Pharmaceuticals & Biopharmaceuticals

Tokyo – September 24, 2026 -- Astellas Pharma Inc. (TSE: 4503) has dosed the first patient in a Phase 3 study evaluating setidegrasib, an investigational KRAS G12D-targeted protein degrader, against docetaxel in previously treated non-small cell lung cancer (NSCLC) patients carrying the KRAS G12D mutation.

Trial targets patients who progressed on chemotherapy and checkpoint inhibitors

The randomized, open-label study will enroll approximately 356 patients across multiple countries whose locally advanced or metastatic NSCLC has progressed after platinum-based chemotherapy and checkpoint inhibitor therapy. Dual primary endpoints are progression-free survival, assessed by blinded independent central review, and overall survival.

Pune, India – September 24, 2026 -- The global bladder cancer treatment market was valued at $5.13 billion in 2025 and is projected to reach $11.33 billion by 2034, expanding at a 9.2% compound annual growth rate, according to a new analysis from Maximize Market Research.

Immunotherapy and antibody-drug conjugates drive treatment shift

Adoption of immune checkpoint inhibitors, antibody-drug conjugates (ADCs), and FGFR inhibitors is accelerating across non-muscle-invasive and muscle-invasive bladder cancer segments. Pharmaceutical companies are directing R&D spend toward intravesical drug delivery, gene therapy, and biomarker-driven precision oncology to improve outcomes for recurrent and metastatic urothelial cancer patients.

London – September 24, 2026 -- Artemis Growth Partners, a global investment firm specializing in regulated medical cannabis and emergent medicinal therapeutics, has appointed James Hayward as Advisory Director following his 35-year career at JPMorgan.

Hayward built JPMorgan's European hedge fund credit franchise over three decades

Hayward founded and led JPMorgan's European hedge fund credit business, working across leveraged finance, high yield, credit derivatives and distressed markets. He will now advise Artemis on capital formation, business development, LP relationships and strategic financing across its global platform, working alongside Co-Founder and CIO William Muecke and Managing Partner E. Stanton McLean.

San Diego – September 24, 2026 -- Viking Therapeutics plans to raise $400 million through simultaneous public offerings of $200 million in common stock and $200 million in convertible senior notes due 2032, with proceeds earmarked for its obesity drug pipeline.

Viking structures two independent capital raises with built-in flexibility

The biopharmaceutical company intends to grant underwriters a 30-day option to purchase an additional $30 million in common stock and a separate 30-day option for up to $30 million more in notes to cover over-allotments. Completion of one offering is not contingent on the other, giving Viking flexibility if market conditions shift. Morgan Stanley & Co. LLC and J.P. Morgan Securities LLC are serving as joint book-running managers for both transactions.

Washington – September 24, 2026 -- Bristol Myers Squibb (BMS) has joined the Rare Access Action Project (RAAP), adding a major biopharmaceutical player to a coalition working to resolve coverage and access barriers for rare disease patients.

RAAP expands coalition with BMS to tackle patient access barriers

RAAP, a coalition of patient advocates and life sciences companies, confirmed BMS's membership as part of its ongoing effort to develop policy solutions for structural access and coverage gaps affecting rare disease patients. Michael Eging, Executive Director of RAAP, said BMS brings a long history of scientific innovation and a strong commitment to patients facing serious and complex diseases.

Los Angeles – September 24, 2026 -- Armata Pharmaceuticals has received an additional $3.7 million in non-dilutive funding from the U.S. Department of War, pushing cumulative government support for its lead bacteriophage candidate AP-SA02 to approximately $32.4 million.

New funds mark first Phase 3-specific allocation under existing DoW award

The $3.7 million tranche represents the first capital earmarked specifically for Phase 3 execution under a previously announced award, following $28.7 million already disbursed. The funding flows through the Medical Technology Enterprise Consortium and is managed by the Naval Medical Research Command's Naval Advanced Medical Development unit, with backing from the Defense Health Agency and Joint Warfighter Medical Research Program.

Vancouver and Glil Yam, Israel – September 24, 2026 -- IM Cannabis Corp. (Nasdaq: IMCC) has regained compliance with Nasdaq's minimum bid price rule, closing a deficiency matter that had threatened its listing status on the exchange.

Nasdaq confirms compliance after 18-day trading streak

The company received written notice from Nasdaq Stock Market LLC on September 24, 2026, confirming it met the $1.00 minimum bid price requirement under Listing Rule 5550(a)(2). The determination followed 18 consecutive business days, from August 27 to September 24, 2026, during which the closing bid price of IMC's ordinary shares stayed at or above $1.00.

Jacksonville, Florida – September 24, 2026 -- Theragen presented machine-learning findings at the Society for Minimally Invasive Spine Surgery (SMISS) 2026 Annual Forum showing that daily wear time of its ActaStim®-S bone growth stimulator predicts clinically meaningful pain improvement after spinal fusion surgery, with benefits plateauing around 13 hours of daily use.

Nearly 7,000 patients and 195,000 patient-days of data feed predictive model

The analysis drew on almost 7,000 patients and approximately 195,000 patient-day observations collected through ActaStim-S, a wearable electrical stimulation device paired with a digital health platform. A standardized device-to-electronic medical record pipeline achieved 99.2% data completeness across the dataset, according to Theragen.

Toronto – September 24, 2026 -- Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) has hit its 110-patient enrollment target for the pivotal Phase III MAVERIC trial ahead of its end-of-September guidance, and will now expand recruitment to as many as 150 patients.

Blinded review shows fewer recurrences than expected in pericarditis trial

A blinded review of patients randomized 1:1 to CardiolRxTM or placebo found a lower-than-anticipated rate of pericarditis recurrence, according to Cardiol. The MAVERIC Steering Committee recommended the enrollment increase to capture enough clinical events for a statistically robust efficacy read.

President and CEO David Elsley said the company is not aware of any change in routine clinical practice that would explain the reduced recurrence rate, calling the finding encouraging.

Suzhou, China – September 24, 2026 -- Innovent Biologics (HKEX: 01801) will present late-breaking Phase 3 data for its CLDN18.2-targeting antibody-drug conjugate IBI343/TAK-921 at the 2026 European Society for Medical Oncology (ESMO) Annual Meeting in Madrid, running October 23-27.

Phase 3 gastric cancer trial secures late-breaking oral slot

Results from the registrational G-HOPE-001 study, comparing Arcotatug Tavetecan against treatment of physician's choice in previously treated advanced gastric or gastroesophageal junction adenocarcinoma, will be delivered as a late-breaking abstract (LBA77) during the October 23 proffered paper session. Dr. Kohei Shitara of Chiba, Japan, will present the first interim analysis of the randomized, open-label trial.