BPC February 21 update

14 small and mid-cap PDUFA dates and Advisory Committee meetings slated for the next three months; Earnings next week

Weekly watchlist

This week we look ahead at upcoming PDUFA dates and Advisory Committee meetings slated for the next three months, with a focus on small and mid-cap companies. We also highlight key companies reporting earnings for the coming week.

Next week we will look at Phase 2 and 3 clinical catalysts left for the quarter.

First, let’s review the week that was with price-moving events.

Baudax Bio, Inc. (NASDAQ:BXRX) announced that the FDA approved the New Drug Application (NDA) for Anjeso (meloxicam injection), which is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Shares closed Friday up 16% to $9.16.

Esperion (NASDAQ: ESPR) received approval from the FDA Friday for Nexletol (bempedoic acid) for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. Shares, however, closed down 10% to $61.76, with investors appearing to react to the insert of adverse reactions into the label, which noted “most common (incidence ≥ 2% and greater than placebo) adverse reactions are upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes”.

Tocagen Inc. (NASDAQ:TOCA) shares closed the week up 292% to $1.90 following its announcement of a reverse merger with privately-held Forte Biosciences, Inc. Upon stockholder approval, the combined company is expected to operate under the name Forte Biosciences. Tocagen holders will own approximately 25.5% of the combined company.

Heron Therapeutics, Inc. (Nasdaq: HRTX) announced that the FDA has extended the review period for the New Drug Application (NDA) for HTX-011 by three months due to reinspection of the contract manufacturing site. The new PDUFA date is June 26, 2020.

BioXcel Therapeutics, Inc. (NASDAQ: BTAI) shares saw a topsy turvy week, closing Monday up 55% to $36.97 following a significant upgrade from analysts at Suntrust, which increased their price target from $24 to $150. However, BioXcel announced later in the week a public offering which saw its shares retrace gains to close the week at $34.89.

Avadel Pharmaceuticals plc (NASDAQ:AVDL) shares closed Friday up 32% to $9.40 following its announcement of a sale of its American Depositary Shares (ADSs) in a private for gross proceeds of $65m. Data from its Phase 3 trial in patients with narcolepsy are due next quarter.

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15 key earnings dates for the week ahead (full list available for premium members)

Mon: CLVS HALO

Tue: AMRN EXEL ICPT JAZZ SUPN

Wed: BMRN ENDP HZNP IONS SRPT

Thur: MYL RIGL SAGE


Upcoming small and mid-cap PDUFA dates and Advisory Committee meetings

Drug Stage Catalyst Market Cap

AQST – Aquestive Therapeutics Inc.
APL-130277
Parkinson’s Disease with motor fluctuations

PDUFA CRL issued January 30, 2019 through partner Sunovion (private company). NDA refiled. New PDUFA date May 21, 2020.
$76.9 million

BPMC – Blueprint Medicines Corporation
Avapritinib
Fourth-line GIST

PDUFA priority review PDUFA date extended by three months to May 14, 2020 to allow for data from the Voyager trial.
$3.1 billion

CLVS – Clovis Oncology Inc.
Rubraca (rucaparib)
Castrate-resistant prostate cancer (mCRPC)

PDUFA priority review PDUFA date under priority review May 15, 2020.
$523.7 million

DBVT – DBV Technologies S.A.
Viaskin Peanut
Peanut allergy - ages 4 to 11 years

PDUFA PDUFA date August 5, 2020 (likely to be extended). Advisory Committee meeting slated for May 15, 2020 has been cancelled.
$433.7 million

DRRX – DURECT Corporation
POSIMIR
Post-operative pain relief

PDUFA CRL Feb 12 2014. Advisory Committee meeting voted 6-6 January 16, 2020 regarding approval. PDUFA date of December 27, 2019 was not met due to the meeting. No guidance announced regarding new timeline.
$305.5 million

ESPR – Esperion Therapeutics Inc.
Bempedoic Acid/ Ezetimibe
Hypercholesterolemia

Approved FDA approval announced February 26, 2020.
$970.9 million

ICPT – Intercept Pharmaceuticals Inc.
Ocaliva (Obeticholic acid (OCA)) - REGENERATE
Adult nonalcoholic steatohepatitis (NASH) patients.

PDUFA priority review Advisory Committee meeting June 9, 2020. PDUFA date June 26, 2020.
$2.1 billion

IGXT – Intelgenx Techs Corp
RIZAPORT (RHB-103)
Migraine

CRL CRL announced March 27, 2020.
$14 million

PBYI – Puma Biotechnology Inc
Neratinib - NALA
Third-line HER2-positive metastatic breast cancer

Approved FDA Approval announced February 26, 2020.
$341.1 million

PTCT – PTC Therapeutics Inc.
Risdiplam (RG7916)
Spinal Muscular Atrophy (SMA) Type 1

PDUFA priority review PDUFA date May 24, 2020 under priority review.
$2.5 billion

RMTI – Rockwell Medical Inc.
IV Triferic
Anemia

Approved FDA approval announced date March 27, 2020.
$151.2 million

URGN – UroGen Pharma Ltd.
MitoGel - UGN-101
Urothelial Carcinoma

PDUFA priority review PDUFA date under priority review April 18, 2020.
$374.4 million

XLRN – Acceleron Pharma Inc.
Luspatercept
Myelodysplastic syndromes (MDS) cancer

PDUFA PDUFA date April 4, 2020. Advisory Committee meeting originally set for December 18, 2019 is no longer required - noted December 6, 2019.
$4.6 billion

ZGNX – Zogenix Inc.
FINTEPLA (ZX008)
Dravet syndrom

PDUFA priority review PDUFA date under priority review extended by three months to June 25, 2020
$1.3 billion