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CSBR Up 36% This Month, ZIOP Hit By Clinical Hold, Watch Out For SRPT Today


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(RTTNews.com) - Today's Daily Dose brings you news about Royalty Pharma's investment in Biohaven Pharma; Champions Oncology's partnership with NSABP Foundation and Puma Biotechnology; upcoming regulatory catalyst of Myriad Genetics; Valeant Pharma's plaque psoriasis setback; Sarepta's presentation to watch out for the day, and FDA hold on Ziopharm's phase I trial of CD19-targeted CAR T therapy.

Read on…

Biohaven Pharmaceutical Holding Co. Ltd. (BHVN) has sold tiered, sales-based participation rights on future global net sales of products containing Rimegepant (BHV-3000) or BHV-3500 and certain derivative compounds thereof to Royalty Pharma for $100 million.

Royalty Pharma has also agreed to purchase $50.0 million in common shares of Biohaven, at a price of $45.00 per share, representing an approximately 19% premium over the 15-day volume-weighted average price through June 15, 2018.

The $150 million investments by Royalty Pharma, in addition to the cash on hand, are expected to be sufficient to fund Biohaven's operations through the end of 2019.

You can find more about BHVN in our report titled "This Day That Year: Biohaven Pharma", posted on May 4, 2018. The stock was then trading around $28.

BHVN closed Monday's trading at $41.64, up 1.88%.

ContraVir Pharmaceuticals Inc. (CTRV) will host a conference call and live audio webcast on Monday, June 25, 2018 at 4:30 p.m. ET to discuss recent corporate, business and clinical updates.

CTRV closed Monday's trading at $1.49, down 1.97%. In after-hours, the stock was up 4.03% at $1.55.

Champions Oncology Inc. (CSBR) has teamed up with NSABP Foundation Inc. and Puma Biotechnology Inc. (PBYI) to develop patient derived xenograft (PDX) models in two multi-center co-clinical PDX trials.

The first trial, dubbed NSABP FB10, is a phase II study evaluating the combination of Trastuzumab emtansine (T-DM1) with neratinib in women with metastatic HER2-positive breast cancer, and is currently enrolling patients.

The second trial, dubbed NSABP FC11, is a phase II study evaluating the combination of neratinib plus trastuzumab or neratinib plus cetuximab in patients with "quadruple wild-type" (KRAS, NRAS, BRAF PIK3CA wild-type) metastatic colorectal cancer based on HER2 status: amplified, non-amplified (wild-type) or mutated.

Visit our Emerging Biostocks page to know more about CSBR.

CSBR closed Monday's trading at $6.30, up 5.88%. The stock has gained 36% since the beginning of this month.

The FDA has approved Johnson & Johnson Vision's iDESIGN Refractive Studio for myopia, hyperopia, and mixed astigmatism.

Johnson & Johnson Vision is a subsidiary of Johnson & Johnson (JNJ).

The iDESIGN Refractive Studio becomes the only system to use topography-integrated, wavefront-guided technology, and the only available LASIK platform indicated for monovision LASIK in presbyopic myopic patients.

Monovision is a procedure designed for patients over 40 years old who are experiencing blurry near vision due to aging of their eyes. In the U.S., an estimated 130 million people could potentially benefit from a monovision procedure, which includes improved distance and near vision, according to the Company.

The iDESIGN Refractive Studio will be marketed by Johnson & Johnson Surgical Vision and be commercially available in Q3 2018.

JNJ closed Monday's trading at $121.32, down 1.05%.

Myriad Genetics Inc.'s (MYGN) supplementary premarket approval (sPMA) application for BRACAnalysis CDx has been accepted by FDA for review as a companion diagnostic for Talazoparib in metastatic breast cancer.

Pfizer's Talazoparib is under priority review by the FDA, with a decision expected in December 2018.

MYGN closed Monday's trading at $40.17, up 1.90%.

Rhythm Pharmaceuticals Inc. (RYTM) has announced a public offering of up to $150.0 million of shares of its common stock.

In addition, the Company intends to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of shares of common stock at the public offering price, less the underwriting discount.

The Company's lead drug candidate is Setmelanotide, under two phase III clinical trials in pro-opiomelanocortin (POMC) and leptin receptor (LEPR) deficiency obesity.

Near-term Catalysts:

-- The initial data from the two phase III trials of both POMC and LEPR deficiency obesity are expected in the third quarter of 2019.

Setmelanotide is also being evaluated in four additional rare genetic disorders of obesity - Bardet-Biedl Syndrome, Alström Syndrome, POMC epigenetic disorders and POMC heterozygous deficiency obesity.

-- A combined pivotal phase III trial of Setmelanotide in Bardet-Biedl Syndrome and Alström Syndrome are expected to be initiated by the end of 2018.

-- Updated data from its ongoing phase II basket studies of Setmelanotide from a larger number of patients with POMC and other MC4 pathway heterozygous deficiency obesities, as well as POMC epigenetic disorders are expected in the first quarter of 2019.

RYTM closed Monday's trading at $28.80, down 11.66%. In after-hours, the stock was down another 1.74% at $28.30.

Sarepta Therapeutics Inc. (SRPT) will be presenting data from at least two patients enrolled in its phase 1/2a trial designed to assess the safety and tolerability of AAVrh74.MHCK7.micro-Dystrophin in individuals with Duchenne muscular dystrophy today.

To date, 4 patients have been enrolled in this study.

SRPT touched a new 52-week high of $107.49 on Monday, before closing the day's trading at $105.24, up 2.88%.

Sol-Gel Technologies Ltd. (SLGL) has initiated a pivotal Phase III clinical program evaluating the safety and efficacy of Epsolay (formerly VERED) in subjects with papulopustular rosacea (also known as subtype II rosacea), a chronic, inflammatory skin condition that most often affects the face.

Epsolay is a once-daily topical cream containing encapsulated benzoyl peroxide, 5%.

The phase III program consists of two randomized, multi-center, double-blind, vehicle-controlled clinical trials at 50 sites in the United States. Each pivotal trial is planned to enroll 350 subjects who will be randomized in a 2:1 ratio to receive Epsolay or vehicle.

The top-line data from the trials are expected in 2019.

SLGL closed Monday's trading at $8.25, down 6.14%.

Shares of Solid Biosciences Inc. (SLDB) rose more than 10% on Monday, following the FDA's decision to lift the clinical hold on IGNITE DMD, the Company's Phase I/II clinical trial of its lead product candidate SGT-001 for the treatment of Duchenne muscular dystrophy (DMD).

The move comes in the wake of the Company satisfactorily addressing all clinical hold questions. Solid has begun activities to resume the clinical trial and plans to reinitiate enrollment as quickly as possible.

The IGNITE DMD was placed on clinical hold by the FDA on March 14, 2018, after 1 patient showed a decrease in platelet count followed by a reduction in red blood cell count and evidence of complement activation.

SLDB closed Monday's trading at $29.38, up 10.87%.

TG Therapeutics Inc. (TGTX) presented promising preliminary 48-week data from its phase II trial of Ublituximab (TG-1101) in relapsing forms of Multiple Sclerosis at the 4th Congress of the European Academy of Neurology on June 18, 2018.

Commenting on the updated results, Michael Weiss, the Company's Executive Chairman and CEO, said, "We are extremely pleased to see that the preliminary Week 48 data presented today from this Phase 2 trial supports the Week 24 data presented earlier this year at the AAN meeting.

According to the Company, the data continue to be impressive and suggestive of a highly efficacious anti-CD20 monoclonal antibody with a manageable safety profile that can be administered in a convenient one-hour infusion.

The Company intends to present the final results from the phase II trial including Week 48 data on up to 48 patients at a major medical meeting later this year.

TGTX closed Monday's trading at $13.80, up 0.73%.

Shares of Valeant Pharmaceuticals International Inc. (VRX) fell more than 12% on Monday, following FDA's decision to reject the Company's New Drug Application for DUOBRII (formerly IDP-118) lotion in the treatment of plaque psoriasis.

The regulatory agency has raised questions regarding pharmacokinetic data. However, no deficiencies related to the clinical efficacy or safety of DUOBRII were specified nor were there any issues with CMC (Chemistry, Manufacturing and Controls) processes.

VRX closed Monday's trading at $23.56, down 12.29%.

Ziopharm Oncology Inc.'s (ZIOP) phase I trial to evaluate CD19-specific CAR-T therapies has been placed on hold by the FDA.

The regulatory agency has requested additional information in support of the investigational new drug (IND) application for the trial.

ZIOP closed Monday's trading at $3.51, down 18.37%.


Read the original article on RTTNews (http://www.rttnews.com/2906171/csbr-up-36-this-month-ziop-hit-by-clinical-hold-watch-out-for-srpt-today.aspx)


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