BC Extra | May 15, 2019
Company News

May 15 Company Quick Takes: Approvals for Bavencio in RCC, Venclexta-Gazyva combo; plus Adaptimmune, Alpine, Advaxis

Bavencio gets RCC approval with Inlyta  FDA approved Bavencio avelumab from Merck KGaA (Xetra:MRK) and Pfizer Inc. (NYSE:PFE) for first-line treatment of advanced renal cell carcinoma in combination with Pfizer's Inlyta axitinib, making Bavencio the...
BC Innovations | Aug 29, 2018
Distillery Therapeutics

Cancer

INDICATION: Cervical cancer; skin cancer Mouse studies suggest a vaccine based on a nanoparticle-HpV16gp2 peptide conjugate could help treat human papillomavirus (HPV)-associated cancers. The conjugate consists of nanoparticles with a polypropylene sulfide core and HpV16gp2...
BC Week In Review | Jul 13, 2018
Clinical News

FDA lifts hold on Phase I/II of axalimogene filolisbac for SCCHN

Advaxis Inc. (NASDAQ:ADXS) said FDA lifted a clinical hold on a Phase I/II combination study that includes the company's axalimogene filolisbac (ADXS11-001). The trial is evaluating the therapy in combination with PD-L1 inhibitor Imfinzi durvalumab...
BC Extra | Jul 13, 2018
Clinical News

Advaxis rises after FDA lifts clinical hold

Advaxis Inc. (NASDAQ:ADXS) jumped $0.12 (10%) to $1.34 Friday after it said FDA lifted a clinical hold on a Phase I/II combination study that includes the company's axalimogene filolisbac (ADXS11-001). The trial is evaluating the...
BC Week In Review | Mar 16, 2018
Clinical News

FDA places hold on Advaxis' combo trial

Advaxis Inc. (NASDAQ:ADXS) said FDA placed a clinical hold on a Phase I/II trial of axalimogene filolisbac (ADXS11-001) in combination with PD-L1 inhibitor Imfinzi durvalumab to treat HPV-related cancers. According to the company, the hold...
BC Extra | Mar 13, 2018
Financial News

Clinical hold sinks Advaxis shares

Advaxis Inc. (NASDAQ:ADXS) tumbled $0.26 (12%) to $1.95 on Tuesday after the company announced late Monday that FDA had placed a clinical hold on a Phase I/II trial of axalimogene filolisbac (ADXS11-001) (see BioCentury Extra,...
BC Extra | Mar 12, 2018
Clinical News

FDA places hold on Advaxis' combo trial

Advaxis Inc. (NASDAQ:ADXS) fell $0.49 (22%) to $1.72 in after-hours trading Monday after it said FDA placed a clinical hold on a Phase I/II trial of axalimogene filolisbac (ADXS11-001) in combination with PD-L1 inhibitor Imfinzi...
BC Week In Review | Mar 2, 2018
Financial News

Advaxis raises $20M in follow-on

Cancer immunotherapy company Advaxis Inc. (NASDAQ:ADXS) raised $20 million on Feb. 22 through the sale of 10 million shares at $2 in a follow-on underwritten by Jefferies and Guggenheim Securities. The price is a 20%...
BioCentury | Oct 6, 2017
Finance

Coasting on catalysts

While buysiders do not expect any sector-moving milestones in the wake of a catalyst-heavy third quarter, they will have at least 21 Phase III milestones and 23 PDUFA dates on their radar. But the biggest...
BioCentury | Jul 8, 2017
Finance

A clinical quarter

Buysiders will find themselves digesting at least 23 Phase III data readouts in the next quarter, two of which could provide clarity on increasingly competitive markets in lung cancer and hemophilia. The third quarter is...
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