Category: Impacting News

U.S. FDA Approves Boehringer Ingelheim’s JASCAYD® (nerandomilast) Tablets as First New Treatment for Adults with Idiopathic Pulmonary Fibrosis

Boehringer Ingelheim USFDA Approval Boehringer Ingelheim JASCAYD® (nerandomilast) tablets are  approved by the U.S. FDA as an oral treatment for idiopathic pulmonary fibrosis (IPF) in adult patients. JASCAYD is the first and only preferential inhibitor of phosphodiesterase 4B (PDE4B) to be approved in this indication. This represents a novel mechanism of action that exerts both antifibrotic and immunomodulatory effects, thereby slowing the decline in lung …

uniQure Announces Positive Topline Results from Pivotal Phase I/II Study of AMT-130 in Patients with Huntington’s Disease

uniQure in the NEWS On September 24, 2025, uniQure N.V. (QURE) - a gene therapy company advancing transformative therapies for patients with severe medical needs, announced positive topline data from the pivotal Phase I/II study of AMT-130 for the treatment of Huntington’s disease. The study met its prespecified primary . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Important: Two Press Releases in the Past 2 Days from Grail & Intellia Therapeutics

Important News from Grail Inc. and Intellia Therapeutics  Grail Inc Press Realease GRAL to Present New Galleri® Data from More Than 32,000 Participants Across the PATHFINDER 2, SYMPLIFY and REFLECTION Studies at ESMO Congress 2025 and EDCC First PATHFINDER 2 Results Accepted as a Late-Breaking Presentation at the European Society for Medical Oncology (ESMO) Congress 2025; Results to be Submitted to FDA as Part of …

Jazz Pharmaceuticals to Treat H3 K27M-Mutant Diffuse Midline Glioma

Jazz Pharmaceuticals On September 9, 2025, Jazz Pharmaceuticals plc (JAZZ) announced that Modeyso™ (dordaviprone) is recommended by the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a category 2A single-agent treatment option for pediatric and adult patients with recurrent or progressive diffuse high-grade glioma harboring an H3 K27M mutation. Modeyso was granted . . . This content is for paid subscribers. Please …

Alnylam Pharmaceuticals Announces Proposed Offering of $500 Million Convertible Senior Notes. The Stock’s Price is Soaring.  

Alnylam Pharmaceuticals Press Release Alnylam Pharmaceuticals, Inc. (ALNY), the leading RNAi therapeutics company, announced today that it has commenced a private offering of $500 million aggregate principal amount of convertible senior notes due 2028 (the “notes”) to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). In connection with this offering …

Regeneron Pharmaceuticals Libtayo® Plus Chemotherapy Results at Five Years Reinforce Significant and Durable Improvements in Survival Outcomes for Advanced Non-Small Cell Lung Cancer

Regeneron Pharmaceuticals Announcement Late-breaking data from exploratory analyses at WCLC show Libtayo plus chemotherapy demonstrates a more than double five-year overall survival rate of 19.4%, compared to 8.8% with chemotherapy alone In a five-year analysis, consistent efficacy was observed across histologies with especially notable benefit in the squamous patient population where median overall survival was 22.3 months. Regeneron Pharmaceuticals, Inc. (REGN . . . This content …

FDA New Approvals of COVID-19 Vaccines

Approved COVID-19 Vaccines As of late August 2025, the U.S. Food and Drug Administration (FDA) has approved updated versions of the COVID-19 vaccines from Pfizer, Moderna and Novavax.  These updated shots are intended to better protect against currently circulating variants. The 2024–2025 formulations of the following vaccines are approved for certain groups: Pfizer (

How to Bring Undervalued Stocks to Their Real Values and What About Intellia Therapeutics Stock?

One bad market day or more can help investors make it a good biotech market day. On the bad market days, many star firms become way undervalued for no reason whatsoever. Instead of selling these stocks Prohost's motto is to buy more. On Another Topic Prohost decided to buy NTLA. Recently this company's stocks started moving up, including yesterday, a bad market day.  We selected …

Ionis Pharmaceuticals DAWNZERA™ Granted US FDA Approval as First and Only RNA-Targeted Prophylactic Treatment for Hereditary Angioedema  

Ionis Pharmaceuticals Ionis Pharmaceuticals (IONS) announced  that the U.S. FDA has approved DAWNZERA™ (donidalorsen) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. DAWNZERA is the first and only RNA-targeted medicine approved for HAE, designed to target plasma prekallikrein (PKK), a key protein that activates inflammatory . . . This content is for paid …

Rhythm Pharmaceuticals Announces the FDA Acceptance of sNDA for Setmelanotide in Acquired Hypothalamic Obesity

Rhythm Pharmaceuticals in the NEWS Rhythm Pharmaceuticals, Inc. (RYTM) announced that the U.S. FDA has accepted for filing the company’s supplemental New Drug Application (sNDA) for setmelanotide seeking approval for the treatment of conditions associated with acquired hypothalamic obesity. The FDA has granted Priority Review of the sNDA and assigned a Prescription Drug User Fee Act (PDUFA

Akero Therapeutics Q2 Financial and Study Results

Akero Therapeutics Akero Therapeutics (AKRO) reported its Q22025 financial results for the period ending June 30, 2025 as well as providing a business update. The report was published from the 96-Week Phase 2b SYMMETRY trial published in the New England Journal of Medicine. Three presentations highlighted data demonstrating statistically significant reversal of MASH compensated cirrhosis, and the anti-fibrotic activity . . . This content is …

Gilead Sciences Announced Its Q2 2025 Financial Results Yesterday

Gilead Sciences Reached Prohost Biotech's Target Gilead Sciences (GILD) reached our target of $120 today. Some investors will sell some and keep some and other investors will sell all the stocks they have. We will keep our stocks as we are increasing the target. Yesterday was Gilead's announcement of its second Quarter 2025 financials. The following is what . . . This content is for …

AstraZeneca Imfinzi Granted Priority Review and Breakthrough Therapy Designation in US for Patients with Resectable Early-Stage Gastric and Gastroesophageal Junction Cancers

AstraZeneca Imfinzi Based on MATTERHORN Phase III trial results which demonstrated a statistically significant and clinically meaningful event-free survival benefit If approved, this will be the first and only perioperative immunotherapy-based regimen in this setting AstraZeneca’s (AZN) supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) has been accepted and granted Priority Review in the US for the treatment . . . This content is for …

Vertex Announces European Commission Approval of ALYFTREK®- a New Once-Daily CFTR Modulator for the Treatment of Cystic Fibrosis

Vertex Pharmaceuticals in the NEWS On Jul. 1, 2025, Vertex Pharmaceuticals (VRTX) announced that the European Commission has granted approval for ALYFTREK® (deutivacaftor/tezacaftor/vanzacaftor) for the treatment of people with cystic fibrosis (CF) ages 6 years and older who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. From . . . This content is for paid subscribers. Please click here …

Why BioNTech Acquiring CureVac Is Good News For BioNTech

BioNTech Announces Strategic Transaction to Acquire CureVac in Public Exchange Offer We wanted to know the reason for the acquisition so we looked at the BioNTech press release about the acquisition and found out the following news. On June 12, 2025, BioNTech (BNTX

Vertex Pharmaceuticals Presents Positive Data for Zimislecel in Type1 Diabetes at the American Diabetes Association 85th Scientific Sessions

Vertex Pharmaceuticals Simultaneous Announcements Vertex Pharmaceuticals (VRTX) announced simultaneous presentation and publication of updated data from Phase 1/2 portion of Phase 1/2/3 FORWARD-101 clinical trial in people with type 1 diabetes (T1D) with impaired hypoglycemic awareness and severe hypoglycemic events (SHEs). The data were featured in oral presentation at the American Diabetes Association (ADA . . . This content is for paid subscribers. Please click here to subscribe …

Cidara Therapeutics Announces Positive Topline Results From Phase 2b Navigate Trial evaluating  CD388 – A Nonvaccine Preventative of Seasonal Influenza

Cidara Therapeutics Cidara Therapeutics uses its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs) comprising targeted small molecules or peptides coupled to a proprietary human antibody fragment (Fc). Cidara’s lead DFC candidate, CD388, is a long-acting antiviral designed to achieve universal prevention of seasonal and pandemic influenza with a single dose by directly inhibiting viral proliferation. In June 2023, CD388 was granted Fast Track …

Exelixis Announces Zanzalintinib in Combination with an Immune Checkpoint Inhibitor Improved Overall Survival in Patients with Metastatic Colorectal Cancer

Exelixis in the NEWS Exelixis (EXEL) announced positive topline results from the STELLAR-303 phase 3 pivotal trial in which zanzalintinib in combination with atezolizumab (Tecentriq®) demonstrated a statistically significant improvement in overall survival (OS) versus regorafenib in the intent-to-treat . . . This content is for paid subscribers. Please click here to subscribe or here to log in.