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Hot Stocks
Protalix director buys $155.8K in common stock » 17:12
01/05/23
01/05
17:12
01/05/23
17:12
PLX

Protalix

$1.43 /

+0.005 (+0.35%)

In a regulatory filing,…

In a regulatory filing, Protalix disclosed that its director Aharon Schwartz bought 110K shares of common stock on January 3 in a total transaction size of $155.8K. Shares are up 4.9% afterhours at $1.50.

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PLX Protalix
$1.43 /

+0.005 (+0.35%)

PLX Protalix
$1.43 /

+0.005 (+0.35%)

Over a month ago
Hot Stocks
Protalix to voluntarily delist common stock from Tel Aviv Stock Exchange » 16:32
12/21/22
12/21
16:32
12/21/22
16:32
PLX

Protalix

$1.28 /

-0.035 (-2.67%)

Protalix BioTherapeutics…

Protalix BioTherapeutics announced that the company's management and Board of Directors have decided that it is in the best interest of the company to voluntarily delist its common stock from the Tel Aviv Stock Exchange. The company believes that delisting its common stock from the TASE will allow management to focus better on the company's primary capital market and reduce its cost of operations as the company will be subject to only one set of listing rules and regulations. Accordingly, the company has requested that the TASE immediately initiate the delisting process.

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PLX Protalix
$1.28 /

-0.035 (-2.67%)

PLX Protalix
$1.28 /

-0.035 (-2.67%)

On The Fly
Biotech Alert: Searches spiking for these stocks today » 11:27
12/07/22
12/07
11:27
12/07/22
11:27
NYMX

Nymox

/

+

, ONCT

Oncternal Therapeutics

$1.05 /

-0.025 (-2.33%)

, IOVA

Iovance Biotherapeutics

$7.56 /

-0.04 (-0.53%)

, PLX

Protalix

$1.17 /

-0.01 (-0.85%)

, CDMO

Avid Bioservices

$12.80 /

-2.04 (-13.75%)

These names in the…

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PLX Protalix
$1.17 /

-0.01 (-0.85%)

ONCT Oncternal Therapeutics
$1.05 /

-0.025 (-2.33%)

NYMX Nymox
/

+

IOVA Iovance Biotherapeutics
$7.56 /

-0.04 (-0.53%)

CDMO Avid Bioservices
$12.80 /

-2.04 (-13.75%)

NYMX Nymox
/

+

ONCT Oncternal Therapeutics
$1.05 /

-0.025 (-2.33%)

08/10/22 H.C. Wainwright
Oncternal Therapeutics price target lowered to $7 from $8 at H.C. Wainwright
05/27/22 Northland
Oncternal updated interim data should be catalyst for shares, says Northland
05/10/22 Maxim
Oncternal Therapeutics initiated with a Buy at Maxim
02/24/22 BTIG
Oncternal Therapeutics initiated with a Buy at BTIG
IOVA Iovance Biotherapeutics
$7.56 /

-0.04 (-0.53%)

11/21/22 JMP Securities
Iovance Biotherapeutics price target lowered to $21 from $25 at JMP Securities
11/20/22 Piper Sandler
Iovance Biotherapeutics price target lowered to $11 from $13 at Piper Sandler
11/18/22 Chardan
Iovance Biotherapeutics price target lowered to $29 from $30 at Chardan
11/18/22 Oppenheimer
Iovance price target lowered to $25 from $27 at Oppenheimer
PLX Protalix
$1.17 /

-0.01 (-0.85%)

CDMO Avid Bioservices
$12.80 /

-2.04 (-13.75%)

12/07/22 Craig-Hallum
Avid Bioservices price target lowered to $25 from $30 at Craig-Hallum
06/30/22 RBC Capital
Avid Bioservices price target lowered to $22 from $32 at RBC Capital
03/09/22 Craig-Hallum
Avid Bioservices price target lowered to $30 from $35 at Craig-Hallum
12/08/21 RBC Capital
Avid Bioservices price target raised to $32 from $27 at RBC Capital
ONCT Oncternal Therapeutics
$1.05 /

-0.025 (-2.33%)

IOVA Iovance Biotherapeutics
$7.56 /

-0.04 (-0.53%)

CDMO Avid Bioservices
$12.80 /

-2.04 (-13.75%)

NYMX Nymox
/

+

IOVA Iovance Biotherapeutics
$7.56 /

-0.04 (-0.53%)

CDMO Avid Bioservices
$12.80 /

-2.04 (-13.75%)

IOVA Iovance Biotherapeutics
$7.56 /

-0.04 (-0.53%)

Conference/Events
Protalix to hold a KOL webcast » 08:20
12/05/22
12/05
08:20
12/05/22
08:20
PLX

Protalix

$1.14 /

+0.015 (+1.34%)

Management holds a Key…

Management holds a Key Opinion Webcast on Fabry Disease & PRX-102 (pegunigalsidase alfa) on December 5 at 8:30 am. Webcast Link

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PLX Protalix
$1.14 /

+0.015 (+1.34%)

Hot Stocks
Protalix, Chiesi Global Rare Diseases announce FDA acceptance of PRX-102 BLA » 06:52
12/05/22
12/05
06:52
12/05/22
06:52
PLX

Protalix

$1.14 /

+0.015 (+1.34%)

Protalix and Chiesi…

Protalix and Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, announced that the FDA has accepted the resubmitted Biologics License Application, or BLA, for pegunigalsidase alfa, or PRX-102, for the proposed treatment of adult patients with Fabry disease. Pegunigalsidase alfa is a purposefully-designed, long-acting recombinant, PEGylated, cross-linked a-galactosidase-A investigational product candidate. The FDA indicated in the BLA filing communication letter that the resubmitted BLA was considered a complete, class 2 response and set an action date of May 9, 2023, under the Prescription Drug User Fee Act.

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PLX Protalix
$1.14 /

+0.015 (+1.34%)

Conference/Events
Protalix to hold a KOL webcast » 04:55
12/05/22
12/05
04:55
12/05/22
04:55
PLX

Protalix

$1.14 /

+0.015 (+1.34%)

Management holds a Key…

Management holds a Key Opinion Webcast on Fabry Disease & PRX-102 (pegunigalsidase alfa) on December 5 at 8:30 am. Webcast Link

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PLX Protalix
$1.14 /

+0.015 (+1.34%)

Conference/Events
Protalix to hold a KOL webcast » 23:42
12/04/22
12/04
23:42
12/04/22
23:42
PLX

Protalix

$1.14 /

+0.015 (+1.34%)

Management holds a Key…

Management holds a Key Opinion Webcast on Fabry Disease & PRX-102 (pegunigalsidase alfa) on December 5 at 8:30 am. Webcast Link

ShowHide Related Items >><<
PLX Protalix
$1.14 /

+0.015 (+1.34%)

Hot Stocks
Protalix, Chiesi Global Rare Diseases resubmits PRX-102 BLA to FDA » 06:42
11/14/22
11/14
06:42
11/14/22
06:42
PLX

Protalix

$1.05 /

+0.04 (+3.96%)

Protalix and Chiesi…

Protalix and Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver therapies and solutions for people affected by rare diseases, announced the resubmission on November 9 of a biologics license application, or BLA, to the FDA, for PRX-102 for the treatment of adult patients with Fabry disease. Pegunigalsidase alfa is a purposefully-designed, long-acting recombinant, PEGylated, cross-linked a galactosidase-A investigational product candidate. The BLA resubmission includes a set of clinical and manufacturing data. The data were compiled from studies that involved more than 140 Fabry disease patients with up to five years of follow up including all three completed studies in the PRX-102 Phase III clinical program including the BALANCE study, the BRIDGE study and the BRIGHT study, as well as the phase I/II clinical trial of PRX-102. The phase I/II data includes data compiled from the related extension study succeeding the phase I/II study. The BLA resubmission also includes safety data compiled from the ongoing phase III extension studies of PRX-102. If approved, Protalix will be eligible to receive a milestone payment from Chiesi upon BLA approval. Protalix and Chiesi anticipate that the FDA will complete its review of the resubmission within six months of receipt.

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Over a quarter ago
Syndicate
Protalix files $100M mixed securities shelf  16:54
04/20/22
04/20
16:54
04/20/22
16:54
PLX

Protalix

$1.30 /

-0.02 (-1.52%)

 
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PLX Protalix
$1.30 /

-0.02 (-1.52%)

PLX Protalix
$1.30 /

-0.02 (-1.52%)

05/03/21 H.C. Wainwright
Protalix price target lowered to $7 from $11 at H.C. Wainwright
04/28/21 Stifel
Protalix, Sanofi updates may signal headwinds for Avrobio, Amicus, says Stifel
Hot Stocks
Protalix, Chiesi announce BALANCE trial meets primary endpoint » 07:00
04/04/22
04/04
07:00
04/04/22
07:00
PLX

Protalix

$1.04 /

-0.025 (-2.35%)

Protalix and Chiesi…

Protalix and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici announced topline results from the BALANCE pivotal Phase III clinical trial evaluating pegunigalsidase alfa, 1 mg/kg, administered every two weeks, compared to agalsidase beta for the treatment of Fabry disease. PRX-102 is a novel, PEGylated enzyme replacement therapy, or ERT, under development for the treatment of Fabry disease. The pivotal Phase III BALANCE clinical trial has been completed and topline results from the final analysis are now available. This is a 24-month, randomized, double-blind, active control study of PRX-102 in adult Fabry patients with deteriorating renal function that was designed to evaluate the safety and efficacy of 1 mg/kg of PRX-102 administered every two weeks compared to agalsidase beta. The study enrolled 78 patients who were previously treated with agalsidase beta for at least one year with an estimated glomerular filtration rate, or eGFR, slope at screening worse than -2 mL/min/1.73 m2/year. Patients were randomized on a 2:1 ratio for switching to PRX-102 or continuing on agalsidase beta. A total of 77 patients were treated; 52 with PRX-102 and 25 with agalsidase beta. As first announced in October 2021, as part of a Type A End-of-Review meeting, the FDA, in principle, agreed that the proposed analysis of the BALANCE study demonstrating non-inferiority to agalsidase beta included in the data package for the PRX-102 biologics license application, or BLA, resubmission has the potential to support the approval of PRX-102 for the treatment of Fabry disease. Given the changed regulatory landscape in the United States with the full approval of agalsidase beta in March 2021, the primary analysis of the BALANCE study was changed from superiority to non-inferiority, as demonstrating superiority is no longer required under FDA guidelines. The primary endpoint of the BALANCE study compared the eGFR annualized changes between the two treatment arms in the ITT analysis set. The study met its pre-specified primary endpoint and demonstrated that PRX-102 was statistically non-inferior to agalsidase beta. The median of the eGFR slope in the PRX-102 arm was -2.514 mL/min/1.73 m2/year and -2.155 mL/min/1.73 m2/year in the agalsidase beta arm, demonstrating a large overlap in the confidence intervals of the two arms. The difference in medians is -0.359 mL/min/1.73 m2/year. The prespecified non-inferiority margin was met. Topline results in the PP analysis set are consistent with the ITT results. The study population was composed of 47 males and 30 females, with a mean age of 44.3 years. The mean duration of prior treatment with agalsidase beta was approximately six years. At baseline, mean eGFR was 73.33 ml/min/1.73m2 and median eGFR was 74.51 ml/min/1.73m2; mean eGFR slope was -8.21 mL/min/1.73 m2/year and median eGFR slope was -7.32 ml/min/1.73m2/year. Forty-seven patients in the PRX-102 arm experienced at least one adverse event compared to 24 in the agalsidase beta arm. The number of events adjusted to 100 years of exposure is 572.36 events for the PRX-102 arm and 816.85 events for the agalsidase beta arm. Treatment-related adverse events were reported for 21 patients in the PRX-102 arm compared to 11 in the agalsidase beta arm. The number of treatment-related events adjusted to 100 years of exposure is 42.85 events for the PRX-102 arm and 152.91 events for the agalsidase beta arm. Usage of infusion pre-medication was tapered down during the study, if possible, for all patients. At baseline, 21 patients in the PRX-102 arm used infusion premedication compared to 16 in the agalsidase beta arm. At the end of the study, only three out of 47 patients in the PRX-102 arm used infusion premedication compared to three out of 24 in the agalsidase beta arm. Even with this reduction in use of premedication, there were fewer reported infusion-related reactions with PRX-102: 11 patients in the PRX-102 arm experienced a total of 13 events compared to six patients experiencing a total of 51 events in the agalsidase beta arm. The number of infusion-related reactions adjusted to 100 infusions is 0.5 for the PRX-102 arm and 3.9 for agalsidase beta arm. Assessment of anti-PRX-102 antibodies or anti-agalsidase beta antibodies, respectively, in the study indicated that, for the PRX-102 arm, 18 patients were anti-drug antibody ADA-positive at baseline, of which 17 had neutralizing antibody activity. For the agalsidase beta arm, eight patients were ADA-positive at baseline, of which seven had neutralizing antibody activity. At the end of the two-year study, 11 patients receiving PRX-102 were ADA-positive, of which seven had neutralizing antibody activity, while in the agalsidase beta arm six were ADA-positive and all six had neutralizing antibody activity. Out of the 78 randomized patients, six patients discontinued the study: out of the five from the PRX-102 arm, one patient withdrew consent prior to the first infusion, two discontinued due to personal reasons, and two due to adverse events; one patient from the agalsidase beta arm discontinued for personal reasons. There were no deaths.

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PLX Protalix
$1.04 /

-0.025 (-2.35%)

PLX Protalix
$1.04 /

-0.025 (-2.35%)

05/03/21 H.C. Wainwright
Protalix price target lowered to $7 from $11 at H.C. Wainwright
04/28/21 Stifel
Protalix, Sanofi updates may signal headwinds for Avrobio, Amicus, says Stifel

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