BPC August 11 update

Fennec FENC issued CRL - shares fall 35%; Fulcrum FULC releases negative interim mid-stage data -48%

Price and Volume Movers

Fennec Pharmaceuticals Inc., (NASDAQ:FENC) shares closed down 35% to $6.66 following news it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for Pedmark for the prevention of ototoxicity associated with cisplatin chemotherapy in pediatric patients with solid tumors. The FDA identified manufacturing deficiencies for the CRL.

Fulcrum Therapeutics, Inc. (Nasdaq: FULC) announced interim analysis of its Phase 2 ReDUX4 trial in subjects with facioscapulohumeral muscular dystrophy (FSHD) showed, in the first 29 randomized subjects, that DUX4-driven gene expression (primary endpoint) did not show a separation from placebo at 16 weeks. Shares closed down 48% to $8.90.

Eton Pharmaceuticals, Inc (Nasdaq: ETON) announced that its partner has not yet received a communication from the FDA regarding its decision on the review of EM-100, which was assigned a PDUFA date of August 10, 2020. The company said it is not aware of any information requests outstanding and expects the FDA to communicate a decision in the coming days. Shares closed down 13% to $6.85.

Mesoblast Limited (NASDAQ:MESO) shares closed down 35% to $11.33 following the release of briefing documents for its upcoming Advisory Committee meeting this Thursday.

Pfenex Inc. (NYSE:PFNX) shares closed up 67% to $12.83 following news released Monday that Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) intends to acquire the company for $12 per share or $438m in equity value on a fully diluted basis. In addition, Ligand will pay $2 per share or $78m as a Contingent Value Right (CVR) in the event a predefined regulatory milestone is achieved by December 31, 2021.

Trevena, Inc. (NASDAQ:TRVN) announced after hours it intends to offer and sell shares of its common stock in an underwritten public offering. Shares are trading down 18% after hours to $2.26, adding to its 12% fall during normal trading hours.

Adverum Biotechnologies, Inc. (NASDAQ:ADVM) also announced after hours that it has commenced an underwritten public offering of $200m of its common stock. Shares, which closed down 17% during normal trading hours, are trading down 3% to $15.05 after hours.

Personalis, Inc. (NASDAQ:PSNL) shares are trading down 7% after hours to $19.75 after it also announced a public offering of $100m of its common stock.

Seres Therapeutics, Inc. (NASDAQ:MCRB) announced after hours that it is commencing an underwritten registered public offering of 8m shares of its common stock.

Moderna, Inc., (NASDAQ:MRNA) announced after hours the U.S. government has secured 100m million doses of its potential COVID-19 vaccine, mRNA-1273. The award of up to $1.525b is for the manufacturing and delivery of 100m doses. Shares are trading up 8% to $74.76 after hours.

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

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

ADVANCERS:

Biofrontera AG (BFRA): $20.32; +53%.

Eyenovia, Inc. (EYEN): $5.03; +38%.

Trevi Therapeutics, Inc. (TRVI): $5.82; +20%.

Vaxart, Inc. (VXRT): $10.75; +14%.

Pieris Pharmaceuticals, Inc. (PIRS): $3.16; +13%.

DECLINERS:

Omeros Corporation (OMER): $15.89; -25%.

iBio, Inc. (IBIO): $2.76; -25%.

Sorrento Therapeutics, Inc. (SRNE): $14.09; -25%.

PDS Biotechnology Corporation (PDSB): $3.00; -23%.

Inovio Pharmaceuticals, Inc. (INO): $14.62; -23%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

APRE – Aprea Therapeutics Inc.
APR-246 (eprenetapopt) and azacitidine
TP53 mutant Myelodysplastic syndromes (MDS)

Phase 2/3 Phase 3 top-line data due by the end of 2020.
$626.3 million

ARCT – Arcturus Therapeutics Holdings Inc.
LUNAR-COV19
COVID-19 vaccine

Phase 1 Phase 1 initiation announced August 11, 2020 with initial data due 4Q 2020.
$1.1 billion

ARQT – Arcutis Biotherapeutics Inc.
ARQ-154
Seborrheic dermatitis

Phase 2 Phase 2 data due early-4Q 2020.
$1 billion

AUPH – Aurinia Pharmaceuticals Inc
Voclosporin ophthalmic solution (VOS) - AUDREY
Dry eye syndrome

Phase 2/3 Phase 2/3 data due 4Q 2020.
$2 billion

AZRX – AzurRx BioPharma Inc.
MS1819 Combination
Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency

Phase 2 Phase 2 top line data due 2Q 2021.
$23.2 million

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

PDUFA GDUFA (PDUFA) date September 15, 2020. Company noted September 16, 2020 that it has yet to receive communication from the FDA regarding its decision
$6.1 billion

CYDY – CytoDyn Inc
Leronlimab
COVID-19 (Mild to Moderate)

Phase 2 Phase 2 data released August 11, 2020 did not report primary endpoint data (TCSS at Day 14). Day 3 subgroup showed clinical improvement but not mentioned to be statistically significant. Secondary NEWS2 was met. No data on other secondary endpoints.
$2 billion

EIDX – Eidos Therapeutics Inc.
Acoramidis (AG10) - ATTRibute-CM
ATTR-CM

Phase 3 Phase 3 enrolment to be completed 1H 2021 with top-line data due 1H 2022.
$2 billion

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

CRL CRL announced August 10, 2020.
$166.3 million

GOSS – Gossamer Bio Inc.
GB001
Nasal polyps / Chronic spontaneous urticaria

Phase 2 Phase 2 data due 2H 2020.
$943.8 million

GSK – GlaxoSmithKline PLC
VIR-7831 / GSK418213
COVID-19 antibody

Phase 2/3 Phase 2/3 trial initiation announced August 31, 2020. Initial data due by end of 2020.
$98.5 billion

MYOV – Myovant Sciences Ltd.
Relugolix - SPIRIT EXTENSION
Endometriosis

Phase 3 Phase 3 data due 1Q 2021.
$2 billion