOKLYN, and TANDEM trials demonstrating significant LDL-C reductions with favorable tolerability profile- - First global regulatory approval of obicetrapib marks a defining milestone for NewAmsterdam and Menarini, expanding treatment

Palisade Bio to Present at Stifel 2026 Virtual Immunology and Inflammation Forum

Presentation scheduled for September 23, 2026 at 1:00 PM ET Access the webcast here Denver, CO, Sept. 21, 2026 (GLOBE NEWSWIRE) — Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a clinical-stage biopharmaceutical company developing next-generation prodrugs for patients living with inflammatory and fibrotic diseases, today announced that JD...

Clene Announces Closing of $4 Million Registered Direct Offering Extending Capital Runway Beyond FDA Decision on CNM-Au8® NDA

Investment was led by Clene’s Chairman of the Board of Directors, alongside founding investor Kensington Capital Holdings, Clene’s Chief Executive Officer and other existing shareholders $4 million registered direct offering was priced at market under Nasdaq rules Proceeds are expected to be

Helus Pharma Presents New Analyses on HLP003 in Major Depressive Disorder at Psych Congress 2026

Poster presentations further characterize clinical profile of HLP003 and Phase 3 PARADIGM program evaluating HLP003 as a potential adjunctive treatment for major depressive disorder (“MDD”) NEW YORK and TORONTO, Sept. 21, 2026 (GLOBE NEWSWIRE) -- Helus Pharma (Nasdaq: HELP) (Cboe CA: HELP) (the

Helus Pharma Presents New Analyses on HLP003 in Major Depressive Disorder at Psych Congress 2026

Poster presentations further characterize clinical profile of HLP003 and Phase 3 PARADIGM program evaluating HLP003 as a potential adjunctive treatment for major depressive disorder (“MDD”) NEW YORK and TORONTO, Sept. 21, 2026 (GLOBE NEWSWIRE) -- Helus Pharma (Nasdaq: HELP) (Cboe CA: HELP) (the

Alkermes Announces Positive Phase 1b Results Demonstrating Clinical Proof-of-Concept for ALKS 7290 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

— ALKS 7290 is the First Orexin 2 Receptor Agonist to Demonstrate Clinically Meaningful Improvements in ADHD Symptoms in Adults — — ALKS 7290 Was Generally Well Tolerated at All Doses Tested in Healthy Volunteers and Adults With ADHD — — Phase 2 Study of ALKS 7290 in Adults With ADHD is Enrolling,

Tiziana Announces Last Patient Completes Last Visit in Phase 2a INFORM-MS Trial of Intranasal Foralumab

BOSTON, Sept. 21, 2026 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody,

FDA Grants Priority Review to Insmed's sNDA for ARIKAYCE® (amikacin liposome inhalation suspension) for Treatment of MAC Lung Disease With PDUFA Target Action Date Set for January 28, 2027

Axsome Therapeutics Announces Results of the Shared Goals Survey of Caregivers of Patients with Alzheimer’s Disease Agitation Presented at Psych Congress 2026 in Connection with World Alzheimer’s Day

The Shared Goals: Navigating Alzheimer’s Agitation survey finds that Alzheimer’s disease agitation is often only recognized after daily life is significantly disrupted Ninety-seven percent of care partners reported that agitation negatively impacted their loved one’s quality of life, and three in

Merck’s KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) Approved in Japan for Subcutaneous Administration for All KEYTRUDA® (pembrolizumab) Indications Approved in Japan

KEYTRUDA QLEX is the first and only subcutaneous immune checkpoint inhibitor in Japan that can be administered by a healthcare provider in as little as one minute RAHWAY, N.J.–(BUSINESS WIRE)– Merck (NYSE:...

OS Therapies Completes FDA Type C Statistical Methods Meeting and Provides Update on Global Regulatory Coordination for OST-HER2 Under Project Orbis

Klygefa recommended for EU approval by CHMP

21 September 2026 Klygefa (gefurulimab) recommended for approval in the EU by CHMP for the treatment of adults with generalised myasthenia gravis (gMG) Recommendation based on PREVAIL Phase III trial demonstrating statistically significant and clinically meaningful improvement in Myasthenia Gravis Activities of Daily Living score If approved, Klygefa will...

PureTech Announces Successful End-of-Phase 1 Meeting with U.S . Food and Drug Administration (FDA) and Receipt of Fast Track Designation for LYT-200 in Relapsed/Refractory (R/R) High-Risk Myelodysplastic Syndromes (HR-MDS)

RNS Number: 4709V PureTech Health PLC 21 September 2026 21 September 2026 PureTech Health plc PureTech Announces Successful End-of-Phase 1 Meeting with U.S. Food and Drug Administration (FDA) and Receipt of Fast Track Designation for LYT-200 in Relapsed/Refractory (R/R) High-Risk Myelodysplastic

Enhertu recommended for approval in EU in early BC

21 September 2026 Enhertu recommended for approval in the EU by CHMP as adjuvant treatment for patients with residual disease after neoadjuvant treatment for HER2-positive early breast cancer Based on DESTINY-Breast05 Phase III trial which showed Enhertu reduced the risk of invasive disease recurrence or death by 53% vs....

Telix + ITM Investor Presentation

Telix and ITM Join Forces to Create Radiopharma Powerhouse

Iovance Biotherapeutics Reports Inducement Grants under NASDAQ Listing Rule 5635(c)(4)

SAN CARLOS, Calif., Sept. 18, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) ("Iovance" or the “Company”), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (“TIL”) therapies for patients with cancer,

New Teva Study Identifies the Attributes that Healthcare Providers Prioritize when Selecting a Treatment for Tardive Dyskinesia in Older Patients

Teva Highlights New Real-World Data Showing UZEDY® (risperidone) Outperforms Other Long-Acting Injectables in Keeping Schizophrenia Patients on Treatment, While Reducing Emergency Care and Healthcare Costs

Teva Announces New Olanzapine LAI (TEV-'749) Post Hoc Data Highlighting High Rates of Stabilization and Long-Term Efficacy as Once-Monthly Subcutaneous Injectable for the Treatment of Schizophrenia in Adults

Zenas BioPharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

WALTHAM, Mass., Sept. 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

Geron Corporation Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

FOSTER CITY, Calif., Sept. 18, 2026 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq: GERN), a hematology-focused biopharmaceutical company pursuing more meaningful moments for people living with blood cancer, today reported that, effective September 17, 2026, it granted stock options to purchase an

U.S. FDA approves Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer

Inluriyo plus Verzenio delivers proven clinical benefit after the evidence-based practice of maximizing initial treatment with an aromatase inhibitor, with or without a CDK4/6 inhibitor In the Phase 3 EMBER-3 trial, Inluriyo in combination with Verzenio doubled median progression-free survival

Novartis receives positive CHMP opinion for Cosentyx® in polymyalgia rheumatica (PMR)

Basel, September 18, 2026 – Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for Cosentyx ® (secukinumab) in polymyalgia rheumatica (PMR).⁸ The opinion supports Cosentyx use for treatment of PMR in adults who have...

Silo Pharma Receives U.S. Patent Allowance for SPC-15 PTSD Treatment, Expanding Intellectual Property Portfolio

Allowed claims cover compositions and methods for preventing or mitigating stress-induced behavioral responses SARASOTA, FLA., Sept. 18, 2026 (GLOBE NEWSWIRE) -- Silo Pharma (Nasdaq: SILO) (“Silo” or “the Company”), a developmental-stage biopharmaceutical company...

Abeona Therapeutics® Congratulates Ultragenyx on U.S. FDA Approval of FAYUVI™ Gene Therapy for Sanfilippo Syndrome Type A (MPS IIIA)

Ocular Therapeutix™ Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

BEDFORD, Mass., Sept. 18, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular” or the “Company”), an integrated biopharmaceutical company committed to redefining the retina experience, today announced that it has granted inducement equity awards to nine newly hired

Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) as Perioperative Treatment for Adults With Resectable Muscle-Invasive Bladder Cancer (MIBC)

Opinion granted based on positive results from the Phase 3 KEYNOTE-B15 trial, which demonstrated improvements in event-free survival, overall survival and pathologic complete response rate If approved, KEYTRUDA plus Padcev would become the first and only PD-1 inhibitor plus antibody-drug conjugate regimen for patients with MIBC regardless of cisplatin...

Merck Launches Your Hive of Whole Health to Support Whole Person Care for People Living With HIV

Debbie Allen, famed actress, director, producer and longtime HIV advocate, joins Merck to launch the initiative and honor the community RAHWAY, N.J.–(BUSINESS WIRE)– Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today launched Your Hive of Whole Health , a multi-year educational program that helps people living with HIV build...

CHMP recommends EU approval of Roche’s Ocrevus for children and adolescents with relapsing multiple sclerosis

Ocrevus addresses a critical need in paediatric neurology as the first high- efficacy anti-CD20 treatment option for people with MS as young as 10 years old In the Phase III OPERETTA 2 study, Ocrevus demonstrated non-inferiority in relapse control and superiority over fingolimod in suppressing brain lesions 1 Safety in children and adolescents was aligned...

Director/PDMR Shareholding

18 September 2026 Transaction by Person Discharging Managerial Responsibilities AstraZeneca PLC (the Company) announces that it was notified on 16 September 2026 that Pascal Soriot, Chief Executive Officer of the Company, purchased 60,000 of the Company's ordinary shares of $0.25 each (Ordinary Shares) on 14 September 2026, as set out below....

PADCEV™ (enfortumab vedotin) in Combination with Keytruda® (pembrolizumab) Receives Positive CHMP Opinion for the Treatment of Adults with Resectable Muscle-Invasive Bladder Cancer

NOMAD POWER SOLUTIONS FILES EXPANDED BUSINESS AND FINANCIAL DISCLOSURE FOLLOWING COMPLETION OF MERGER

Phase 3 Pediatric EMPAVELI Data Published in Clinical Journal of the American Society of Nephrology Show Reduction in Proteinuria and Stabilized Kidney Function in Adolescents with C3G or Primary IC-MPGN

EMPAVELI-treated adolescents achieved a 75% relative reduction in proteinuria within 6 months versus placebo EMPAVELI is the only approved treatment for adolescents with C3G and primary IC-MPGN, based on VALIANT study Publication follows a recent FDA label update to expand EMPAVELI’s indication to

Puma Biotechnology Initiates ALISCA®-Lung2, a Phase II Trial of Alisertib in Combination with Paclitaxel for the Treatment of Patients with Advanced Small Cell Lung Cancer

LOS ANGELES --(BUSINESS WIRE)--Sep. 17, 2026-- Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the initiation of its ALISertib in CAncer (ALISCA ® -Lung2) Phase II trial (PUMA-ALI-4202; NCT07465757) of alisertib in combination with paclitaxel for the treatment of

Oculis Publishes Notifications of Transactions by Persons Discharging Managerial Responsibilities

ZUG, Switzerland, Sept. 17, 2026 (GLOBE NEWSWIRE) -- The attached notification relates to the purchase of ordinary shares by a member of the Company’s Board of Directors. Attachment notification-of-managers-transaction-lionel-carnot-14-september-2026

argenx announces results of Extraordinary General Meeting of Shareholders and appointment of Thomas M. Brakel and Khurem Farooq as Non-Executive Directors

September 17, 2026 – 22:01PM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology innovation company, today announced the results of the Extraordinary General Meeting of Shareholders and appointments of Thomas M. Brakel and Khurem Farooq as non-executive

Xenon Announces Azetukalner NDA Submission to FDA for Focal Seizures and Provides Update on Psychiatry Clinical Program

New Drug Application for azetukalner in focal seizures submitted to U.S. Food and Drug Administration; X-TOLE3 and X-ACKT continue to enroll focal seizure and PGTCS patients, respectively Enrollment in X-NOVA2 study in MDD completed with approximately 360 total patients; topline data readout