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QURE On Fast Track, Music To CNCE's Ears, CRBP Gets A Facelift, OBLN Deflated

Oct19 101917

The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of October 19, 2017.

GAINERS

1. uniQure N.V. (QURE)

Gained 60.08% to close Thursday's (Oct.19) trading at $15.16.

News: The Company announced that following multi-disciplinary meetings with the FDA and EMA, it has planned to expeditiously advance AMT-061 into a pivotal study in 2018 for patients with severe and moderately severe hemophilia B.

AMT-061 combines an AAV5 vector with the FIX-Padua mutant. AMT-060 has been tested in 10 patients in an ongoing Phase I/II clinical trial. All critical quality attributes of AMT-061 are expected to be comparable to those of AMT-060.

In a separate press release, uniQure announced that it has acquired a patent family that broadly covers the FIX-Padua variant and its use in gene therapy for the treatment of coagulopathies, including hemophilia B.

2. Concert Pharmaceuticals Inc. (CNCE)

Gained 18.19% to close Thursday's trading at $16.50.

News: The Patent Trials and Appeal Board of the U.S. Patent and Trademark Office has denied Incyte Corp.'s (INCY)'s petition challenging the Patent No. 9,249,149 covering Concert's CTP-543, an investigational compound for the treatment of alopecia areata.

The patent 9,249,149 claims that CTP-543 is a novel composition of matter. In April 2017, Incyte had filed an Inter Partes Review Petition (IPR) against Concert seeking to invalidate that patent.

CTP-543 is under a phase 2a clinical trial for alopecia areata. The Company expects the trial to be completed in the second half of 2018.

3. Infinity Pharmaceuticals Inc. (INFI)

Gained 14.29% to close Thursday's trading at $2.40.

News: No news

Near-term catalyst:

The Company will be reporting clinical and translational data from monotherapy dose-escalation component of its ongoing phase 1/1b study of IPI-549 in patients with advanced solid tumors during an oral session at the 2017 Society for Immunotherapy of Cancer (SITC) Annual Meeting on November 10, 2017.

4. Corbus Pharmaceuticals Holdings Inc. (CRBP)

Gained 10% to close Thursday's trading at $7.70.

News: The Company announced positive topline results from its 16-week Phase 2 study of safety and efficacy of Anabasum in dermatomyositis.

Dermatomyositis is a rare and serious systemic autoimmune condition characterized by skin and muscle involvement. The disease is characterized by distinct skin lesions that can be accompanied by erosions, photosensitivity, itch, ulcers, calcinosis and hair loss as well as other abnormalities.

In the study, the mean improvement in the primary efficacy outcome, the Cutaneous Dermatomyositis Disease Area and Severity Index ("CDASI") activity score, a validated outcome measure of skin disease severity, was 9.3 points for Anabasum treatment at the end of the study versus a reduction of 3.7 points for placebo treatment.

5. Cidara Therapeutics Inc. (CDTX)

Gained 8.66% to close Thursday's trading at $6.90.

News: The Company announced the pricing of a private placement of 3.36 million shares of its common stock at a price of $6.00 per share.

The gross proceeds to Cidara from the private placement are expected to be approximately $20 million. The private placement is expected to close on or about October 24, 2017.

6. Versartis Inc. (VSAR)

Gained 6.80% to close Thursday's trading at $2.75.

News: No news

Recent event:

-- On Sep.21, 2017, after the bell, the Company announced that its phase III study of Somavaratan in pre-pubertal children with Growth Hormone Deficiency, dubbed VELOCITY, did not meet the trial goals. The news sent the stock tumbling nearly 88% on Sep.22, 2017.

7. ObsEva SA (OBSV)

Gained 6.50% to close Thursday's trading at $10.49.

News: No news

Pipeline & Catalysts:

The Company's most advanced investigational drug is OBE2109, under phase III clinical trials for the treatment of heavy menstrual bleeding (HMB) associated with uterine fibroids (UF) in pre-menopausal women, dubbed PRIMROSE 1 and PRIMROSE 2. A Phase 2b clinical trial of OBE2109 for the treatment of pain associated with endometriosis (EM), dubbed EDELWEISS, is also underway.

Also in the pipeline are Nolasiban to improve pregnancy and live birth rates in women undergoing assisted reproduction by in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) for low fertility, and OBE022 for the treatment of preterm labor.

Nolasiban advanced to phase III testing as recently as March of this year. The phase III trial, known as IMPLANT2, is being conducted at approximately 50 fertility clinics across Europe, and is expected to enroll about 760 women who have undergone assisted reproduction technology (ART).

The Company expects to complete enrollment in its phase III IMPLANT 2 trial of nolasiban for ART by the end of 2017, with top line data expected in the first half of 2018.

The phase 2b EDELWEISS trial of OBE2109 for the treatment of endometriosis is expected to complete enrollment in late 2017 or early 2018, with data expected from the first 12-week evaluation period around mid-2018.

OBE022 for pre-term labor is expected to move into a Phase 2a clinical trial, dubbed PROLONG, in the fourth quarter of 2017, with top line data release expected around year end 2018.

8. Altimmune Inc. (ALT)

Gained 6.40% to close Thursday's trading at $2.66.

News: No news

Near-term catalysts:

-- Initial clinical data from a Phase 1 study of HepTcell, ongoing in the UK and South Korea, are expected this quarter (Q4, 2017). HepTcell is an immunotherapeutic with a potential cure for chronic hepatitis B.
-- Data from the phase II clinical study of NasoVAX, its intranasally administered recombinant flu vaccine is expected in the first quarter of 2018.
-- A bridging study of SparVax-L, a lyophilized anthrax vaccine, is expected to begin this quarter, with topline data anticipated in the first quarter of 2018.
-- A Phase 1 trial of NasoShield, a next-generation intranasal, single-dose, first-in-class anthrax vaccine, is expected to begin during the 1Q-2018, with topline data anticipated in the 2Q-2018.

LOSERS

1. Immune Design Corp. (IMDZ)

Lost 16.03% to close Thursday's trading at $5.50.

News: No news

Near-term catalyst:

-- Data from phase II study of G100 in combination with Keytruda are expected to be presented in December of this year.

2. Ovid Therapeutics Inc. (OVID)

Lost 10.09% to close Thursday's trading at $7.40.

News: No news

The Company made its debut on the NASDAQ Global Select Market on May 5, 2017, offering its shares at a price of $15.00 each.

Pipeline:

The Company's pipeline includes OV101, a potential treatment for Angelman syndrome and Fragile X syndrome, and TAK-935/OV935 for treatment of adults with rare epilepsies.
A phase II clinical trial of OV101 in adults with Angelman syndrome, dubbed STARS, a phase I trial of OV101 in adolescents diagnosed with Angelman syndrome or Fragile X syndrome, and a phase 1b/2a clinical trial of TAK-935/OV935 in adults with rare epilepsies are underway.

Near-term catalysts:

-- The top line data from the phase I trial evaluating OV101 in adolescents diagnosed with Angelman syndrome or Fragile X syndrome are expected to be available in the second half of 2017.
-- Data from the phase 1b/2a clinical trial of TAK-935/OV935 are expected next year.

3. Obalon Therapeutics Inc. (OBLN)

Lost 7.72% to close Thursday's trading at $8.73.

News: No news

Obalon is the maker of the first and only FDA approved swallowable, gas-filled balloon for weight loss.

Recent event:

On August 2, 2017, the Company reported second quarter financial results.

The Company's total revenues of $2.0 million for the second quarter of 2017, compared to $0.8 million for the second quarter of 2016. Net loss was reported at $7.7 million or $0.46 compared to a net loss of $4.1 million or $7.15 in the second quarter of 2016.

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