BPC January 18 update

15 Upcoming PDUFA dates slated for the next ten weeks

Weekly watchlist

 This week’s watch list looks ahead at upcoming PDUFA (FDA approval) dates, a topic which has garnered attention recently due to the U.S. government shutdown.

Scott Gottlieb, M.D, commissioner of the FDA noted in a tweet mid-week that PDUFA is our most vulnerable program and will run out of money first. We’ll get into February but how far into Feb is still very fluid. We’re trying to free resources to extend its runway. We said 4/5 weeks counting this week. That could change but is our rough estimate right now”.

We have pulled 15 stocks with PDUFA dates slated for about the next ten weeks, providing that the FDA is able to manoeuvre itself through the shutdown.

Immunomedics, Inc. (NASDAQ: IMMU) shares closed down Friday 26% to $13.31 following news it received a Complete Response Letter (CRL) from the FDA for the Biologics License Application (BLA) of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC). The company noted Chemistry, Manufacturing and Control issues for the CRL.

Lexicon Pharmaceuticals (NASDAQ:LXRX) shares closed Friday down 23% to $5.96 following news the FDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) delivered a split vote, 8-8, that the benefits outweigh the risks of Sotagliflozin for the treatment of type 1 diabetes. The PDUFA date for a final decision is March 22, 2019.

Aptinyx Inc. (NASDAQ: APTX) shares slumped to close Wednesday down 66% to $5.98 following news that its Phase 2 trial of NYX-2925 in patients with painful diabetic peripheral neuropathy (DPN) did not meet the primary endpoint. Aptinyx, a recent IPO, listed in June 2018 at a price of $16 per share.

Verona Pharma plc (Nasdaq:VRNA) shares closed the week down 38% to $6.25 following news its Phase 2 trial of RPL554 when used as a maintenance treatment for patients with moderate to severe chronic obstructive pulmonary disease (COPD), failed to meet its primary endpoint.

Aimmune Therapeutics, Inc. (NASDAQ: AIMT) announced that it has been notified by the FDA that as a result of the U.S. government shutdown, the FDA will not commence review of its Biologics License Application for AR101, for the treatment of peanut allergy until the shutdown has ended.

Tyme Technologies, Inc. (NASDAQ: TYME) shares slumped Friday to close down 35% to $2.41 following the release of data from its open label Phase 2 trial evaluating SM-88 for the treatment of pancreatic cancer. An overall response rate of 12% was noted, lower than expectations.

Exelixis, Inc. (NASDAQ:EXEL) announced the FDA approved Cabometyx (cabozantinib) for patients with hepatocellular carcinoma (HCC) (liver cancer) who have been previously treated with sorafenib. 

15 upcoming PDUFA dates over the next ten weeks:

Drug Stage Catalyst Market Cap

ADMA – ADMA Biologics Inc
RI-002
Primary Immune Deficiency Diseases

PDUFA CRL issued July 29 2016. New PDUFA date April 2, 2019.
$201.6 million

AERI – Aerie Pharmaceuticals Inc.
Roclatan
Glaucoma

PDUFA PDUFA date March 14, 2019.
$1.8 billion

ALKS – Alkermes plc
ALKS 5461
Major depressive disorder

CRL CRL announced February 1, 2019.
$5.2 billion

BHC – Bausch Health Companies Inc.
DUOBRII (halobetasol propionate and tazarotene)
Psoriasis

PDUFA CRL issued June 18, 2018. Noted February 15, 2019 that the FDA has been unable to meet the PDUFA data of February 15, 2019 and expects a decision soon.
$8.3 billion

EOLS – Evolus Inc.
DWP-450
Glabellar lines

Approved FDA Approval announced February 1, 2019.
$672.3 million

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

PDUFA PDUFA date April 1, 2019.
$54.2 million

JNJ – Johnson & Johnson
Esketamine
Treatment resistant depression

PDUFA priority review PDUFA estimate March 3, 2019 assuming priority review. FDA Advisory Committee Meeting February 12, 2019 voted 14-2 that benefits outweigh risks.
$366.4 billion

KPTI – Karyopharm Therapeutics Inc.
Selinexor
Quadruple Refractory Multiple Myeloma

PDUFA priority review PDUFA date under priority review April 6, 2019. Advisory Committee Meeting February 26, 2019 - 12:30pm. Briefing notes released February 22, 2019.
$307.8 million

LXRX – Lexicon Pharmaceuticals Inc.
Sotagliflozin
Type 1 Diabetes

PDUFA PDUFA date March 22, 2019. Advisory Committee Meeting January 17, 2019 voted 8-8 that benefits outweigh risks.
$583.6 million

MRK – Merck & Company Inc. (new)
KEYTRUDA - EORTC1325/KEYNOTE-054
Melanoma

Approved FDA Approval announced February 19, 2019.
$210 billion

MTFB – Motif Bio plc
Iclaprim
Acute bacterial skin and skin structure infections (ABSSSI)

CRL CRL issued February 14, 2019.
$28.6 million

REGN – Regeneron Pharmaceuticals Inc.
Dupixent (dupilumab)
Atopic dermatitis 12-17 year-olds

PDUFA priority review PDUFA date under priority review March 11, 2019.
$46.2 billion

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

PDUFA CRL announced May 24, 2018. New PDUFA date March 24, 2019.
$179.6 million

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

PDUFA priority review PDUFA date extended three months to March 19, 2018. Advisory Committee meeting November 2, 2018 voted 17-1 recommending approval.
$7.2 billion
RIZAPORT
Acute migraine

PDUFA PDUFA date for NDA resubmission April 1, 2019.