The Daily Biotech Pulse: Merck's Keytruda Clinches Another FDA Win, KemPharm Close To NDA Filing For ADHD Drug

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

Scaling The Peaks

(Biotech stocks hitting 52-week highs on April 11)

• Edap Tms SA EDAP

Down In The Dumps

(Biotech stocks hitting 52-week lows on April 11)

• ABIOMED, Inc. ABMD
• Alcon AG ALC NVS Tuesday)
• Acorda Therapeutics Inc ACOR
• Akorn, Inc. AKRX
• Concert Pharmaceuticals Inc CNCE
• Helius Medical Technologies Inc HSDT
• OUTLOOK THERAPEUTICS, INC. OTLK(announced pricing of common stock and warrant offering)
• Precision BioSciences Inc DTIL
• Revance Therapeutics Inc RVNC
• Scpharmaceuticals Inc SCPH
• Vaxart Inc VXRT
• Teligent Inc TLGT
• Teva Pharmaceutical Industries Ltd TEVA

Stock In Focus

Merck's Keytruda Okayed For Advanced Lung Cancer

Merck & Co., Inc. MRK announced FDA approval for its Keytruda as a monotherapy for first-line treatment of patients with stage 3 non-small cell lung cancer, who cannot undergo surgery or chemoradiation, or metastatic NSCLC patients and whose tumors express PD-L1 with no EGFR or ALK genomic tumor aberrations.

The company said the approval was granted based on the Phase 2 KEYNOTE-042 trial.

Keytruda has been a major driver for Merck, helping the large-cap pharma stock post notable gains in 2018,

The stock rose 0.45 percent to $80.20 in after-hours trading.

KemPharm Inching Closer to NDA Filing For ADHD Prodrug After pe-NDA Meeting With FDA

Specialty pharma company KemPharm Inc KMPH said the FDA concluded a pre-NDA meeting with the company regarding its investigational candidate KP415 that is being evaluated for attention deficit hyperactivity disorder. The feedback from the meeting held Thursday, according to the company, suggested that the regulatory package it had prepared for the NDA submission will be sufficient for filing.

Since the feedback is based on a review of the summary of data package, the final decision by the FDA will hinge on the review of the entire package.

The company said it plans NDA filing in late second quarter or early third quarter.

The stock jumped 23.67 percent to $2.09 in after-hours trading.

Eiger Presents Positive Data For Investigational Hepatitis D Virus Candidate

Eiger Biopharmaceuticals Inc EIGR presented the end of study post-treatment results of the Phase 2 study of LIMT HDV study as an oral late-breaker presentation at the International Liver Congress in Vienna.

The study, which evaluated 33 patients with chronic hepatitis D virus, or HDV, given a monotherapy Lambda 180 microgram or Lambda 120 microgram, as subcutaneous injections on a weekly basis for 48 weeks with 24 weeks of follow-up, showed that Lambda interferon was well tolerated in HDV-infection patients who were previously treated with Alfa interferon.

"Low episodes of cytopenia, flu-like symptoms, and psychiatric events in the LIMT HDV study suggest Lambda interferon is particularly attractive for development as a monotherapy or in combination for HDV," the company said.

The stock gained 1.61 percent to $14.50 in after-hours trading.

X4 Commences Common Stock & Warrant Offering

X4 Pharmaceuticals Inc XFOR commenced an underwritten public offering of shares of its common stock and Class A warrants to purchase its common stocks. All the shares earmarked for the offering are sold by the company.

The stock slumped 25.50 percent to $11.25 in after-hours trading.

Viveve Expects In-line Q1 Revenues, Gets CE Mark Approval For its Radiofrequency System

Viveve Medical Inc VIVE received CE Mark clearance for its next-generation Viveve 2.0 cryogen-cooled monopolar radiofrequency system and tips in the European Union.

The system and its consumable treatment tips are now available in over 30 European countries.

Viveve also said its first-quarter revenues are likely to come in line with expectations. It also expects to release the results from the VIVEVE II trial for improved sexual function in women in April 2020.

The penny stock rallied 34.72 percent to 78 cents in after-hours trading.

On The Radar

Clinical Trial Readouts

The European Association for the Study of the Liver International Liver Congress 2019 Presentations

Spring Bank Pharmaceuticals Inc SBPH – full Phase 2 data for inarigivir and vemlidy (hepatitis B virus)
Albireo Pharma Inc ALBO – Phase 2 data for A4250 (liver disease)
Altimmune Inc ALT – Phase 1 data for HepTCell (hepatitis B)