BioTech Health X

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.

Petros Pharmaceuticals Advances STENDRA OTC Bid with Positive FDA Feedback Table of Contents Hide A Unique Drug In The ED Market, Understanding STENDRAErectile Dysfunction Drug Total Market Size…

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

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

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.

SyneuRx CEO Dr. Emil Tsai Exclusive Interview with Insights & Projections Table of Contents Hide About SyneuRxAbout CEO Guochuan Emil Tsai, MD, Ph.D, MASCan you please introduce yourself and…

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.

Krystal Biotech Announces FDA IND Acceptance for KB407 Cystic Fibrosis Clinical Trial Table of Contents Hide About Krystal Biotech’s KB407KB407 Phase 1 Trial OverviewCystic Fibrosis OverviewAbout Krystal Biotech, Inc. Leader…

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.

ImmunityBio Announces FDA Acceptance of BLA for N-803 Anktiva Bladder Cancer Drug In breaking news, clinical-stage biotechnology company ImmunityBio, Inc. (NASDAQ: IBRX) has announced acceptance by the FDA review of…

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 Regains Nasdaq Compliance Meeting Minimum Bid Price Requirement Brickell Biotech (Nasdaq: BBI) has regained compliance meeting the minimum bid price requirement for continued listing on Nasdaq exchange.

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).

Merck Announces Failure in Keytruda Head and Neck Cancer Phase 3 Clinical Trial Today Merck & Co. (NYSE: MRK) announced that Keytruda has failed the Phase 3 clinical trial KEYNOTE-412 evaluating…

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.

Ocugen Announces FDA Clinical Hold Removal for Phase 2/3 COVAXIN (BBV152) Clinical Trial Table of Contents Hide About OcugenAbout COVAXIN (BBV152)COVAXIN (BBV152) Previous Clinical Holds Biotechnology company Ocugen, Inc. (NASDAQ: OCGN)…

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.

EF Hutton Initiates Coverage of Cel-Sci (CVM) with $17 Price Target Ahead of Rumored News Table of Contents Hide About Cel-Sci CorporationEF Hutton Analyst Tim Moore Coverage of Cel-SciEF Hutton Key Points for…

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.

Legend Biotech Appoints Dr. Guowei Fang As Head of Global Research and Early Development Table of Contents Hide About Legend BiotechAbout Dr. Guowei Fang Global biotechnology company Legend Biotech Corporation (NASDAQ: LEGN)…