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

ALDR – Alder BioPharmaceuticals Inc.
Eptinezumab ALD403
Frequent episodic migraine

PDUFA PDUFA date February 21, 2020.
$950.3 million

APLS – Apellis Pharmaceuticals Inc.
APL-2 subcutaneous
Auto-immune Hemolytic Anemia (AIHA) and Cold agglutinin disease (CAD)

Phase 2 Phase 2 data released June 15, 2019
$1.7 billion

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.
$1 billion

DERM – Dermira Inc.
Glycopyrronium tosylate
Primary axillary hyperhidrosis

Approved Approval announced June 29, 2018.
$462.1 million

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

Phase 2b Phase 2b primary endpoint met - June 28, 2018.
$10.1 million

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

Phase 2 Phase 2 data released June 25, 2018 - endpoints not met.
$74.9 million

OBSV – ObsEva SA

Phase 2b Phase 2b presented June 25, 2019.
$445.5 million

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

Phase 2 Phase 2 additional data due 2020.
$703.8 million

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

Phase 2 Phase 3 trial dependent on funding.
$31.7 million