Category: Impacting News

Exelixis First Quarter 2022 Financial Results. See Also: Milestones in Clinical and Pipeline Development

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 (

Positive News for Two Undervalued Firms in the Prohost Portfolio

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.

Interesting News from PTC Therapeutics and Arcturus Therapeutics Holdings

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 …

Gilead Sciences: The FDA Lifts Partial Clinical Hold on MDS and AML Magrolimab Studies. See Also: BioNTech

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 …

News From Vertex and Cassava: Two Prohost Portfolio Selected Biotech Firms 

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 …

What Happens to Intellia When the U.S. Patent and Trademark Office Changes Previous Patent Decisions?

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 …

Karyopharm Therapeutics Getting a Boost in the Midst of a Chaotic Market

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 . . . …

Who Forgot About Enanta Pharmaceuticals?

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, …

An Important Milestone for Regenxbio Treatment of Wet AMD

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. …

Why Intellia Therapeutics Acquisition of Rewrite Therapeutics Is Important

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 NK Cell Therapy CYNK-001 Receives US FDA Fast Track Designation for AML Treatment

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 …

Amgen: Positive Results from Otezla® Phase 3 DISCREET Study in Moderate to Severe Genital Psoriasis

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 …

The FDA Granted Orphan Drug Designation to Regenxbio Investigational Gene Therapy Drug RGX-202 for Duchenne Muscular Dystrophy

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 …

Let’s Talk About 3 Firms with Important News: Cassava Sciences, Vertex Pharmaceuticals and Gilead Sciences

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 …

Sangamo Therapeutics: Preliminary Data Shows Tolerability and Sustained Elevated α-Gal A Enzyme Activity in Patients with Fabry Disease

Sangamo Therapeutics Preliminary Results Evaluating Isaralgagene Civaparvovec for Fabry Disease Sangamo Therapeutics (SGMO) announced preliminary results from the Phase 1/2 STAAR clinical study evaluating isaralgagene civaparvovec, or ST-920 - a wholly owned gene therapy product candidate, for Fabry disease. As of the September 17, 2021 cutoff date, results from the four patients treated in the first two dose cohorts (0.5e13 vg . . . This content is for …

Why Merck’s Stock Price Soared. See Also: Pulmotect Inhaled PUL-042 for Respiratory Symptoms of COVID-19 and Fujirebio Agreement with ADDF

Merck Stock Soared Great expectations for Merck (MRK) future growth and the future of novel treatments for patients with severe devastating and life-threatening diseases. Keytruda - Merck's cancer immunotherapy drug, has reached a milestone and molnupiravir - its COVID-19 pill, sales revenues are expected to generate $5 billion to $7 billion through 2022, subject to emergency use authorization, at the end of November 2021. The …

Intellia Therapeutics Receives U.S. FDA Orphan Drug Designation for NTLA-2001 See Also: Important News from Ultragenyx Pharmaceutical

Intellia Therapeutics Granted Orphan Drug Designation for NTLA-2001 Intellia Therapeutics (NTLA) announced that the U.S. FDA has granted orphan drug designation to NTLA-2001 for the treatment of transthyretin (ATTR) amyloidosis. This investigational therapy is the first CRISPR therapy to be administered systemically to edit a disease-causing gene inside the human body. NTLA-2001 has the potential to be the first single-dose treatment for ATTR amyloidosis as it …