Bristol-Myers Squibb Product Deucravacitinib Bristol-Myers Squibb (BMY) product deucravacitinib has demonstrated positive results from the Phase 2 PAISLEY study in comparison to placebo in patients with moderate to severe systemic lupus erythematosus (SLE). The study met the primary endpoint. Deucravacitinib is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor. The product has a unique mechanism of . . . This content is for paid …

United Therapeutics Approval for Tyvaso DPI™ The US FDA approved United Therapeutics (UTHR) product Tyvaso DPI™ (treprostinil) inhalation powder for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (ILD) to improve exercise ability. Tyvaso DPI represents a new formulation and inhalation device for inhaled treprostinil and is the only dry powder inhaler approved by the . . . This content is …

Alnylam Pharmaceuticals Alnylam Pharmaceuticals (ALNY) led the translation of RNA interference (RNAi) into a new class of innovative therapeutics, transforming the lives of people afflicted with rare and prevalent diseases with unmet needs. RNAi is a natural cellular process of gene silencing that represents  promising and rapidly advancing frontiers in biology and drug . . . This content is for paid subscribers. Please click here to …

Regeneron Pharmaceuticals and Sanofi Announce FDA Approval of Dupixent® Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the U.S. FDA has approved Dupixent (dupilumab . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Exelixis Press Release This press release covers a large part of Exelixis accomplishments, including important details about its pipeline products, especially, cabozantinib, in addition to new results from clinical trials. We advise Prohost subscribers to read this press release, so they can get a better understanding about this firm and why we believe it a great achiever.  Exelixis On May 10,  Exelixis (

Exelixis CABOMETYX Approval Exelixis (EXEL) partner Ipsen received approval from the European Commission (EC) for CABOMETYX® (cabozantinib) as a monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), which is refractory or not eligible to radioactive iodine (RAI . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Arcturus Therapeutics Holdings News Arcturus Therapeutics Holdings (ARCT) shared topline data from an ongoing Phase 1/2/3 trial evaluating ARCT-154, Arcturus’ self-amplifying mRNA vaccine candidate against COVID-19. The ongoing Phase 1/2/3 registrational study, sponsored by Arcturus’ collaborator Vinbiocare Biotechnology Joint Stock Company – a member of Vingroup Joint Stock Company, enrolled over . . . This content is for paid subscribers. Please click here to subscribe or here to log …

FDA Lifts Partial Clinical Hold on Gilead Sciences Studies of Magrolimab On April 12, 2022, Gilead Sciences (GILD) announced that the U.S. FDA lifted the partial clinical hold placed on studies evaluating its investigational agent magrolimab in combination with azacitidine. The FDA removed the partial hold after reviewing the comprehensive safety data from each trial. Enrollment in the U.S. can resume . . . This …

Vertex Pharmaceuticals Statistically Significant Results From Vertex VX-548 for Acute Pain Vertex Pharmaceuticals (VRTX) announced positive results from two Phase 2 proof-of-concept (POC) studies that investigated treatment with the selective NaV1.8 inhibitor VX-548 for acute pain following abdominoplasty surgery or bunionectomy surgery. Treatment with an initial dose of 100 mg followed by 50 mg . . . This content is for paid subscribers. Please click here …

Intellia Therapeutics Loses Technology Patent and Suffers a Selloff A selloff of Intellia Therapeutics (NTLA) stock occured when the U.S. Patent and trademark office ruled that CRISPR genome editing technology patent belongs to the Broad Institute. It's stating that a team of researchers led by Feng Zhang beat Jennifer Doudna and Emmanuelle Charpentier in making CRISPR editing possible. This new . . . This content …

We do not dare invest in the stock market at a time when almost all the stocks, both large and small, are yo-yoing for unknown reasons. The positive criteria has all but vanished, leaving behind it unparalleled inflation that is causing enormous chaos.   Karyopharm Therapeutics Inc During this hectic atmosphere Karyopharm Therapeutics (KPTI) announced that its Phase 3 SIENDO study has met . . . …

Enanta Pharmaceuticals Expectations Expecting Dosing in a First-in-Human Study of EDP-235, an Oral 3CL Protease Inhibitor Specifically Designed for the Treatment of COVID-19 The Firm Completed Enrollment in RSVP, a Phase 2b Conducted Trial of EDP-938 in Adults With Community-Acquired Respiratory Syncytial Virus (RSV) Expects Topline Data in the Second Quarter of 2022 The Firm has Plans to Initiate a Phase 1 Study of EDP-323, …

Regenxbio Good News for wet AMD On January 10, 2022,  Regenxbio Inc. (RGNX) announced the initiation of ASCENT, the second of two Phase 3 pivotal trials to evaluate the efficacy and safety of subretinal delivery of RGX-314 in patients with wet age-related macular degeneration (wet AMD). RGX-314 is being investigated as a potential one-time gene therapy for . . . This content is for paid subscribers. …

Intellia Therapeutics Acquires Rewrite Therapeutics The acquisition is, indeed good news. By acquiring Rewrite Therapeutics, Intellia Therapeutics (NTLA) has inherited a versatile DNA writing platform which enables a range of innovative genome editing strategies. The acquisition is expected to further expand Intellia’s industry-leading genome editing toolbox by adding a highly complementary platform to its existing CRISPR/Cas9 and . . . This content is for paid …

Celularity Inc Celularity Inc. (CELU) announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its non-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer (NK) cell therapy, CYNK-001 created for the treatment of acute myeloid leukemia (AML). Headquartered in Florham Park, N.J., Celularity is a clinical . . . This content is for paid subscribers. Please click here to subscribe …

Ionis Pharmaceuticals and AstraZeneca in Collaboration to Treat ATTR with Eplontersen Ionis Pharmaceuticals (IONS) announced entering into a strategic collaboration agreement with AstraZeneca (

Amgen Announces Positive Results from Otezla Study for Psoriasis Amgen (AMGN) announced positive top-line results from the DISCREET trial - a Phase 3, multicenter, randomized, placebo-controlled, double-blind study to assess the efficacy of Otezla® (apremilast) in adults with moderate to severe genital psoriasis and moderate to severe plaque psoriasis. The study demonstrated that oral Otezla 30 mg twice daily achieved a . . . This content …

Regenxbio Granted Orphan Drug Designation for RGX-202 Regenxbio (RGNX) announced the U.S. FDA granted Orphan Drug Designation for RGX-202 - a potential one-time gene therapy for the treatment of Duchenne muscular dystrophy. RGX-202 is designed to deliver a novel, optimized microdystrophin transgene with a unique C-terminal domain and a . . . This content is for paid subscribers. Please click here to subscribe or here to log …

Cassava Sciences, Vertex Pharmaceuticals and Gilead Sciences All Have Good News Cassava Sciences & Alzheimer's Disease Cassava Sciences (SAVA) announced the initiation of a second Phase 3 trial of simufilam, its investigational drug for Alzheimer’s disease. This second Phase 3 study is designed to evaluate the safety and efficacy of simufilam over 78 weeks in approximately 1,000 Alzheimer’s . . . This content is for …

Gilead Sciences Collaboration with Arcus Biosciences Sends Stock Through the Roof There is no doubt that Gilead Sciences (GILD) is appreciating Arcus Biosciences (