BPC June 29 update

Intercept ICPT -40% and Heron HRTX -28% issued Complete Response Letters; Akero AKRO data due Tuesday

Price and Volume Movers

Akero Therapeutics, Inc. (Nasdaq: AKRO) announced that data from its Phase 2a trial of AKR-001 in patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) will be released after-hours on Tuesday, June 30, 2020.

Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) shares closed up 13% to $26.00 on news its Phase 3 trial of rilonacept, met its prespecified primary and all major secondary efficacy endpoints, showing that rilonacept improved clinically meaningful outcomes associated with the unmet medical need in recurrent pericarditis.

Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT) announced that the FDA issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for obeticholic acid (OCA) for the treatment of fibrosis due to nonalcoholic steatohepatitis (NASH). The CRL indicated that the predicted benefit of OCA remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to NASH. Shares slid to close down 40% to $46.70.

Heron Therapeutics, Inc. (Nasdaq: HRTX) shares closed down 28% to $14.26 on news that it also received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for HTX-011 for the management of postoperative pain. The letter noted four non-clinical issues in the CRL. Three relate to confirming exposure of excipients in preclinical reproductive toxicology studies, and the fourth relates to changing the manufacturing release specification of the allowable level of an impurity based on animal toxicology coverage.

Pacira BioSciences, Inc. (NASDAQ: PCRX) shares rallied to closed up 18% to $52.02 in response to the news. The company currently has on the market a non-opioid pain management, exparel, for the same indication as Heron.

Verrica Pharmaceuticals Inc. (NASDAQ:VRCA) shares are trading down 19% to $11.40 after hours following its announcement that the FDA has noted deficiencies that preclude discussion of labelling and post-marketing requirements/commitments for its review of the New Drug Application (NDA) for VP-102, for the treatment of molluscum contagiosum. The assigned PDUFA date is July 13, 2020.

ObsEva SA (NASDAQ: OBSV) announced that it will release Phase 3 data from the PRIMROSE 1 and PRIMROSE 2 clinical trials of linzagolix for the treatment of heavy menstrual bleeding due to uterine fibroids, on Monday July 6, 2020.

Offerings / private placements:

Liquidia Technologies, Inc. (NASDAQ:LQDA): $8.74; -18% AH. Common stock offering.

Acceleron Pharma Inc. (NASDAQ:XLRN): $93.38; -3% AH. Common stock offering $400m.

CRISPR Therapeutics (NASDAQ:CRSP): $71.71; -4% AH. Common stock offering $325m.

Achieve Life Sciences, Inc. (NASDAQ:ACHV): $0.39; -6%. Registered direct offering $6m.

BioNTech SE (NASDAQ:BNTX): $65.80; +6%. Private placement $250m.

Therapix Biosciences Ltd. (NASDAQ:TRPX): $0.60; -16%. Private placement ADSs/warrants $2.6m.

-

Major price movers (stocks priced > $1.00, volume > 50k):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume:

ADVANCERS:

PDS Biotechnology Corporation (PDSB): $2.60; +60%.

Can-Fite BioPharma Ltd. (CANF): $2.19; +16%.

iBio, Inc. (IBIO): $2.46; +14%.

Trevi Therapeutics, Inc. (TRVI): $6.87; +14%.

DECLINERS:

Cleveland BioLabs, Inc. (CBLI): $2.45; -42%.

IMARA Inc. (IMRA): $28.48; -17%.

Aravive, Inc. (ARAV): $12.00; -15%.

CohBar, Inc. (CWBR): $1.61; -13%.

NGM Biopharmaceuticals, Inc. (NGM): $19.58; -12%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AKRO – Akero Therapeutics Inc.
AKR-001
Nonalcoholic steatohepatitis (NASH)

Phase 2a Phase 2a dose groups all met primary endpoint - March 31, 2020. Further data released June 30, 2020 noted 48% of patients achieved at least a one-stage improvement in fibrosis without worsening of NAFLD activity score (NAS) and 28% achieved at least a two-stage improvement in fibrosis.
$946.8 million

ALT – Altimmune Inc.
T-COVID
COVID-19

Phase 1/2 Phase 1/2 trial to commence July 2020 with data due 4Q 2020.
$225.2 million

HRTX – Heron Therapeutics Inc.
HTX-011
Post operative pain

CRL CRL announced June 29, 2020.
$1.4 billion

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

CRL CRL announced June 29, 2020.
$1.6 billion

ITRM – Iterum Therapeutics plc
Sulopenem
Uncomplicated urinary tract infections (uUTI)

Phase 3 Phase 3 data released June 29, 2020. One of two primary endpoints met.
$21.2 million

KNSA – Kiniksa Pharmaceuticals Ltd.
Rilonacept (RHAPSODY)
Pericarditis

Phase 3 Phase 3 data met primary endpoint and all major secondary efficacy endpoints - June 29, 2020.
$1.4 billion

MRK – Merck & Company Inc. (new)
Keytruda KN-177
Colorectal cancer (CRC)

Approved FDA Approval announced June 29, 2020.
$198.8 billion

NMTR – 9 Meters Biopharma Inc.
Larazotide
Celiac disease

Phase 3 Phase 3 interim analysis due 1H 2021 with top-line data due 2H 2021.
$61.6 million

OBSV – ObsEva SA
Linzagolix OBE2109 - PRIMROSE 1
Uterine fibroids

Phase 3 Phase 3 data due July 6, 2020.
$274.2 million

SGEN – Seattle Genetics Inc.
Tisotumab Vedotin (innovaTV 204 )
Cervical Cancer

Phase 2 Phase 2 data noted 24% ORR with a median duration of response of 8.3 months.
$29.3 billion

TFFP – TFF Pharmaceuticals Inc - Ordinary Shares
Tacrolimus Inhalation Powder
Prophylaxis of lung allograft rejection

Phase 1 Phase 1 initiation announced June 29, 2020.
$115.6 million

TNXP – Tonix Pharmaceuticals Holding Corp.
TNX-102 SL (Tonmya)
Fibromyalgia

Phase 3 Phase 3 interim analysis due September 2020. Top-line data due 4Q 2020.
$32.6 million

VRCA – Verrica Pharmaceuticals Inc.
VP-102
Molluscum contagiosum

PDUFA PDUFA date July 13, 2020. However, the company noted on June 29, 2020 that the FDA reported deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. PDUFA date remains unchanged but likely to be extended or CRL issued.
$265.9 million