KPTI To Test XPOVIO In COVID-19, PTCT Will Have To Wait, SAGE Slashes Workforce

pharma 010919 08apr20

Today's Daily Dose brings you news about Idera's private placement; Karyopharm's COVID-19 drug initiative; Merck's regulatory catalyst in June; delay in FDA decision of PTC Therapeutics' spinal muscular atrophy drug candidate and Sage Therapeutics' cost-cutting measures.

Read on…

Idera Pharmaceuticals Inc. (IDRA) has sold shares of common stock together with accompanying warrants to purchase additional shares of common stock, for aggregate gross proceeds of $5.0 million to a fund affiliated with an institutional investor.
The price per share paid for the common stock was $1.52 each, and the common stock warrants have an exercise price of $2.28 per share.

The investor may make a further investment of an additional $5.0 million to purchase shares of common stock, together with accompanying common stock warrants to purchase additional shares of common stock. The price per share for the common stock will be $1.76 per share. The common stock warrants, if issued, will have an exercise price of $2.71 per share.

IDRA closed Tuesday's trading at $1.24, down 1.59%. In after-hours, the stock was up 29.03% to $1.60.

Karyopharm Therapeutics Inc. (KPTI) is planning to explore the potential of its approved multiple myeloma drug Selinexor, marketed as XPOVIO, in hospitalized patients with severe COVID-19.

Selinexor is an oral, selective inhibitor of nuclear export (SINE) compound which blocks the cellular protein XPO1. In addition to its roles in cancer, XPO1 also has a role in viral replication.

SINE compounds have been shown to disrupt the replication of multiple viruses in vitro and in vivo. In particular, SINE compounds have recently been identified as having the potential to interfere with key host protein interactions with SARS-CoV-2, the virus that causes COVID-19, noted the Company.

The Company is planning to initiate a global randomized clinical trial of Selinexor to treat patients with COVID-19. The proposed clinical trial to treat hospitalized patients with COVID-19 would be the first study of an XPO1 inhibitor in patients with severe viral infections.

KPTI closed Tuesday's trading at $18.58, down 2.93%.

Merck's (MRK) new supplemental Biologics License Application for KEYTRUDA has been accepted for priority review by the FDA, with a decision expected on June 16, 2020.

The application seeks accelerated approval of KEYTRUDA monotherapy for the treatment of patients whose tumors are tumor mutational burden-high (TMB-H) who have progressed following prior treatment.

Keytruda, Merck's blockbuster drug, is already indicated for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, and endometrial carcinoma.

The drug raked in annual sales of $11.1 billion in 2019 compared to $7.2 billion in 2019.

MRK closed Tuesday's trading at $78.56, down 2.18%.

The FDA decision on PTC Therapeutics Inc.'s (PTCT) Risdiplam, proposed for the treatment of spinal muscular atrophy, has now been extended by 3 months to August 24, 2020.

The development of Risdiplam is being executed globally by Roche, including in the U.S.

The delay in the decision date is due to Roche's submission of additional data from a pivotal trial to help provide access to Risdiplam for a broad range of people living with spinal muscular atrophy.

Spinal muscular atrophy (SMA) is a severe, inherited, progressive neuromuscular disease that causes devastating muscle atrophy and disease-related complications.

There are two FDA-approved drugs to treat spinal muscular atrophy - Ionis Pharma's (IONS) Spinraza, approved in 2016, and Novartis' Zolgensma, approved in May 2019.

PTCT closed Tuesday's trading at $42.79, down 4.83%. In after-hours, the stock was up 5.40% to $45.10.

In a bid to rein in costs and reallocate resources to advance its portfolio, Sage Therapeutics Inc. (SAGE) is laying off 340 people, which is approximately 53 percent of its workforce, besides mulling a reduction in expenses.

The changes are expected to result in annualized cost savings of approximately $170 million, including SG&A savings of $150 million, for the Company.

Sage expects to incur a one-time cost of roughly $31 million, associated with the reduction in workforce, primarily in the second quarter of 2020. The Company anticipates operating expenses in 2020 to be lower than the previous year.

The Company had cash, cash equivalents, restricted cash, and marketable securities of approximately $1.0 billion at the end of 2019, which is expected to support operations into 2022.

SAGE closed Tuesday's trading at $29.03, up 2.33%.

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