BPC JUNE 17 UPDATE
17 Biotech Stocks to Watch June/July 2017; Biotech Week in Review ~ 16 June 2017
Weekly watchlist
A number of key June catalysts from last week's BioPharmCatalyst Watch List hit trading screens during the last week. However, there is still a plateful of catalysts left on the calendar for June, yet only two weeks remain in the month. In this week's watch list we highlight a number of such catalysts while also including a handful slated for July or "mid-2017", which most likely refers to either June/July.
Before we do so, let's review the week that was with five key biotech events.
Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) announced that the FDA approved Epinephrine pre-filled syringe for the emergency treatment of allergic reactions. The good news was welcomed by both investors and the company not only due to the fact that the FDA had issued two previous Complete Response Letters (CRLs) but also due to the news having a significant positive impact on its share price, with shares surging Thursday to close up 53% to $5.75 before retracing some ground (8%) on Friday.
Coherus BioSciences, Inc. (NASDAQ:CHRS) shares dropped sharply to close the week down 28% to $14.85 following its announcement that the FDA issued a CRL for its Biologics License Application (BLA) for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate. No further trials were requested by the FDA and the company expects to respond to the agency in the coming months.
Axovant Sciences (NYSE: AXON) provided a key pipeline update when it reported financial results for the latest quarter. It noted that data from its Phase 3 MINDSET trial of intepirdine in subjects with mild-to-moderate Alzheimer's disease will be released in late September. While this update alone did not have a large impact on its share price this latest week, this key biotech binary event is shaping up as a major stock price moving event for 3Q 2017.
Omeros Corporation (NASDAQ:OMER) shares surged to close the week up 55% to $23.75. The bullish move was in response to news that the company was granted Breakthrough Therapy Designation (BTD) by the FDA for OMS721 for the treatment of Immunoglobulin A (IgA) nephropathy. BTD is issued if the FDA believes that preliminary data indicates that the drug may demonstrate substantial improvement over existing therapies. Once granted, the FDA will expedite the development and review of such drugs.
Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) shares closed the week down 15% to $4.30 following its announcement Wednesday that it did not meet the primary endpoint in its Phase 2b clinical trial of ADX-102 in patients with allergic conjunctivitis. The company did note, however, that it intends to proceed with Phase 3 trials based on it coming close to meeting the one-point threshold required for primary efficacy among seasonal allergy patients.
18 Upcoming Biotech Stocks to Watch below – June/July 2017:
DRUG STAGE CATALYST
AGIO
AG-348
Pyruvate kinase deficiency
Phase 2 Phase 2 first data released at EHA meeting June 2016. Updated data due at EHA June 24, 2017 with further data due 2H 2017.
ALDR
ALD403 - PROMISE 1
Frequent episodic migraine
Phase 3 Phase 3 PROMISE 1 topline data due 2Q 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.
CLVS
Rucaparib ARIEL3
Ovarian cancer patients with a BRCA-like mutation
Phase 3 Pivotal trial initiated late 2013. Enrolment completed 2Q 2016. Data due June 2017.
BLUE
LentiGlobin - HGB-207 Northstar-2
non-β0/β0 transfusion-dependent thalassemia (TDT)
Phase 3 Noted on December 14, 2016 that Phase 3 dosing has commenced. Early data due at EHA June 25, 2017.
CARA
CR845
Osteoarthritis (OA)
Phase 2b Phase 2b trial initiated September, 2016. Data are due 2Q 2017.
CYTR
Aldoxorubicin
Relapsed/refractory small cell lung cancer
Phase 2b Phase 2b data due 2Q 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.
GBT
GBT440
Sickle cell disease in adolescents
Phase 1/2 Phase 2a initiated June 2016. Preliminary data due at European Hematology Association (EHA) - June 24, 2017.
GEMP
Gemcabene - COBALT-1
Homozygous Familial Hypercholesterolemia (HoFH)
Phase 2b Phase 2b data due June 2017.
NEOS
Cotempla XR-ODT
Attention deficit hyperactivity disorder (ADHD)
PDUFA CRL issued November 2015. PDUFA date June 19, 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.
PBYI
Neratinib
Third-line HER2-positive metastatic breast cancer
Phase 3 Phase 3 data due 2Q 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".
PTLA
Betrixaban (The APEX Study)
Venous thromboembolism (VTE) Prevention
PDUFA priority review PDUFA date under priority review June 24, 2017. Phase 3 data released March 2016 did not meet primary endpoint.
STML
SL-401
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) cancer
Phase 2 Phase 2 enrollment completed - noted March 23, 2017. Update on patients enrolled in Stages 1 and 2 due at EHA June 23, 2017 with top-line data from Stage 3 due 2H 2017.
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