BPC August 10 update

Seres MCRB surges 389% on positive late-stage data; Pfenex PFNX to be bought out by Ligand LGND +58% after hours

Price and Volume Movers

Seres Therapeutics, Inc. (Nasdaq: MCRB) shares surged to close up 389% to $22.70 on news that data from its Phase 3 ECOSPOR III trial of SER-109 for recurrent C. difficile infection (CDI) met the primary endpoint, exhibiting a highly statistically significant absolute decrease of 30.2% in the proportion of patients who experienced a recurrence in CDI within eight weeks of administration versus placebo.

Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) announced it intends to acquire Pfenex Inc. (NYSE:PFNX) 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, for a total transaction value of up to $516m. Pfenex shares are trading up 58% to $12.10 after hours.

Trevena, Inc. (NASDAQ: TRVN) shares closed up 32% to $3.13 following news released late-Friday that it received approval from the FDA for Olinvyk (oliceridine), an opioid agonist for the management of moderate to severe acute pain in adults.

Reata Pharmaceuticals, Inc. (NASDAQ:RETA) shares closed down 33% to $104.41 following an update of its program for Friedreich’s Ataxia. The company noted that its NDA filing, potentially to be filed in 1Q 2021, will be reevaluated if it is required to conduct a second pivotal trial if the FDA deems its upcoming crossover study to be insufficient for filing. Data from the trial are due next quarter.

Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) announced that it received a Complete Response Letter on August 7 for its New Drug Application for Ryanodex for the treatment of exertional heat stroke (“EHS”). Shares closed down 8% to $43.26.

Mallinckrodt plc (NYSE: MNK) announced that the FDA has accepted for review the Stratatech Biologics License Application (BLA) for StrataGraft, for the treatment of adult patients with deep partial-thickness thermal burns. The FDA granted a priority review with a PDUFA date of February 2, 2021. Shares closed up 4% to $1.50.

Omeros Corporation (NASDAQ:OMER) shares closed up 50% to $21.32 with investors reacting to news that COVID-19 patients with Acute Respiratory Distress Syndrome (ARDS) taking narsoplimab, who initially required mechanical ventilation, all recovered following treatment. A public offering was also announced after hours, with shares trading down 10%.

Catalyst Pharmaceuticals, Inc. (Nasdaq:CPRX) announced in its second quarter earnings report that top-line data from its Phase 3 trial of Firdapse in anti-MuSK antibody positive myasthenia gravis patients did not meet primary or secondary endpoints. Shares are currently trading down 12% to $3.74 after hours.

Equillium, Inc. (NASDAQ:EQ) shares are trading up 21% to $12.25 after hours following the release of interim data from its Phase 1b open label trial of itolizumab in acute graft-versus-host disease (aGVHD). Across the first two dose cohorts itolizumab has been generally well tolerated to date, and five of seven patients achieved a complete response (CR) by Day 29.

Mesoblast Limited (NASDAQ:MESO) shares, which closed normal trading up 9%, are trading down 18% to $14.30 after hours following the release of briefing documents for its upcoming Advisory Committee meeting this Thursday.

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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:

Adamas Pharmaceuticals, Inc. (ADMS): $4.98; +32%.

Sorrento Therapeutics, Inc. (SRNE): $18.82; +31%.

AlloVir, Inc. (ALVR): $41.05; +19%.

Eton Pharmaceuticals, Inc. (ETON): $7.83; +18%.

Lipocine Inc. (LPCN): $2.15; +17%.

DECLINERS:

Navidea Biopharmaceuticals, Inc. (NAVB): $3.46; -28%.

Recro Pharma, Inc. (REPH): $3.34; -24%.

Baudax Bio, Inc. (BXRX): $2.76; -20%.

Aileron Therapeutics, Inc. (ALRN): $1.24; -14%.

Momenta Pharmaceuticals, Inc. (MNTA): $28.55; --13%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AKBA – Akebia Therapeutics Inc.
Vadadustat - PRO2TECT
Non-dialysis patients with anemia related to CKD (NDD-CKD)

Phase 3 Phase 3 trial met efficacy primary endpoint but did not meet primary safety MACE endpoint.
$401.3 million

ANAB – AnaptysBio Inc.
ANB020 - etokimab
Nasal polyps

Phase 2 Phase 2 data failed to meet primary endpoints after 8 weeks. 16 week data due by the end of 2020.
$439 million

CALA – Calithera Biosciences Inc.
Telaglenastat - Keapsake
Non-small cell lung cancer (NSCLC) patients with genetic mutation NRF2/KEAP1

Phase 2 Phase 2 enrolment to commence 3Q 2020 with interim data due 2021.
$269.5 million

CCXI – ChemoCentryx Inc.
Avacopan -AURORA
Hidradenitis Suppurativa (HS)

Phase 2b Phase 2b data due early-4Q 2020.
$3.8 billion

CLSD – Clearside Biomedical Inc.
XIPERE (Suprachoroidal CLS-TA)
Macular edema associated with non-infectious uveitis

NDA Filing CRL received October 18, 2019. To resubmit 1H 2021.
$80.2 million

CPRX – Catalyst Pharmaceuticals Inc.
Firdapse
MuSK-antibody positive myasthenia gravis (MuSK-MG)

Phase 3 Phase 3 trial did not meet primary endpoint - August 10, 2020.
$347.6 million

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

CRL CRL announced August 10, 2020.
$542 million

GILD – Gilead Sciences Inc.
Remdesivir
COVID-19 Coronavirus

NDA Filing NDA filing announced August 10, 2020.
$81.6 billion

MNK – Mallinckrodt plc
StrataGraft skin tissue
Deep partial thickness severe burns - skin defects

PDUFA priority review PDUFA date under priority review February 2, 2021.
$115.9 million

OVID – Ovid Therapeutics Inc.
OV101 - NEPTUNE
Adolescents with Angelman syndrome

Phase 3 Phase 3 data due 4Q 2020.
$423.7 million

RETA – Reata Pharmaceuticals Inc.
Omaveloxolone
Friedreich’s ataxia (FA)

Phase 2 NDA filing due 1Q 2021 assuming FDA views crossover study data as sufficiently positive to provide confirmatory evidence for filing. Data due 4Q 2020.
$3.5 billion

WVE – Wave Life Sciences Ltd.
WVE-120101 (PRECISION-HD1)
Huntington’s disease

Phase 1/2 Phase 1b/2a top line data 1Q 2021.
$717.7 million