BPC October 08 update

Goldman Sachs downgrades CLVS -12%; NKTR -13%; PBYI -22%; Clinuvel CLVLY FDA Approval

Price and Volume Movers

Clinuvel Pharmaceuticals Limited (OTC: CLVLY) announced that the FDA granted approval to Scenesse (afamelanotide) to increase pain-free light exposure in adult patients with a history of phototoxic reactions (damage to skin) from erythropoietic protoporphyria.

Novartis (NYSE: NVS) announced the FDA approved Beovu (brolucizumab) injection, also known as RTH258, for the treatment of wet age-related macular degeneration (AMD).

Nektar Therapeutics (NASDAQ: NKTR) shares closed down 13% to $16.18. Goldman Sachs downgraded its rating of the company to Sell from Buy with a price target of $16 compared with $54 prior.

Novelion Therapeutics Inc. (NASDAQ:NVLN) announced that it will be delisted from NASDAQ and trading will be suspended effective at the open of business on October 9, 2019, and will likely trade on the over-the-counter market (OTC).

Clovis Oncology, Inc. (NASDAQ: CLVS) shares closed down 12% to $3.16. Analysts at Goldman Sachs maintained their Sell rating and lowered their price target to $3 from $13 prior.

Puma Biotechnology (NASDAQ:PBYI) shares also fell on a Goldman Sachs downgrade, from Neutral to Sell, while decreasing their price target from $24 to $8. Shares closed down 22% to $7.86.

DBV Technologies (NASDAQ:DBVT) announced after hours its intention to issue up to $125m of new ordinary shares.

-

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

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

ADVANCERS:

EDAP TMS S.A. (EDAP): $4.83; +5%.

Spring Bank Pharmaceuticals, Inc. (SBPH): $3.08; +4%.

Akari Therapeutics, Plc (AKTX): $2.04; +4%.

Celsion Corporation (NASDAQ: CLSN): $1.82; +4%.

Vistagen Therapeutics Inc (NASDAQ: VTGN): $1.09; +4%.

DECLINERS:

Ocugen, Inc. (OCGN): $1.28; -32%.

Enlivex Therapeutics Ltd (ENLV): $8.52; -12%.

Adamas Pharmaceuticals Inc (ADMS): $3.75; -11%.

Fulcrum Therapeutics Inc (FULC): $5.77; -11%.

CEL-SCI Corporation (CVM): $8.24; -11%.


Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AVRO – AVROBIO Inc.
AVR-RD-04
Cystinosis

Phase 1/2 Phase 1/2 commencement of dosing announced October 8, 2019.
$443.3 million

CLVLY – Clinuvel Pharms Ltd S/Adr
SCENESSE
Phototoxicity and anaphylactoid reactions in adult patients with erythropoietic protoporphyria (EPP)

Approved FDA approval announced October 8, 2019.
$1.1 billion

INCY – Incyte Corporation
Baricitinib
Atopic dermatitis

Phase 3 Phase 3 BREEZE-AD7 trial met primary endpoint - August 23, 2019.
$16.9 billion

NVS – Novartis AG
RTH258 (brolucizumab)
Wet age-related macular degeneration (AMD)

Approved FDA Approval announced October 8, 2019.
$198.7 billion

SLRX – Salarius Pharmaceuticals
Seclidemstat
Ewing sarcoma

Phase 1 Phase 1 maximum tolerated dose to be met in early 2020 with initial data due later that year.
$21.4 million

VTGN – VistaGen Therapeutics Inc.
AV-101 - ELEVATE
Adjunctive Treatment Major Depressive Disorder

Phase 2 Phase 2 data due 4Q 2019.
$50.8 million