AKCA Gets EC Nod, FDA Panel To Review Malaria Drug Today, OVID Awaits Data In Q3

pharma daily 071118

Today's Daily Dose brings you news about stock offering of Assembly Biosciences, AcelRx Pharmaceuticals and Myovant Sciences; anticipated milestones of Ovid Therapeutics for the second half of this year; European Commission's approval of Akcea's TEGSEDI; Achieve Life Sciences' progress with Cytisine as an aid to smoking cessation; FDA approval of Bristol-Myers Squibb Opdivo in combination with Yervoy for yet another indication, and a regulatory event to watch out for today.

Read on...

Assembly Biosciences Inc. (ASMB) has offered to sell 4 million shares of its common stock to the public at a price of $36.00 each.

The gross proceeds to Assembly from this offering are expected to be $144 million. The underwriters have a 30-day option to purchase up to an additional 600,000 shares of common stock.

Assembly Biosciences is a clinical-stage biotechnology company advancing a new class of oral therapeutics for the treatment of hepatitis B virus (HBV) infection and novel oral live biotherapeutics for disorders associated with the microbiome. The Company's lead drug candidate is ABI-H0731.

Clinical Trials & Near-term Catalysts:

-- Two Phase 2a trials of ABI-H0731 for the treatment of patients with chronic HBV infection were initiated as recently as July 9.
-- Initial data from the Phase 2a trials of ABI-H0731 are expected in the first half of 2019.

ASMB closed Wednesday's trading at $36.71, down 7.72%.

AcelRx Pharmaceuticals Inc. (ACRX) has commenced an underwritten public offering of shares of its common stock. The Company expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering.

Late last month, the European Commission approved the Company's DZUVEO (under development in the U.S. as DSUVIA) for the management of acute moderate to severe pain in adults in medically monitored settings.

The resubmitted New Drug Application for DSUVIA is under FDA review with a decision expected on November 3, 2018. DSUVIA was issued a Complete Response Letter last October.

ACRX closed Wednesday's trading at $3.40, down 1.45%. In after-hours, the stock was down another 7.35% to $3.15.

Akcea Therapeutics Inc. (AKCA) and Ionis Pharmaceuticals Inc.'s (IONS), TEGSEDI has received marketing authorization approval from the European Commission for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).

TEGSEDI is also under regulatory review in the United States and Canada.

The FDA decision on TEGSEDI is set for October 6, 2018.

AKCA closed Wednesday's trading at $25.33, up 4.93%.

Achieve Life Sciences Inc. (ACHV) is planning to conduct a Phase 2b optimization trial of Cytisine in approximately 250 smokers in the U.S.

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.

If all goes well as planned, the Company plans to initiate the Phase 3 program in 2019.

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.

ACHV closed Wednesday's trading at $4.00, up 10.80%.

The FDA has approved Bristol-Myers Squibb Co.'s (BMY) Opdivo in combination with Yervoy for previously treated patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer.

Colorectal cancer (CRC) is cancer that develops in the colon or the rectum. Approximately 15% of CRC patients and 4-5% of metastatic CRC patients have MSI-H or dMMR biomarkers.

DNA mismatch repair deficiency (dMMR) occurs when the proteins that repair mismatch errors in DNA replication are missing or non-functional, leading to microsatellite instability-high (MSI-H) tumors.

Opdivo and Yervoy are blockbuster drugs of Bristol-Myers. In 2017, the global sales of Opdivo were $4.95 billion, up 31% over 2016, and that of Yervoy totaled $1.24 billion, up 18% over 2016.

BMY closed Wednesday's trading at $55.34, up 0.07%.

On July 12, 2018, an FDA advisory committee is scheduled to review GlaxoSmithKline PLC's (GSK) single-dose Tafenoquine 150mg for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients 16 years of age and older.

If approved, Tafenoquine would be the first new medicine for the prevention of relapse of P vivax malaria in more than 60 years.

Tafenoquine is being developed in collaboration by GlaxoSmithKline and the not-for-profit Medicines for Malaria Venture.

GSK closed Wednesday's trading at $41.10, down 0.80%.

Merck's (MRK) supplemental Biologics License Application seeking accelerated approval for KEYTRUDA as a treatment for previously treated patients with advanced hepatocellular carcinoma has been accepted for priority review, with a decision expected on November 9, 2018.

Keytruda is already approved in the indications of metastatic, non-small lung cancer, Hodgkin's lymphoma, melanoma, head and neck cancer, gastric cancer and cervical cancer.

The blockbuster drug recorded annual sales of $3.81 billion in 2017, and quarterly sales of $1.46 billion in the first quarter of 2018.

MRK closed Wednesday's trading at $61.90, down 0.64%.

Shares of Myovant Sciences Ltd. (MYOV) were down more than 17% in extended trading on Wednesday, following the commencement of an underwritten public offering of $75 million of its common shares.

The underwriters are expected to be provided a 30-day option to purchase up to an additional $11.25 million of the Company's common shares in the offering.

Clinical Trials & Near-term catalysts:

Myovant's lead product candidate is Relugolix, under phase III development. The Company licensed rights to the drug candidate from Takeda outside Japan and certain other Asian countries.

Also in the pipeline is MVT-602, for the treatment of female infertility as part of assisted reproduction, which is under phase I testing. MVT-602 was also licensed from Takeda.

Relugolix is under five international Phase 3 clinical trials namely:

-- Two phase III trials in women with heavy menstrual bleeding associated with uterine fibroids, dubbed LIBERTY 1 & 2.
-- Two phase III trials in women with endometriosis-associated pain, known as SPIRIT 1 & 2.
-- A phase III trial in men with advanced prostate cancer, dubbed HERO.

Completion of enrollment in all the five phase III studies is expected this year.
Top-line data for LIBERTY 1 is expected in second quarter of 2019. The data from the all Relugolix Phase 3 clinical studies in uterine fibroids, endometriosis and prostate cancer are anticipated during 2019.

Phase II trials with MVT-602 are planned for this year.

MYOV closed Wednesday's trading at $24.10, up 2.12%. In after-hours, the stock was down 17.01% at $20.00.

Ovid Therapeutics Inc. (OVID) has advanced OV101, for the treatment of adolescents and young adult males with Fragile X syndrome, into phase II testing.

Fragile X syndrome is the most common inherited form of intellectual disability and autism, with a prevalence of 1 in 3,600 to 4,000 males and 1 in 4,000 to 6,000 females in the United States. Individuals with Fragile X syndrome often have a range of behavioral challenges, such as cognitive impairment, anxiety, mood swings, hyperactivity, attention deficit, poor sleep, self-injury and heightened sensitivity to various stimuli, such as sound.

The phase II trial, dubbed ROCKET, is designed to enroll up to 30 males age 13 to 22 with a confirmed diagnosis of Fragile X syndrome. The primary endpoint of the study is safety and tolerability of OV101 over 12 weeks of treatment in three different cohorts. The secondary efficacy endpoint will evaluate changes in behavior during 12 weeks of treatment.

The Company has important events coming its way in the second half of this year.

-- The top-line data from a 12-week phase II trial evaluating OV101 for the treatment of adults and adolescents ages 13 to 49 years with a confirmed diagnosis of Angelman syndrome, dubbed STARS, is expected to be reported in the third quarter of 2018.
-- Enrollment in a phase 1b/2a clinical trial of TAK-935/OV935 in adults with Developmental and Epileptic Encephalopathies is ongoing. Top-line data from this trial are expected in the second half of 2018.

OVID closed Wednesday's trading at $9.56, up 2.36%.

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