BPC June 27 update

Potential biotech stock events for the upcoming week; Biotech week in review

Weekly watchlist

Only two trading days remain in the second quarter of 2020, yet a number of clinical trial readouts slated for release have yet to be announced. It is not uncommon for companies to miss their guided timelines by a few days, and with COVID-19 potentially adding to the delays, it would not be surprising if some of the events listed below slip into early July. Let us see which companies reach their deadlines over the first two trading days of the week.

First, let’s review the week that was with notable healthcare news.

COVID-19

Vaxart, Inc. (NASDAQ: VXRT) shares surged to close the week up 209% to $8.04. The company put out a couple press releases, which garnered interest in the stock, aided by the recent increase in COVID-19 cases in the U.S. Of note, the company announced that its COVID-19 vaccine has been selected to participate in a non-human primate (NHP) challenge study, organized and funded by Operation Warp Speed, a new national program aiming to provide substantial quantities of vaccine by January 2021. Unlike most other vaccines, Vaxart is developing a vaccine tablet instead of a needle injection. Shares of the company have increased by approximately 2500% over the past six months.

REGULATORY:

Chiasma, Inc. (NASDAQ:CHMA) announced the FDA approved Mycapssa for long-term maintenance treatment in acromegaly patients. Shares, however, sold off on the news, closing Friday down 7% to $6.08.

Zogenix, Inc. (NASDAQ:ZGNX) announced late-Thursday that the FDA approved Fintepla for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older. Shares also sold off on the news, closing down 9% to $25.47.

DEALS:

Translate Bio (NASDAQ:TBIO) shares closed the week up 27% to $19.48 on news it has expanded their existing collaboration and license agreement with Sanofi to develop mRNA vaccines for infectious diseases. Translate Bio will receive a total upfront payment of $425m, consisting of a $300m cash payment and a private placement common stock investment of $125m at $25.59 per share. The company also announced an equity offering raising $125m, which saw shares pull back late in the week.

uniQure N.V. (NASDAQ:QURE) announced a license agreement with CSL Behring for rights to etranacogene dezaparvovec, its gene therapy for patients with hemophilia B. uniQure will receive a $450m upfront payment and is eligible to receive up to $1.6b in milestone payments. However, shares fell sharply Thursday, closing down 22% to $49.22 as hopes diminished of a buyout of the company.

CLINICAL:

Myovant Sciences (NYSE: MYOV) shares closed Tuesday up 14% to $19.90 on news its second Phase 3 trial of once-daily relugolix combination therapy in women with pain associated with endometriosis, met the co-primary efficacy endpoints and all seven key secondary endpoints.

Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) shares fell Tuesday by 43% to $0.35 following its announcement that it will not advance its current Phase 1/2 trial of vecabrutinib for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL) into the planned Phase 2 portion due to lack of efficacy.

Millendo Therapeutics, Inc. (Nasdaq: MLND) also announced that it will not continue development of nevanimibe in patients with congenital adrenal hyperplasia. The decision was made following an interim review of Phase 2b data. Shares closed Tuesday down 17% to $1.99.


Potential biotech stock events for the upcoming week:

Drug Stage Catalyst Market Cap

AKRO – Akero Therapeutics Inc.
AKR-001
Nonalcoholic steatohepatitis (NASH)

Phase 2a Phase 2a BALANCED trial data presented at AASLD meeting November 15, 2020. Phase 2a Cohort C (F4) readout and Phase 2b/3 initiation 1H 2021.
$1 billion

INO – Inovio Pharmaceuticals Inc.
INO-4800
COVID-19 vaccine

Phase 2 Phase 2 part of Phase 2/3 trial is ongoing.
$1.6 billion

ITRM – Iterum Therapeutics plc
Sulopenem
Uncomplicated urinary tract infections (uUTI)

NDA Filing NDA filing announced November 30, 2020.
$85.4 million

LLY – Eli Lilly and Company
LY3127804
COVID-19

Phase 2 Phase 2 enrolling.
$192.5 billion

OBSV – ObsEva SA
Linzagolix OBE2109 - PRIMROSE 1
Uterine fibroids

Phase 3 Phase 3 data trial met primary endpoint - July 6, 2020. Placebo adjusted rates lower than competition.
$247.6 million

REGN – Regeneron Pharmaceuticals Inc.
Kevzara (Sarilumab)
Coronavirus COVID-19

Phase 3 Phase 3 trial did not meet primary endpoint - July 2, 2020.
$57.9 billion

RVNC – Revance Therapeutics Inc.
DAXI (RT002)
Lateral Canthal (Crow’s Feet) Lines

Phase 2 Phase 2 top-line data released June 30, 2020. 88% of subjects achieved a score of none or mild wrinkle or line severity at Week 4 in at least one treatment group.
$1.9 billion

RVNC – Revance Therapeutics Inc.
DAXI (RT002)
Forehead lines

Phase 2 Phase 2 data noted 100% of subjects achieved a score of none or mild wrinkle or line severity at Week 4 in at least one treatment group - June 30, 2020.
$1.9 billion

ZYNE – Zynerba Pharmaceuticals Inc.
Zygel ZYN002
Fragile X syndrome

Phase 2/3 Phase 2/3 trial did not meet primary endpoint - June 30, 2020. Further trial to be initiated in 2021.
$106.6 million