Weekly Biopharmaceutical Update. This includes catalysts coming at the bottom of the page.
BPC JULY 07 UPDATE
15 July/mid-2017 Biotech Catalysts
Weekly watchlist
July promises to be another active month with a plateful of PDUFA action dates, Advisory Committee Meetings and clinical data readouts. 15 such events are highlighted below (note that catalysts slated for "mid-2017" are included in the list).
First, let’s review the week that was with five key events.
The first of which, is a website update from BioPharmCatalyst. The BioPharmCatalyst Biotech Stocks page has been created to track the Top 10 intra-day Gainers, Losers and stocks with highest levels of Relative Volume. All financial data on BioPharmCatalyst are now updated throughout the day with data delayed by 15-35 minutes.
Ocular Therapeutix Inc (NASDAQ:OCUL) shares slid to close Friday down 25% to $7.12. The downward move follows an article by STAT journalist Adam Feuerstein that the company is still having issues responding to manufacturing concerns noted in a Form 483 issued by the FDA in May. An FDA Form 483 is issued to companies when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements. The company has an upcoming PDUFA date slated for July 19 for DEXTENZA to treat ocular inflammation and pain following cataract surgery. This follows the issuance of a Complete Response Letter in July 2016 due to manufacturing deficiencies.
Celgene Corporation (NASDAQ:CELG) and BeiGene, Ltd. (NASDAQ:BGNE) announced Wednesday that they have entered into a partnership for the development of BeiGene’s PD-1 inhibitor, BGB-A317, for patients with solid tumor cancers. BeiGene will receive upfront $263m and Celgene will purchase 32.7m shares (American Depositary Shares ADS) at $59.55 per ADS . BeiGene is also eligible to receive up to $980 million in development, regulatory and sales milestone payments and royalties on future sales of BGB-A317. Shares of BeiGene surged to close the shortened week up 56% to $70.18.
Inotek Pharmaceuticals Corporation (NASDAQ: ITEK) shares plummeted in the after-hours session Friday following the failure of its Phase 2 trial of trabodenoson and latanoprost for the treatment of glaucoma. The company noted that after eight weeks of treatment no meaningful clinical advantage in intraocular pressure (IOP) reduction was observed. Shares closed the session down 45% to $0.95.
Merck (NYSE:MRK) announced Wednesday that the FDA has placed a clinical hold on three Keytruda trials (KEYNOTE-183,185 and 023), for the treatment of multiple myeloma. This decision follows a review of data that indicate that the risks of KEYTRUDA plus pomalidomide or lenalidomide outweigh any potential benefit for patients with multiple myeloma. Shares closed down the week 1.5% to $63.16.
15 Biotech Catalysts for July 2017 (binary events slated for “mid-2017 are included in this list). Note “SAGE” is officially slated for 3Q, however, it is added given that prior guidance was for release 2Q 2017.
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
Fitusiran
Hemophilia A and B
Phase 2 Phase 2 Open-label Extension Study new data due July 10, 2017 at ISTH.
ARNA
Ralinepag
Pulmonary Arterial Hypertension
Phase 2 Phase 2 data due July 2017.
AZN
Durvalumab +/- tremelimumab (MYSTIC)
Lung cancer
Phase 3 Phase 3 PFS data mid-2017.
BMRN
BMN 270
Hemophilia A
Phase 1/2 Phase 1/2 update due at International Society of Thrombosis and Haemostasis (ISTH) 2017 Congress, July 11, 2017. Phase 2b trial to be initiated 3Q 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.
NVS
CTL019
Relapsed/Refractory B-Cell Acute lymphoblastic leukemia
PDUFA priority review PDUFA date under priority review announced March 29, 2017. No date given. Assume 6-month review - September 29, 2017. Advisory Committee Meeting July 12, 2017.
OCUL
DEXTENZA
Ocular inflammation and pain following cataract surgery
PDUFA CRL July 25 2016 - due to manufacturing deficiencies. NDA resubmitted, PDUFA date July 19, 2017.
ONCE
SPK-9001
Hemophilia B
Phase 1/2 Phase 1/2 data at ASH 2016. Update released April 6, 2017 with further update due July 10, 2017 at International Society on Thrombosis and Haemostasis (ISTH).
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.
PCRX
EXPAREL
Single-dose injection femoral nerve block for total knee arthroplasty surgery
Phase 3 Phase 3 trials initiated 1Q 2016. Data from two trials due mid-2017.
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. July 15 estimate based on company guidance of "mid-July".
SAGE
SAGE-547
SRSE
Phase 3 Phase 3 data due 3Q 2017 - updated timeline received May 9, 2017. Previous guidance was for data release 2Q 2017.
BPC JULY 07 UPDATE
15 July/mid-2017 Biotech Catalysts
Weekly watchlist
July promises to be another active month with a plateful of PDUFA action dates, Advisory Committee Meetings and clinical data readouts. 15 such events are highlighted below (note that catalysts slated for "mid-2017" are included in the list).
First, let’s review the week that was with five key events.
The first of which, is a website update from BioPharmCatalyst. The BioPharmCatalyst Biotech Stocks page has been created to track the Top 10 intra-day Gainers, Losers and stocks with highest levels of Relative Volume. All financial data on BioPharmCatalyst are now updated throughout the day with data delayed by 15-35 minutes.
Ocular Therapeutix Inc (NASDAQ:OCUL) shares slid to close Friday down 25% to $7.12. The downward move follows an article by STAT journalist Adam Feuerstein that the company is still having issues responding to manufacturing concerns noted in a Form 483 issued by the FDA in May. An FDA Form 483 is issued to companies when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements. The company has an upcoming PDUFA date slated for July 19 for DEXTENZA to treat ocular inflammation and pain following cataract surgery. This follows the issuance of a Complete Response Letter in July 2016 due to manufacturing deficiencies.
Celgene Corporation (NASDAQ:CELG) and BeiGene, Ltd. (NASDAQ:BGNE) announced Wednesday that they have entered into a partnership for the development of BeiGene’s PD-1 inhibitor, BGB-A317, for patients with solid tumor cancers. BeiGene will receive upfront $263m and Celgene will purchase 32.7m shares (American Depositary Shares ADS) at $59.55 per ADS . BeiGene is also eligible to receive up to $980 million in development, regulatory and sales milestone payments and royalties on future sales of BGB-A317. Shares of BeiGene surged to close the shortened week up 56% to $70.18.
Inotek Pharmaceuticals Corporation (NASDAQ: ITEK) shares plummeted in the after-hours session Friday following the failure of its Phase 2 trial of trabodenoson and latanoprost for the treatment of glaucoma. The company noted that after eight weeks of treatment no meaningful clinical advantage in intraocular pressure (IOP) reduction was observed. Shares closed the session down 45% to $0.95.
Merck (NYSE:MRK) announced Wednesday that the FDA has placed a clinical hold on three Keytruda trials (KEYNOTE-183,185 and 023), for the treatment of multiple myeloma. This decision follows a review of data that indicate that the risks of KEYTRUDA plus pomalidomide or lenalidomide outweigh any potential benefit for patients with multiple myeloma. Shares closed down the week 1.5% to $63.16.
15 Biotech Catalysts for July 2017 (binary events slated for “mid-2017 are included in this list). Note “SAGE” is officially slated for 3Q, however, it is added given that prior guidance was for release 2Q 2017.
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
Fitusiran
Hemophilia A and B
Phase 2 Phase 2 Open-label Extension Study new data due July 10, 2017 at ISTH.
ARNA
Ralinepag
Pulmonary Arterial Hypertension
Phase 2 Phase 2 data due July 2017.
AZN
Durvalumab +/- tremelimumab (MYSTIC)
Lung cancer
Phase 3 Phase 3 PFS data mid-2017.
BMRN
BMN 270
Hemophilia A
Phase 1/2 Phase 1/2 update due at International Society of Thrombosis and Haemostasis (ISTH) 2017 Congress, July 11, 2017. Phase 2b trial to be initiated 3Q 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.
NVS
CTL019
Relapsed/Refractory B-Cell Acute lymphoblastic leukemia
PDUFA priority review PDUFA date under priority review announced March 29, 2017. No date given. Assume 6-month review - September 29, 2017. Advisory Committee Meeting July 12, 2017.
OCUL
DEXTENZA
Ocular inflammation and pain following cataract surgery
PDUFA CRL July 25 2016 - due to manufacturing deficiencies. NDA resubmitted, PDUFA date July 19, 2017.
ONCE
SPK-9001
Hemophilia B
Phase 1/2 Phase 1/2 data at ASH 2016. Update released April 6, 2017 with further update due July 10, 2017 at International Society on Thrombosis and Haemostasis (ISTH).
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.
PCRX
EXPAREL
Single-dose injection femoral nerve block for total knee arthroplasty surgery
Phase 3 Phase 3 trials initiated 1Q 2016. Data from two trials due mid-2017.
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. July 15 estimate based on company guidance of "mid-July".
SAGE
SAGE-547
SRSE
Phase 3 Phase 3 data due 3Q 2017 - updated timeline received May 9, 2017. Previous guidance was for data release 2Q 2017.
1
'Everything works out in the end,,,If it hasn't worked out,,it's not the end'
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