BPC June 05 update

​InflaRx IFRX shares plunge 92% on failed drug trial

Price and Volume Movers

InflaRx (Nasdaq: IFRX) announced top-line data from its Phase 2b trial of IFX-1, in patients suffering from moderate to severe Hidradenitis Suppurativa (HS), did not meet the primary endpoint of a dose response signal, assessed by the Hidradenitis Suppurativa Clinical Response (HiSCR) score at week 16. The placebo performed better than IFX-1 in both medium and high doses. While the lower IFX-1 dose read out a better result, it was not statistically significant. Shares plunged to close the session down 92% to $3.06.

ChemoCentryx, Inc. (NASDAQ: CCXI) saw its shares fall in response to the above data, closing down 19% to $8.96. The company is also developing its own candidate for Hidradenitis Suppurativa (HS), with data due from its Phase 2b trial in 2020.

Eli Lilly and Company (NYSE: LLY) announced late-Tuesday that the FDA has approved Emgality (galcanezumab-gnlm) injection for the treatment of episodic cluster headache in adults.

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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:

Evolus, Inc. (EOLS): $16.35; +16%.

Auris Medical Holding AG (EARS): $2.90; +14%.

Genocea Biosciences, Inc. (GNCA): $6.71; +13%.

Allena Pharmaceuticals, Inc. (ALNA): $5.59; +12%.

Neon Therapeutics, Inc. (NTGN): $5.50; +12%.

DECLINERS:

HOOKIPA Pharma Inc. (HOOK): $8.05; -18%.

Seres Therapeutics, Inc. (MCRB): $3.30; -18%.

Zafgen, Inc. (ZFGN): $1.51; -15%.

Kaleido BioSciences, Inc. (KLDO): $13.87; -14%.

Xeris Pharmaceuticals, Inc. (XERS): $9.53; -14%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ACRS – Aclaris Therapeutics Inc.
ATI-502 (ATI-50002-AGA-201) - open label
Androgenetic alopecia (AGA) - Hair loss

Phase 2 Phase 2 6-month data noted increase in hair count of 8.6 hairs/cm2. 12 month data due YE 2019.
$36.1 million

ALNY – Alnylam Pharmaceuticals Inc.
Givosiran
Acute hepatic porphyrias

PDUFA priority review PDUFA date under priority review February 4, 2020.
$9 billion

ALRN – Aileron Therapeutics Inc.
ALRN-6924 and IBRANCE (palbociclib)
Solid tumors

Phase 2a Phase 2a preliminary data due at ESMO Sept 27-Oct 1, 2019 with final data due 2H 2020.
$16.4 million

ALRN – Aileron Therapeutics Inc.
ALRN-6924
Small Cell Lung Cancer (SCLC)

Phase 1/2 Phase 1b/2 trial to commence September 2019 with data due 2Q 2020.
$16.4 million

ANAB – AnaptysBio Inc.
ANB020 - etokimab
Severe adult eosinophilic asthma

Phase 2a Phase 2b trial to be initiated 4Q 2019.
$1.3 billion

ARDX – Ardelyx Inc.
Tenapanor - AMPLIFY
Hyperphosphatemia - adjunctive therapy to phosphate binders

Phase 3 Phase 3 data due 3Q 2019.
$155.1 million

CNCE – Concert Pharmaceuticals Inc.
CTP-543 - open label (Once-Daily vs. Twice-Daily)
Alopecia areata

Phase 2 Phase 2 trial to be completed 4Q 2019.
$248.9 million

FLXN – Flexion Therapeutics Inc.
FX201
Osteoarthritis (OA)

Phase 1 Clinical trials to commence 2H 2019 following IND filing.
$418.8 million

IFRX – InflaRx N.V.
IFX-1
Hidradenitis Suppurativa

Phase 2b Phase 2b data June 5, 2019 did not meet primary endpoint.
$68.3 million

LLY – Eli Lilly and Company
Galcanezumab
Cluster headache

Approved FDA Approval announced June 4, 2019.
$106.7 billion

LQDA – Liquidia Technologies Inc.
LIQ861 - INSPIRE
Pulmonary arterial hypertension

Phase 3 NDA filing due late-2019.
$111.7 million

MNOV – MediciNova Inc.
MN-166
Amyotrophic lateral sclerosis (ALS)

Phase 2/3 Phase 2b/3 trial launched - June 5, 2019. Enrolment to commence soon.
$362 million

NGM – NGM Biopharmaceuticals Inc.
NGM313 / MK-3655
Non-alcoholic steatohepatitis (NASH) and Type 2 diabetes

Phase 2 Phase 2 trial to be initiated 2020.
$984 million

ONCY – Oncolytics Biotech Inc.
Pelareorep, paclitaxel and avelumab - BRACELET-1
HR+ / HER2- breast cancer

Phase 2 Phase 2 trial planned for 1Q 2020 with interim data due 2H 2020.
$12.8 million