BPC May 07 update

Large caps Regeneron REGN Mylan MYL and Allergan AGN down on earnings; Reverse splits effective for Axovant AXGT and DelMar DMPI

Price and Volume Movers

Catalyst Pharmaceuticals Inc (NASDAQ: CPRX) shares closed Tuesday down 40% to $3.69 following news released late-Monday the FDA granted the approval of Ruzurgi to Jacobus Pharmaceutical Company, Inc. for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to less than 17 years of age. Catalyst Pharmaceuticals currently markets Firdapse in adults but while the labels differ doctors will have the option to prescribe Ruzurgi off-label to adults.

Regeneron Pharmaceuticals Inc (NASDAQ: REGN) shares closed down 7% to $320.22 on the back of its first quarter earnings miss reported today. The company earned $4.45 per share on total revenues of $1.712 billion. Analysts had been expecting earnings of $5.52 per share on revenue of $1.76b.

Other large-caps falling today following their respective 1Q earnings reports included Mylan NV (NASDAQ: MYL), which fell 24% to $21.58 and Allergan plc (NYSE: AGN), down 5% to $140.23; -5%.

Ritter Pharmaceuticals Inc (NASDAQ: RTTR) shares closed up 16% to $1.01. The company announced that the final patient in its first pivotal Phase 3 clinical trial of RP-G28 for the potential treatment of Lactose intolerance (LI), has completed the treatment dosing period. Data are due in early 4Q 2019, in line with previous guidance.

DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) announced that it will effect a 1-for-10 reverse stock split effective as of the commencement of trading on Wednesday, May 8, 2019.

Axovant Gene Therapies Ltd. (Nasdaq: AXGT) also announced a reverse share split of its common shares on a 1-for-8 basis will become effective from the start of trading on May 8, 2019.

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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:

ARCA biopharma, Inc. (ABIO): $12.58; +11%.

Eagle Pharmaceuticals, Inc. (EGRX): $56.95; +7%.

Syndax Pharmaceuticals, Inc. (SNDX): $7.81; +6%.

Moleculin Biotech, Inc. (MBRX): $1.40; +6%.

Evofem Biosciences, Inc. (EVFM): $4.45; +6%.

DECLINERS:

Intersect ENT, Inc. (XENT): $25.10; -24%.

TherapeuticsMD, Inc. (TXMD): $3.80; -16%.

Idera Pharmaceuticals, Inc. (IDRA): $3.34; -16%.

AMAG Pharmaceuticals, Inc. (AMAG): $10.43; -12%.

Insmed Incorporated (INSM): $28.26; -12%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AGTC – Applied Genetic Technologies Corporation
AAV-based gene therapy
X-linked Retinitis Pigmentosa (XLRP)

Phase 1/2 Phase 1/2 dose escalation data due 3Q 2019. Expansion data due 4Q 2019.
$69.4 million

ARRY – Array BioPharma Inc.
Encorafenib and cetuximab - BEACON CRC
BRAF-Mutant Colorectal Cancer

Phase 3 Phase 3 interim analysis May 21, 2019 met primary ORR and OS endpoints.
$5.7 billion

AZN – Astrazeneca PLC
Calquence
Relapsed/refractory chronic lymphocytic leukaemia

Phase 3 Phase 3 positive interim data released May 7, 2019. Trial to be stopped early.
$99.4 billion

BHVN – Biohaven Pharmaceutical Holding Company Ltd.
BHV-3500
Acute treatment of migraine

Phase 2/3 Phase 2/3 top-line data due 4Q 2019.
$2.7 billion

BLCM – Bellicum Pharmaceuticals Inc.
BPX-601
Pancreatic cancer

Phase 1 Phase 1 initial data due at ASCO June 1, 2019, 8am CT.
$125.6 million

BLRX – BioLineRx Ltd.
AGI-134
Solid tumors

Phase 1/2 Phase 1/2 initial safety data 2H 2019. Efficacy data due YE 2020.
$51.3 million

BTAI – BioXcel Therapeutics Inc.
BXCL501
Schizophrenia - Agitation

Phase 2 Phase 2 trial to be initiated soon with Phase 3 pivotal trial to commence 2H 2019
$172.3 million

EGRX – Eagle Pharmaceuticals Inc.
Ryanodex
Nerve agent (NA) exposure

Data released May 7, 2019 noted lower incidence of brain damage.
$773.4 million

EVFM – Evofem Biosciences Inc.
Amphora - AMPREVENCE
Prevention of urogenital Chlamydia trachomatis infection in women

Phase 2/3 Phase 2b data due fall of 2019.
$180.4 million

GLMD – Galmed Pharmaceuticals Ltd.
Aramchol - ARMOR
Non-Alcoholic Steatohepatitis (NASH)

Phase 3 Phase 3 trial to commence 3Q 2019 with initial data due 4Q 2022.
$144 million

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

Phase 2/3 NDA filing due 2H 2019.
$2.3 billion

RDHL – Redhill Biopharma Ltd.
RHB-105
H. pylori

NDA Filing NDA filing announced May 7, 2019.
$165.6 million

RTTR – Ritter Pharmaceuticals Inc.
RP-G28
Lactose intolerance

Phase 3 Phase 3 data due early 4Q 2019.
$7.5 million

ZEAL – Zealand Pharma A/S
Glepaglutide - extension trial
Short bowel syndrome

Phase 3 Phase 3 commencement of enrolment announced May 7, 2019.
$665.5 million