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SPHS Rebounds, ACHV Soars On New Data, PBYI Gains On CHMP Opinion, SPPI Abuzz

pharma daily 061218 lt

The following are some of today's top gainers in the pharma/biotech sector.

1. Sophiris Bio Inc. (SPHS)

Gained 34.82% to close Tuesday's (June 26) trading at $3.02. The stock recovered most of what it lost yesterday.

On June 25, 2018 Sophiris plunged more than 40% on news that a patient died upon receiving a second administration of Topsalysin in its ongoing Phase 2b clinical trial in localized prostate cancer.

In the same phase IIb trial, a single administration of Topsalysin continues to demonstrate an ability to ablate targeted prostate cancer cells with 10 of 35 patients (29%) demonstrating a clinical response of which 6 patients had a complete ablation with no detectable cancer on targeted biopsy of the treated area, the Company added.

The cause of the patient's death is currently being investigated, and as a precaution, the patients enrolled in the phase IIb trial won't be receiving the second administration of Topsalysin.

2. Achieve Life Sciences Inc. (ACHV)

Gained 34.21% to close Tuesday's trading at $5.10.

News: The Company announced positive results from a series of drug metabolism, drug-drug interaction and transporter studies with Cytisine.

Cytisine is a product candidate being evaluated as an aid to smoking cessation. It has been approved and marketed in Central and Eastern Europe as a smoking cessation treatment for more than 15 years.

Given the fact that smokers are as likely as anyone to take medications for a range of conditions, the positive study data suggests that Cytisine may be administered with other medications without the need to modify the dose of the co-administered drug, added the Company.

Recent events:

-- On May 23, 2018, the Company effected a reverse stock split of its shares of common stock at a ratio of 1-for-10.
-- On June 19, 2018, the Company closed an underwritten public offering of units for gross proceeds of $13.8 million, which included the full exercise of the underwriter's over-allotment option. The offering was comprised of Class A Units, priced at a public offering price of $4.00 per unit.

3. Puma Biotechnology Inc. (PBYI)

Gained 24.36% to close Tuesday's trading at $63.55.

News: The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive trend vote recommending the approval of Neratinib for the extended adjuvant treatment of early stage HER2-positive hormone receptor positive breast cancer.

On February 22, 2018, the CHMP had adopted a negative opinion, recommending the refusal of the marketing authorisation for Nerlynx, following which, the Company requested a re-examination of the CHMP's opinion.

The FDA approved Neratinib for extended adjuvant treatment of early stage HER2-positive breast cancer last July.

4. Avinger Inc. (AVGR)

Gained 15.43% to close Tuesday's trading at $1.87.

News: The Company announced that several physicians have successfully treated over 40 patients in the US across 13 sites with the next-generation Pantheris image-guided atherectomy system for the treatment of peripheral artery disease (PAD).

The next-generation Pantheris system was granted FDA clearance last month, and it received the CE Mark approval last December.

5. Spectrum Pharmaceuticals Inc. (SPPI)

Gained 14.59% to close Tuesday's trading at $21.75.

News: The Company is exploring a sale amid takeover interest, Bloomberg reports citing people familiar with the matter.

6. Invuity Inc. (IVTY)

Gained 14.29% to close Tuesday's trading at $4.00.

News: No news

Invuity is a medical technology company focused on minimal access surgery.

Recent event:

-- On May 3, 2018, the Company announced financial results for the three months ended March 31, 2018.

The net loss for the first quarter of 2018 narrowed to $11.2 million or $0.62 per share from $13.2 million or $0.78 per share for the first quarter of 2017. Revenue was $9.5 million in the recent first quarter, up 5.3% from $9.0 million in the first quarter of 2017 driven primarily by strong market acceptance of PhotonBlade.

Looking ahead to 2018, Invuity continues to expect revenue to exceed $46 million. Full year 2017 revenue was $39.6 million.

7. Sorrento Therapeutics Inc. (SRNE)

Gained 11.81% to close Tuesday's trading at $7.10.

News: No news

Recent events & Near-term Catalysts:

-- Effective June 25, 2018, Sorrento was added to the FTSE Russell 3000/2000 indexes.
-- The Company is seeking to be listed on the Hong Kong stock exchange also by Q1, 2019.
-- The commercialization of ZTlido, a next-generation non-opioid, lidocaine patch proposed for the relief of pain associated with post-herpetic neuralgia, is expected in Q4, 2018.

8. Innovate Biopharmaceuticals Inc. (INNT)

Gained 11.46% to close Tuesday's trading at $20.91. This is the second straight day of double digit gain for the stock.

News: No news

Recent event:

As part of the 2018 Russell indexes reconstitution, the Company was added as a member of the broad-market Russell 3000, 2000 and Microcap Indexes, effective June 25, 2018.


The lead drug candidate is Larazotide acetate (INN-202), which has successfully completed its phase 2b efficacy clinical trial for celiac disease. Also in the pipeline are INN-108, indicated for mild to moderate ulcerative colitis, which is entering Phase II trials this year, and INN-329, entering phase III trial for Magnetic Resonance Cholangiopancreatography (MRCP).

Near-term Catalyst:

Phase III registration clinical trials of Larazotide acetate for celiac disease are expected to begin later in 2018.

9. Genprex Inc. (GNPX)

Gained 11.46% to close Tuesday's trading at $8.61.

News: The Company announced that it has selected 4Clinics Group Sprl to provide support for the clinical development of its lead drug candidate, Oncoprex, for the treatment of non-small cell lung cancer.

Clinical Trial:

A phase I/II clinical trial evaluating Oncoprex in combination with Tarceva for the treatment of non-small cell lung cancer is underway.

Recent event:

The Company went public on the Nasdaq Capital Market on March 29, 2018, offering its shares at a price of $5.00 each.

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