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.
$1.2 billion

ALLK – Allakos Inc.
Antolimab (AK002)
Eosinophilic Gastritis

Phase 3 Phase 3 top-line data due 2H 2021.
$4.1 billion

ANAB – AnaptysBio Inc.
ANB019 - POPLAR
Palmo-plantar pustular psoriasis

Phase 2 Phase 2 data due 1Q 2021.
$481.2 million

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

Phase 3 Phase 3 trial met primary endpoint.
$509.9 million

ATNX – Athenex Inc.
Oraxol
Metastatic breast cancer

NDA Filing NDA to be filed in 2020.
$950.5 million

AZRX – AzurRx BioPharma Inc.
MS1819 - OPTION 2
Cystic fibrosis

Phase 2 Phase 2 top line data due in 1Q 2021.
$27.5 million

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

Approved FDA Approval announced May 15, 2020.
$2.7 billion

NTRP – Neurotrope Inc.
Bryostatin
Alzheimer's disease

Phase 2 Phase 2 trial did not meet primary endpoint - September 9, 2019.
$30.1 million

RTRX – Retrophin Inc.
Fosmetpantotenate
Pantothenate kinase-associated neurodegeneration (PKAN)

Phase 3 Phase 3 top-line data did not meet endpoints - August 22, 2019.
$977.4 million

RYTM – Rhythm Pharmaceuticals Inc.
Setmelanotide
POMC deficiency obesity / Leptin Receptor Deficiency Obesity

PDUFA priority review PDUFA date under priority review November 27, 2020.
$842.2 million