The Daily Biotech Pulse: FDA Approves Merck HIV Drugs, Five Prime CEO Quits, HTG Molecular Announces Secondary 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 Sept. 19.)

• 10X Genomics Inc TXG (listed its shares on Nasdaq on Sept. 12)
• Bioanalytical Systems, Inc. BASI
• China Biologic Products Holdings Inc CBPO (announced a go-private offer)
• Cesca Therapeutics Inc KOOL
• Enlivex Therapeutics Ltd ENLV
• Medpace Holdings Inc MEDP
• Medtronic PLC MDT (announced CE Mark approval for its advanced continuous glucose monitoring system in Europe)

Down In The Dumps

(Biotech stocks that hit 52-week lows Sept. 19)

• BioNano Genomics Inc BNGO (announced commencement of common stock offering)
• Catalyst Biosciences Inc CBIO
• Clovis Oncology Inc CLVS
• Endologix, Inc. ELGX
• Kalvista Pharmaceuticals Inc KALV
• PDL BioPharma Inc PDLI
• Sophiris Bio Inc SPHS
• Stealth BioTherapeutics Corp MITO
• Stoke Therapeutics Inc STOK
• Viveve Medical Inc VIVE

Stocks In Focus

Zimmer Biomet to Distribute Align's Intraoral Scanners

Zimmer Biomet Holdings Inc ZBH announced a multinational distribution agreement with Align Technology, Inc. ALGN for the distribution of the latter's iTero Element family of intraoral scanners. The companies did not disclose the other terms of the deal.
Under the deal, Zimmer Biomet Dental will distribute the iTero Element scanners in Europe, with the distribution expanding to the U.S. and Canada starting in October.

Emmaus Withdraws European Regulatory Application For Sickle Cell Disease Drug

Emmaus Life Sciences Inc EMMA announced the withdrawal of the marketing authorization approval it had filed with the European Medicines Agency for its xyndari in sickle cell disease.
Xyndari was approved under the brand name Endari by the FDA for reducing the acute complications of sickle cell disease in adults and pediatric patients 5 and older.
Despite the results of a Phase 3 study — on the basis of which the FDA had vetted the drug — and the other data submitted to the EMA's Committee for Medicinal Products for Human Use, the committee maintained its initial opinion that the regulatory application did not demonstrate xyndari's effectiveness at reducing the number of sickle cell disease crises or hospital visits.

Prevail Therapeutics To Be Added To R3K, R2K Indexes

Gene therapy company Prevail Therapeutics Inc PRVL, which recently went public, said its shares will be added to the Russell 2000 and Russell 3000 and Microcap indexes, effective after the close of markets Sept. 20.

Five Prime CEO Quits

Five Prime Therapeutics Inc FPRX said its CEO Aron Knickerbocker has resigned from the company to pursue new opportunities. The company named board chairman Bill Ringo to the post of CEO on an interim basis.
The stock slid 0.55% to $5.41 in after-hours trading.

HTG Molecular To Offer Shares

HTG Molecular Diagnostics Inc HTGM said it intends to offer, subject to market and other conditions, shares of its common stock in an underwritten public offering.
The shares slid 13.75% to 69 cents in after-hours trading.

Kiniksa Presents Positive Preclinical Data Supporting the Clinical Development of KPL-716

Kiniksa Pharmaceuticals Ltd KNSA said it made a presentation at the 49th annual meeting of the European Society of Dermatological Research in Bordeaux, France, of preclinical data supporting the clinical development of KPL-716, an investigational fully human monoclonal antibody that targets oncostatin M receptor beta.
The company said the data support the ongoing Phase 2 development of KPL-716 in prurigo nodularis and select pruritic conditions.
The stock rose 1.41% to $9.35 in after-hours trading.

FDA OKs Roche Screening Test For Blood Donors

Roche Holdings AG Basel ADR RHHBY said the FDA approved the cobas Babesia test for use on the cobas 6800/8800 Systems for individual blood donation testing.
"This is Roche's first commercially available whole blood test to screen donations and follows May 2019 FDA-updated industry guidance recommending screening and testing for Babesia, to reduce the risk of transmitting the parasite through transfusions," the company said.

InspireMD Prices Secondary Offering

InspireMD Inc NSPR said it has priced its underwritten public offering of 2.78 million units at $1.80 per unit. The offering is expected to raise gross proceeds of about $5 million. Each unit contains one share of common stock and one Series E warrant to purchase one share of common stock at an exercise price of $1.80 per share.

Fibrogen, Astellas Receive Japanese Regulatory Clearance For Anemia Drug 

FibroGen Inc FGEN and Astellas Pharma Inc ALPMF announced that Japan's Ministry of Health, Labor and Welfare approved roxadustat, with the trade name Evrenzo in Japan, for the treatment of anemia associated with chronic kidney disease in dialysis patients.

On The Radar

PDUFA Dates

The FDA approved Merck & Co., Inc. MRK's sNDAs for Pifeltro in combination with other retrovirals and Delstrigo in people living with HIV-1 who are switching from a stable antiretroviral regimen and who are virologically surpressed. 
Novo Nordisk A/S NVO's NDA for Semaglutide is pending before the FDA. Semaglutide is being evaluated as an adjunct to diet and exercise to improve blood sugar in adults with Type 2 diabetes.

Clinical Trial Readout

Leap Therapeutics Inc LPTX will present updated Phase 2 data for DKN-01 and paclitaxel in endometrial cancer at the 2019 annual global meeting of the International Gynaecologic Cancer Society in Rio de Janeiro, Brazil.
Related Links: The Week Ahead In Biotech: Novo Nordisk And Merck Await FDA Rulings, 2 IPOs On Deck