BioPharm Catalyst. These are great to review to se
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Posted On: 09/29/2017 8:02:48 AM
BioPharm Catalyst. These are great to review to see what's is coming up for reviews by the FDA. I always check out the pps and charts which can sometimes give an indication whether the company projects good or bad news from the data.
Zynerba ZYNE surges on data; PTCT - FDA panel votes data are inconclusive; RedHill RDHL data due October 3
Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE) shares surged to close up 53% to $9.44 following the release of data from its Phase 2 trial evaluating ZYN002 cannabidiol (CBD) gel in pediatric and adolescent patients with Fragile X syndrome (FXS). The company noted that the trial met its primary endpoint, achieving a 46% improvement in the total score of Anxiety, Depression, and Mood Scale (ADAMS) at week twelve compared to baseline. However, investors were quick to point out that the trial was an uncontrolled open-label trial and the improvement shown would be entirely consistent with placebo, as explained @AF_biotech on Twitter.
RedHill Biopharma Ltd. (NASDAQ:RDHL) announced that top-line results from its Phase 2 trial of Bekinda for diarrhea-predominant irritable bowel syndrome (IBS-D) will be released on Tuesday, October 3rd, 2017.
AbbVie (NYSE: ABBV) announced an agreement with Amgen regarding the intellectual property rights of Humira and Amgen’s biosimilar product. Under the terms of the agreement Amgen will have rights from late 2018 to market its product in Europe but will need to wait until 2023 before the US license period commences. Amgen will pay royalties as specified under the agreement, the exact amount was not disclosed. Shares of Abbvie closed up 5% to $88.96.
Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP) announced that the FDA has set a PDUFA date under priority review of January 28, 2018 for the supplemental New Drug Application (sNDA) for lubiprostone (AMITIZA) in children aged 6 to 17 years with pediatric functional constipation.
PTC Therapeutics, Inc. (NASDAQ
TCT) shares are trading up 9% to $19.00 in the after-hours session following the meeting of the FDA Peripheral and Central Nervous Systems Drugs Advisory Committee (PCNS) to discuss ataluren (Translarna) for the treatment of nonsense mutation dystrophinopathy. The panel's vote was as follows:
0 - the data suggest that ataluren is not effective.
10 - although it is possible that ataluren may be effective, the data are inconclusive, and more work would be needed to establish whether ataluren is effective.
1 - the data are sufficient to conclude that ataluren is effective.
Prothena Corporation plc (NasdaqRTA) announced that data from its Phase 1b trial of PRX003 in patients with psoriasis did not display sufficient efficacy to warrant further development. Shares are down 6% to $64.00 in the after-hours session.
Major price movers (stocks priced > $1.00, volume > 50k):
Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume INCLUDING sub-$1 stocks.
ADVANCERS:
Madrigal Pharmaceuticals Inc (NASDAQ:MDGL): $46.19; +25%.
Spectrum Pharmaceuticals, Inc.(NASDAQ:SPPI): $13.49; +23%.
Catabasis Pharmaceuticals Inc (NASDAQ:CATB): $2.23; +22%.
Aradigm Corporation (NASDAQ:ARDM): $3.88; +21%.
MannKind Corporation (NASDAQ:MNKD): $2.22; +20%.
DECLINERS:
Kitov Pharmaceuticals Holdings (NASDAQ:KTOV): $1.96; -12%.
ADMA Biologics Inc (NASDAQ:ADMA): $2.92; -11%.
Endo International (NASDAQ:ENDP): $8.15; -10%.
Alcobra Ltd (NASDAQ:ADHD): $1.01; -9%.
Zogenix, Inc.(NASDAQ:ZGNX): $12.88; -8%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: GALE
NeuVax in combination with Herceptin
Breast cancer
PHASE 2B Phase 2b completion of enrollment announced September 28, 2017 - with interim efficacy analysis due 6 months following - estimate 2Q 2018. Full data due 2019.
TICKER: PRTA
PRX003
Psoriatic Arthritis
PHASE 1B Phase 1b data released September 28, 2017 - insufficient meaningful clinical effect for further development.
TICKER: PTCT
Ataluren
Duchenne muscular dystrophy caused by nonsense mutations (nmDMD)
PDUFA Received a Refusal to File letter for their NDA Filing - February 23 2016. Appeal rejected October 17, 2016. Decision made to resubmit NDA during 1Q 2017 under protest. New PDUFA date October 24, 2017. Advisory Committee Meeting September 28, 2017 voted that although it is possible that ataluren may be effective, the data are inconclusive, and more work would be needed to establish whether ataluren is effective.
TICKER: REPH
Intravenous (IV) meloxicam
Acute pain following bunionectomy surgery
PDUFA Phase 3 data from second trial released November 28, 2016. Primary endpoint met. NDA filing announced July 31, 2017. NDA acceptance announced September 28 ,2017. No PDUFA data announced - estimate July 28, 2017.
TICKER: SCMP
Lubiprostone
Pediatric functional constipation
PDUFA PDUFA date for sNDA under priority review January 28, 2018.
TICKER: ZYNE
ZYN002
Fragile X syndrome
PHASE 2 Phase 2 data released September 28, 2017. Company noted data were positive with primary endpoint met. Note though that trial was uncontrolled/open-label.
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Zynerba ZYNE surges on data; PTCT - FDA panel votes data are inconclusive; RedHill RDHL data due October 3
Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE) shares surged to close up 53% to $9.44 following the release of data from its Phase 2 trial evaluating ZYN002 cannabidiol (CBD) gel in pediatric and adolescent patients with Fragile X syndrome (FXS). The company noted that the trial met its primary endpoint, achieving a 46% improvement in the total score of Anxiety, Depression, and Mood Scale (ADAMS) at week twelve compared to baseline. However, investors were quick to point out that the trial was an uncontrolled open-label trial and the improvement shown would be entirely consistent with placebo, as explained @AF_biotech on Twitter.
RedHill Biopharma Ltd. (NASDAQ:RDHL) announced that top-line results from its Phase 2 trial of Bekinda for diarrhea-predominant irritable bowel syndrome (IBS-D) will be released on Tuesday, October 3rd, 2017.
AbbVie (NYSE: ABBV) announced an agreement with Amgen regarding the intellectual property rights of Humira and Amgen’s biosimilar product. Under the terms of the agreement Amgen will have rights from late 2018 to market its product in Europe but will need to wait until 2023 before the US license period commences. Amgen will pay royalties as specified under the agreement, the exact amount was not disclosed. Shares of Abbvie closed up 5% to $88.96.
Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP) announced that the FDA has set a PDUFA date under priority review of January 28, 2018 for the supplemental New Drug Application (sNDA) for lubiprostone (AMITIZA) in children aged 6 to 17 years with pediatric functional constipation.
PTC Therapeutics, Inc. (NASDAQ
TCT) shares are trading up 9% to $19.00 in the after-hours session following the meeting of the FDA Peripheral and Central Nervous Systems Drugs Advisory Committee (PCNS) to discuss ataluren (Translarna) for the treatment of nonsense mutation dystrophinopathy. The panel's vote was as follows: 0 - the data suggest that ataluren is not effective.
10 - although it is possible that ataluren may be effective, the data are inconclusive, and more work would be needed to establish whether ataluren is effective.
1 - the data are sufficient to conclude that ataluren is effective.
Prothena Corporation plc (Nasdaq
RTA) announced that data from its Phase 1b trial of PRX003 in patients with psoriasis did not display sufficient efficacy to warrant further development. Shares are down 6% to $64.00 in the after-hours session. Major price movers (stocks priced > $1.00, volume > 50k):
Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume INCLUDING sub-$1 stocks.
ADVANCERS:
Madrigal Pharmaceuticals Inc (NASDAQ:MDGL): $46.19; +25%.
Spectrum Pharmaceuticals, Inc.(NASDAQ:SPPI): $13.49; +23%.
Catabasis Pharmaceuticals Inc (NASDAQ:CATB): $2.23; +22%.
Aradigm Corporation (NASDAQ:ARDM): $3.88; +21%.
MannKind Corporation (NASDAQ:MNKD): $2.22; +20%.
DECLINERS:
Kitov Pharmaceuticals Holdings (NASDAQ:KTOV): $1.96; -12%.
ADMA Biologics Inc (NASDAQ:ADMA): $2.92; -11%.
Endo International (NASDAQ:ENDP): $8.15; -10%.
Alcobra Ltd (NASDAQ:ADHD): $1.01; -9%.
Zogenix, Inc.(NASDAQ:ZGNX): $12.88; -8%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: GALE
NeuVax in combination with Herceptin
Breast cancer
PHASE 2B Phase 2b completion of enrollment announced September 28, 2017 - with interim efficacy analysis due 6 months following - estimate 2Q 2018. Full data due 2019.
TICKER: PRTA
PRX003
Psoriatic Arthritis
PHASE 1B Phase 1b data released September 28, 2017 - insufficient meaningful clinical effect for further development.
TICKER: PTCT
Ataluren
Duchenne muscular dystrophy caused by nonsense mutations (nmDMD)
PDUFA Received a Refusal to File letter for their NDA Filing - February 23 2016. Appeal rejected October 17, 2016. Decision made to resubmit NDA during 1Q 2017 under protest. New PDUFA date October 24, 2017. Advisory Committee Meeting September 28, 2017 voted that although it is possible that ataluren may be effective, the data are inconclusive, and more work would be needed to establish whether ataluren is effective.
TICKER: REPH
Intravenous (IV) meloxicam
Acute pain following bunionectomy surgery
PDUFA Phase 3 data from second trial released November 28, 2016. Primary endpoint met. NDA filing announced July 31, 2017. NDA acceptance announced September 28 ,2017. No PDUFA data announced - estimate July 28, 2017.
TICKER: SCMP
Lubiprostone
Pediatric functional constipation
PDUFA PDUFA date for sNDA under priority review January 28, 2018.
TICKER: ZYNE
ZYN002
Fragile X syndrome
PHASE 2 Phase 2 data released September 28, 2017. Company noted data were positive with primary endpoint met. Note though that trial was uncontrolled/open-label.
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'Everything works out in the end,,,If it hasn't worked out,,it's not the end'
https://twitter.com/twitter/statuses/957208055766241280
https://twitter.com/twitter/statuses/957208055766241280
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