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BioTech Health X delivers the latest BioTech Updates, Health Coverage, Genomics & BioTech Stock Analysis.

04/20/2024

Petros Pharmaceuticals is one step closer to changing the game in men’s health with STENDRA potentially becoming the first OTC erectile dysfunction medication.

Thanks to positive U.S. Food and Drug Administration feedback, a new era of accessibility is on the horizon. Learn more about this significant progress and what it means for consumers.

Table of Contents Hide A Unique Drug In The ED Market, Understanding STENDRAErectile Dysfunction Drug Total Market Size…

09/19/2022

In a shocking failure, Virios Therapeutics announced this morning pre-market that topline results from its FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of Herpes Simplex Virus-1 (“HSV-1”)) study of oral IMC-1 for the treatment of fibromyalgia did not achieve statistical significance.

Since market open, the stock price has dropped a massive 70% from $8.77 at market close on Friday, September 16th. NASDAQ: VIRI is currently trading at $2.58 as of publication wiping out over $50 Million in company market cap and valuation.

Virios Therapeutics FORTRESS Fibromyalgia Phase 2 Trial did NOT achieve statistical significance dropping stock 70% erasing $50 Million in market cap.

09/14/2022

Cel-Sci Corporation recently presented its Phase 3 data at ESMO 2022, which revealed that Neoadjuvant Multikine achieved groundbreaking tumor response and extended overall survival in locally advanced head and neck cancer patients.

On September 10, 2022, Dr. Philip Lavin, a biostatistician with 80 U.S. Food and Drug Administration approvals/clearances, and Dr. József Tímár, Professor and Director of the Central Pathology Laboratory at Semmelweis Egyetem presented poster presentations at the ESMO - European Society for Medical Oncology annual Congress in Paris, France.

CEL-SCI Phase 3 Multikine ESMO 2022 Poster Presentations from Dr. Philip Lavin & Dr. József Tímár show groundbreaking response & extended overall survival.

09/02/2022

Our BioTech Health X CEO Series continues with an exclusive interview with Dr. Emil Tsai of 心悅生醫 SyneuRx as he discusses the background and foundation of the company, how COVID-19 affected the business along with what is ahead in the years to come.

Table of Contents Hide About SyneuRxAbout CEO Guochuan Emil Tsai, MD, Ph.D, MASCan you please introduce yourself and…

08/01/2022

Leader in redosable gene therapy Krystal Biotech (Nasdaq: KRYS) announced today the U.S. Food and Drug Administration accepted the company’s Investigational New Drug (IND) application for the evaluation of KB407 in a cystic fibrosis (CF) clinical trial.

Table of Contents Hide About Krystal Biotech’s KB407KB407 Phase 1 Trial OverviewCystic Fibrosis OverviewAbout Krystal Biotech, Inc. Leader…

07/28/2022

In breaking news, clinical-stage biotechnology company ImmunityBio (Nasdaq: IBRX) has announced acceptance by the U.S. Food and Drug Administration review of a Biologics License Application (BLA) for N-803 (Anktiva) the company's antibody cytokine fusion protein as a treatment for patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease.

In breaking news, clinical-stage biotechnology company ImmunityBio, Inc. (NASDAQ: IBRX) has announced acceptance by the FDA review of…

07/22/2022

Clinical-stage pharmaceutical company Brickell Biotech (Nasdaq: BBI) announced that the company has received formal notice from Nasdaq stating that Brickell has regained compliance meeting the minimum bid price requirement for continued listing on the exchange and, accordingly, the scheduled hearing has been canceled and Brickell’s common stock will continue to be listed and traded on Nasdaq.

Brickell Biotech (Nasdaq: BBI) has regained compliance meeting the minimum bid price requirement for continued listing on Nasdaq exchange.

07/20/2022

Today Merck announced that KEYTRUDA (pembrolizumab) Injection 100 mg has failed the Phase 3 clinical trial KEYNOTE-412 evaluating the company’s anti-PD-1 therapy with concurrent chemoradiation therapy that was followed by Keytruda as maintenance therapy in a Keytruda regimen.

The trial did not meet its primary endpoint which was event-free survival (EFS) for treatment of patients with unresected locally advanced head and neck squamous cell carcinoma (HNSCC).

Today Merck & Co. (NYSE: MRK) announced that Keytruda has failed the Phase 3 clinical trial KEYNOTE-412 evaluating…

05/23/2022

Biotechnology company Ocugen, Inc. (NASDAQ: OCGN) announced today that the U.S. Food and Drug Administration (FDA) has removed the clinical hold that was recently placed on the Ocugen COVAXIN™ (BBV152) Phase 2/3 clinical trial known as OCU-002 with dosing to resume immediately for those enrolled in the study.

COVAXIN (BBV152) is an inactivated COVID-19 vaccine that uses adjuvant Alhydroxiquim-II designed to boost immune response and longer-lasting immunity.

Table of Contents Hide About OcugenAbout COVAXIN (BBV152)COVAXIN (BBV152) Previous Clinical Holds Biotechnology company Ocugen, Inc. (NASDAQ: OCGN)…

04/21/2022

EF Hutton has recently initiated a BUY on Cel-Sci Corporation with a price target of $17.00 citing opportunities for growth as a pre-surgery immunotherapy candidate for cancer patients and upcoming near-term catalysts for the company.

Table of Contents Hide About Cel-Sci CorporationEF Hutton Analyst Tim Moore Coverage of Cel-SciEF Hutton Key Points for…

04/01/2022

Global biotechnology company Legend Biotech Corporation (NASDAQ: LEGN) announced today that Guowei Fang, Ph.D. will take over as Senior Vice President, Global Head of Research and Early Development after the resignation of Frank Fan, M.D., Ph.D., who resigned from the Company effective March 30, 2022.

Legend Biotech is focused on the development, manufacture and commercialization of novel therapies to treat life-threatening diseases. The company is currently working to develop advanced cell therapy treatments across a multitude of diverse technology platforms including but not limited to allogenic and autologous chimeric antigen receptor T-cell, T-Cell receptor (TCR-T) along with the company’s natural killer (NK) cell-based immunotherapy.

Table of Contents Hide About Legend BiotechAbout Dr. Guowei Fang Global biotechnology company Legend Biotech Corporation (NASDAQ: LEGN)…

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