ACST On Watch, ITCI Jumps 250% On Trial Data, CVM Slumps, FDA Nod For AGN

(RTTNews) - Today's Daily Dose brings you news about FDA approvals of Allergan and Intra-Cellular Therapies; blockbuster deal signed between Roche and Sarepta; and positive phase III trial results of Progenics Pharmaceuticals, among others.

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The FDA has approved Allergan plc's (AGN) UBRELVY (ubrogepant) for the acute treatment of migraine with or without aura in adults.

UBRELVY is the first and only orally-administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the treatment of migraine attacks once they start. In clinical trials, just one dose of UBRELVY quickly eliminated patients' migraine pain and their most bothersome migraine symptom compared with placebo at two hours, noted the Company.

The drug has been approved in two dose strengths, 50 mg, and 100 mg.

AGN closed Monday's trading at $191.53, up 0.65%.

Shares of Acasti Pharma Inc. (ACST) slumped as much as 59% in intraday trading on Monday on no news.

The Company's topline data from a phase III trial of its prescription drug candidate CaPre for the treatment of severe hypertriglyceridemia, dubbed TRILOGY 1, are due this month. Another phase III trial of CaPre, known as TRILOGY 2, is also underway, with topline data expected next month.

ACST closed Monday's trading at $2.18, down 24%.

Shares of CEL-SCI Corporation (CVM) dropped more than 8% in extended trading on Monday after the Company announced that it intends to offer shares of its common stock for sale in an underwritten public offering.

In addition, the Company expects to grant the underwriter a 45-day option to purchase up to an additional 15 percent of the shares of common stock offered in the public offering solely to cover over-allotments.

A phase III trial of the Company's lead drug candidate Multikine in head and neck cancer is underway, with results expected to be reported soon. It is the largest phase III study in the world for the treatment of head and neck cancer.

CVM closed Monday's trading at $9.55, up 4.49%. In after-hours, the stock was down 8.38% to $8.75.

Shares of Intra-Cellular Therapies Inc. (ITCI) jumped as much as 250% to touch a three-year high of $43.56 in intraday trading on Monday, following positive regulatory news.

The FDA has approved the Company's CAPLYTA (lumateperone) for the treatment of schizophrenia in adults. The commercial launch of the drug is expected to be initiated in late Q1 2020.

Schizophrenia is a serious mental illness impacting approximately 2.4 million adults in the United States.

ITCI closed Monday's trading at $36.51, up 193.49%.

Sarepta Therapeutics Inc. (SRPT) has granted Roche exclusive commercial rights to its investigational gene therapy for Duchenne muscular dystrophy SRP-9001 outside the United States under a deal worth up to $2.85 billion.

SRP-9001 is under a phase II trial, which is expected to be completed by 2022.

As per the deal terms, Sarepta will receive $1.15 billion in an upfront payment and an equity investment; up to $1.7 billion in regulatory and sales milestones; and royalties on net sales, anticipated to be in the mid-teens.

Roche obtains the exclusive right to launch and commercialize SRP-9001 outside the United States while Sarepta retains all rights to the investigational gene therapy in the United States.

The global development expenses will be shared equally by Roche and Sarepta.

SRPT closed Monday's trading at $135.58, up 7.46%.

Progenics Pharmaceuticals Inc.'s (PGNX) phase III trial evaluating the diagnostic performance and clinical impact of PyL in men with biochemical recurrence of prostate cancer, dubbed CONDOR, has achieved the primary endpoint.

PyL is the Company's PSMA-targeted small molecule positron emission tomography (PET) imaging agent designed to visualize prostate cancer.

Based on the positive results, the Company plans to submit a New Drug Application to the FDA for PyL in the second half of 2020.

PGNX touched a new 52-week high of $6.37 in intraday trading on Monday, before closing at $5.67, up 9.67%.

Stoke Therapeutics Inc. (STOK) has been added to the NASDAQ Biotechnology Index.

The NASDAQ Biotechnology Index tracks the performance of a set of NASDAQ-listed securities that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark. The selected companies are required to meet eligibility requirements, including minimum market capitalization, average daily trading volume, and seasoning as a public company, among other criteria.

Stoke Therapeutics is an early-stage biopharmaceutical company developing antisense oligonucleotide medicines for genetic diseases affecting the central nervous system, eye, liver, and kidney.

The lead product candidate is STK-001, to treat Dravet syndrome, a severe and progressive genetic epilepsy. The Company plans to submit an investigational new drug application to the FDA, seeking to initiate a phase I trial of STK-001 in early 2020.

STOK closed Monday's trading at $26.87, down 8.42%.