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ADXS

Advaxis

$1.58

0.01 (0.64%)

08:07
07/10/18
07/10
08:07
07/10/18
08:07

Advaxis withdraws MMA for axalimogene filolisbac, submits IND for ADXS-HOT

Advaxis announced a clinical update. Advaxis' regulatory action in Europe is based on European Medicines Agency, or EMA, feedback following its initial review indicating the application will likely need additional data to support a conditional approval. The February submission included data from the Phase 2 GOG-0265 study in 50 patients, which showed a 12-month overall survival rate, primary efficacy endpoint, of 38% in women with persistent, recurrent or metastatic carcinoma of the cervix, representing a 55% improvement over a model-predicted 12-month overall survival rate of 24.5%. As more than half of the women treated in this study had received multiple prior lines of therapy including with bevacizumab treatment, the 38% 12-month overall survival rate was unprecedented when compared against historical data. The company continues to believe that the results from the GOG-0265 study are clinically meaningful and provide proof-of-concept that axalimogene filolisbac demonstrated clinical activity in metastatic cervical cancer. The withdrawal of this application does not impact the ongoing clinical trials of axalimogene filolisbac. As previously communicated, Advaxis is actively seeking a partner to support the late-stage cervical cancer program. The company also announced that it has submitted an IND with the FDA to study its first product candidate from the ADXS-HOT program, ADXS-503, for the treatment of NSCLC. Upon allowance of the IND for ADXS-503, the company plans to initiate an open-label, Phase 1/2 clinical trial. Further details of the study design will be provided after the IND is allowed. Advaxis expects the first patient will be dosed by the end of 2018. Additionally, Advaxis anticipates submitting a second IND from the ADXS-HOT program within the next six months, for its drug candidate referred to as ADXS-504, for the treatment of prostate cancer.

ADXS Advaxis
$1.58

0.01 (0.64%)

03/13/18
CANT
03/13/18
NO CHANGE
Target $5
CANT
Overweight
Advaxis price target lowered to $5 from $19 at Cantor Fitzgerald
Cantor Fitzgerald analyst Mara Goldstein lowered his price target for Advaxis to $5 after a clinical hold was placed on the Phase I/II AXAL plus durvalumab trial. The analyst, however, thinks it is "very possible" that the hold will be resolved. Further, Advaxis has sufficient capital into 2019, which is a "counterpoint to the clinical hold," Goldstein tells investors in a research note. She keeps an Overweight rating on Advaxis shares.
03/14/18
HCWC
03/14/18
NO CHANGE
Target $6
HCWC
Buy
Advaxis drug unlikely culprit of patient death, says H.C. Wainwright
H.C. Wainwright analyst Swayampakula Ramakanth lowered his price target for Advaxis (ADXS) to $6 from $23 after the FDA placed a clinical hold on the Phase 1/2 study investigating the combination of the company's axalimogene filolisbac and AstraZeneca's (AZN) durvalumab for the treatment of HPV-associated cervical and head and neck cancers. Based on its previous safety profile, axalimogene is unlikely to be the cause of death for this patient, Ramakanth tells investors in a research note. The analyst, however, notes that it would likely take several months before the FDA is able to reach a decision and lift the clinical hold. He anticipates a one-to-two quarter delay to the axal plus durva combination therapy program but keeps a Buy rating on Advaxis shares.
06/13/18
JEFF
06/13/18
DOWNGRADE
Target $2
JEFF
Hold
Advaxis downgraded to Hold from Buy at Jefferies
Jefferies analyst Biren Amin downgraded Advaxis to Hold and cut his price target for the shares to $2 from $9. The analyst prefers to step to the sidelines pending proof-of-concept data. He sees no clear path to partnering for axalimogene filolisbac and notes efficacy data for the ADXS-NEO and ADXS-HOT programs are likely two years away.
06/13/18
06/13/18
DOWNGRADE

On The Fly: Top five analyst downgrades
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. Square (SQ) downgraded to Neutral from Buy at Buckingham with analyst Chris Brendler saying he is taking a "breather" following the year-to-date share outperformance but raised his price target to $65 from $55. 2. Yelp (YELP) downgraded to Sell from Hold at Aegis. 3. AT&T (T) was downgraded to Sell from Neutral at MoffettNathanson while Time Warner (TWX) was downgraded to Neutral from Buy at the firm. Time Warner was also downgraded to Market Perform from Outperform at Barrington. 4. Comcast (CMCSA) downgraded to Market Perform from Outperform at Raymond James. 5. Advaxis (ADXS) downgraded to Hold from Buy at Jefferies. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.

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