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Clinical Hold On IGNITE DMD Douses SLDB, PTI Awaits Data In Q2, CPRX On Watch


Today's Daily Dose brings you news about Arcus' IPO; Catalyst Pharma's near-term catalysts; FDA clinical hold on Solid Biosciences' IGNITE DMD study, and clinical trial events of Proteostasis that are worth keeping an eye on.

Read on…

Arcus Biosciences (RCUS) has priced its IPO of 8 million shares of common stock at $15.00 per share. The shares are expected to begin trading on the New York Stock Exchange on March 15, 2018 under the symbol "RCUS".

The offering is expected to close on March 19, 2018, subject to customary closing conditions. The gross proceeds from the offering are estimated to be $120 million. The Company has also granted the underwriters a 30-day option to purchase from the Company an additional 1.2 million shares of common stock.

The Company's lead drug candidate is AB928, a potent and selective dual antagonist of the adenosine receptors known as A2aR and A2bR. A phase I trial of AB928 in healthy volunteers is underway. Data from this trial are expected in Q2, 2018.

Another clinical drug candidate is AB122. A phase I study of AB122 in subjects with advanced solid tumors is underway in Australia.

Catalyst Pharmaceuticals Inc. (CPRX) is planning to resubmit its NDA for Firdapse in patients with Lambert-Eaton Myasthenic Syndrome in the first quarter of 2018.

In 2015, the FDA had refused to accept the NDA for review, saying that the application was not sufficiently complete.

In the European Union, Firdapse received the regulatory nod in December 2009, and has been marketed there by BioMarin since April 2010. In Europe, the drug is reportedly set to cost $60,000 a patient /year.

The other events planned for this year include:

-- Enroll first subject in a phase III trial of Firdapse in treating MuSK antibody positive Myasthenia Gravis in H1 2018.
-- Enroll first subject in Phase 2 study of Firdapse in ambulatory patients with Spinal Muscular Atrophy (SMA) Type 3 in the second quarter of 2018.
-- Complete enrollment in phase III study of Firdapse in congenital myasthenic syndromes before the end of 2018, and report top-line results from this trial in the first quarter of 2019.

CPRX closed Wednesday's trading at $2.98, down 4.79%.

Proteostasis Therapeutics Inc. (PTI) has a couple of events to watch out for in the coming months.

Results from 14-day study of PTI-801 in cystic fibrosis patients on background Orkambi are expected in Q2'18.

A study of a double combination of PTI-801 and PTI-808 in cystic fibrosis is ongoing, and initial results are expected in the middle of 2018.

A triple combination study of PTI-428 + PTI-801 + PTI-808 is on track to be initiated in Q2'18, with preliminary results anticipated in 2H'18.

PTI closed Wednesday's trading at $6.55, up 2.74%.

Shares of Solid Biosciences Inc. (SLDB) plunged more than 54% in after-hours on Wednesday, after its Phase I/II trial of SGT-001 for Duchenne Muscular Dystrophy, IGNITE DMD, was placed on hold by the FDA.

The first patient dosed in IGNITE DMD experienced a decrease in platelet count followed by a reduction in red blood cell count and there was an evidence of complement activation, several days after administration of SGT-001. The patient was hospitalized and was given medical treatment. He is continuing outpatient assessments per protocol, added the Company.

SLDB closed Wednesday's trading at $26.31, down 0.49%. In after-hours, the stock plunged 54.16% to $12.06.

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