BPC June 23 update

11 Biotech Stock events to watch next week; Biotech week in review

Weekly watchlist

 Last week saw a steady stream of price moving biotech news and the last week of the first half of 2018 promises more of the same. An unusually large number of catalysts are still slated for release this month. It is not uncommon for companies to miss their time guidance by around a week so let’s see which companies meet their timelines.

First, news from the week that was:

Heron Therapeutics, Inc. (NASDAQ: HRTX) shares surged Thursday to close up 30% to $39.95 following news that its Phase 2b trial of HTX-011 in total knee arthroplasty and breast augmentation achieved the primary endpoints in both trials. 

Sarepta Therapeutics, Inc. (NASDAQ:SRPT) shares closed Tuesday up 37% to $143.93 following the release of positive preliminary data from its Phase 1/2a gene therapy clinical trial assessing micro-Dystrophin gene therapy in three patients with Duchenne muscular dystrophy (DMD). 

Anika Therapeutics, Inc. (NASDAQ: ANIK) shares closed Wednesday down 38% to $28.77 following news that its Phase 3 CINGAL trial in patients with osteoarthritis in the knee did not meet its primary endpoint.

ObsEva SA (NASDAQ: OBSV) announced Monday that its Phase 2b Edelweiss trial of linzagolix for the treatment of endometriosis-associated pain met the primary endpoint for the three top doses. Shares closed up 23% to $17.87.

PTC Therapeutics (NASDAQ: PTCT) shares closed Monday up 28% to $47.88 following the presentation of data from its Phase 1 trial of risdiplam for the treatment of spinal muscular atrophy (SMA) but sold off Tuesday following the DMD data from Sarepta.

Valeant Pharmaceuticals International, Inc. (NYSE: VRX) announced that it was issued a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for IDP-118 lotion in the treatment of plaque psoriasis. Shares closed Monday down 12% to $23.56.

Catalyst Biosciences, Inc. (Nasdaq:CBIO) shares slumped Monday to close down 64% to $9.11 following an update of its Phase 1/2 trial of CB 2679d/ISU304 for the treatment of severe hemophilia B that noted the presence of a neutralizing antibodies in patients' blood.

Ziopharm Oncology, Inc. (Nasdaq:ZIOP) announced Monday the FDA has placed on clinical hold its Sleeping Beauty Phase 1 trial to evaluate CD19-specific CAR-T therapies. Shares closed down 18% to $3.51.

11 biotech stock events to watch for the final week of June:

Drug Stage Catalyst Market Cap

ALKS – Alkermes plc
Aripiprazole Lauroxil NanoCrystal Dispersion (ALNCD)
Schizophrenia

Approved FDA approval announced July 2, 2018.
$3.4 billion

CARA – Cara Therapeutics Inc.
IV CR845
Acute pain

Phase 3 Phase 3 data released June 27, 2018. Company noted primary endpoint met but data mixed.
$1.1 billion

CTIC – CTI BioPharma Corp.
Pacritinib - PAC203
Myelofibrosis

Phase 2/3 Phase 2 data to be presented 3Q 2019 with Phase 3 trial to commence also in 3Q 2019 with data due mid-2021.
$49.5 million

DERM – Dermira Inc.
Glycopyrronium tosylate
Primary axillary hyperhidrosis

Approved Approval announced June 29, 2018.
$438.4 million

GBT – Global Blood Therapeutics Inc.
Voxelotor
Sickle cell disease

PDUFA priority review PDUFA date under priority review February 26, 2020.
$3.2 billion

GEMP – Gemphire Therapeutics Inc.
Gemcabene - INDIGO-1
Severe Hypertriglyceridemia (SHTG)

Phase 2b Phase 2b primary endpoint met - June 28, 2018.
$7.7 million

GWPH – GW Pharmaceuticals Plc
Epidiolex
Dravet Syndrome and Lennox-Gastaut syndrome

Approved Approval announced June 25, 2018.
$4.2 billion

MACK – Merrimack Pharmaceuticals Inc.
MM-141 - CARRIE
Cancer - front line pancreatic cancer

Phase 2 Phase 2 data released June 25, 2018 - endpoints not met.
$71.6 million

SPHS – Sophiris Bio Inc.
Topsalysin (PRX302)
Localized low to intermediate risk prostate cancer

Phase 2 Phase 3 trial dependent on funding.
$25.1 million