BPC June 28 update

​Sarepta SRPT shares rally on the back of DMD data from Pfizer PFE; Retrophin RTRX FDA Approval +9%

Price and Volume Movers

Sarepta Therapeutics, Inc. (NASDAQ: SRPT) shares rallied to close up 17% to $151.95 following the release of initial Phase 1b clinical data from Pfizer Inc. (NYSE:PFE) regarding its Phase 1b trial of PF-06939926, in patients with Duchenne muscular dystrophy (DMD). Data from six patients were released. Investors and analysts noted safety concerns from the trial where one of the six participants developed a rapid antibody response which resulted in acute kidney injury, hemolysis, and reduced platelet count.

Retrophin, Inc. (NASDAQ: RTRX) announced that the FDA approved 100 mg and 300 mg tablets of Thiola EC (tiopronin), a new formulation of Thiola, to be used for the treatment of cystinuria. Shares are trading up 9% to $21.95 after hours.

Sorrento Therapeutics, Inc. (Nasdaq: SRNE) shares closed down 21% to $2.67 on the back of a public offering of 8,333,334 shares with attached warrants at a price of $3 per share and accompanying warrants for gross proceeds of $25m.

Avid Bioservices, Inc. (NASDAQ: CDMO) shares surged to close up 40% to $5.60 following the report of stronger than expected earnings reported late-Wednesday, with revenue of $17.1m compared with estimates of $15.7m.

aTyr Pharma, Inc. (Nasdaq: LIFE) announced a 1-for-14 reverse stock split of its common stock will become effective after trading closes on June 28, 2019.

BioLineRx Ltd.(NASDAQ: BLRX) announced a change in the exchange ratio for its American Depositary Shares (ADSs), which effectively will result in a 1-for-15 reverse stock split. The change will be effective from July 15. Shares are trading down 12% after hours to $0.32.

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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:

Xenetic Biosciences, Inc. (XBIO): $5.60; +40%.

Constellation Pharmaceuticals, Inc. (CNST): $12.28; +22%.

AcelRx Pharmaceuticals, Inc. (ACRX): $2.53; +20%.

Verrica Pharmaceuticals Inc. (VRCA): $11.62; +20%.

Adaptive Biotechnologies Corporation (ADPT): $48.30; +20%.

DECLINERS:

Oasmia Pharmaceutical AB (OASM): $1.02; -24%.

Bellicum Pharmaceuticals, Inc. (BLCM): $1.70; -15%.

Aduro BioTech, Inc. (ADRO): $1.54; -12%.

Prevail Therapeutics Inc. (PRVL): $13.20; -12%.

Arrowhead Pharmaceuticals, Inc. (ARWR): $26.50; -8%.

Pipeline updates:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ACIU – AC Immune SA
RG6100 (Anti-Tau RO7105705)
Alzheimer’s disease

Phase 2 Phase 2 data due 3Q 2020.
$323.6 million

JNJ – Johnson & Johnson
Daratumumab - MAIA
Newly Diagnosed Multiple Myeloma (NDMM)

Approved FDA Approval announced June 28, 2019.
$337 billion

KRTX – Karuna Therapeutics Inc.
KarXT
Acute psychosis in patients with schizophrenia

Phase 2 Phase 2 top-line data due late-2019.
$364.8 million

KRTX – Karuna Therapeutics Inc.
KarXT
Schizophrenia - cognitive symptoms

Phase 1b Phase 1b trial to commence 1H 2020.
$364.8 million

KRTX – Karuna Therapeutics Inc.
KarXT
Schizophrenia - negative symptoms

Phase 1b Phase 1b trial to commence 1H 2020.
$364.8 million

KRTX – Karuna Therapeutics Inc.
KarXT
Alzheimer’s disease

Phase 1b Phase 1b trial to commence 2H 2019.
$364.8 million

PFE – Pfizer Inc.
PF-06939926
Duchenne muscular dystrophy (DMD)

Phase 1b Phase 1b data June 28, 2019 noted safety concerns. Phase 3 trial to commence 1H 2020.
$201.7 billion

PFE – Pfizer Inc.
PF-06439535
Biosimilar bevacizumab

Approved FDA Approval announced June 28, 2019.
$201.7 billion

PFE – Pfizer Inc.
Sildenafil and inhaled nitric oxide (iNO)
Persistent Pulmonary Hypertension (PPHN)

Phase 3 Phase 3 trial did not meet primary endpoint - June 28, 2019.
$201.7 billion

REPL – Replimune Group Inc.
RP1 and nivolumab
Solid tumors

Phase 1/2 Phase 1 data to be presented at SITC November 8, 2019, 7:00 a.m. ET.
$443.6 million

REPL – Replimune Group Inc.
RP1 and cemiplimab
Cutaneous squamous cell carcinoma (CSCC)

Phase 2 Phase 2 commencement of enrolment announced October 15, 2019.
$443.6 million

REPL – Replimune Group Inc.
RP2 and nivolumab
Solid tumors

Phase 1 Phase 1 trial to be initiated 3Q 2019.
$443.6 million

RTRX – Retrophin Inc.
New formulation of Thiola (tiopronin)
Cystinuria

Approved FDA Approval announced June 28, 2019.
$482.8 million