BioPharm Update: Puma PBYI receives FDA Appro
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Posted On: 07/17/2017 11:58:27 PM
BioPharm Update:
Puma PBYI receives FDA Approval; Repros RPRX clinical hold remains in place; NVAX data July 24
Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that the FDA has approved NERLYNX (neratinib) for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer. Approval was based on the placebo controlled ExteNET trial. After two years, invasive disease-free survival (iDFS) was 94.2% in patients treated with neratinib compared with 91.9% in those receiving placebo (HR 0.66; 95% CI: 0.49, 0.90, p=0.008). Shares are currently trading up 9% to $93.65 in the after-hours session.
Paratek Pharmaceuticals, Inc. (Nasdaq
RTK) announced that it met all primary and secondary endpoints in its Phase 3 trial of omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Shares are currently trading up 4.2% in the after-hours session to $26.00 after closing up 3.7% during normal trading hours.
Repros Therapeutics Inc., (Nasdaq:RPRX) noted that the FDA has kept in place the clinical hold for Proellex. The FDA also indicated that the company will be required to compile a large pre-approval safety data base to support future development. Shares slumped to close down 33% to $0.385.
Novavax, Inc. (Nasdaq:NVAX) announced it will host a conference on Monday, July 24, 2017, at 4:30 p.m. ET where it will announce top-line data from its Phase 2 safety and immunogenicity trial of the RSV F Vaccine in older adults (60 years of age and older).
Spark Therapeutics (NASDAQ:ONCE) announced that the FDA has granted priority review for the Biologics License Application (BLA) of voretigene neparvovec, for the treatment of patients with vision loss due to confirmed biallelic RPE65-mediated inherited retinal disease (IRD). The PDUFA date is January 12, 2018.
CymaBay Therapeutics, Inc. (Nasdaq:CBAY) announced interim results from its ongoing low-dose Phase 2 study of seladelpar in patients with primary biliary cholangitis (PBC). A planned interim analysis showed after 12 weeks of treatment a significant reduction in alkaline phosphatase (AP) levels of of 39% and 45% for the 5 mg and 10 mg groups, respectively. Shares closed up 6% to $5.98 after trading as high as $7.77 early in the session. After hours, the company announced that it intends to offer and sell 10m shares of its common stock.
Other Major price movers (stocks priced > $1.00, volume > 100k):
Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume INCLUDING sub-$1 stocks.
ADVANCERS:
Soligenix, Inc. (NASDAQ:SNGX): $2.82; +36%.
AcelRx Pharmaceuticals Inc (NASDAQ:ACRX): $3.15; +31%.
ImmunoCellular Therapeutics Ltd (NYSEMKT:IMUC): $1.22; +18%.
Inotek Pharmaceuticals Corp (NASDAQ:ITEK): $1.05; +13%.
Mirati Therapeutics, Inc. (NASDAQ:MRTX): $4.35; +12%.
DECLINERS:
Cyclacel Pharmaceuticals Inc (NASDAQ:CYCC): $3.08; -12%.
Concordia International Corp (NASDAQ:CXRX): $1.59; -10%.
Radius Health Inc (NASDAQ:RDUS): $42.97; -9%.
Dimension Therapeutics Inc (NASDAQ
MTX): $1.30; -7%.
Sangamo Therapeutics Inc (NASDAQ:SGMO): $9.40; -7%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: AMGN
EVENITY (Romosozumab)
Osteoporosis
CRL CRL issued July 16, 2017.
TICKER: AXSM
AXS-05 ADVANCE-1
Agitation in patients with Alzheimer’s disease (AD)
PHASE 2/3 Phase 2/3 initiation announced July 17, 2017.
TICKER: CBAY
Seladelpar
Primary biliary cholangitis (PBC)
PHASE 2 Phase 2 top-line data released late May 2016. Positive interim data from second trial data released July 17, 2017.
TICKER: NVAX
RSV F Vaccine immunogenicity trial
Respiratory Syncytial Virus (RSV) in older adults
PHASE 2 Phase 2 trial initiation announced January 19, 2017. Data to be released July 24, 2017.
TICKER: PBYI
Neratinib (NERLYNX)
Extended adjuvant HER2-positive early stage breast cancer
APPROVED Approval announced July 17, 2017. Advisory Committee Meeting May 24, 2017 voted 12-4 in favor of recommending approval.
TICKER: ONCE
Voretigene neparvovec (SPK-RPE65)
Inherited retinal dystrophies
PDUFA PRIORITY REVIEW PDUFA date January 12, 2018 under priority review.
TICKER: PRTK
Omadacycline - oral
Acute bacterial skin and skin structure infections (ABSSSI)
PHASE 3 Phase 3 data released July 17, 2017 - all endpoints met.
TICKER: RDHL
BEKINDA
IBS-D
PHASE 2 Phase 2 top-line data due September 2017. Noted July 17, 2017 that last patient has been enrolled.
TICKER: RPRX
Proellex
Uterine fibroids (oral treatment)
PHASE 2B Noted July 17, 2017 that clinical hold remains in place. Also noted large pre-approval safety data base required to support future development.
Puma PBYI receives FDA Approval; Repros RPRX clinical hold remains in place; NVAX data July 24
Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that the FDA has approved NERLYNX (neratinib) for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer. Approval was based on the placebo controlled ExteNET trial. After two years, invasive disease-free survival (iDFS) was 94.2% in patients treated with neratinib compared with 91.9% in those receiving placebo (HR 0.66; 95% CI: 0.49, 0.90, p=0.008). Shares are currently trading up 9% to $93.65 in the after-hours session.
Paratek Pharmaceuticals, Inc. (Nasdaq
RTK) announced that it met all primary and secondary endpoints in its Phase 3 trial of omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Shares are currently trading up 4.2% in the after-hours session to $26.00 after closing up 3.7% during normal trading hours. Repros Therapeutics Inc., (Nasdaq:RPRX) noted that the FDA has kept in place the clinical hold for Proellex. The FDA also indicated that the company will be required to compile a large pre-approval safety data base to support future development. Shares slumped to close down 33% to $0.385.
Novavax, Inc. (Nasdaq:NVAX) announced it will host a conference on Monday, July 24, 2017, at 4:30 p.m. ET where it will announce top-line data from its Phase 2 safety and immunogenicity trial of the RSV F Vaccine in older adults (60 years of age and older).
Spark Therapeutics (NASDAQ:ONCE) announced that the FDA has granted priority review for the Biologics License Application (BLA) of voretigene neparvovec, for the treatment of patients with vision loss due to confirmed biallelic RPE65-mediated inherited retinal disease (IRD). The PDUFA date is January 12, 2018.
CymaBay Therapeutics, Inc. (Nasdaq:CBAY) announced interim results from its ongoing low-dose Phase 2 study of seladelpar in patients with primary biliary cholangitis (PBC). A planned interim analysis showed after 12 weeks of treatment a significant reduction in alkaline phosphatase (AP) levels of of 39% and 45% for the 5 mg and 10 mg groups, respectively. Shares closed up 6% to $5.98 after trading as high as $7.77 early in the session. After hours, the company announced that it intends to offer and sell 10m shares of its common stock.
Other Major price movers (stocks priced > $1.00, volume > 100k):
Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume INCLUDING sub-$1 stocks.
ADVANCERS:
Soligenix, Inc. (NASDAQ:SNGX): $2.82; +36%.
AcelRx Pharmaceuticals Inc (NASDAQ:ACRX): $3.15; +31%.
ImmunoCellular Therapeutics Ltd (NYSEMKT:IMUC): $1.22; +18%.
Inotek Pharmaceuticals Corp (NASDAQ:ITEK): $1.05; +13%.
Mirati Therapeutics, Inc. (NASDAQ:MRTX): $4.35; +12%.
DECLINERS:
Cyclacel Pharmaceuticals Inc (NASDAQ:CYCC): $3.08; -12%.
Concordia International Corp (NASDAQ:CXRX): $1.59; -10%.
Radius Health Inc (NASDAQ:RDUS): $42.97; -9%.
Dimension Therapeutics Inc (NASDAQ
MTX): $1.30; -7%. Sangamo Therapeutics Inc (NASDAQ:SGMO): $9.40; -7%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: AMGN
EVENITY (Romosozumab)
Osteoporosis
CRL CRL issued July 16, 2017.
TICKER: AXSM
AXS-05 ADVANCE-1
Agitation in patients with Alzheimer’s disease (AD)
PHASE 2/3 Phase 2/3 initiation announced July 17, 2017.
TICKER: CBAY
Seladelpar
Primary biliary cholangitis (PBC)
PHASE 2 Phase 2 top-line data released late May 2016. Positive interim data from second trial data released July 17, 2017.
TICKER: NVAX
RSV F Vaccine immunogenicity trial
Respiratory Syncytial Virus (RSV) in older adults
PHASE 2 Phase 2 trial initiation announced January 19, 2017. Data to be released July 24, 2017.
TICKER: PBYI
Neratinib (NERLYNX)
Extended adjuvant HER2-positive early stage breast cancer
APPROVED Approval announced July 17, 2017. Advisory Committee Meeting May 24, 2017 voted 12-4 in favor of recommending approval.
TICKER: ONCE
Voretigene neparvovec (SPK-RPE65)
Inherited retinal dystrophies
PDUFA PRIORITY REVIEW PDUFA date January 12, 2018 under priority review.
TICKER: PRTK
Omadacycline - oral
Acute bacterial skin and skin structure infections (ABSSSI)
PHASE 3 Phase 3 data released July 17, 2017 - all endpoints met.
TICKER: RDHL
BEKINDA
IBS-D
PHASE 2 Phase 2 top-line data due September 2017. Noted July 17, 2017 that last patient has been enrolled.
TICKER: RPRX
Proellex
Uterine fibroids (oral treatment)
PHASE 2B Noted July 17, 2017 that clinical hold remains in place. Also noted large pre-approval safety data base required to support future development.
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