BPC July 04 update

Upcoming small and mid cap PDUFA and Advisory Committee dates scheduled for the third quarter

Weekly watchlist

The shortened Independence Day trading week saw just a few notable price moving catalysts which we note below. Last week we highlighted catalysts likely to occur over the next month. This week, we take a broader view focusing on regulatory events slated for the current quarter for small and mid-cap firms, including notable PDUFA and Advisory Committee meeting dates.

Karyopharm Therapeutics Inc. (Nasdaq:KPTI) shares closed the week up 47% to $8.81 following news on Wednesday that the FDA approved oral Xpovio (selinexor) in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies. Continued approval may be contingent upon data from its ongoing Phase 3 Boston trial, with data slated for release in early 2020.

Amarin Corporation plc (NASDAQ:AMRN) shares rallied to close the week up 19% to $23.16 on news that it is increasing revenue guidance for 2019 and planning to further increase its commercial expansion efforts for Vascepa by doubling the size of its current sales force. Guidance increased from $350m to $380m-$420m.

Unum Therapeutics Inc. (NASDAQ: UMRX) shares closed the week down 8% to $2.40 following its announcement the FDA has placed a clinical hold on its Phase 1 trial (ATTCK-20-2) evaluating ACTR087 in combination with rituximab patients with relapsed/refractory CD20+ B cell non-Hodgkin lymphoma. The clinical hold was initiated on news one patient experienced serious adverse events that included Grade 3 neurotoxicity and cytomegalovirus (CMV) infection, and Grade 4 respiratory distress.

Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS) shares performed consistently well throughout the week, closing the shortened week up 74% to $6.50.


Upcoming small and mid-cap PDUFA and Advisory Committee dates scheduled for the third quarter:

Drug Stage Catalyst Market Cap

AIMT – Aimmune Therapeutics Inc.
Peanut Allergy

PDUFA PDUFA date late-January 2020. Advisory Committee meeting September 13, 2019 voted in favor of supporting approval.
$1.4 billion

AMRN – Amarin Corporation plc
High Triglycerides With Mixed Dyslipidemia

PDUFA priority review Advisory Committee meeting November 14, 2019. PDUFA date under priority review September 28, 2019 extended to December 28, 2019.
$6.1 billion

ARDX – Ardelyx Inc.
Tenapanor (T3MPO-2)
Constipation-predominant irritable bowel syndrome (IBS-C)

Approved FDA approval announced September 12, 2019.
$300.2 million

AVDL – Avadel Pharmaceuticals plc
Hospital product

PDUFA PDUFA date extended by three months to December 15, 2019.
$126.6 million

BHVN – Biohaven Pharmaceutical Holding Company Ltd.
Nurtec (riluzole) (BHV-0223)
Amyotrophic lateral sclerosis (ALS)

CRL CRL issued July 19, 2019.
$2.5 billion

IPCIF – Intellipharmaceutics International Inc - Ordinary Shares
Pain relief

PDUFA CRL issued September 25, 2017. NDA resubmitted with new PDUFA date of August 28, 2019. Noted July 26, 2019 that PDUFA date will be delayed. No updated date provided.
$3.9 million

ITCI – Intra-Cellular Therapies Inc.

PDUFA PDUFA date extended by three months to December 27, 2019. No advisory committee meeting expected.
$488.3 million

KALA – Kala Pharmaceuticals Inc.
KPI‑121 0.25%
Dry eye disease

CRL CRL issued August 8, 2019. Data from Stride 3 trial due 4Q 2019 are required for resubmission.
$155.4 million

NBRV – Nabriva Therapeutics plc
Lefamulin - Intravenous and Oral
Moderate to severe Community Acquired Bacterial Pneumonia (CABP)

Approved FDA approval announced August 19, 2019.
$167.3 million

NKTR – Nektar Therapeutics
Lower back pain

PDUFA PDUFA date August 29, 2019. Company noted the date will not be met due to the postponement of an advisory committee meeting.
$3.5 billion

SRPT – Sarepta Therapeutics Inc.
Golodirsen - Exon 53
Duchenne muscular dystrophy

CRL CRL issued August 19, 2019.
$6.2 billion

VNDA – Vanda Pharmaceuticals Inc.
HETLIOZ (tasimelteon)
Jet Lag Disorder

CRL CRL issued August 19, 2019.
$714.9 million

XERS – Xeris Pharmaceuticals Inc.
Glucagon Rescue Pen
Severe hypoglycemia

Approved FDA Approval announced September 10, 2019.
$287.7 million