BioPharm Catalysts
CARA releases disappointing Phase 2b osteoarthritis data - shares slide 26%
Cara Therapeutics, Inc. (Nasdaq:CARA) shares have fallen sharply in the after-hours session, currently trading down 26% to $18.92 following disappointing data from its Phase 2b trial of CR845, in patients with osteoarthritis (OA) of the knee or hip. The company noted that all patients (OA of the knee or hip) maintained on the 5.0 mg dose to the end of the eight-week treatment period exhibited a 35 percent reduction in mean joint pain score (p=0.111 vs. placebo). Patients maintained on the 1.0 mg and 2.5 mg tablet strengths did not exhibit significant reductions in mean joint pain scores compared to placebo.
Alkermes plc (NASDAQ: ALKS) announced preliminary top-line results from ENLIGHTEN-1, the first of two Phase 3 trials of ALKS 3831 compared with olanzapine and placebo for the treatment of schizophrenia. The trial met the primary endpoint, with ALKS 3831 demonstrating statistically significant reductions in Positive and Negative Syndrome Scale (PANSS) scores compared to placebo (p<0.001). The most common adverse events for both the ALKS 3831 and olanzapine treatment groups were weight gain, somnolence and dry mouth. Investors appear weary of the weight gain noted with shares currently trading down 2.8% to $56.30 in the after-hours session.
Amgen (NASDAQ:AMGN) announced the FDA has approved the supplemental Biologics License Application (sBLA) for Vectibix (panitumumab) for patients with wild-type RAS metastatic colorectal cancer (mCRC) as first-line therapy in combination with FOLFOX and as monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy.
Omeros Corporation (NASDAQ: OMER) responded to a short report published by Art Doyle (Twitter: @ArtDoyle2017) which saw its stock sell of 9% in Wednesday’s session. The article focused on inaccuracies and deception in regard to the development of OMS721. Omeros response saw shares close up marginally 1.2% to $20.59 in Thursday’s session.
This report is replete with falsehoods, misleading statements and incorrect analyses and conclusions. “Art Doyle” states that it stands to profit in the event that Omeros’ share price declines. The report is actionable and the company is pursuing legal remedies. Omeros intends to hold all responsible parties accountable.
Nymox Pharmaceutical Corporation (NASDAQ:NYMX) shares closed up 12% to $4.60. While no news was released by the company, an insider purchase by Director James George Robinson might explain the move.
Moleculin Biotech, Inc., (NASDAQ: MBRX) shares, which shot up from $0.81 last week to $3.28 at Wednesday’s close, closed down 9% during normal trading hours to $2.97. Shares are currently down a further 21% to $2.34 in the after-hours session. The company held a conference call falling short of investor expectations of what the company previously signposted as including a new discovery of a metabolic inhibitor with the potential to treat pancreatic cancer.
Major price movers (stocks priced > $1.00, volume > 100k):
ADVANCERS:
Strongbridge Biopharma (NASDAQ:SBBP): $7.35; +20%.
Obseva SA (NASDAQ:OBSV): $7.50; +19%.
Conatus Pharmaceuticals Inc (NASDAQ:CNAT): $6.20; +11%
Minerva Neurosciences Inc (NASDAQ:NERV): $8.75; +10%.
Proteon Therapeutics Inc (NASDAQ
RTO): $1.50; +7%.
DECLINERS:
Cascadian Therapeutics Inc (NASDAQ:CASC): $3.73; -12%.
Bellicum Pharmaceuticals Inc (NASDAQ:BLCM): $12.02; -10%.
OncoSec Medical Inc (NASDAQ:ONCS): $1.15; -7%.
Cleveland BioLabs, Inc. (NASDAQ:CBLI): $3.00; -9%.
Prima BioMed Ltd (ADR) (NASDAQBMD): $2.16; -7%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: ACHN
ACH-4471
Paroxysmal nocturnal hemoglobinuria (PNH)
PHASE 2 Phase 2 initiation announced April 6, 2017. Interim data due 2Q 2017 according to company guidance. However, analysts at Leerink suggest that data will be released in July/August timeframe during next earnings release.
TICKER: ACOR
INBRIJA (CVT-301)
OFF episodes of Parkinson’s disease (PD)
NDA FILING Phase 3 data released February 9, 2017 - primary endpoint met. NDA filing announced June 29, 2017.
TICKER: ACRS
A-101
Common warts (verruca vulgaris)
PHASE 2B Phase 2 data released August 2016. Phase 2b trial initiation announced June 29, 2017.
TICKER: ADRO
CRS-207 with KEYTRUDA
Gastric cancer
PHASE 2 Phase 2 trial initiation noted June 29, 2017.
TICKER: ALKS
ALKS 3831 - ENLIGHTEN-1
Schizophrenia
PHASE 3 Phase 3 preliminary data released June 30, 2017. Primary endpoint met - adverse events included weight gain.
TICKER: BTX
OpRegen
Dry age-related macular degeneration (AMD)
PHASE 1/2 Phase 2 second cohort underway. Interim data presented at May 8, 2017 at ARVO conference. Third cohort enrollment pending DSMB review due mid-2017.
TICKER: CARA
CR845
Osteoarthritis (OA)
PHASE 2B Phase 2b data released June 29, 2017 - trial failed.
TICKER: CYTK
CK-2127107
Limited mobility
PHASE 1B Phase 1b trial initiation announced June 29, 2017.
TICKER: AMGN
Vectibix (Panitumumab)
Wild-Type RAS Metastatic Colorectal Cancer
APPROVED sBLA approval announced June 29, 2017.
TICKER: KMPH
KP415
ADHD
PHASE 2 Phase 1 trial completed December 2016. Efficacy trials to commence 2H 2017, with data 1H 2018.
TICKER: MYOV
Relugolix - SPIRIT 2
Endometriosis-associated pain
PHASE 3 Phase 3 initiation announced June 29, 2017.
TICKER: MYOV
Relugolix - SPIRIT 1
Endometriosis-associated pain
PHASE 3 Phase 3 initiation announced June 29, 2017.
CARA releases disappointing Phase 2b osteoarthritis data - shares slide 26%
Cara Therapeutics, Inc. (Nasdaq:CARA) shares have fallen sharply in the after-hours session, currently trading down 26% to $18.92 following disappointing data from its Phase 2b trial of CR845, in patients with osteoarthritis (OA) of the knee or hip. The company noted that all patients (OA of the knee or hip) maintained on the 5.0 mg dose to the end of the eight-week treatment period exhibited a 35 percent reduction in mean joint pain score (p=0.111 vs. placebo). Patients maintained on the 1.0 mg and 2.5 mg tablet strengths did not exhibit significant reductions in mean joint pain scores compared to placebo.
Alkermes plc (NASDAQ: ALKS) announced preliminary top-line results from ENLIGHTEN-1, the first of two Phase 3 trials of ALKS 3831 compared with olanzapine and placebo for the treatment of schizophrenia. The trial met the primary endpoint, with ALKS 3831 demonstrating statistically significant reductions in Positive and Negative Syndrome Scale (PANSS) scores compared to placebo (p<0.001). The most common adverse events for both the ALKS 3831 and olanzapine treatment groups were weight gain, somnolence and dry mouth. Investors appear weary of the weight gain noted with shares currently trading down 2.8% to $56.30 in the after-hours session.
Amgen (NASDAQ:AMGN) announced the FDA has approved the supplemental Biologics License Application (sBLA) for Vectibix (panitumumab) for patients with wild-type RAS metastatic colorectal cancer (mCRC) as first-line therapy in combination with FOLFOX and as monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy.
Omeros Corporation (NASDAQ: OMER) responded to a short report published by Art Doyle (Twitter: @ArtDoyle2017) which saw its stock sell of 9% in Wednesday’s session. The article focused on inaccuracies and deception in regard to the development of OMS721. Omeros response saw shares close up marginally 1.2% to $20.59 in Thursday’s session.
This report is replete with falsehoods, misleading statements and incorrect analyses and conclusions. “Art Doyle” states that it stands to profit in the event that Omeros’ share price declines. The report is actionable and the company is pursuing legal remedies. Omeros intends to hold all responsible parties accountable.
Nymox Pharmaceutical Corporation (NASDAQ:NYMX) shares closed up 12% to $4.60. While no news was released by the company, an insider purchase by Director James George Robinson might explain the move.
Moleculin Biotech, Inc., (NASDAQ: MBRX) shares, which shot up from $0.81 last week to $3.28 at Wednesday’s close, closed down 9% during normal trading hours to $2.97. Shares are currently down a further 21% to $2.34 in the after-hours session. The company held a conference call falling short of investor expectations of what the company previously signposted as including a new discovery of a metabolic inhibitor with the potential to treat pancreatic cancer.
Major price movers (stocks priced > $1.00, volume > 100k):
ADVANCERS:
Strongbridge Biopharma (NASDAQ:SBBP): $7.35; +20%.
Obseva SA (NASDAQ:OBSV): $7.50; +19%.
Conatus Pharmaceuticals Inc (NASDAQ:CNAT): $6.20; +11%
Minerva Neurosciences Inc (NASDAQ:NERV): $8.75; +10%.
Proteon Therapeutics Inc (NASDAQ
RTO): $1.50; +7%. DECLINERS:
Cascadian Therapeutics Inc (NASDAQ:CASC): $3.73; -12%.
Bellicum Pharmaceuticals Inc (NASDAQ:BLCM): $12.02; -10%.
OncoSec Medical Inc (NASDAQ:ONCS): $1.15; -7%.
Cleveland BioLabs, Inc. (NASDAQ:CBLI): $3.00; -9%.
Prima BioMed Ltd (ADR) (NASDAQ
BMD): $2.16; -7%. Pipeline updates below:
DRUG STAGE CATALYST
TICKER: ACHN
ACH-4471
Paroxysmal nocturnal hemoglobinuria (PNH)
PHASE 2 Phase 2 initiation announced April 6, 2017. Interim data due 2Q 2017 according to company guidance. However, analysts at Leerink suggest that data will be released in July/August timeframe during next earnings release.
TICKER: ACOR
INBRIJA (CVT-301)
OFF episodes of Parkinson’s disease (PD)
NDA FILING Phase 3 data released February 9, 2017 - primary endpoint met. NDA filing announced June 29, 2017.
TICKER: ACRS
A-101
Common warts (verruca vulgaris)
PHASE 2B Phase 2 data released August 2016. Phase 2b trial initiation announced June 29, 2017.
TICKER: ADRO
CRS-207 with KEYTRUDA
Gastric cancer
PHASE 2 Phase 2 trial initiation noted June 29, 2017.
TICKER: ALKS
ALKS 3831 - ENLIGHTEN-1
Schizophrenia
PHASE 3 Phase 3 preliminary data released June 30, 2017. Primary endpoint met - adverse events included weight gain.
TICKER: BTX
OpRegen
Dry age-related macular degeneration (AMD)
PHASE 1/2 Phase 2 second cohort underway. Interim data presented at May 8, 2017 at ARVO conference. Third cohort enrollment pending DSMB review due mid-2017.
TICKER: CARA
CR845
Osteoarthritis (OA)
PHASE 2B Phase 2b data released June 29, 2017 - trial failed.
TICKER: CYTK
CK-2127107
Limited mobility
PHASE 1B Phase 1b trial initiation announced June 29, 2017.
TICKER: AMGN
Vectibix (Panitumumab)
Wild-Type RAS Metastatic Colorectal Cancer
APPROVED sBLA approval announced June 29, 2017.
TICKER: KMPH
KP415
ADHD
PHASE 2 Phase 1 trial completed December 2016. Efficacy trials to commence 2H 2017, with data 1H 2018.
TICKER: MYOV
Relugolix - SPIRIT 2
Endometriosis-associated pain
PHASE 3 Phase 3 initiation announced June 29, 2017.
TICKER: MYOV
Relugolix - SPIRIT 1
Endometriosis-associated pain
PHASE 3 Phase 3 initiation announced June 29, 2017.
'Everything works out in the end,,,If it hasn't worked out,,it's not the end'
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https://twitter.com/twitter/statuses/957208055766241280
