BPC April 25 update

Biotech earnings for the week ahead + PDUFA dates to watch for May and June

Weekly watchlist

The first full week of first quarter earnings kicks off this week following an early preview last week from a handful companies, notably, Biogen, Lilly and Sanofi.

We note key companies reporting earnings with a focus on mid and large cap high revenue companies, while our watch list focuses on upcoming PDUFA and Advisory Committee meeting dates slated over the next two months.

First, let’s review the week that was with notable news and price-moving events.

Gilead Sciences, Inc. (NASDAQ: GILD) shares closed the week down 5% to $79.64. News was reported Thursday that the WHO accidentally posted draft documents from a Chinese trial of remdesivir that noted the treatment did not improve the condition of patients with COVID-19 or reduce the presence of the virus in the bloodstream. WHO later removed the document from its website. Gilead responded by saying that the document contained inappropriate characterizations and that the trial’s findings were inconclusive as the trial was terminated early due to low enrolment and, as a result, it was underpowered to enable statistically meaningful conclusions. Data are due later this month and in May from three separate trials.

Biogen Inc. (Nasdaq: BIIB) announced in its first quarter earnings report that its Biological License Application (BLA) of aducanumab, for the potential treatment of Alzheimer’s disease, will be filed in the third quarter of 2020, compared with previous guidance of early 2020. Shares closed the week down 13% to $297.80.

Immunomedics, Inc. (NASDAQ: IMMU) announced that the FDA issued an early approval of Trodelvy (sacituzumab govitecan) for the treatment of adult patients with metastatic triple-negative breast cancer (TNBC) who have received at least two prior therapies for metastatic disease. Shares closed the week up 41% to $28.44.

Exelixis, Inc. (NASDAQ: EXEL) shares closed the week up 36% to $26.53 following news that its Phase 3 CheckMate -9ER trial with Bristol Myers Squibb (NYSE: BMY), evaluating Opdivo in combination Cabometyx compared to sunitinib in previously untreated advanced or metastatic renal cell carcinoma (RCC), met the primary endpoint of progression-free survival (PFS) at final analysis, as well as the secondary endpoints of overall survival (OS) at a pre-specified interim analysis, and objective response rate (ORR).


15 Key companies reporting 1Q earnings:






PDUFA and Adcom meetings slated for May and June:

Drug Stage Catalyst Market Cap

AQST – Aquestive Therapeutics Inc.
Parkinson’s Disease with motor fluctuations

Approved FDA approval announced May 21, 2020.
$163.5 million

BPMC – Blueprint Medicines Corporation
Fourth-line GIST

CRL CRL issued May 15, 2020.
$3.5 billion

CHMA – Chiasma Inc.
Mycapssa - OPTIMAL

PDUFA PDUFA date June 26, 2020.
$264.2 million

CLVS – Clovis Oncology Inc.
Rubraca (rucaparib)
Castrate-resistant prostate cancer (mCRPC)

Approved FDA Approval announced May 15, 2020.
$608.9 million

EPZM – Epizyme Inc.
Follicular lymphoma

PDUFA priority review PDUFA date June 18, 2020 under priority review.
$1.8 billion

EVFM – Evofem Biosciences Inc.
Amphora - AMPOWER
contraceptive vaginal gel

Approved FDA Approval announced May 22, 2020.
$271.4 million

EVOK – Evoke Pharma Inc.
Gimoti - EVK-001
Female diabetic gastroparesis

PDUFA CRL issued April 2, 2019. NDA resubmitted with new PDUFA date of June 19, 2020.
$61 million

HRTX – Heron Therapeutics Inc.
Post operative pain

PDUFA PDUFA date extended by three months to June 26, 2020.
$1.7 billion

ICPT – Intercept Pharmaceuticals Inc.
Ocaliva (Obeticholic acid (OCA)) - REGENERATE
Adult nonalcoholic steatohepatitis (NASH) patients.

PDUFA priority review Advisory Committee meeting set for June 9, 2020 has been postponed. New date TBA. PDUFA date June 26, 2020 will also be extended. Date TBC.
$2.4 billion

KPTI – Karyopharm Therapeutics Inc.
Diffuse Large B-Cell Lymphoma (DLBCL)

PDUFA priority review PDUFA date under priority review June 23, 2020.
$1.4 billion

NBRV – Nabriva Therapeutics plc
Complicated urinary tract infections (cUTI)

PDUFA CRL issued April 30, 2019. New PDUFA date June 19, 2020. Company noted May 29, 2020 that there is a substantial likelihood that the FDA will not be able to complete its review due to COVID-19.
$114 million

VIE – Viela Bio Inc.
Neuromyelitis Optica Spectrum Disorder

PDUFA PDUFA date June 11, 2020.
$2.4 billion

ZGNX – Zogenix Inc.
Dravet syndrom

PDUFA priority review PDUFA date under priority review extended by three months to June 25, 2020
$1.6 billion