Yahoo Finance

The company said these results will complete the data required for finalizing the NDA submission. The NDA submission is planned for the second quarter of 2020, according to Sol-Gel.

The company also priced its underwritten public offering of 2.09 million shares together with ordinary share warrants to purchase 1.67 million shares at a combined public offering price of $11 per share and accompanying warrants.

The stock, which gained 10.07% to $15.41 in after-hours trading, was down 21.07% at $11.05 in Friday's premarket session.

Epizyme's Application For Tazverik Label Expansion Accepted For Priority Review

Epizyme Inc (NASDAQ: EPZM) said the FDA accepted for priority review its sNDA for Tazverik, or tazemetostat, for patients with relapsed or refractory follicular lymphoma who have received at least two prior lines of systemic therapy.

View more earnings on IBB

The PDUFA action date is fixed for June 18, 2020. The drug was approved by the FDA to treat epithelioid sarcoma earlier this year.

Medigus Signs Deal Valued Up To $9M To Supply Equipment To Latin America

Medigus ADR (NASDAQ: MDGS) announced the signing of a non-bounding MOU agreement with L-1 Systems for the licensing and sale of know-how and goods related to the Medigus Ultrasonic Surgical Endostapler system in the Latin American region. The contract is worth $4 million, with the potential for an additional $5 million for support services to be provided during the first year following the signing of a definitive agreement.

The stock was trading 9.58% higher to $1.83 in Friday's premarket session.

Assertio Completes Sale Of Collegium Pharma's Pain Franchise

Assertio Therapeutics Inc (NASDAQ: ASRT) said it has closed its previously disclosed deal to sell its Nucynta franchise of products to Collegium Pharmaceutical Inc (NASDAQ: COLL) for $375 million less royalties paid to Assertio in 2020.

Assertio shares were trading 4.44% higher to $1.41 at the time of publication Friday.

Eisai To Voluntarily Withdraw Weight Loss Drug Due To Cancer Risk

The FDA required Eisai Co., Ltd (OTC: ESALY), the manufacturer of Belviq and Belviq XR, to voluntarily withdraw the weight-loss drug from the U.S. market following a safety clinical trial revealing an increased occurrence of cancer. In response, the company said it has submitted a request to voluntarily withdraw the drug.

J&J's Crohn's Disease Drug Shows Efficacy In Late-stage Trial

Johnson & Johnson (NYSE: JNJ)'s Janssen unit announced interim data from the Phase 3b STARDUST study that is evaluating Stellara in moderately to severely active Crohn's disease, showing 79% of patients achieving clinical response at week 16, and 67% in clinical remission. Intestinal ultrasound responses were detected as early as week four, the company said.

The data was presented as digital oral presentations at the 15th Congress of the European Crohn's & Colitis Organization.

Roche's Tecentriq Approved In China For Small Cell Lung Cancer

Roche Holdings AG Basel (OTC: RHHBY) said the China National Medical Products Administration has approved its Tecentriq in combination with chemotherapy for the first-line treatment of patients with extensive-stage small cell lung cancer.

Earnings

DexCom, Inc. (NASDAQ: DXCM) reported fourth-quarter revenue of $462.8 million, up 37% year-over-year. The non-GAAP income per share climbed from 56 cents to $1.15, exceeding the 74-cent-per-share consensus estimate. The company guided to 2020 revenue of $1.725 billion to $1.775 billion, in line with the Street estimate.

The shares were trading 8.64% higher to $274 at in Friday's premarket session.

Aytu Bioscience Inc's (NASDAQ: AYTU) fiscal year second-quarter revenue climbed 77% to $3.2 million. The net loss per share narrowed from 72 cents to a penny. Analysts expected a loss of 24 cents per share on revenue of $2.74 million.

The stockwas jumpinh 13.17% to 86 cents in Friday's premarket session.

On The Radar Clinical Readouts

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) is due to present at the ECCO Congress Phase 2 open-label extension data for etrasimod in ulcerative colitis.

Adcom Meeting

FDA's Tobacco Products Scientific Advisory Committee is scheduled to meet to discuss the modified risk tobacco product applications submitted by 22nd Century Group Inc (NYSE: XXII) for VLN King and VLN Menthol King combusted, filtered cigarettes. The company is pitching the tobacco products as "very low nicotine content" cigarettes.

Earnings

ImmunoGen, Inc. (NASDAQ: IMGN) (before the market open)

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

See more from Benzinga

• The Daily Biotech Pulse: Deciphera Cancer Drug Gets Priority Review, Fast Track Designation For Soligenix, Revolution Medicines IPO

• The Daily Biotech Pulse: J&J Intensifies Efforts On COVID-19 Cure, Adamas Reports Positive, Long-Term Gocovri Data

• The Daily Biotech Pulse: LogicBio Slapped With Clinical Hold, Agile Inks Debt Deal Ahead of Twirla Approval, Gilead Builds Stake In Sierra Oncology

© 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.