The Daily Biotech Pulse: Xeris Jumps On Positive Data, Mixed Results For Merck's Keytruda-Chemo Combo In Lung Cancer, Intra-Cellular Announces Offering

The following is a roundup of top developments in the biotech space over the last 24 hours. 

Scaling The Peaks

(Biotech stocks that hit 52-week highs on Jan. 6.)

• Agile Therapeutics Inc AGRX
• Aimmune Therapeutics Inc AIMT
• Audentes Therapeutics Inc BOLD
• BioNTech SE – ADR BNTX
• Esperion Therapeutics Inc ESPR
• Inspire Medical Systems Inc INSP
• Nevro Corp NVRO
• Nymox Pharmaceutical Corp NYMX (announced publication of a peer reviewed research report on the experimental studies for its fexapotide triflutate treatment for prostate enlargement and low-grade prostate cancer)
• Orthopediatrics Corp KIDS (announced sale of its adult Vilex business in Tennessee to Squadron Capital and used the proceeds for the repayment of term loan due to Squadron)
• Oyster Point Pharma Inc OYST
• Sanofi SA SNY (JPMorgan upgraded the shares from Neutral to Overweight, citing an attractive valuation)
• Soligenix, Inc. Common Stock SNGX
• Sutro Biopharma Inc STRO
• Varian Medical Systems, Inc. VAR
• Veru Inc VERU

Down In The Dumps

(Biotech stocks that hit 52-week lows on Jan. 6.)

• Akorn, Inc. AKRX
• Edesa Biotech Inc EDSA (announced $4.36-million registered offering of its common shares)
• Evelo Biosciences Inc EVLO
• Evolus Inc EOLS
• GenMark Diagnostics, Inc GNMK
• Nabriva Therapeutics PLC – ADR NBRV
• Predictive Oncology Inc POAI
• Second Sight Medical EYES
• Spectrum Pharmaceuticals, Inc. SPPI
• Therapix Biosciences Ltd – ADR TRPX
• Xeris Pharmaceuticals Inc XERS

Stocks In Focus

Xeris Reports Positive Results For Glucagon In Exercise-Induced Hypoglycemia

Xeris reported positive topline results for the in-clinic Phase 2 study of its developmental ready-to-use glucagon for the prevention of hypoglycemia during and after moderate-to-high-intensity aerobic exercise in adults with Type 1 diabetes mellitus.

The company said it will release the results of the ongoing blinded outpatient study in the first half of 2020.

The shares were climbing 21.24% to $7.02 in Tuesday's premarket session. 

Related Link: Attention Biotech Investors: Mark Your Calendar For These January PDUFA Dates

Intra-Cellular To Offer 10M Shares

Intra-Cellular Therapies Inc ITCI, which recently received FDA approval for its schizophrenia drug lumateperone, said it has commenced an underwritten public offering of 10 million shares of its common stock. All the shares earmarked for the offering are to be sold by the company.

The stock was down 2.74% to $29.78 in the premarket session. 

Arena To Target Growth With Expanded Pipeline, Collaboration  

Arena Pharmaceuticals, Inc. ARNA said its expanded pipeline will include two new indications for etrasimod in an update on its strategic portfolio expansion plan aimed at driving near- and long-term growth. 

The company is aiming to kickstart growth with an expanded collaboration with Beacon Discovery — Project Cabrillo — that's focused on new immunology and inflammation targets as well as forming a neuroscience subsidiary.

Arena said it will have eight Phase 2 and Phase 3 readouts in 2020-21 and is targeting one new IND filing per year for the next five years.

Hepion Announces Publication Supporting Efficacy Of NASH Drug

Hepion Pharmaceuticals Inc HEPA said the peer-reviewed journal Expert Opinion On Investigational Drugs published a paper on cyclophilin inhibition, a family of modulatory enzymes that are being targeted by the company's non-alcoholic steatohepatitis experimental drug CRV431.

"The scientific literature provides abundant evidence that pharmacologic inhibition of cyclophilins with compounds such as Hepion's CRV431 could help to resolve multiple pathophysiological activities that occur in NASH, including mitochondrial dysfunction, liver cell death, inflammation, and most notably, fibrotic scarring of the liver, the company said.

The stock was rallying by 16% to $6.09 in Tuesday's premarket session. 

Merck's Keytruda-Chemo Combo Produces Mixed Results In Small Cell Lung Cancer Study

Merck & Co., Inc. MRK announced results from the Phase 3 KEYNOTE-604 trial, which evaluated its Keytruda in combination with chemotherapy as a first-line treatment of patients with extensive stage small cell lung cancer, which showed that the study met one of its dual primary endpoints of progression-free survival, while it did not meet the other primary endpoint of overall survival.

The stock was down 1.08% at $90.65 at the time of publication. 

Mirati Appoints New COO, CCO

Mirati Therapeutics Inc MRTX announced the appointment of Charles Baum, a former Spark Therapeutics executive, as its executive vice president and chief operating officer. The company also appointed Benjamin Hickey as executive vice president and chief commercial officer, reporting directly to Baum. Additionally, the company announced two internal promotions.

Rhythm Pharma's CEO To Step Down

Rhythm Pharmaceuticals Inc RYTM said Keith Gottesdiener will step down as CEO, president and board member after the completion of its NDA submission for setmelanotide, a MC4R agonist, for the treatment of pro-opiomelanocortin and leptin receptor deficiency obesities.

The company said it expects to complete the rolling submission of the NDA by the first quarter of 2020. The company also reiterated its previous guidance on major milestones, including a Phase 3 top-line data readout for setmelanotide in Bardet-Biedl and Alström syndromes in the fourth quarter of 2020 or early in the first quarter of 2021.

Rhythm also said it is well-capitalized, with sufficient resources to fund its operations through at least the end of 2021.

On The Radar

Earnings

AngioDynamics, Inc. ANGO (before the market open)

Related Link: 8 Biotech Stocks Morgan Stanley Recommends For 2020