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
AGTC-501
X-linked Retinitis Pigmentosa (XLRP)

Phase 1/2 Phase 1/2 further data due 2H 2020.
$126.3 million

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.
$144.3 billion

BHVN – Biohaven Pharmaceutical Holding Company Ltd.
Vazegepant
Acute treatment of migraine

Phase 3 Phase 3 trial to be initiated mid-2020.
$3.9 billion

BLCM – Bellicum Pharmaceuticals Inc.
BPX-601
Pancreatic cancer

Phase 1/2 Phase 1 Cohort 5C data due 2H 2020.
$42.4 million

BLRX – BioLineRx Ltd.
AGI-134
Solid tumors

Phase 1/2 Phase 1/2 data due 2H 2021. Delayed due to COVID-19.
$29.7 million

BTAI – BioXcel Therapeutics Inc.
BXCL501 (SERENITY I)
Schizophrenia - Agitation

Phase 3 Phase 3 data due July 2020.
$912.3 million

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

sNDA Filing sNDA filing due 2H 2020.
$678 million

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

Phase 2/3 Phase 2b data met primary endpoint - December 2, 2019.
$170 million

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

Phase 3 Phase 3 initial data due 2H 2023.
$102.8 million

PFE – Pfizer Inc.
Encorafenib and cetuximab - BEACON CRC
BRAF-Mutant Colorectal Cancer

Approved FDA Approval announced April 8, 2020.
$200.9 billion

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

PDUFA priority review PDUFA date extended to August 24, 2020.
$3.3 billion

QLGN – Qualigen Therapeutics Inc.
RP-G28
Lactose intolerance

Phase 3 Phase 3 data failed to meet primary endpoint - September 12, 2019.
$9.4 million

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

Approved FDA Approval announced November 4, 2019.
$245.8 million

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

Phase 3 Phase 3 commencement of enrolment announced May 7, 2019.
$1.4 billion