BioPharm Catalyst -(MNKD has been on a bit of a run. Glad I got out last Friday - see highlighted section)
Ardelyx, Inc. (NASDAQ: ARDX) shares are trading up 34% to $7.25 in the after-hours session following news that it met the primary endpoint and all secondary endpoints in its Phase 3 T3MPO-2 trial of tenapanor for the treatment of irritable bowel syndrome with constipation (IBS-C). The primary endpoint, the combined responder rate for six of 12 weeks, showed that 36.5% of patients, compared with 23.7% on placebo ( p<0.001), had at least a 30% reduction in abdominal pain and an increase of one or more complete spontaneous bowel movements (CSBM) in the same week for at least six of the 12 weeks of the treatment period. Rates of diarrhea were higher in the tenapanor arm (16.0% vs. 3.7%). Results from its first Phase 3 trial, released in May, showed primary endpoint data of 27% vs 18.7% (p=0.02) and rates of diarrhea of 14.6% vs 1.7% for placebo. The company expects to submit a NDA filing in 2H 2018.
Trevena, Inc. (NASDAQ:TRVN) announced that it will be reducing its workforce by 30% as it halts its investment in early stage research. While it intends to complete its ongoing Phase 1 trial of TRV250 for acute migraine, it will assess options for further development following the trial. Trevena noted that it still intends to file its New Drug Application with the FDA for OLINVO later this month. Shares have slid in the after-hours session, currently trading down 11% to $2.11.
Aerie Pharmaceuticals Inc (NASDAQ:AERI) shares surged 16% to $64.30 following the release of briefing documents for its upcoming FDA panel meeting that support the efficacy of its NDA of Rhopressa for the treatment of patients with open-angle glaucoma or ocular hypertension. The FDA Dermatologic and Ophthalmic Drugs Advisory Committee will meet on October 13 to review Rhopressa. The PDUFA goal date is February 28, 2018.
Merck (NYSE: MRK) announced that it will not submit regulatory approval for anacetrapib, for the treatment of lowering cholesterol. The decision follows its announcement mid-year that it met the primary endpoint in its Phase 3 REVEAL trial but did not meet they key secondary endpoint of major atherosclerotic events.
Bioblast Pharma Ltd (NASDAQ:ORPN) shares closed up 54% to $3.24 following the receipt of a patent from the European Patent Office (EPO) for Mitochondrial proteins constructs and uses.
Intellipharmaceutics International Inc. (Nasdaq:IPCI) announced a registered direct offering with institutional investors for the sale of 3,636,364 shares at a price of $1.10 per share for gross proceeds of approximately $4m. Warrants with an exercise price of $1.25 per share were included in the offering. Shares closed down 5% to $1.08.
MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX) announced that it will sell 769,231 shares at a price of $0.65 per share in a registered direct offering for gross proceeds of approximately $500,000. Shares closed up 24% to $0.78.
MannKind Corporation (NASDAQ:MNKD) announced a registered direct offering of 10,166,600 shares of at an offering price of $6 per share, for gross proceeds of approximately $61m. Shares closed down 18% to $5.47.
Protagonist Therapeutics, Inc. (Nasdaq: PTGX) also announced that it intends to offer shares of its common stock in an underwritten public offering. Shares are trading down 12% to $17.45 in the after-hours session.
Other 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:
Kitov Pharmaceuticals (NASDAQ:KTOV): $3.15; +56%.
Sorrento Therapeutics Inc (NASDAQ:SRNE): $3.70; +48%.
CASI Pharmaceuticals Inc (NASDAQ:CASI): $3.28; +48%.
Celsion Corporation (NASDAQ:CLSN): $5.84; +27%.
Akari Therapeutics (NASDAQ:AKTX): $7.40; +23%.
DECLINERS:
Chiasma Inc (NASDAQ:CHMA): $2.55; -12%.
Endocyte, Inc. (NASDAQ:ECYT): $4.83; -7%.
Sierra Oncology Inc (NASDAQ:SRRA): $1.70; -6%.
Beigene Ltd (NASDAQ:BGNE): $108.05; -6%.
Adaptimmune Therapeutics (NASDAQ:ADAP): $7.84; -6%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: ABEO
ABO-102
Sanfilippo syndrome type A (MPS IIIA)
PHASE 1/2 Phase 1/2 commencement of enrollment in pivotal trial expansion announced October 11, 2017.
TICKER: ARDX
Tenapanor (T3MPO-2)
Constipation-predominant irritable bowel syndrome (IBS-C)
PHASE 3 Phase 3 data released October 11, 2017. Primary endpoint met but with relatively high rates of diarrhea. NDA filing due 2H 2018.
TICKER: AKTX
Coversin
Paroxysmal nocturnal hemoglobinuria (PNH)
PHASE 2 Phase 2 interim data released April 24, 2017. Further update due at ASH December 9-12, 2017. Phase 3 program to commence 1Q 2018.
TICKER: JNJ
Apalutamide
Non-metastatic castration-resistant prostate cancer (CRPC)
NDA FILING NDA filing announced October 11, 2017.
TICKER: MRK
Anacetrapib (MK-0859)
Raising HDL-C and reducing LDL-C
PHASE 3 Phase 3 data due released June 27, 2017. Primary endpoint met but noted August 29, 2017 that key secondary endpoint was not met. Announced October 11, 2017 that it will not seek regulatory approval.
TICKER: ONCS
ImmunoPulse IL-12 - PISCES
Melanoma - cancer
PHASE 2B Phase 2b data due mid-2018.
TICKER: ONCS
ImmunoPulse IL-12
Melanoma
PHASE 2 Updated data due at SITC meeting - November 11, 2017.
TICKER: SGEN
SGN-LIV1A (I-SPY 2)
Neoadjuvant for newly diagnosed Stage 2 or 3 HER2 negative breast cancer
PHASE 2 Phase 2 trial to be initiated.
TICKER: SGEN
SGN-LIV1A + KEYTRUDA
First-line triple negative breast cancer (TNBC)
PHASE 1/2 Phase 1/2 trial to be initiated.
TICKER: TRVN
Oliceridine (TRV130)
Moderate to severe acute pain
PHASE 3 Phase 3 APOLLO-1 and APOLLO-2 data released February 21, 2017 - primary endpoints met. Confirmed October 11, 2017 that NDA filing due this month.
TICKER: TTNP
Ropinirole implant
Parkinson's disease
PHASE 1/2 Phase 1/2 treatment has commenced - noted October 11, 2017.
Ardelyx, Inc. (NASDAQ: ARDX) shares are trading up 34% to $7.25 in the after-hours session following news that it met the primary endpoint and all secondary endpoints in its Phase 3 T3MPO-2 trial of tenapanor for the treatment of irritable bowel syndrome with constipation (IBS-C). The primary endpoint, the combined responder rate for six of 12 weeks, showed that 36.5% of patients, compared with 23.7% on placebo ( p<0.001), had at least a 30% reduction in abdominal pain and an increase of one or more complete spontaneous bowel movements (CSBM) in the same week for at least six of the 12 weeks of the treatment period. Rates of diarrhea were higher in the tenapanor arm (16.0% vs. 3.7%). Results from its first Phase 3 trial, released in May, showed primary endpoint data of 27% vs 18.7% (p=0.02) and rates of diarrhea of 14.6% vs 1.7% for placebo. The company expects to submit a NDA filing in 2H 2018.
Trevena, Inc. (NASDAQ:TRVN) announced that it will be reducing its workforce by 30% as it halts its investment in early stage research. While it intends to complete its ongoing Phase 1 trial of TRV250 for acute migraine, it will assess options for further development following the trial. Trevena noted that it still intends to file its New Drug Application with the FDA for OLINVO later this month. Shares have slid in the after-hours session, currently trading down 11% to $2.11.
Aerie Pharmaceuticals Inc (NASDAQ:AERI) shares surged 16% to $64.30 following the release of briefing documents for its upcoming FDA panel meeting that support the efficacy of its NDA of Rhopressa for the treatment of patients with open-angle glaucoma or ocular hypertension. The FDA Dermatologic and Ophthalmic Drugs Advisory Committee will meet on October 13 to review Rhopressa. The PDUFA goal date is February 28, 2018.
Merck (NYSE: MRK) announced that it will not submit regulatory approval for anacetrapib, for the treatment of lowering cholesterol. The decision follows its announcement mid-year that it met the primary endpoint in its Phase 3 REVEAL trial but did not meet they key secondary endpoint of major atherosclerotic events.
Bioblast Pharma Ltd (NASDAQ:ORPN) shares closed up 54% to $3.24 following the receipt of a patent from the European Patent Office (EPO) for Mitochondrial proteins constructs and uses.
Intellipharmaceutics International Inc. (Nasdaq:IPCI) announced a registered direct offering with institutional investors for the sale of 3,636,364 shares at a price of $1.10 per share for gross proceeds of approximately $4m. Warrants with an exercise price of $1.25 per share were included in the offering. Shares closed down 5% to $1.08.
MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX) announced that it will sell 769,231 shares at a price of $0.65 per share in a registered direct offering for gross proceeds of approximately $500,000. Shares closed up 24% to $0.78.
MannKind Corporation (NASDAQ:MNKD) announced a registered direct offering of 10,166,600 shares of at an offering price of $6 per share, for gross proceeds of approximately $61m. Shares closed down 18% to $5.47.
Protagonist Therapeutics, Inc. (Nasdaq: PTGX) also announced that it intends to offer shares of its common stock in an underwritten public offering. Shares are trading down 12% to $17.45 in the after-hours session.
Other 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:
Kitov Pharmaceuticals (NASDAQ:KTOV): $3.15; +56%.
Sorrento Therapeutics Inc (NASDAQ:SRNE): $3.70; +48%.
CASI Pharmaceuticals Inc (NASDAQ:CASI): $3.28; +48%.
Celsion Corporation (NASDAQ:CLSN): $5.84; +27%.
Akari Therapeutics (NASDAQ:AKTX): $7.40; +23%.
DECLINERS:
Chiasma Inc (NASDAQ:CHMA): $2.55; -12%.
Endocyte, Inc. (NASDAQ:ECYT): $4.83; -7%.
Sierra Oncology Inc (NASDAQ:SRRA): $1.70; -6%.
Beigene Ltd (NASDAQ:BGNE): $108.05; -6%.
Adaptimmune Therapeutics (NASDAQ:ADAP): $7.84; -6%.
Pipeline updates below:
DRUG STAGE CATALYST
TICKER: ABEO
ABO-102
Sanfilippo syndrome type A (MPS IIIA)
PHASE 1/2 Phase 1/2 commencement of enrollment in pivotal trial expansion announced October 11, 2017.
TICKER: ARDX
Tenapanor (T3MPO-2)
Constipation-predominant irritable bowel syndrome (IBS-C)
PHASE 3 Phase 3 data released October 11, 2017. Primary endpoint met but with relatively high rates of diarrhea. NDA filing due 2H 2018.
TICKER: AKTX
Coversin
Paroxysmal nocturnal hemoglobinuria (PNH)
PHASE 2 Phase 2 interim data released April 24, 2017. Further update due at ASH December 9-12, 2017. Phase 3 program to commence 1Q 2018.
TICKER: JNJ
Apalutamide
Non-metastatic castration-resistant prostate cancer (CRPC)
NDA FILING NDA filing announced October 11, 2017.
TICKER: MRK
Anacetrapib (MK-0859)
Raising HDL-C and reducing LDL-C
PHASE 3 Phase 3 data due released June 27, 2017. Primary endpoint met but noted August 29, 2017 that key secondary endpoint was not met. Announced October 11, 2017 that it will not seek regulatory approval.
TICKER: ONCS
ImmunoPulse IL-12 - PISCES
Melanoma - cancer
PHASE 2B Phase 2b data due mid-2018.
TICKER: ONCS
ImmunoPulse IL-12
Melanoma
PHASE 2 Updated data due at SITC meeting - November 11, 2017.
TICKER: SGEN
SGN-LIV1A (I-SPY 2)
Neoadjuvant for newly diagnosed Stage 2 or 3 HER2 negative breast cancer
PHASE 2 Phase 2 trial to be initiated.
TICKER: SGEN
SGN-LIV1A + KEYTRUDA
First-line triple negative breast cancer (TNBC)
PHASE 1/2 Phase 1/2 trial to be initiated.
TICKER: TRVN
Oliceridine (TRV130)
Moderate to severe acute pain
PHASE 3 Phase 3 APOLLO-1 and APOLLO-2 data released February 21, 2017 - primary endpoints met. Confirmed October 11, 2017 that NDA filing due this month.
TICKER: TTNP
Ropinirole implant
Parkinson's disease
PHASE 1/2 Phase 1/2 treatment has commenced - noted October 11, 2017.
'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
