BPC JULY 15 UPDATE
10 Upcoming Biotech Catalysts; Biotech Week in Review ~ July 14, 2017
Weekly watchlist
The first full trading week of July ended on a positive note with the IBB (iShares NASDAQ Biotechnology Index ETF) approaching 52-week highs. While the newsflow was certainly not excessive, one only has to look at the BioPharmCatalyst FDA Calendar to realise that the next four weeks will without a doubt be packed with FDA related events and clinical trial readouts.
Before we look at 10 upcoming catalysts for the next four weeks, let's review the week that was.
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) shares closed Tuesday’s session up 41% to $26.00 following its announcement that its Phase 2 trial of ralinepag for the treatment of pulmonary arterial hypertension (PAH) met the primary endpoint of a significant improvement in pulmonary vascular resistance (PVR) compared to placebo (0.03). The company took advantage of the positive sentiment by announcing a stock offering which saw its shares pull back some its gains, closing the week at $24.28.
Ocular Therapeutix, Inc. (NASDAQ:OCUL) announced early in the week that that it received a Complete Response Letter (CRL) from the FDA for its NDA of DEXTENZA for the treatment of ocular pain following ophthalmic surgery. The company has had ongoing challenges in regard to manufacturing deficiencies identified by the FDA since first concerns were raised when it was issued a CRL in July 2016.
The FDA Oncologic Drugs Advisory Committee overwhelmingly voted 10-0 in favor of recommending approval for CTL019, in development by Novartis (NVS), as a treatment for pediatric and young adult patients with relapsed and refractory B-cell acute lymphoblastic leukemia (ALL). CTL019 is on track to become the first approved CAR-T therapy, with final approval under priority review expected by September 29, 2017.
Amicus Therapeutics (Nasdaq:FOLD) and its investors received much welcome news Tuesday when it announced that the FDA no longer requires the company to initiate a Phase 3 trial prior to submitting its New Drug Application (NDA) for migalastat in patients with Fabry disease. This took many off guard as the FDA had previously requested Amicus to complete an additional Phase 3 trial. Data were not expected to be released until 2019. However, Tuesday’s news will allow Amicus to file its NDA by the end of 2017. Shares closed the week up 23% to $12.84.
Let’s now have a look over TEN upcoming catalysts, all of which should hit the screens within the next four weeks:
DRUG STAGE CATALYST
ACRX
Zalviso
Post-operative pain following open abdominal surgery and hip or knee replacement surgery
Phase 3 CRL Jul 26 2014. Additional clinical trial required. Phase 3 trial initiated September 2016. Data due mid-2017.
ALNY
Patisiran APOLLO
Familial Amyloidotic Polyneuropathy (FAP) in Patients with ATTR
Phase 3 Phase 3 data due mid-2017.
AZN
Durvalumab +/- tremelimumab (MYSTIC)
Lung cancer
Phase 3 Phase 3 PFS data mid-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.
IPCI
Rexista
Pain relief
PDUFA Advisory Committee Meeting July 26, 2017. PDUFA date September 25, 2017.
IRWD
IW-3718
Gastroesophageal reflux disease (GERD)
Phase 2b Phase 2b data due mid-2017.
PBYI
PB272 ExteNET trial
Extended adjuvant HER2-positive early stage breast cancer
PDUFA NDA filing announced July 21, 2016. Announced acceptance of NDA Filing September 20, 2016. PDUFA estimate July 21, 2017. Advisory Committee Meeting May 24, 2017 voted 12-4 in favor of recommending approval.
PRTK
Omadacycline - oral
Acute bacterial skin and skin structure infections (ABSSSI)
Phase 3 Phase 3 completion of enrollment announced May 8, 2017. Data due mid-July 2017. Estimate data coming week of July 17, 2017.
RDHL
RHB-104 MAP US
Crohn’s disease
Phase 3 Phase 3 DSMB safety analysis released December 13, 2016 - trial to continue as planned. Interim efficacy analysis due early August 2017 - assume latest possible date is August 15.
VSTM
Duvelisib - DUO
Cancer - relapsed/refractory chronic lymphocytic leukemia (CLL)
Phase 3 Phase 3 data due mid-2017.
10 Upcoming Biotech Catalysts; Biotech Week in Review ~ July 14, 2017
Weekly watchlist
The first full trading week of July ended on a positive note with the IBB (iShares NASDAQ Biotechnology Index ETF) approaching 52-week highs. While the newsflow was certainly not excessive, one only has to look at the BioPharmCatalyst FDA Calendar to realise that the next four weeks will without a doubt be packed with FDA related events and clinical trial readouts.
Before we look at 10 upcoming catalysts for the next four weeks, let's review the week that was.
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) shares closed Tuesday’s session up 41% to $26.00 following its announcement that its Phase 2 trial of ralinepag for the treatment of pulmonary arterial hypertension (PAH) met the primary endpoint of a significant improvement in pulmonary vascular resistance (PVR) compared to placebo (0.03). The company took advantage of the positive sentiment by announcing a stock offering which saw its shares pull back some its gains, closing the week at $24.28.
Ocular Therapeutix, Inc. (NASDAQ:OCUL) announced early in the week that that it received a Complete Response Letter (CRL) from the FDA for its NDA of DEXTENZA for the treatment of ocular pain following ophthalmic surgery. The company has had ongoing challenges in regard to manufacturing deficiencies identified by the FDA since first concerns were raised when it was issued a CRL in July 2016.
The FDA Oncologic Drugs Advisory Committee overwhelmingly voted 10-0 in favor of recommending approval for CTL019, in development by Novartis (NVS), as a treatment for pediatric and young adult patients with relapsed and refractory B-cell acute lymphoblastic leukemia (ALL). CTL019 is on track to become the first approved CAR-T therapy, with final approval under priority review expected by September 29, 2017.
Amicus Therapeutics (Nasdaq:FOLD) and its investors received much welcome news Tuesday when it announced that the FDA no longer requires the company to initiate a Phase 3 trial prior to submitting its New Drug Application (NDA) for migalastat in patients with Fabry disease. This took many off guard as the FDA had previously requested Amicus to complete an additional Phase 3 trial. Data were not expected to be released until 2019. However, Tuesday’s news will allow Amicus to file its NDA by the end of 2017. Shares closed the week up 23% to $12.84.
Let’s now have a look over TEN upcoming catalysts, all of which should hit the screens within the next four weeks:
DRUG STAGE CATALYST
ACRX
Zalviso
Post-operative pain following open abdominal surgery and hip or knee replacement surgery
Phase 3 CRL Jul 26 2014. Additional clinical trial required. Phase 3 trial initiated September 2016. Data due mid-2017.
ALNY
Patisiran APOLLO
Familial Amyloidotic Polyneuropathy (FAP) in Patients with ATTR
Phase 3 Phase 3 data due mid-2017.
AZN
Durvalumab +/- tremelimumab (MYSTIC)
Lung cancer
Phase 3 Phase 3 PFS data mid-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.
IPCI
Rexista
Pain relief
PDUFA Advisory Committee Meeting July 26, 2017. PDUFA date September 25, 2017.
IRWD
IW-3718
Gastroesophageal reflux disease (GERD)
Phase 2b Phase 2b data due mid-2017.
PBYI
PB272 ExteNET trial
Extended adjuvant HER2-positive early stage breast cancer
PDUFA NDA filing announced July 21, 2016. Announced acceptance of NDA Filing September 20, 2016. PDUFA estimate July 21, 2017. Advisory Committee Meeting May 24, 2017 voted 12-4 in favor of recommending approval.
PRTK
Omadacycline - oral
Acute bacterial skin and skin structure infections (ABSSSI)
Phase 3 Phase 3 completion of enrollment announced May 8, 2017. Data due mid-July 2017. Estimate data coming week of July 17, 2017.
RDHL
RHB-104 MAP US
Crohn’s disease
Phase 3 Phase 3 DSMB safety analysis released December 13, 2016 - trial to continue as planned. Interim efficacy analysis due early August 2017 - assume latest possible date is August 15.
VSTM
Duvelisib - DUO
Cancer - relapsed/refractory chronic lymphocytic leukemia (CLL)
Phase 3 Phase 3 data due mid-2017.
'Everything works out in the end,,,If it hasn't worked out,,it's not the end'
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