BPC July 25 update

Key companies reporting earnings this upcoming week; Biotech stock catalysts remaining for mid-2019

Weekly watchlist

The second week of biotech earnings season coupled with a number of key readouts saw steady news flow throughout the week.

The week ahead also sees further price moving earnings events to look forward to. We highlight companies with expected annual revenues of over $100m that are set to report. As noted last week, earnings releases for mid-large cap companies are a significant catalyst, whereas the impact is very limited on smaller cap firms which do not have approved treatments on the market.

We also highlight events which have been signalled as occurring in mid-2019 or in early August. Note this list does not include events slated for “3Q 2019”, which we will highlight next week. First, let’s highlight price moving events from the week that was.

Sanofi (NASDAQ: SNY) announced late-Friday it notified Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) that it is terminating its collaboration to develop Zynquista (sotagliflozin) in all diabetes programs. The news follows mixed data from three Phase 3 trials of sotagliflozin for the treatment of diabetes. Lexicon responded claiming that it considers the notice invalid and Sanofi to be in breach of contract. Shares of Lexicon closed the after-hours session on Friday down 50% to $2.82.

Achillion Pharmaceuticals, Inc. (Nasdaq: ACHN) shares closed the week up 95% to $4.65. The company noted it achieved positive data from its Phase 1 multiple ascending dose (MAD) trial of ACH-5228 in healthy volunteers.

Intec Pharma Ltd. (NASDAQ: NTEC) shares slumped to close the week down 84% to $0.48 on news that it failed to meet the primary endpoint in its pivotal Phase 3 trial evaluating the safety and efficacy of Accordion Pill-Carbidopa/Levodopa (AP-CD/LD) for the symptoms of advanced Parkinson's disease (PD).

ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) announced that it did not meet the primary endpoint in its Phase 3 Enhance trial of pimavanserin as an adjunctive treatment in adult schizophrenia patients. Shares closed the week down 9% to $23.34.

Chiasma, Inc. (NASDAQ: CHMA) shares closed Tuesday up 27% to $7.86 following its announcement that it met all primary and secondary endpoints in its pivotal Phase 3 trial evaluating Mycapssa, for the maintenance treatment of adults with acromegaly. However, shares actually closed lower for the week, on the back of a post-data offering of common stock.

Marinus Pharmaceuticals, Inc. (NASDAQ: MRNS) announced negative data from its Phase 2 Magnolia clinical trial of ganaxolone in women with postpartum depression (PPD). Shares closed the week down 71% to $1.12.

Intra-Cellular Therapies, Inc. (NASDAQ: ITCI) shares closed the week down 29% to $8.37 on news the the FDA has cancelled the Psychopharmacologic Drugs Advisory Committee meeting for its New Drug Application (NDA) for lumateperone for the treatment of schizophrenia. Originally scheduled for July 31, 2019, the company said the FDA cancelled the meeting to allow sufficient time to review new information regarding non-clinical trials and any forthcoming information, which may result in an extension of the PDUFA date of September 27, 2019.

Key companies reporting 2Q earnings:





Key catalysts remaining for July/August (not including catalysts designated as "3Q").

Drug Stage Catalyst Market Cap

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

Phase 3 Phase 3 data met primary endpoint - August 6, 2019.
$1.2 billion

ALKS – Alkermes plc
Diroximel fumarate (BIIB098) - Head-to-head trial versus Tecfidera -
Relapsing Remitting Multiple Sclerosis (RRMS)

Phase 3 Phase 3 top-line data met primary endpoint - July 30, 2019.
$2.9 billion

ALLK – Allakos Inc.
Antolimab (AK002)
Eosinophilic Gastritis

Phase 3 Phase 3 top-line data due 2H 2021.
$4.2 billion

ATNX – Athenex Inc.
Metastatic breast cancer

NDA Filing NDA to be filed in 2020.
$948.4 million

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

Phase 2 Phase 2 top line data due in 1Q 2021.
$27.7 million

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

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

GLYC – GlycoMimetics Inc.
GMI-1070 (rivipansel)
Vaso-occlusive crisis of sickle cell disease

Phase 3 Phase 3 data failed to meet endpoints - August 2, 2019. Biomarker data to be presented at FSCDR meeting September 23-25, 2020,
$189.9 million

KALA – Kala Pharmaceuticals Inc.
EYSUVIS (KPI‑121) 0.25%
Dry eye disease

PDUFA CRL issued August 8, 2019. NDA resubmitted with new PDUFA date of October 30, 2020.
$524.7 million

LPTX – Leap Therapeutics Inc.
Esophagogastric adenocarcinoma

Phase 1/2 Phase 1/2 data August 6, 2019 noted 50% ORR.
$118 million

NBRV – Nabriva Therapeutics plc
Lefamulin - Intravenous and Oral
Moderate to severe Community Acquired Bacterial Pneumonia (CABP)

Approved FDA approval announced August 19, 2019.
$103.6 million

RARE – Ultragenyx Pharmaceutical Inc.
Ornithine Transcarbamylase (OTC) Deficiency

Phase 1/2 Phase 1/2 data from Cohort 4 due by the end of 2020. Phase 3 trial to commence 1H 2021.
$5.1 billion

SRPT – Sarepta Therapeutics Inc.
Golodirsen - Exon 53
Duchenne muscular dystrophy

Approved FDA Approval announced December 12, 2019.
$12.5 billion