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Fri, Sep 18, 2026

15 updates
NVS
10:51 AM

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...

novartis.com
MRK
6:55 AM

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.com
AZN
6:00 AM

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....

astrazeneca.com

Thu, Sep 17, 2026

21 updates
BIIB
4:15 PM

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

Trial Results • Phase 3Results event Thu, Sep 17, 2026biogen.com
PBYI
4:07 PM

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

Trial Start • Phase 2Trial initiation Thu, Sep 17, 2026pumabiotechnology.com
RHHBY
2:30 PM

Roche announces grand opening of its Innovation Center Boston to drive advancements in Cardiovascular, Renal and Metabolic diseases

The center will be a hub for Roche and Genentech, bringing together expertise in Cardiovascular, Renal and Metabolism, as well as for data science and AI specialists to drive innovation in drug discovery and development It will expand Roche’s and Genentech’s presence in Boston, reflecting a long-term commitment to one of the world’s leading life sciences...

roche.com
LEXX
9:13 AM

Lexaria Updates Financial Position

KELOWNA, BC / ACCESS Newswire / September 17, 2026 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms is providing the following update....

lexariabioscience.com
FENC
7:30 AM

Fennec Pharmaceuticals Announces Oral Presentation of Detailed Results from Investigator-Initiated Phase 2 STS-J01 Clinical Study of Pedmark® in Japan at SIOP 2026

~ Primary Endpoint Met: American Speech-Language-Hearing Association (ASHA)-Defined Hearing Loss Occurred in 24.0% of Patients Versus the Prespecified Historical Benchmark of 56.4% (P=0.001) ~ ~ 84% of Patients Had Grade 0 Hearing Loss by Brock Criteria; No Grade 3 or Grade 4 Hearing Loss Was

Presentation / Abstract • Phase 2SIOP oral presentation Thu, Sep 17, 2026fennecpharma.com
AXSM
7:00 AM

Axsome Therapeutics Presents Ten Posters Exemplifying its Innovative Psychiatry and Neurology Portfolio at Psych Congress 2026

NEW YORK, Sept. 17, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced presentations of new data in major depressive disorder and Alzheimer’s disease agitation

Presentation / Abstract • Phase 3Psych Congress presentation Thu, Sep 17, 2026, 9:00 AM CTaxsome.com
RHHBY
1:00 AM

Roche’s Lunsumio-based regimen significantly improves progression-free survival in follicular lymphoma in phase III CELESTIMO study

Phase III CELESTIMO study met its primary endpoint at the interim analysis demonstrating a statistically significant and clinically meaningful reduction in the risk of disease progression in people with follicular lymphoma who have received at least one prior line of treatment Data reinforce the potential of this Lunsumio-based regimen to improve clinical...

Trial Results • Phase 3roche.com

Wed, Sep 16, 2026

14 updates
BIIB
4:06 PM

Biogen to Report Third Quarter 2026 Financial Results October 28, 2026

Cambridge, Mass.— Biogen Inc. (Nasdaq: BIIB) today announced it will report third quarter 2026 financial results Wednesday, October 28, 2026, before the financial markets open. Following the release of the financials, the Company will host a live webcast with Biogen management at 8:30 a.m. ET.

biogen.com
EYPT
7:00 AM

EyePoint Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

WATERTOWN, Mass., Sept. 16, 2026 (GLOBE NEWSWIRE) -- EyePoint, Inc. (Nasdaq: EYPT), a company committed to developing and commercializing therapeutics to help improve the lives of patients with serious retinal diseases, today announced that the Company granted non-statutory stock options to new

eyepoint.bio
FATE
7:00 AM

Fate Therapeutics Selected for Four Presentations Highlighting its Off-the-Shelf CAR T-Cell Portfolio in Autoimmune Disease at ACR Convergence 2026

SAN DIEGO, Sept. 16, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disease,

Presentation / Abstract • Phase 1/2ACR poster presentation Sun, Nov 8, 2026, 10:30 AM ETfatetherapeutics.com
ALKS
7:00 AM

Alkermes Announces Appointment of Anne C. Whitaker to Board of Directors

DUBLIN --(BUSINESS WIRE)--Sep. 16, 2026-- Alkermes plc (Nasdaq: ALKS) today announced the appointment of a new independent director, Anne C. Whitaker, to the company’s Board of Directors (the Board). Ms. Whitaker is a seasoned biopharmaceutical executive and experienced board director who brings

alkermes.com
VTRS
6:59 AM

Viatris Announces Approval of WAKIX® (Pitolisant) in Japan, a First-in-Class Treatment for Narcolepsy and Excessive Daytime Sleepiness Associated With Obstructive Sleep Apnea Syndrome

Approval Addresses High Unmet Medical Need and Further Advances Viatris' Innovative Portfolio in Japan PITTSBURGH, Sept. 16, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that Japan's Ministry of Health, Labour and Welfare has granted approval for

viatris.com