The following information gives dates for upcoming
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Posted On: 07/22/2017 9:45:07 AM
The following information gives dates for upcoming FDA PDUFA dates. You can read below why the action with AEZS was so tremendous. I am in NEOS and considering DVAX, although I have been unable to catch a break with that company twice since 2009. It's a good read to keep track as what is coming down the road.
BPC JULY 21 UPDATE
10 Upcoming PDUFA dates for small-cap biotech stocks
Weekly watchlist
The latest BioPharmCatalyst watch list takes a look at upcoming PDUFA dates all due within the next four months for small cap biotech stocks. Recent FDA regulatory news in favor of Puma Biotechnology Inc (NASDAQ
BYI) but against Ocular Therapeutix Inc (NASDAQ:OCUL) has put the spotlight back on companies expecting upcoming decisions from the FDA. In a rarity in the biotech space, next week sees TWO FDA Advisory Committee Meetings for small cap biotech stocks, IntelliPharmaCeutics Intl Inc (NASDAQ:IPCI) and Dynavax Technologies Corporation (NASDAQ
VAX).
First let's review the week that was with five key events that made headlines.
Puma Biotechnology, Inc. (Nasdaq: PBYI) won FDA approval for Nerlynx (neratinib) for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy. Approval was based on an invasive disease-free survival (iDFS) rate of 94.2% in its ExteNET trial compared with 91.9% in those receiving placebo (HR 0.66; 95% CI: 0.49, 0.90, p=0.008). Shares closed the week up 5.3% to $94.30.
Sarepta Therapeutics Inc (NASDAQ:SRPT) shares closed the week up 23% to $43.41 following better than expected revenue reported in its 2Q earnings release. Sales from Exondys 51, approved by the FDA in 2016 for the treatment of Duchenne muscular dystrophy, were $35m in 2Q 2017, above market estimates of around $22m. Guidance was also raised for 2017 to between $125m and $130m, above previous consensus of $105m.
Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) announced positive data from its Phase 1 and Phase 2 trials of three different triple combination regimens in people with cystic fibrosis (CF) who have one F508del mutation and one minimal function mutation (F508del/Min). The efficacy of the drug combinations was measured by improvements in the percentage predicted forced expiratory volume in one second (ppFEV1). Data from the Phase 1 and 2 trials exhibited impressive improvements in ppFEV1 of between 9.6 and 12.0 percentage points. Shares closed the week up 25% to $163.17.
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced that it met the primary endpoint in its Phase 2b trial evaluating IW-3718 in adult patients with uncontrolled gastroesophageal reflux disease (GERD). The trial measured IW-3718 plus a proton pump inhibitor (PPI) against patients teated with a PPI alone. The data showed that patients treated with IW-3718 plus a PPI showed a mean decrease of 58.0% from baseline in heartburn severity compared to 46.0% in patients treated with a PPI alone (p = 0.04). While the data were statistically significant (p=0.04), the 12 point percentage difference was less than investor expectations, which saw shares sold off closing the week down 10% to $17.22.
Shares of Aeterna Zentaris Inc. (NASDAQ: AEZS) surged to close the week up 166% to $2.87. The FDA announced Tuesday that its New Drug Application (NDA) of Macrilen (macimorelin) for patients with growth hormone deficiency in adults (AGHD) was accepted and granted a PDUFA date of December 30, 2017. As a conservative estimate, over 95% of NDAs are accepted for filing by the FDA. The company received a Complete Response Letter (CRL) in November 2014 and followed that up with a Phase 3 trial in January 2017, which failed with the company noting at the time that it was very disappointed about the outcome of the trial.
10 Upcoming PDUFA dates for small cap biotech stocks:
DRUG STAGE CATALYST
ACRX
ARX-04 (SAP303)
Moderate-to-severe acute pain following a surgical procedure
PDUFA PDUFA date October 12, 2017. Noted June 7, 2017 that an Advisory Committee Meeting is no longer planned.
ADMS
ADS-5102
Levodopa-Induced Dyskinesia
PDUFA PDUFA date August 24, 2017.
ATRS
VIBEX QuickShot
Testosterone deficiency
PDUFA PDUFA date October 20, 2017.
DVAX
HEPLISAV-B
Hepatitis B
PDUFA CRL February 25, 2013 and November 14, 2016. New PDUFA August 10, 2017. Advisory Committee Meeting July 28, 2017.
FLXN
Zilretta - FX006
Osteoarthritis of the knee
PDUFA PDUFA date October 6, 2017.
HRTX
CINVANTI (HTX-019)
Prevention of chemotherapy-induced nausea and vomiting (CINV)
PDUFA PDUFA date November 12, 2017.
IPCI
Rexista
Pain relief
PDUFA Advisory Committee Meeting July 26, 2017. PDUFA date September 25, 2017.
KMDA
KamRAB
Prophylaxis of rabies disease
PDUFA PDUFA date August 29, 2017.
NEOS
NT-0201
Attention deficit hyperactivity disorder (ADHD)
PDUFA PDUFA date September 15, 2017.
PTCT
Translarna
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.
BPC JULY 21 UPDATE
10 Upcoming PDUFA dates for small-cap biotech stocks
Weekly watchlist
The latest BioPharmCatalyst watch list takes a look at upcoming PDUFA dates all due within the next four months for small cap biotech stocks. Recent FDA regulatory news in favor of Puma Biotechnology Inc (NASDAQ
BYI) but against Ocular Therapeutix Inc (NASDAQ:OCUL) has put the spotlight back on companies expecting upcoming decisions from the FDA. In a rarity in the biotech space, next week sees TWO FDA Advisory Committee Meetings for small cap biotech stocks, IntelliPharmaCeutics Intl Inc (NASDAQ:IPCI) and Dynavax Technologies Corporation (NASDAQVAX). First let's review the week that was with five key events that made headlines.
Puma Biotechnology, Inc. (Nasdaq: PBYI) won FDA approval for Nerlynx (neratinib) for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy. Approval was based on an invasive disease-free survival (iDFS) rate of 94.2% in its ExteNET trial compared with 91.9% in those receiving placebo (HR 0.66; 95% CI: 0.49, 0.90, p=0.008). Shares closed the week up 5.3% to $94.30.
Sarepta Therapeutics Inc (NASDAQ:SRPT) shares closed the week up 23% to $43.41 following better than expected revenue reported in its 2Q earnings release. Sales from Exondys 51, approved by the FDA in 2016 for the treatment of Duchenne muscular dystrophy, were $35m in 2Q 2017, above market estimates of around $22m. Guidance was also raised for 2017 to between $125m and $130m, above previous consensus of $105m.
Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) announced positive data from its Phase 1 and Phase 2 trials of three different triple combination regimens in people with cystic fibrosis (CF) who have one F508del mutation and one minimal function mutation (F508del/Min). The efficacy of the drug combinations was measured by improvements in the percentage predicted forced expiratory volume in one second (ppFEV1). Data from the Phase 1 and 2 trials exhibited impressive improvements in ppFEV1 of between 9.6 and 12.0 percentage points. Shares closed the week up 25% to $163.17.
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced that it met the primary endpoint in its Phase 2b trial evaluating IW-3718 in adult patients with uncontrolled gastroesophageal reflux disease (GERD). The trial measured IW-3718 plus a proton pump inhibitor (PPI) against patients teated with a PPI alone. The data showed that patients treated with IW-3718 plus a PPI showed a mean decrease of 58.0% from baseline in heartburn severity compared to 46.0% in patients treated with a PPI alone (p = 0.04). While the data were statistically significant (p=0.04), the 12 point percentage difference was less than investor expectations, which saw shares sold off closing the week down 10% to $17.22.
Shares of Aeterna Zentaris Inc. (NASDAQ: AEZS) surged to close the week up 166% to $2.87. The FDA announced Tuesday that its New Drug Application (NDA) of Macrilen (macimorelin) for patients with growth hormone deficiency in adults (AGHD) was accepted and granted a PDUFA date of December 30, 2017. As a conservative estimate, over 95% of NDAs are accepted for filing by the FDA. The company received a Complete Response Letter (CRL) in November 2014 and followed that up with a Phase 3 trial in January 2017, which failed with the company noting at the time that it was very disappointed about the outcome of the trial.
10 Upcoming PDUFA dates for small cap biotech stocks:
DRUG STAGE CATALYST
ACRX
ARX-04 (SAP303)
Moderate-to-severe acute pain following a surgical procedure
PDUFA PDUFA date October 12, 2017. Noted June 7, 2017 that an Advisory Committee Meeting is no longer planned.
ADMS
ADS-5102
Levodopa-Induced Dyskinesia
PDUFA PDUFA date August 24, 2017.
ATRS
VIBEX QuickShot
Testosterone deficiency
PDUFA PDUFA date October 20, 2017.
DVAX
HEPLISAV-B
Hepatitis B
PDUFA CRL February 25, 2013 and November 14, 2016. New PDUFA August 10, 2017. Advisory Committee Meeting July 28, 2017.
FLXN
Zilretta - FX006
Osteoarthritis of the knee
PDUFA PDUFA date October 6, 2017.
HRTX
CINVANTI (HTX-019)
Prevention of chemotherapy-induced nausea and vomiting (CINV)
PDUFA PDUFA date November 12, 2017.
IPCI
Rexista
Pain relief
PDUFA Advisory Committee Meeting July 26, 2017. PDUFA date September 25, 2017.
KMDA
KamRAB
Prophylaxis of rabies disease
PDUFA PDUFA date August 29, 2017.
NEOS
NT-0201
Attention deficit hyperactivity disorder (ADHD)
PDUFA PDUFA date September 15, 2017.
PTCT
Translarna
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.
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