BPC July 30 update

Selection of Biotech stocks with PDUFA dates slated for August/September; Earnings week ahead; Biotech Week in Review

Weekly watchlist

This week’s list of biotech stock events to watch focuses on upcoming PDUFA (FDA Approval) dates over the next two months for predominantly small and mid-cap companies. We also preview the earnings week ahead for top revenue earning companies.

First, review the week that was with notable events.

COVID-19 VACCINE:

Moderna, Inc., (Nasdaq: MRNA) announced that it has commenced its Phase 3 efficacy trial of its mRNA vaccine candidate (mRNA-1273) against COVID-19.

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) also announced they have commenced a Phase 2/3 safety and efficacy trial of their vaccine candidate, BNT162b2, against COVID-19.

Sanofi (NASDAQ:SNY) and GlaxoSmithKline plc (NYSE:GSK) announced that the U.S, government will provide up to $2.1b for the development and manufacture of their potential COVID-19 vaccine. A total of six drugs are now included in the U.S. government Operation Warp Speed program, with others being AstraZeneca, Johnson & Johnson, Moderna, Novavax and Pfizer. Sanofi expects a Phase 1/2 trial to start in September, followed by a Phase 3 trial by the end of 2020. If the data are positive, the companies will seek regulatory approval in the first half of 2021.

OTHER CLINICAL:

TCR2 Therapeutics Inc. (NASDAQ:TCRR) shares closed Monday up 25% to $16.39 on news that 2/5 (40%) of patients showed unconfirmed partial responses in its Phase 1 trial of TC-210 in patients with mesothelin-expressing solid tumors. Two other patients exhibited stable disease through six months. Shares closed the week at $16.75.

REGULATORY:

Bristol Myers Squibb (NYSE:BMY) and bluebird bio, Inc. (NASDAQ:BLUE) announced the resubmission of their Biologics License Application (BLA) to the FDA for idecabtagene vicleucel (ide-cel; bb2121), for the treatment of adult patients with relapsed and refractory multiple myeloma. This submission follows a Refusal-to-file letter received in May earlier this year.

MorphoSys (NASDAQ:MOR) and Incyte (Nasdaq:INCY) announced late-Friday that the FDA has approved Monjuvi (tafasitamab) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

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Biotech earnings for the upcoming week (selection of 15):

Mon: NBIX

Tue: AMRN INCY MNK BMRN JAZZ

Wed: TEVA REGN ENDP SRPT

Thur: IRWD BMY MYL AMRX FGEN

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Small/mid cap Biotech stocks with PDUFA dates slated for August/September:

Drug Stage Catalyst Market Cap

AQST – Aquestive Therapeutics Inc.
Libervant - AQST-203
Epileptic seizures

PDUFA PDUFA date September 27, 2020.
$218.9 million

BHC – Bausch Health Companies Inc.
EM-100
Allergic conjunctivitis

PDUFA PDUFA date August 10, 2020 extended to September 15, 2020.
$6.1 billion

BMRN – BioMarin Pharmaceutical Inc.
Valoctocogene roxaparvovec (BMN 270)
Hemophilia A

PDUFA priority review PDUFA date under priority review August 21, 2020.
$21.5 billion

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

CRL CRL issued August 4, 2020
$256.8 million

EGRX – Eagle Pharmaceuticals Inc.
Ryanodex
Exertional heat stroke (EHS)

CRL CRL announced August 10, 2020.
$597.5 million

FENC – Fennec Pharmaceuticals Inc.
Pedmark (sodium thiosulfate)
Cisplatin-Induced Hearing Loss

CRL CRL announced August 10, 2020.
$158.7 million

GLPG – Galapagos NV
Filgotinib
Rheumatoid arthritis (RA)

PDUFA NDA filing announced December 19, 2019. PDUFA estimate under priority review August 19, 2020.
$12.4 billion

LPCN – Lipocine Inc.
TLANDO - LPCN 1021
Men with low testosterone (Low T)

PDUFA PDUFA date August 28, 2020
$138.1 million

MESO – Mesoblast Limited
Remestemcel-L (MSC-100-IV)
acute graft versus host disease (aGVHD) in children

PDUFA priority review PDUFA date under priority review September 30, 2020. FDA Oncologic Drugs Advisory Committee meeting scheduled for August 13, 2020.
$1.4 billion

MNK – Mallinckrodt plc
Terlipressin
Hepatorenal syndrome (HRS) Type 1

PDUFA PDUFA date September 12, 2020. Advisory Committee Meeting July 15, 2020 voted 8-7 that the benefits outweigh the risks.
$118 million

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

Approved FDA Approval announced August 7, 2020.
$3.2 billion

TCDA – Tricida Inc.
TRC 101
Chronic kidney disease

PDUFA PDUFA date August 22, 2020. Company noted July 15, 2020 that the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments.
$684.9 million

TRVN – Trevena Inc.
Oliceridine (TRV130)
Moderate to severe acute pain

Approved FDA Approval announced August 7, 2020.
$245.4 million