BPC June 15 update

Small cap biotech stock catalysts left for June; Biotech Week in Review

Weekly watchlist

 Last week we took a look at clinical readouts left for June. This week, we narrow that down to focus on small cap stocks only while also adding in regulatory events left on the table.

First, let's review the week that was with six price moving newsmakers.

Sage Therapeutics (NASDAQ: SAGE) shares closed Tuesday up 20% to $175.76 following its announcement of an accelerated development plan for SAGE-217 for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Its ongoing Phase 2 trial for PPD has been designated as a pivotal trial with data due 4Q 2018, while its previously completed placebo-controlled study in MDD has been considered as pivotal, with one additional Phase 3 pivotal trial anticipated in 2H of 2018.

Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) shares surged 151% Tuesday following its report of mixed top-line data from its Phase 2b trial of Aramchol for the treatment of non-alcoholic steatohepatitis (NASH), with the trial meeting and missing various endpoints. Shares finished the week up 141% to $16.40.

Madrigal Pharmaceuticals, Inc. (MDGL) shares closed Wednesday up 11% to $313.24 following a report by Bloomberg that it is exploring a sale of the company.

vTv Therapeutics Inc. (Nasdaq:VTVT) announced that results from Part B of its trial of azeliragon in people with mild Alzheimer’s disease did not meet co-primary efficacy endpoints, consistent with findings in Part A of the trial. Shares pared back most of its losses for the week after closing Wednesday’s session down 13%.

scPharmaceuticals Inc. (Nasdaq:SCPH) shares closed Wednesday down 22% to $5.93 following the issuance of a Complete Response Letter from the FDA for its regulatory filing of Furoscix for the treatment of patients with heart failure.

Vical Incorporated (Nasdaq:VICL) shares closed Monday down 26% to $1.21 following news that its Phase 2 clinical trial of its vaccine candidate for herpes did not meet its primary endpoint.  

Small cap biotech stock catalysts left for June:

Drug Stage Catalyst Market Cap

AKAO – Achaogen Inc.
Plazomicin
Complicated urinary tract infections (cUTI)

Approved FDA approval for cUTI but CRL received for the treatment of bloodstream infection (BSI).
$75.6 million

ALDR – Alder BioPharmaceuticals Inc.
ALD403 - PROMISE 2
Frequent episodic migraine

Phase 3 Phase 3 PROMISE 2 data released January 8, 2017 - endpoints met. 6-mth data to be presented June 29, 2018 noted 43% of patients achieved 75% or greater reduction of monthly migraine days. PK Comparability Study 4Q 2018. BLA filing due 1Q 2019.
$906.7 million

APLS – Apellis Pharmaceuticals Inc.
APL-2 subcutaneous
Auto-immune Hemolytic Anemia (AIHA)

Phase 2 Phase 2 monotherapy data due at ASH December 3, 2018: 6:00 PM.
$847.7 million

CARA – Cara Therapeutics Inc.
IV CR845
Acute pain

Phase 3 Phase 3 data released June 27, 2018. Company noted primary endpoint met but data mixed.
$751.1 million

DERM – Dermira Inc.
Glycopyrronium tosylate
Primary axillary hyperhidrosis

Approved Approval announced June 29, 2018.
$409 million

DRRX – DURECT Corporation
Remoxy
Chronic pain

CRL CRL issued September 26, 2016. NDA refiled but additional CRL issued August 6, 2018. Noted November 12, 2018 that it will meet with the FDA January 31, 2019 to discuss further.
$144.2 million

GEMP – Gemphire Therapeutics Inc.
Gemcabene - INDIGO-1
Severe Hypertriglyceridemia (SHTG)

Phase 2b Phase 2b primary endpoint met - June 28, 2018.
$17 million

MACK – Merrimack Pharmaceuticals Inc.
MM-141 - CARRIE
Cancer - front line pancreatic cancer

Phase 2 Phase 2 data released June 25, 2018 - endpoints not met.
$60.3 million

OBSV – ObsEva SA
OBE2109
Endometriosis

Phase 2b Phase 3 trial to be initiated early 2019.
$559.5 million

RYTM – Rhythm Pharmaceuticals Inc.
Setmelanotide
POMC Heterozygous Deficiency Obesity, Alstrom Syndrome, POMC Epigenetic Disorders

Phase 2 Phase 2 updated data due 1Q 2019.
$987.9 million

SPHS – Sophiris Bio Inc.
Topsalysin (PRX302)
Localized low to intermediate risk prostate cancer

Phase 2 Phase 2b complete data due by end of 2018.
$59 million

ZGNX – Zogenix Inc.
ZX008 - Study 1504
Dravet syndrom

Phase 3 Phase 3 data released July 12, 2018. Primary endpoint met.
$1.7 billion