BPC July 03 update

​Karyopharm KPTI receives FDA approval for multiple myeloma therapy

Price and Volume Movers

Karyopharm Therapeutics Inc. (Nasdaq:KPTI) announced that the FDA approved oral Xpovio (selinexor) in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies. This approval was granted under accelerated approval based on a response rate of 25.3%. Continued approval may be contingent upon data from its ongoing Phase 3 Boston trial. The company recently noted that data from the Boston trial are slated for release towards the end of 2019 or early 2020. Shares surged on the news, closing the shortened session up 36%, before adding a further 6% after hours to $9.45.

RedHill Biopharma Ltd. (Nasdaq: RDHL) announced the FDA has accepted for review the New Drug Application (NDA) for Talicia (RHB-105) for H. pylori infection. Priority Review designation was granted with a PDUFA date of November 2, 2019.

-

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

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

ADVANCERS:

Corvus Pharmaceuticals, Inc. (CRVS): $6.30; +26%.

Spring Bank Pharmaceuticals, Inc. (SBPH): $4.79; +20%.

Melinta Therapeutics, Inc. (MLNT): $7.89; +18%.

Karuna Therapeutics, Inc. (KRTX): $24.45; +13%.

Correvio Pharma Corp. (CORV): $2.24; +12%.

DECLINERS:

Advaxis, Inc. (ADXS): $1.90; -18%.

Avadel Pharmaceuticals plc (AVDL): $2.12; -11%.

Kaleido BioSciences, Inc. (KLDO): $9.40; -10%.

Novavax, Inc. (NVAX): $5.08; -10%.

Palatin Technologies, Inc. (PTN): $1.00; -7%.

Pipeline updates:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

EARS – Auris Medical Holding Ltd.
AM-201
Healthy volunteers

Phase 1b Phase 1b data from second part of trial due 1Q 2020.
$6.3 million

GSK – GlaxoSmithKline PLC
Otilimab (MOR103/GSK3196165)
Rheumatoid Arthritis

Phase 3 Phase 3 ContRAst trial initiation announced July 3, 2019.
$106.1 billion

KPTI – Karyopharm Therapeutics Inc.
Selinexor
Quadruple Refractory Multiple Myeloma

Approved FDA Approval announced July 3, 2019. Continued approval may be contingent upon data from its Phase 3 Boston trial (data due late-2019/early 2020).
$662.5 million

PBYI – Puma Biotechnology Inc
Neratinib SUMMIT
HER2 non-amplified breast cancer that has a HER2 mutation

Phase 2 Phase 2 additional data presented July 3, 2019 at ESMO. Median PFS 1.8 months. 2/20 partial responses. 4/20 stable disease.
$252.8 million

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

PDUFA priority review PDUFA date under priority review November 2, 2019.
$180.1 million