The Daily Biotech Pulse: FDA Nod For Immunomedics, Lilly's Solid Q1 Beat, Predictive Oncology Restructures Debt

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech stocks htitting 52-week highs April 22.)

• Dr.Reddy's Laboratories Ltd RDY
• Johnson & Johnson JNJ (reacted to a sell-side upgrade)
• Cue Biopharma Inc CUE (announced a clinical study collaboration with Merck)
• Exelixis, Inc. EXEL
• GenMark Diagnostics, Inc GNMK
• Immunomedics, Inc. IMMU
• Immunovant Inc IMVT
• Kiniksa Pharmaceuticals Ltd KNSA
• OraSure Technologies, Inc. OSUR
• Repligen Corporation RGEN
• Repro-Med Systems, Inc. KRMD
• Verastem Inc VSTM

Down In The Dumps

(Biotech stocks hitting 52-week lows April 22)

• Cyclacel Pharmaceuticals Inc CYCC
• Viveve Medical Inc VIVE

Stocks In Focus

Immunomedics' Trodelvy Approved For Metastatic Triple-Negative Breast Cancer

Immunomedics said the FDA approved its sacituzumab govitecan-hziy — Trodelvy — for the treatment of adult patients with metastatic triple-negative breast cancer, who have received at least two prior therapies for metastatic disease. Trodelvy is the first antibody drug conjugate approved by the FDA for this indication.

The company noted that Trodelvy comes with a black box warning for severe neutropenia and severe diarrhea.

The stock jumped 33.55% to $29.34 in after-hours trading.

Incyte Announces Publication Of Positive Jakafi Data In Acute Graft-Versus-Host Disease

Incyte Corporation INCY announced publication in the New England Journal of Medicine of data from the Phase 3 REACH2 study, which showed Jakafi improved outcomes across a range of efficacy measures in patients with steroid-refractory acute graft-versus-host disease compared to best available therapy.

The company noted that patients treated with Jakafi experienced a significantly greater overall response rate versus best available therapy at Day 28, which is the primary endpoint of the study.

Quidel Applies For FDA EUA For Lyra Direct SARS-CoV-2 Assay For Direct Sampling

Quidel Corporation QDEL said it has applied for an Emergency Use Authorization from the FDA for the Lyra Direct SARS-CoV-2 Assay to allow direct sample processing.

"Under the new EUA, the Lyra Direct SARS-CoV-2 Assay no longer requires an upfront sample extraction. The Lyra Direct SARS-CoV-2 Assay uses a reformulated buffer that replaces the extraction step with a simple 10-minute heat step, saving approximately 50 minutes in processing time," the company said.

The stock was up 1.45% at $125.50 in Thursday's premarket session. 

See also: The Week Ahead In Biotech (April 19-25): Eli Lilly, Biogen Earnings On Tap, Sanofi Awaits FDA Decision

Sanofi's BTK Inhibitor Found Effective, Safe For Relapsing Multiple Sclerosis In Midstage Study

Sanofi SA SNY said its investigational BTK inhibitor SAR442168 that is being evaluated for relapsing forms of multiple sclerosis in a Phase 2b study showed that the compound significantly reduced disease activity associated with multiple sclerosis, as measured by magnetic resonance imaging.

The Phase 2 study evaluated four doses of the compound ranging from 5mg to 60mg after 12 weeks and used placebo data obtained at four weeks. The dose response was measured after 12 weeks by measuring the number of new brain lesions on MRI.

This investigational asset has been licensed from Principia Biopharma Inc PRNB.

Predictive Oncology Reaches Agreement With CEO To Exchange Debt For Equity

Predictive Oncology Inc POAI said it has entered into an exchange agreement with its CEO Dr. Carl Schwartz that allowed it to exchange a $2.1-million promissory note for newly issued shares of common stock at market value.

The agreement helps the company strengthen its balance sheet and simplify its capital structure as it embarks on commercialization of its highly valuable database of cancer tumors for the advancement of predictive medicine.

"It reinforces my commitment and demonstrates my beliefs in our ability to emerge as a leader in the application of artificial intelligence to oncology therapies," Schwartz said.

The stock was higher by 0.72% at $1.39 in the premarket session. 

Entasis Says Innoviva Completes Initial Investment Worth $3.3M

Entasis Therapeutics Holdings Inc ETTX said it has completed the initial $3.3-million closing of a $35-million common stock and warrant securities investment with Innoviva Inc. INVA.

The company also noted that upon satisfaction of certain closing conditions, Innoviva will purchase the balance of the $35 million in Entasis common stock and warrant securities in a second closing anticipated later in the second quarter of 2020.

Entasis shares added 1.01% to $3 in after-hours trading.

Obseva Announces Publication Of Positive Phase 2b Data On Linzagolix In Endometriosis

Obseva SA OBSV announced publication of two abstracts in Obstetrics and Gynecology, discussing results from Phase 2b EDELWEISS trial of linzagolix in endometriosis. The results showed that significant improvement in quality of life outcomes was maintained or increased after 52 weeks of treatment with linzagolix. Small, expected, non-clinically relevant increases in serum lipids observed at 12 weeks became generally stable at 52 weeks.

The stock was up 0.88% at $2.29 in the premarket session. 

Therapix Gets New CEO

Therapix Biosciences Ltd – ADR TRPX announced the appointment of Gilad Bar-Lev as CEO, effective May 6. Bar-Lev will replace Dr. Ascher Shmulewitz, who is occupying the position on an interim basis. Shmulewitz will continue to serve as the chairman of the board, the company said.

WPD's In-Licensed Drug Annamycin Found Safe In Early Stage Study In Acute Myeloid Leukemia 

WPD Pharmaceuticals Inc. (WCOTF) said the single arm U.S. Phase 1 study of its drug candidate Annamycin in treating relapsed or refractory acute myeloid leukemia was completed, with the study demonstrating the safety of the drug candidate. The company noted that the primary safety signal was the absence of cardiotoxicity, a serious and often treatment-limiting issue prevalent with currently approved anthracyclines.

WPD licensed the drug candidate from Moleculin Biotech Inc MBRX.

On The Radar

Earnings

• Eli Lilly And Co LLY (revenue climbed 15% to $5.86 billion and non-GAAP EPS rose 32% to $1.75; both metrics exceeded estimates)
• Centogene NV CNTG (before the market opens)
• Neurometrix Inc NURO (before the market opens)
• West Pharmaceutical Services Inc. WST (before the market opens)
• Edwards Lifesciences Corp EW (after the close)
• Merit Medical Systems, Inc. MMSI (after the close)

Related Link: Moderna Gains More Than 40% This Week: What You Should Know