logo
Share SHARE
FONT-SIZE Plus   Neg

CAPR Is Hot, VBLT In Rally Mode, MYOK's Data Heartening, MediWound Bleeds

Sept19-091917-lt.jpg

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

GAINERS

1. Capricor Therapeutics Inc. (CAPR)

Gained 70.45% to close Tuesday's (Sep.19) trading at $2.25. This is the second straight day of gain for the stock.

News: No news

Near-term catalysts:

-- The Company is slated to present six-month follow-up results from the randomized Phase I/II HOPE-Duchenne clinical trial of CAP-1002 in boys and young men with Duchenne muscular dystrophy at the 22nd International Congress of the World Muscle Society on Wednesday, October 4, 2017.

Positive top-line results from a safety and exploratory efficacy analysis of six-month data from the randomized 12-month Phase I/II HOPE Clinical Trial of CAP-1002 were reported on April 25, 2017.

-- The top-line 12-month results from the HOPE-Duchenne Trial are expected to be reported in the fourth quarter of 2017.

2. Vascular Biogenics Ltd. (VBLT)

Gained 24.14% to close Tuesday's trading at $7.20. This is the second straight day of gain for the stock.

New: No news

Near-term catalysts:

-- A final DSMC review of the Company's phase III study of VB-111 in patients with recurrent glioblastoma (rGBM), dubbed GLOBE, is expected in late September.
-- Top-line data from the GLOBE trial anticipated in Q1 2018.
-- Initiation of a phase III study of VB-111 in ovarian cancer by year-end 2017.
-- Initiation of exploratory clinical study of VB-111 in combination with a checkpoint inhibitor in lung cancer in Q1 2018.

Related Link

Keep An Eye On These Biotech Stocks This Month

3. MyoKardia Inc. (MYOK)

Gained 8.17% to close Tuesday's trading at $48.35.

News: The Company presented additional positive data from the first patient cohort of its phase II study of Mavacamten in symptomatic, obstructive hypertrophic cardiomyopathy (oHCM) patients, dubbed PIONEER-HCM.

The new data indicated that Mavacamten treatment led to a meaningful reduction, in the first few weeks of treatment, in resting left ventricular outflow tract (LVOT) gradient with a less pronounced reduction in resting left ventricular ejection fraction (LVEF). The rapid reduction in LVOT gradient, observed in 9 out of 10 patients by week 2, supported the addition of a second, low-dose cohort in the PIONEER-HCM trial.

MyoKardia initially reported positive topline results from this first patient cohort on August 7, 2017, which met the primary endpoint of change in post-exercise peak LVOT gradient from baseline to week 12 as well as key secondary endpoints, including peak oxygen consumption (peak VO2).

4. Epizyme Inc. (EPZM)

Gained 7.84% to close Tuesday's trading at $19.25.

News: The Company announced the closing of public offering of common stock and full exercise of underwriters' option to purchase additional shares.

On September 14, 2017, the Company offered to sell 9.18 million shares of its common stock to the public at a price of $15.25 each, before underwriting discounts. In addition, Epizyme granted the underwriters a 30-day option to purchase up to an additional 1.37 million shares of common stock.

The net proceeds to Epizyme from the offering are approximately $151.3 million.

Upcoming 2017 Milestones

-- Epizyme anticipates engaging with the U.S. FDA in the second half of 2017 to review data from its ongoing Phase 2 study in relapsed or refractory patients with NHL and discussing potential registration paths for Tazemetostat.
-- The company plans to begin a clinical study evaluating Tazemetostat as a combination agent for the treatment of patients with Follicular Lymphoma by the end of 2017.
-- Epizyme plans to announce the next development candidate from its novel, internally discovered pipeline of epigenetic programs by the end of 2017.

5. Quidel Corp. (QDEL)

Gained 6.45% to close Tuesday's trading at $43.55. This is the second straight day of gain for the stock.

News: No news

Recent event:

On September 18, 2017, the Company announced a revised Agreement for its pending acquisition of Alere's B-type Naturietic Peptide (BNP) Assay business run on Beckman Coulter Analyzers.

The revised agreement reflects Quidel's direct commercial responsibility for all Beckman Coulter BNP sales globally, while the business arrangement for the pending acquisition of Alere's Triage MeterPro assets is substantially unchanged.

Quidel will acquire the Triage business, including real estate for the San Diego Triage facilities, and the global BNP business for a total consideration of up to $680 million, comprised of the previously announced $400 million purchase price for the Triage business, $40 million in contingent consideration for the EEA BNP business, and $240 million in deferred consideration for the rest-of-world BNP business.

LOSERS

1. Supernus Pharmaceuticals Inc. (SUPN)

Lost 23.36% to close Tuesday's trading at $38.05.

News: Following an interim analysis of its first phase III clinical trial of SPN-810 for impulsive aggression in patients aged 6 to 12 years who have attention deficit hyperactivity disorder, the Company has decided to eliminate the lower dose of 18 mg of SPN-810.

Moving forward, all patients will be randomized to either the 36 mg dose arm or placebo, and enrollment is expected to continue through mid-2018.

2. MediWound Ltd. (MDWD)

Lost 17.36% to close Tuesday's trading at $5.00.

News: The Company has priced an underwritten public offering of 4.4 million of its ordinary shares at $5.00 each.

The underwriters have a 30-day option to purchase up to 660,000 additional ordinary shares. The offering is scheduled to close on or about September 21, 2017, and the gross proceeds from it are expected to be $22 million.

3. ProQR Therapeutics N.V. (PRQR)

Lost 15.97% to close Tuesday's trading at $5.00.

Near-term catalyst:

The Company is slated to release top-line data from its Phase 1b clinical trial of QR-010 cystic fibrosis patients post-market close on Monday, September 25, 2017.

The Phase 1b trial is a 28-day, safety and tolerability study conducted in patients that have cystic fibrosis due to two copies of the F508del mutation (homozygotes). A total of 4 dose levels were studied: 6.25, 12.5, 25 and 50mg of QR-010 in solution per dose administered via inhalation.

4. MannKind Corp. (MNKD)

Lost 11.40% to close Tuesday's trading at $2.02.

News: No news

Near-term catalyst:

The Company had a positive pre-IND meeting with the FDA during June 2017 and, as a result, will be advancing treprostinil Technosphere for the treatment of pulmonary arterial hypertension with the intention of filing an investigational new drug application by the end of 2017.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

comments powered by Disqus
Follow RTT