Cassava Sciences Announces Top-Line Clinical Data for Simulfilam Cassava Sciences Press Release Today Cassava Sciences (SAVA) announced top-line clinical data today from a pre-planned interim analysis of an on-going open-label study with its drug candidate simufilam in patients with mild-to-moderate Alzheimer’s disease. In a study funded by the National Institutes of Health (NIH), ADAS-Cog11 . . . This content is for paid subscribers. Please click here to subscribe …

Seagen and Genmab Granted FDA Accelerated Approval for TIVDAK™ The U.S. FDA granted accelerated approval to Seagen Inc (SGEN) and Genmab A/S (

Gilead Sciences New Data from Trodelvy® Study Gilead Sciences (GILD) has recently announced new data from the Phase 3 ASCENT study evaluating Trodelvy® in patients with relapsed or refractory metastatic triple-negative breast cancer (TNBC) who received two or more prior systemic therapies, at least one of them for metastatic disease. Trodelvy has shown to improve progression-free survival (PFS . . . This content is for paid …

Intellia Therapeutics IND Application of NTLA-5001 for AML is Accepted by the US FDA NTLA-5001 is Intellia Therapeutics (NTLA) first wholly-owned ex vivo CRISPR genome editing candidate for the treatment of cancer. It is an autologous T cell receptor (TCR)-T cell therapy engineered to target the Wilms’ Tumor (WT1) antigen for the treatment of all genetic subtypes . . . This content is for paid …

Jounce Therapeutics Jounce Therapeutics (JNCE) is a clinical-stage immunotherapy company developing therapies enabling the immune system to attack tumors and provide long-lasting benefits to patients through a biomarker-driven approach. Jounce has ongoing multiple development stage programs while simultaneously advancing additional early-stage assets from its robust discovery engine based on its Translational Science. Jounce Therapeutics Lead Products

Regenxbio and AbbVie in the NEWS Regenxbio (RGNX) stock soared today. The Company, along with AbbVie (ABBV

IVERIC bio Stock Rally IVERIC bio (ISEE) stock rallied in early, premarket trading today as Stifel Nicolaus initiated a buy rating and a price target of $22. In premarket the stock was trading over $13.37, UP over $4 and still moving. Following the tumbling of the firm's stock . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Gain Therapeutics Inc in the News Gain Therapeutics, Inc. (GANX) announced today topline data from its  study conducted at the University of Maryland School of Medicine (UMSOM). The study, evaluating two lead Structurally Targeted Allosteric Regulators (STARs) compounds – GT-02287 and GT-02329 – for the treatment of Gaucher and GBA1 Parkinson’s Disease, demonstrated positive effects . . . This content is for paid subscribers. Please …

Impel NeuroPharma FDA Approval for TRUDHESA The U.S. Food and Drug Administration (FDA) approved Impel NeuroPharma (IMPL) product TRUDHESA (dihydroergotamine mesylate (DHE)), previously known as INP104, a nasal spray for the treatment of acute migraine with or without aura in adults. Using Impel’s proprietary Precision Olfactory Delivery (POD®) technology enables a gentle, quick delivery of . . . This content is for paid subscribers. Please …

Can-Fite Biopharma Good News We learned, from Petach Tikva, Israel, that Can-Fite Biopharma (CANF) – a biotechnology company advancing its pipeline of small molecule drugs that address inflammatory, cancer and liver diseases, announced its completion of enrollment of all patients (>400) planned for its Phase 3 Comfort™ study with the firm’s product Piclidenoson in patients with moderate to severe plaque psoriasis.  Piclidenoson is a novel, …

TCR2 Therapeutics TCR2 Therapeutics (TCRR) is a clinical-stage cell therapy company developing a pipeline of novel T cell therapies for patients suffering from cancer. TCR2’s proprietary T cell receptor (TCR) Fusion Construct T cells (TRuC®-T cells) specifically recognize and kill cancer cells by harnessing signaling from the entire TCR, independent of human leukocyte antigens (HLA). In . . . This content is for paid subscribers. Please …

The most important news in biological sciences is the high degree of success the biological revolution can reach. We can feel the great value every time an untreatable, devastating condition is successfully treated thanks to discoveries made possible through the information brought in by the unparalleled revolution that allows for a better understanding of the living body mechanisms of actions in health and in diseases. …

Cassava Sciences Released a Statement  Cassava Sciences, Inc. (SAVA) – a biotechnology company focused on Alzheimer’s disease, today released a statement regarding plasma p-tau analysis from a previously disclosed randomized, controlled Phase 2b clinical study in patients with Alzheimer’s disease. For this study, Cassava Sciences contracted with Quanterix Corp., a highly regarded, independent laboratory, to perform sample testing on blinded samples. The Phase 2b clinical …

Agenus Good News for Balstilimab Monotherapy Agenus (AGEN) announced that results from a global Phase 2 clinical study of balstilimab monotherapy in recurrent/metastatic cervical cancer were published online in the international peer-reviewed journal Gynecologic Oncology. From the CMO of Agenus Steven O’Day, MD, Chief Medical Officer of Agenus, said, “Publication of these data marks another significant achievement toward our objective to provide effective therapeutic options to …

Cassava Sciences Responds to Misleading Posts Cassava Sciences (SAVA) today issued a response to claims that were posted online yesterday after market hours. Cassava Sciences believes the claims made in this post regarding scientific integrity are false and misleading. The Company stands behind its science, its scientists, and its scientific collaborators; it is responding to ensure the facts are known and respected . . . …

Cara Therapeutics and Vifor Pharma Granted US FDA Approval of KORSUVA™ Indeed, the U.S. Food and Drug Administration (FDA) approved Cara Therapeutics (CARA) and Vifor Pharma injectable product KORSUVA™ (difelikefalin) - a first-in-class kappa opioid receptor (KOR) agonist that targets the body’s peripheral nervous system, for moderate-to-severe pruritus associated with chronic kidney . . . This content is for paid subscribers. Please click here to subscribe or here to …

Axsome Therapeutics Inc and Major Depressive Disorder In a teleconference on August 20, 2021, the U.S. Food and Drug Administration (FDA) informed Axsome Therapeutics (AXSM) that its review of the new drug application (NDA) for AXS-05, for the treatment of major depressive disorder, would not be completed by the Prescription Drug User Fee Act (PDUFA

Sutro Biopharma Inc Granted Fast Track Designation for STRO-002 by the US FDA Sutro Biopharma Inc (STRO) announced that the U.S. FDA granted Fast Track designation for its STRO-002 – a folate receptor alpha (FolRα)-targeting antibody-drug conjugate (ADC), for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior lines of systemic therapy. From …

Virpax Pharmaceuticals  Virpax Pharmaceuticals (VRPX) - a company specializing in developing product candidates for pain management, CNS and anti-viral indications, announced the receipt of a written pre-investigational new drug (pre-IND) response from the U.S. Food and Drug Administration (FDA) for MMS019, its patented and proprietary high-density molecular masking spray under development for use . . . This content is for paid subscribers. Please click here to subscribe …

BeiGene Ltd and EUSA Pharma Receive Approval from China NMPA for QARZIBA®  BeiGene Ltd (BGNE) and EUSA Pharma announced that China National Medical Products Administration (NMPA) has granted QARZIBA® (dinutuximab beta) conditional approval for the treatment of high-risk neuroblastoma in patients aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response followed by myeloablative therapy and stem cell …