BPC August 02 update

Biotech stocks to watch reporting earnings; Key 3Q clinical readouts; Biotech week in review

Weekly watchlist

With August underway it is time to re-examine which major clinical data readouts are on the table for the two remaining months of the third quarter. GlycoMimetics (NASDAQ: GLYC) is a late scratch from the list following data released late-Friday (6:45pm).

We will also see the peak of second quarter earnings with likely around 200 companies covered by BioPharmCatalyst reporting this coming week. We highlight the key revenue earning companies that are set to report.

First, let’s review the week that was with most movers coming from earnings reports.

EARNINGS MOVERS: (% change for the week)

Vanda Pharmaceuticals (NASDAQ:VNDA): 15:31; +23%.

Acadia Pharmaceuticals (NASDAQ: ACAD): $28.73; +23%.

Coherus BioSciences, Inc. (Nasdaq: CHRS): $20.02: +20%.

Neurocrine Biosciences (NASDAQ: NBIX): $94.05; +8%.

Acorda Therapeutics, Inc. (NASDAQ: ACOR): 3:10; -54%.

Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX): $1.20; -79% (earnings + split with Sanofi).

OTHER MOVERS:

Aclaris Therapeutics, Inc. (NASDAQ: ACRS) released data from its Phase 2 trial of ATI-501 (AUAT-201 Oral) for the treatment of alopecia areata (AA). The trial met its primary endpoint of the change from baseline in the Severity of Alopecia Tool (SALT) score at week 24 across three doses versus placebo. However, shares closed the week down 36% to $1.11 due to lower SALT scores compared with Pfizer’s Phase 2 Janus kinase (JAK) inhibitors which released data last year.

Pfizer Inc. (NYSE:PFE) and GlycoMimetics, Inc. (NASDAQ: GLYC) announced late-Friday their Phase 3 trial of rivipansel (GMI-1070) in patients aged six and older with sickle cell disease (SCD) who were hospitalized for a vaso-occlusive crisis (VOC) and required treatment with intravenous (IV) opioids, did not meet its primary or key secondary efficacy endpoints. Shares of GlycoMimetics closed the after-hours session down 40% to $5.50.

Mylan N.V. (Nasdaq: MYL) and Pfizer Inc. (NYSE: PFE) announced a definitive agreement to combine Mylan with Upjohn, Pfizer’s off-patent branded and generic established medicines business, creating a new global pharmaceutical company. Under the agreement, each Mylan share would be converted into one share of the new company. Pfizer shareholders would own 57% of the combined new company, and Mylan shareholders would own 43%. The new company is expected to have revenue of $19-$20b in 2020. Shares of Mylan closed the week up 7% to $19.84.

Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS) shares closed the week up 17% to $5.55 following news it will make a late-breaking presentation of its Phase 1 multiple ascending dose trial of PRS-060, for the treatment of asthma, at the 2019 European Respiratory Society International Congress on October 1, 2019.

Key companies reporting 2Q earnings:

T: BHC ENDP JAZZ MNK REGN SAGE SUPN

W: AMAG IONS TEVA

Th: AMRX HZNP NKTR PCRX

Key clinical data readouts remaining for August and September:

Drug Stage Catalyst Market Cap

AKCA – Akcea Therapeutics Inc.
Volanesorsen
Familial partial lipodystrophy (FPL)

Phase 3 Phase 3 data met primary endpoint - August 6, 2019.
$2 billion

ALLK – Allakos Inc.
AK002
Eosinophilic Gastritis

Phase 2 Phase 2 top-line data met primary and secondary endpoints - August 5, 2019. Extension data due 1H 2020. Phase 3 trial to commence 1Q 2020.
$4.3 billion

ALNY – Alnylam Pharmaceuticals Inc.
Inclisiran - ORION 11
Cardiovascular disease (ASCVD)

Phase 3 Phase 3 data to be presented at ESC September 2, 2019 at 9:22 am CET.
$9 billion

ANAB – AnaptysBio Inc.
ANB019
Palmo-plantar pustular psoriasis

Phase 2 Phase 2 data due 1H 2020.
$1.3 billion

ARDX – Ardelyx Inc.
Tenapanor - AMPLIFY
Hyperphosphatemia - adjunctive therapy to phosphate binders

Phase 3 Phase 3 data due 3Q 2019.
$155.1 million

ATNX – Athenex Inc.
Oraxol
Metastatic breast cancer

Phase 3 Phase 3 top-line data met primary endpoint (ORR), secondary endpoints (PFS/OS) yet to hit.
$1.2 billion

AZRX – AzurRx BioPharma Inc.
MS1819-SD (OPTION)
Cystic fibrosis

Phase 2 Phase 2 data due September 2019.
$25.8 million

DCPH – Deciphera Pharmaceuticals Inc.
Ripretinib DCC-2618 - INVICTUS
Gastrointestinal Stromal Tumors (GIST) - fourth-line

NDA Filing Phase 3 data met PFS primary endpoint - August 13, 2019. Secondary ORR endpoint not achieved. NDA filing due 1Q 2020.
$1.4 billion

NTRP – Neurotrope Inc.
Bryostatin
Alzheimer's disease

Phase 2 Phase 2 data due 3Q 2019.
$73.8 million

RTRX – Retrophin Inc.
RE-024 fosmetpantotenate
Pantothenate kinase-associated neurodegeneration (PKAN)

Phase 3 Phase 3 top-line data due 3Q 2019.
$764.6 million

RYTM – Rhythm Pharmaceuticals Inc.
Setmelanotide
POMC deficiency obesity

Phase 3 Phase 3 trial met primary endpoint - August 7, 2019.
$711 million