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GEMP Gets Facelift, Castle Bio To Debut Today, What's The Buzz About Baqsimi?

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Today's Daily Dose brings you news about FDA approval of the first needle-free treatment for severe hypoglycemia; mixed results from Bristol-Myers' CheckMate -227 trial; merger of Gemphire Therapeutics with a privately-held company; and reverse stock split of Pluristem Therapeutics, among others.

Read on...

Until yesterday, the treatment of severe hypoglycemia was a glucagon injection that involves a clunky and complicated system. Today, with FDA approving glucagon nasal powder Baqsimi from Eli Lilly (LLY), patients with severe hypoglycemia can breathe a little easier.

Severe hypoglycemia refers to a condition where blood sugar levels fall below the normal range where he or she becomes confused or unconscious or suffers from other symptoms that require assistance from another person to treat. People with diabetes who are using insulin treatment are prone to severe hypoglycemia.

While insulin lowers blood sugar levels by moving the glucose from the bloodstream into the cells, Baqsimi increases blood sugar levels in the body by stimulating the liver to release stored glucose into the bloodstream.

The newly approved Baqsimi, which is a powder administered into the nose, via an intranasal spray, is easy to use. Baqsimi will come in a single-use dispenser.

LLY closed Wednesday's trading at $108.52, up 0.28%.

Bristol-Myers Squibb Co.'s (BMY) Part 1a of its phase III trial evaluating Opdivo plus low-dose Yervoy, dubbed CheckMate -227, met the co-primary endpoint of overall survival, demonstrating a superior benefit versus chemotherapy in first-line non-small cell lung cancer patients whose tumors express PD-L1 more than or equal to 1%.

However, Part 2 of the CheckMate -227 trial did not meet the primary endpoint of overall survival with Opdivo plus chemotherapy versus chemotherapy in patients with first-line non-squamous non-small cell lung cancer, regardless of PD-L1 status.

BMY closed Wednesday's trading at $43.23, up 0.42%. In pre-market trading on Thursday, the stock is down 2.41% to $42.19.

Cara Therapeutics Inc. (CARA) has priced its underwritten public offering of 5.5 million shares at $23.00 per share. The offering is expected to close on or about July 29, 2019, subject to the satisfaction of customary closing conditions.

The gross proceeds from the offering are expected to be approximately $126.5 million.
The underwriters have a 30-day option to purchase up to 825,000 additional shares of the Company's common stock.

The Company announced positive topline data from its pivotal phase III trial of KORSUVA Injection in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus, dubbed KALM-1, in May of this year.

A phase II trial of Oral KORSUVA for the treatment of pruritus in patients with atopic dermatitis was initiated as recently as July 9, 2019.

CARA closed Wednesday's trading at $26.27, up 3.10%.

Castle Biosciences Inc. has priced its initial public offering of 4 million shares of its common stock at $16.00 per share. The shares are expected to begin trading on The Nasdaq Global Market on July 25, 2019, under the symbol "CSTL."

Founded in 2007, Castle Biosciences is a commercial-stage dermatological cancer company selling genetic tests to make more accurate treatment decisions.

Products & Pipeline:

The company's lead product, DecisionDx-Melanoma, a genetic test that predicts the risk of metastasis or recurrence for patients diagnosed with invasive cutaneous melanoma, a deadly skin cancer. The company also markets DecisionDx-UM, a proprietary genetic test that predicts the risk of metastasis for patients with uveal melanoma, a rare eye cancer.

The company also has two late-stage proprietary products - a genetic test to predict the risk of metastasis in patients diagnosed with cutaneous squamous cell carcinoma, and another genetic test designed to assist physicians in the diagnosis of suspicious pigmented lesions. Both these products are expected to be commercially launched in the second half of 2020.

Financial Numbers…

For the year ended December 31, 2018, the company's net loss narrowed to $10.2 million or $5.33 per share from $15.3 million or $8.08 per share in 2017. Annual revenue in 2018 increased to $22.8 million from $13.8 million in 2017.

Gemphire Therapeutics Inc. (GEMP), a clinical-stage biopharmaceutical company developing therapies for dyslipidemia and nonalcoholic fatty liver disease, has agreed to merge with privately-held NeuroBo Pharmaceuticals Inc.

NeuroBo will merge with a wholly-owned subsidiary of Gemphire in an all-stock transaction, and will focus on clinical-stage drug candidates for the treatment of neurodegenerative diseases. The merger is expected to close in the second half of 2019.

Following the completion of the merger, Gemphire will change its name to NeuroBo Pharmaceuticals Inc., and plans to change its ticker symbol on the Nasdaq Capital Market to "NRBO."

NeuroBo Pharma's lead drug candidate is NB-01 for diabetic neuropathic pain, with phase III clinical trials expected to begin in the fourth quarter of 2019. The Company is also developing NB-02 for the treatment of neurodegenerative diseases associated with the pathological dysfunction of the amyloid-beta and tau proteins in the human brain, which include Alzheimer's disease and tauopathies.

GEMP closed Wednesday's trading at $0.72, down 0.21%.

Seeking to improve its capital structure and market positioning while also maintaining compliance with the Nasdaq minimum bid price requirement, Pluristem Therapeutics Inc. (PSTI) has announced a 1-for-10 reverse split of its common stock and authorized preferred stock.

The reverse split will be effective as of market open on July 25, 2019, on Nasdaq.

The Company's common stock will not trade on the Tel-Aviv Stock Exchange on July 25, 2019.

A phase III pivotal study of PLXPAD for the treatment of critical limb ischemia is underway.

Critical Limb Ischemia (CLI) is the most severe form of peripheral artery disease (PAD), a chronic illness in which blood flow to the limbs is obstructed.

PSTI closed Wednesday's trading at $0.43, down 25.08%.

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