BPC February 15 update

Nine small and mid cap companies with upcoming PDUFA dates slated for March and April; Biotech week in Review

Weekly watchlist

Biotech week in Review:

Motif Bio plc (NASDAQ: MTFB) announced Thursday it received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for iclaprim for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The company noted additional data are needed to further evaluate the risk for liver toxicity before the NDA may be approved. Shares closed Thursday down 73% to $2.81.

AstraZeneca plc (NYSE: AZN) was one of the top performers among companies reporting 4Q earnings. Shares closed Thursday up 9% to $39.98 following the release of increasing revenue from its oncology portfolio.

Caladrius Biosciences, Inc. (Nasdaq: CLBS) announced after hours Wednesday that top-line data from its T-Rex Study, a Phase 2a trial of CLBS03 as a treatment for recent-onset type 1 diabetes, showed no improvement in the primary endpoint of preservation of C-peptide levels vs. placebo. Shares closed Thursday down 25% to $4.00.

Gilead Sciences, Inc. (NASDAQ: GILD) announced Monday that its Phase 3 STELLAR-4 trial of selonsertib, in patients with compensated cirrhosis (F4) due to nonalcoholic steatohepatitis (NASH), did not meet the primary endpoint. Investors of NASH stocks now turn their attention to a Phase 3 readout by Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT) slated for this quarter.

DBV Technologies (Nasdaq: DBVT) closed Thursday up 11% to $7.86 on news that it plans to resubmit its Biologics License Application (BLA) to the FDA for Viaskin Peanut in children with peanut allergy, in 3Q 2019. The company withdrew its BLA in December 2018 following correspondence with the FDA regarding additional data required on manufacturing procedures and quality controls.

This week for our watch list we highlight notable PDUFA dates slated for March and April, with a focus solely on small and mid-cap companies. Looking closer ahead to next week, eyes will be on companies reporting 4Q earnings. Notable earnings calls are listed below.

Regarding other potential catalysts, Karyopharm Therapeutics Inc. (Nasdaq:KPTI) is due to appear at an FDA Advisory Committee meeting regarding its New Drug Application (NDA) for selinexor on Tuesday February 26, 2019. Briefing notes for meetings are generally released two days prior, which potentially could mean a release this coming Friday.

Notable earnings dates for the upcoming week:



Fri: MNTA.


Drug Stage Catalyst Market Cap

ADMA – ADMA Biologics Inc
Primary Immune Deficiency Diseases

Approved FDA Approval announced April 1, 2019.
$234.3 million

AERI – Aerie Pharmaceuticals Inc.

Approved FDA Approval announced March 12, 2019.
$1.1 billion

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

NDA Filing CRL issued April 2, 2019. NDA to be resubmitted 4Q 2019.
$21.2 million

HRTX – Heron Therapeutics Inc.
Post operative pain

CRL CRL announced May 1, 2019.
$1.4 billion

JAZZ – Jazz Pharmaceuticals plc
Excessive sleepiness associated with narcolepsy

Approved FDA Approval announced March 20, 2019.
$7.6 billion

LXRX – Lexicon Pharmaceuticals Inc.
Type 1 Diabetes

CRL CRL issued March 22, 2019.
$145.6 million

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

NDA Filing CRL issued April 30, 2019. NDA resubmission due early 4Q 2019.
$167.3 million

REPH – Recro Pharma Inc.
Intravenous (IV) meloxicam
Acute pain following bunionectomy surgery

CRL First CRL announced May 24, 2018. Second CRL issued March 22, 2019.
$241.5 million

SAGE – Sage Therapeutics Inc.
Brexanolone - SAGE-547 (202C)
Postpartum Depression - moderate

Approved FDA approval announced March 19, 2018.
$8.4 billion