Roche has announced a definitive agreement to acquire Poseida Therapeutics for $9.00 per share in cash, totaling approximately $1.0 billion. This acquisition aims to bolster Roche's presence in the CAR-T therapy space, targeting hematological malignancies, solid tumors, and autoimmune diseases. Meanwhile, Merck, AstraZeneca, and Novartis have reported positive outcomes from their respective drug development programs.
Merck's Winrevair Shows Promise in Advanced PAH
Merck's phase III ZENITH study evaluating Winrevair (sotatercept) in patients with advanced pulmonary arterial hypertension (PAH) met its primary endpoint. The study focused on patients with WHO Group 1 functional class (FC) III or IV, who are at high risk of mortality. Results demonstrated that Winrevair, when added to background PAH therapy, led to a statistically significant and clinically meaningful reduction in the risk of morbidity or mortality events compared to placebo. These events included all-cause death, lung transplantation, or PAH-related hospitalizations.
Based on the compelling efficacy data, an independent data monitoring committee (DMC) recommended that the study be stopped early and that patients with advanced PAH be offered Winrevair through an open-label extension study. Winrevair received approval in the United States in March for treating PAH WHO Group 1, based on the STELLAR study results.
Novartis' Kisqali Approved in EU for Early Breast Cancer
The European Commission (EC) has approved Novartis’ Kisqali (ribociclib) for a broader patient population, specifically for the adjuvant treatment of adults with HR+/HER2- early breast cancer (EBC) at high risk of disease recurrence. This approval is based on data from the phase III NATALEE study. Kisqali, in combination with an aromatase inhibitor (AI), has already been approved for EBC patients in the United States by the FDA in September 2024 and is also approved for metastatic breast cancer (MBC) treatment in several countries.
Roche's Acquisition of Poseida Therapeutics
Roche's acquisition of Poseida Therapeutics aims to enhance its portfolio of allogeneic pre-clinical and clinical-stage CAR-T therapies. The deal includes a non-tradeable contingent value right (CVR) potentially adding up to $4.00 per share in cash, bringing the total deal value to approximately $1.5 billion. The transaction is expected to close in the first quarter of 2025, pending customary closing conditions. Roche and Poseida already have an existing collaboration to develop off-the-shelf CAR-T cell therapies for hematological malignancies.
However, Roche also announced that its phase III SKYSCRAPER-01 study, which evaluated tiragolumab combined with Tecentriq in non-small cell lung cancer (NSCLC), did not meet its primary endpoint of overall survival at the final analysis.
AstraZeneca's Truqap Shows Promise in Prostate Cancer
AstraZeneca’s phase III study evaluating Truqap in combination with Johnson & Johnson’s Zytiga (abiraterone) and androgen deprivation therapy (ADT) in PTEN-deficient metastatic hormone-sensitive prostate cancer met its primary endpoint of radiographic progression-free survival (rPFS). Data from the CAPItello-281 study demonstrated that the Truqap combination led to a statistically significant and clinically meaningful improvement in rPFS compared to abiraterone and ADT with placebo in patients with this aggressive form of prostate cancer. Truqap is currently approved for treating HR-positive (or ER-positive), HER2-negative locally advanced or metastatic breast cancer.
Nyrada Inc. Reports Positive Preclinical Study for NYR-BI03
Nyrada Inc. reported that the preclinical study for its lead drug candidate NYR-BI03 showed strong efficacy limiting cardiovascular damage associated with coronary heart disease. NYR-BI03 demonstrated superior efficacy compared to Captopril, an FDA-approved therapy. The Company remains on track to commence a Phase 1 clinical trial for its lead drug candidate in 4Q’2024. The clinical trial follows the positive preclinical trial results announced earlier in the year with regards to the stroke study, which showed NYR-BI03 achieved a statistically significant neuroprotective effect, rescuing 42% of brain tissue in the penumbra region of treated animals.
Orthocell Limited Reports Revenue Growth
Orthocell Limited reported revenue of $2.03 million for the September quarter, the second consecutive quarter of record revenue reported by the Company. The Company’s product suite includes Striate+ and Remplir. Straite+ is currently sold in US, Canada, Europe, UK, Australia and New Zealand with Remplir sold in Australia, New Zealand and recently receiving approval for sale in Singapore. The Company is seeking to add new markets with the Company continuing to accelerate its program of regulatory approvals into new jurisdictions. The Company has submitted the final data for the approval process with the FDA for Remplir with the Company anticipating submission and approval in 1Q’2025.
Respiri Limited Secures Remote Patient Monitoring Agreements
Respiri Limited entered into two individual remote patient monitoring (RPM) agreements with Liliha Healthcare Center and The Care Center of Honolulu, which are Skilled Nursing Facilities (SNFs) based in Hawaii. The agreements are worth US$1 million p.a. at an annual patient recruitment rate of 33%. This could increase to as much as US$2.4 million with 100% recruitment from the two facilities, which have ~1,000 patient discharges every year.
Tryptamine Therapeutics Secures Funding for TRP-8803 Clinical Trials
Tryptamine Therapeutics share price was up 77.8% in October, with the share price jumping sharply on the announcement that the Company had secured $6 million to accelerate the Company’s clinical trial strategy for TRP-8803, the Company’s lead drug candidate. The Company has completed a Phase 2a clinical trial for the treatment of binge eating disorder, which demonstrated an average reduction in binge eating episodes of more than 80%.
